COVID-19 Vaccine Medical Conditions
While the mass roll-out of Covid-19 vaccines have saved millions of lives and restarted the global economy, they are not one hundred percent safe for everyone. A growing body of evidence suggests that some vaccines may have an adverse health impact on certain individuals.
Johnson and Johnson Vaccine and blood clots relationship
The Johnson and Johnson vaccine has been linked with a rare and dangerous form of blot clot known as cerebral venous sinus thrombosis or CVST, which develops in the brain’s venous sinuses. Outside of the Johnson and Johnson vaccine, this form of blood clots can be caused by dehydration, inherited disorders, and infections/ obstructions in the brain, however, these cases are extremely uncommon (3). The same vaccine recipients also developed thrombocytopenia, which is characterized by abnormally low platelets levels in their blood. This is unusual in someone with a major blood clot because platelets have the function of helping blood clot. The majority of the people who suffered from blood clots were women aged 18- 48, however, one man also experienced the same effect during clinical trials for the vaccine (3) (5). As of May 2021, there have been 28 suspected cases of blot clotting relating to the vaccine, three of whom have died.
The early symptoms of this rare blood clot are; severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, small red spots on the skin (petechiae), new or easy bruising (3). Symptoms are usually experienced between 4-30 days. Evaluation of the suspected blood clot should include complete blood count, peripheral smear, D-dimer, fibrinogen, coagulation panel, renal and liver function, and electrolytes, as well as PF4-heparin ELISA if available. Consultation with hematology is recommended if suspected or confirmed. Treatment may include intravenous immunoglobulin and anticoagulation while avoiding heparin-based agents and platelet transfusion (4).
There is a strong association between blot clots and the COVID-19 virus. Researchers have found that close to 20% of COVID-19 patients in the ICU develop blood clots (3). There are no known reports of blood clots and the Pfizer-BioNTech or Moderna Vaccine, however, there is a small number of reported serious blood clots for women vaccine recipients of the AstraZeneca vaccine, which is not authorized for use in the United States (3). The Johnson and Johnson vaccine was momentarily put on pause, while an evaluation of the risks was weighed. The FDA ended the pause on April 23, 2021, and added a warning label to the vaccine, ultimately deciding that the benefits of the vaccine outweigh the potential hazard (3).
Works Cited
“CDC Recommends Use of Johnson & Johnson's Janssen COVID-19 Vaccine Resume.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 6 May 2021, www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/JJUpdate.html.
Dawn Kopecki, Rich Mendez. “CDC Says 28 Blood Clot Cases, 3 Deaths May Be Linked to J&J Covid Vaccine.” CNBC, CNBC, 13 May 2021, www.cnbc.com/2021/05/12/cdc-says-28-blood-clot-cases-3-deaths-may-be-linked-to-jj-covid-vaccine.html.
Katella, Kathy. “The Johnson & Johnson Vaccine and Blood Clots: What You Need to Know.” Yale Medicine, Yale Medicine, 23 Apr. 2021, www.yalemedicine.org/news/coronavirus-vaccine-blood-clots.
Long, Brit et al. “Thrombosis with thrombocytopenia syndrome associated with COVID-19 vaccines.” The American journal of emergency medicine, vol. 49 58-61. 25 May. 2021, doi:10.1016/j.ajem.2021.05.054
Mahase E. Covid-19: US suspends Johnson and Johnson vaccine rollout over blood clots BMJ 2021; 373 :n970 doi:10.1136/bmj.n970
Links:
https://www.yalemedicine.org/news/coronavirus-vaccine-blood-clots
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8143907/
https://www.bmj.com/content/373/bmj.n970
Covid Vaccine and GBS
GBS is an acquired demyelinating polyneuropathy often beginning in the lower extremities and ascending over time with a loss of reflexes. Some cases start a few days or weeks after respiratory or gastrointestinal viral infection. Facial weakness is not unusual but is not as predominant compared with severe appendicular weakness and respiratory dysfunction (George). Early presentation of GBS is consistent with lower and/or upper extremity numbness, weakness, and tingling resulting in beginning of complete paralysis.
