Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vasculitis
Clinical narrative: SARS-COV-2 ANTIBODY TEST; SARS-COV-2 ANTIBODY TEST NEGATIVE; CYTOKINE INCREASED; INTERLEUKIN LEVEL INCREASED; MACROPHAGE INFLAMMATORY PROTEIN-1 ALPHA INCREASED; FEELING ABNORMAL; MUSCULAR WEAKNESS; FATIGUE; BALANCE DISORDER; NEURALGIA; CHEST PAIN; DYSPNOEA; BLOOD PRESSURE INCREASED; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAERS ID: 1762322) concerned a 72 year old female of unspecified race and ethnic origin.. The patient's height, and weight were not reported. The patient had no current illness and any history at the time of the vaccination. Patient had no history of covid-19. The patient was previously treated with Shingrix- varicella zoster vaccine rge (cho) for an unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry: unknown) dose was not reported, 1 total was administered on 14-MAR-2021 to left arm for unknown indication. No concomitant medications were reported.  On 22-MAR-2021, the patient started experiencing severe fatigue, brain fog, nerve pain (neuralgia), muscular weakness, chest pain, balance difficulty (balance disorder), shortness of breath (dyspnoea), feeling abnormal. Patient also had high blood pressure (reported as blood pressure increased) which took her into physician office and urgent care/emergency room. Patient underwent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test which came positive. On 04-APR-2021, (21 days after vaccination) patient underwent spike protein immunoglobulin G (IgG) test- (SARS-CoV-2 IgG antibody test) which was found to be positive. On 08-SEP-2021, the cytokine panel resulted in identified biomarkers of platelet activation and vascular inflammation with cytokine increased, macrophage inflammatory protein-1 alpha increased, elevated soluble cluster of differentiation (sCD) 40L, interleukin level increased- (elevated interleukins (IL)-4 and elevated interleukins (IL)-6), elevated vascular endothelial growth factor (VEGF), elevated CCL4 sCD40L at 61302 pg/mL with reference range less than 30000. On 27-SEP-2021, the patient underwent telemedicine appointment to review, and still 6 months out after vaccination patient was identified with level of platelet activation and identifiable vascular inflammation along with cytokine elevation was at toxic levels and dangerous. On 30-SEP-2021, the patient again underwent SARS-CoV-2 spike protein immunoglobulin G (IgG) test- (SARS-CoV-2 IgG antibody test) which came positive and also did nucleocapsid antibody test which came negative. It was reported that, these elevated markers were identified as also elevated in long haul cases according to peer-reviewed research and yet negative coronavirus disease-19 (COVID-19) tests, negative nucleocapsid antibody tests but still more than 6 months after vaccination evidence of spike proteins quantitative measure above 70 reference greater- than 0.8. Due to severity of cytokine panel results patient was advised by three doctors that not to take booster shot. Laboratory data (dates unspecified) included: Blood work confirmed with no underlying health conditions and consistent with medical records prior to injection. Patient was ruled out for risk factors including no genetic variants for increased risk in underlying health conditions and also no increased risk for blood clotting. It was reported that, on 14-OCT-2021, she would began treatment protocol for long haul with the same mechanism of injury seen in post-vaccine patients as well. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from balance disorder, blood pressure increased, chest pain, cytokine increased, dyspnoea, fatigue, feeling abnormal, interleukin level increased, macrophage inflammatory protein-1 alpha increased, muscular weakness, neuralgia, sars-cov-2 antibody test, sars-cov-2 antibody test negative, and sars-cov-2 test positive. This report was serious (Life Threatening). This case, from the same reporter was linked to 20210340967 and 20211035038. This report was associated with a product quality complaint: 90000198164. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 03-NOV-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result added.; Sender's Comments: V1: The additional information in this version is Product quality complaint investigation result. This doesnot alter causality of previously reported events.  20211032197-covid-19 vaccine ad26.cov2.s-balance disorder, blood pressure increased, chest pain, cytokine increased, dyspnoea, fatigue, feeling abnormal, interleukin level increased, macrophage inflammatory protein-1 alpha increased, muscular weakness, neuralgia, sars-cov-2 antibody test, sars-cov-2 antibody test negative, and sars-cov-2 test positive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).