Vaccine-associated GBS has been supported by the medical literature and many reputable studies. In particular, the influenza vaccine (flu shot) has been confirmed to be causally related to GBS if the onset of the GBS began within 42 days of receiving the flu shot. Aside from the flu vaccine, there have been several reported cases of GBS related to the COVID-19 vaccine worldwide. Two reports detail cases of an unusual variant of GBS associated with the AstraZeneca adenovirus vector COVID-19 vaccine. Symptoms for these two individuals began between ten and twenty-two days later. The GBS which was experienced in these cases was characterized by a disproportionately frequent and severe bilateral facial paresis (3). Another paper details a case report of a woman who developed GBS ten days after receiving the Johnson & Johnson vaccine in a clinical trial in Boston. The Vaccine Adverse Event Reporting System (VAERS), used by people in the U.S. identified 279 (59 J&J, 97 Moderna, 121 Pfizer, 2 unknown) reports that explicitly specified GBS in the symptom field of the VAERS submission following COVID vaccination (3). In Kerala, India, seven cases of GBS were reported in a four-week period after receiving the AstraZeneca vaccine. These individuals were predominantly female, and symptoms occurred within two weeks of the first dose (5). Although there is no current association between GBS and the Covid-19 vaccine, scientists and researchers have indicated the need to closely examine the link between these two further.
More recently, however, the FDA released a new warning on the Johnson and Johnson vaccine and an association with GBS. As of July 13, 2021, 100 people have reported GBS or GBS-like symptoms to the VAERS database. Out of these 100 cases, 95 have been considered serious and required hospitalization (4). Evidence is still formulating on the causal link between GBS and COVID-19 vaccine, but this association warrants further investigation and immunologists and researchers have indicated the need to closely examine the link between these two further given the associations between other vaccines and the onset of GBS.
Works Cited
Allen, Christopher Martin, et al. “Guillain–Barré Syndrome Variant Occurring after SARS‐CoV‐2 Vaccination.” Wiley Online Library, John Wiley & Sons, Ltd, 2 July 2021, onlinelibrary.wiley.com/doi/10.1002/ana.26144.
“COVID-19 Vaccines and the GBS: CIDP Community.” GBS/CIDP Foundation International, 18 June 2021, www.gbs-cidp.org/covid-19-vaccines-and-the-gbscidp-community/.
George, Judy. “Unusual Variant of Guillain-Barré Syndrome Linked to COVID Vaccines.” Medical News, MedpageToday, 22 June 2021, www.medpagetoday.com/infectiousdisease/covid19vaccine/93227.
Lafraniere, Sharon, and Noah Weiland. “F.D.A. Attaches Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine.” The New York Times, The New York Times, 12 July 2021, www.nytimes.com/2021/07/12/us/politics/fda-warning-johnson-johnson-vaccine-nerve-syndrome.html.
Maramattom, Boby V., et al. “Guillain‐Barré Syndrome Following ChAdOx1‐S/NCoV‐19 Vaccine.” Wiley Online Library, John Wiley & Sons, Ltd, 22 June 2021, onlinelibrary.wiley.com/doi/10.1002/ana.26143.
Links
https://www.gbs-cidp.org/covid-19-vaccines-and-the-gbscidp-community/
https://www.medpagetoday.com/infectiousdisease/covid19vaccine/93227
https://onlinelibrary.wiley.com/doi/10.1002/ana.26144
https://onlinelibrary.wiley.com/doi/10.1002/ana.26143
Covid Vaccine and Immune Thrombocytopenia
There have been several reports of immune thrombocytopenia after exposure to Moderna, Pfizer–BioNTech, and AstraZeneca (not legal in the United States) vaccines. One report details a group of 39 individuals who reported a new syndrome of thrombosis and thrombocytopenia that developed 5 to 24 days after initial vaccination with the AstraZeneca vaccine. This group affected was largely women under 50 years of age.
For example, cases of immune thrombocytopenia and bleeding without thrombosis that were induced or revealed after exposure to the messenger RNA (mRNA)–based vaccines produced by Moderna (mRNA-1273) and Pfizer–BioNTech (BNT162b2) have been reported
The Journal has now highlighted three independent descriptions of 39 persons with a newly described syndrome characterized by thrombosis and thrombocytopenia that developed 5 to 24 days after initial vaccination with ChAdOx1 nCoV-19 (AstraZeneca), a recombinant chimpanzee adenoviral vector encoding the spike protein of SARS-CoV-2.3-5 T
hese persons were healthy or in medically stable condition, and very few were known to have had previous thrombosis or a preexisting prothrombotic condition. Most of the patients included in these reports were women younger than 50 years of age, some of whom were receiving estrogen-replacement therapy or oral contraceptives.
A remarkably high percentage of the patients had thromboses at unusual sites — specifically, cerebral venous sinus thrombosis or thrombosis in the portal, splanchnic, or hepatic veins. Other patients presented with deep venous thrombi, pulmonary emboli, or acute arterial thromboses. The median platelet counts at diagnosis were approximately 20,000 to 30,000 per cubic millimeter (range, approximately 10,000 to 110,000), but the rate of decline in platelet counts that preceded thrombosis is unknown. High levels of d-dimers and low levels of fibrinogen were common and suggest systemic activation of coagulation. Approximately 40% of the patients died, some from ischemic brain injury, superimposed hemorrhage, or both conditions, often after anticoagulation.
This constellation of thrombosis and thrombocytopenia prompted consideration of heparin-induced thrombocytopenia as the diagnosis. However, none of the patients had known exposure to heparin before the onset of illness.
Although the pathogenesis of this syndrome of vaccine-induced immune thrombotic thrombocytopenia (VITT) is not yet clear, certain findings were consistent across the three studies
. In almost every patient, high levels of antibodies to platelet factor 4 (PF4)–polyanion complexes were identified by enzyme-linked immunosorbent assay (ELISA), as well by assays based on platelet activation, which, when tested, was enhanced by addition of PF4.
In contrast to heparin-induced thrombocytopenia, however, binding of antibody to PF4 occurred in the absence of heparin.
This serologic pattern mirrors findings in patients with “atypical” or “autoimmune” heparin-induced thrombocytopenia, in whom thrombi develop in the absence of known previous exposure to heparin,6 but the distribution of thrombi in patients with that condition clearly differs from that in patients with VITT.
On the basis of these reports, the diagnosis of VITT should be confirmed with an approved PF4 ELISA. Reliance cannot be placed on the rapid assays that are often used to detect heparin-induced thrombocytopenia unless they have been validated to make or to rule out a diagnosis of VITT, given the potential differences in antigenic target or sensitivity.5
No thrombotic signal was detected in clinical trials leading to the approval of the ChAdOx1 nCoV-19 vaccine,9 which has now been administered to 34 million people worldwide. The incidence of VITT, as initially estimated, is perhaps 1 case per 100,000 exposures. This should be considered in the context of the incidence of cerebral venous sinus thrombosis in the general population (estimated at 0.22 to 1.57 cases per 100,000 per year).
The initial focus of these reports may reflect a propensity to study patients with severe thrombosis occurring in unusual locations, and a more complete picture of thrombotic complications is likely to emerge over time. More information on potential risk factors other than young age and female sex is needed. Also needed are data on the prevalence and titer of anti-PF4–related antibodies in all vaccine recipients, especially those who had thrombosis at sites other than those commonly reported to date among patients with VITT, in order to apply Bayesian analyses to estimate disease probability on the basis of both clinical features and antibody titer in optimized assays. This may be complicated to achieve, because many cases of thrombosis that occur after vaccination are unlikely to be directly provoked by this exposure. Better understanding of how the vaccine induces these platelet-activating antibodies might also provide insight into the duration of antigen exposure and the risk of reoccurrence of thrombosis, which will inform the need for extended anticoagulation and might lead to improvements in vaccine design.
Additional cases have now been reported to the European Medicines Agency, including at least 169 possible cases of cerebral venous sinus thrombosis and 53 possible cases of splanchnic vein thrombosis among 34 million recipients of the ChAdOx1 nCoV-19 vaccine, 35 possible cases of central nervous system thrombosis among 54 million recipients of the Pfizer–BioNTech mRNA vaccine, and 5 possible (but unvetted) cases of cerebral venous sinus thrombosis among 4 million recipients of the Moderna mRNA vaccine. Six possible cases of cerebral venous sinus thrombosis (with or without splanchnic vein thrombosis) have been reported among the more than 7 million recipients of the Johnson & Johnson/Janssen Ad26.COV2.S adenoviral vector vaccine. It must be emphasized that not all of these case reports have been subject to rigorous central review, nor have results of tests for anti-PF4 antibodies been reported; however, these numbers may be underestimates, since reporting is voluntary. Nevertheless, they clearly indicate the need for maintaining a high level of concern when patients present with central nervous system or abdominal symptoms after receiving any SARS-CoV-2 vaccine.
https://www.nejm.org/doi/full/10.1056/nejme2106315
Cases of apparent secondary immune thrombocytopenia (ITP) after SARS-CoV-2 vaccination with both the Pfizer and Moderna versions have been reported and reached public attention. Public alarm was heightened following the death of the first identified patient from an intracranial hemorrhage, which was reported on the Internet, then in USA Today1 and then in The New York Times.2 Described below, we have collected a series of cases of very low platelet counts occurring within 2 weeks of vaccination in order to enhance our understanding of the possible relationship, if any, between SARS-CoV-2 vaccination and development of ITP with implications for surveillance and management.
twenty case reports of patients with thrombocytopenia following vaccination, 17 without pre-existing thrombocytopenia and 14 with reported bleeding symptoms prior to hospitalization were identified upon review of data available from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), agencies of the U.S. Department of Health and Human Services (HHS) Vaccine Adverse Events Reporting System (VAERS), published reports,3, 4 and via direct communication with patients and treating providers. These cases were investigated as suspicious for new onset, post-vaccination secondary ITP; we could not exclude exacerbation of clinically undetected ITP.
The reports describing 19 of 20 patients included age (range 22–73 years old; median 41 years) and gender (11 females and 8 males). Nine received the Pfizer vaccine and 11 received the Moderna vaccine. All 20 patients were hospitalized and most patients presented with petechiae, bruising or mucosal bleeding (gingival, vaginal, epistaxis) with onset of symptoms between 1–23 days (median 5 days) post vaccination. Platelet counts at presentation were available for all 20 cases with the majority being at or below 10 × 109/L (range 1–36 × 109/L; median 2 × 109/L).
Thus, the incidence of an immune-mediated thrombocytopenia post SARS-CoV-2 vaccination appears either less than or roughly comparable to what would be seen if the cases were coincidental following vaccination, perhaps enhanced somewhat by heightened surveillance of symptomatic patients. These estimates are very rough so this information should be considered very preliminary. It also assumes that all cases of clinically significant ITP are reported.
The incidence of secondary ITP following other types of vaccines provides an inconsistent picture. It is estimated that approximately 1:40 000 children develop secondary ITP after receiving measles-mumps-rubella (MMR) vaccine.7 Well-documented cases of acquired immune thrombocytopenia have been reported after varicella and other vaccinations as well, including one described in this issue of the American Journal of Hematology following Shingrix recombinant Zoster vaccine.
The reported cases also provide insight into diagnosis and treatment. Most of the patients responded to treatment with corticosteroids and IVIG but showed little benefit from platelet transfusion, a pattern consistent with that of ITP. There was no response in the two patients treated with rituximab but they were only evaluable for up to 2 weeks; in addition, rituximab would impair the response to vaccination, if given within days to 2 weeks of the vaccination and for at least 4-6 months subsequently.
In summary, we cannot exclude the possibility that the Pfizer and Moderna vaccines have the potential to trigger de novo ITP (including clinically undiagnosed cases), albeit very rarely. Distinguishing vaccine-induced ITP from coincidental ITP presenting soon after vaccination is impossible at this time. Additional surveillance is needed to determine the true incidence of thrombocytopenia post vaccination. If the incidence of thrombocytopenia post vaccination is higher than that based on available case reports, we anticipate that many more cases will be reported in the coming weeks as a higher proportion of the population is vaccinated. It may be worthwhile to see whether exacerbations of other conditions considered to have an autoimmune pathophysiology occur as well to gain a better understanding of host response to vaccination.
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