Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count abnormal, Headache, Heart rate, Heart rate increased
Clinical narrative: NEUROPATHY PERIPHERAL; SARS-COV-2 ANTIBODY TEST NEGATIVE; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; SARS-COV2 TEST NEGATIVE; CONDITION AGGRAVATED; BLOOD PRESSURE INCREASED; HEART RATE INCREASED; BLOOD TEST ABNORMAL; BLOOD THYROID STIMULATING HORMONE ABNORMAL; METABOLIC FUNCTION TEST ABNORMAL; VENOGRAM NORMAL; PAIN; FULL BLOOD COUNT ABNORMAL; EPISTAXIS; PARAESTHESIA; PLATELET DISORDER; VISION BLURRED; MIGRAINE; CHILLS; FATIGUE; HEADACHE; MYALGIA; ASTHENIA; NAUSEA; This spontaneous report received from a patient via a Regulatory Authority concerned a 37 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included asthma, interstitial lung disease, keratoconjunctivitis, traumatic brain injury, gastric bypass recipient, and premature birth survivor, and concurrent conditions included narcolepsy, atypical emphysema, rheumatoid arthritis, chronic migraine with aura, type II diabetes, irritable bowel syndrome (possibly inflammatory bowel), obsessive-compulsive disorder, attention deficit hyperactivity disorder, chronic sinus issues, chronic skin issues, Stevens-Johnson Syndrome, and polyethylene glycol allergy. The patient was previously treated with influenza vaccine; and experienced drug allergy when treated with citalopram hydrobromide, pertussis vaccine, fluoxetine hydrochloride, infliximab, and ziprasidone. The patient was on antacid (with calcium, magnesium, and zinc). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and expiry: Unknown) dose was not reported, frequency 1 total, administered on 09-APR-2021 for prophylactic vaccination on left arm. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, ascorbic acid/bioflavonoids nos/biotin/calcium pantothenate/choline bitartrate/cyanocobalamin/folic acid/glutamic acid/inositol/methyl hesperidin/nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine hydrochloride/tocopheryl acetate, caffeine, ergocalciferol, levocetirizine dihydrochloride, methylphenidate hydrochloride, omeprazole, riboflavin, simeticone, topiramate, and tramadol. Post vaccination, within a couple of days, the patient started having chills, fatigue, nausea, muscle and body aches, and headaches. It got continually worse, and the patient eventually developed a migraine, blurred vision, tingling, severe nose bleeds, weakness (like peripheral neuropathy). The symptoms all got worse and worse, and eventually, the patient went to the neurologist. They did a CT venogram, the results were normal. The blood pressure (BP) was elevated, and they noted that the patient had a really high heart rate. The blood work had abnormalities on the CBC and metabolic panels. The patient was sent back to her primary care physician (PCP) and found abnormal results in her blood work. Plus, the physician found abnormalities in the test for thyroid stimulating hormone. The patient still had elevated BP. A Polymerase Chain Reaction (PCR) Covid-19 test was done, and the patient tested negative. They also tested for antibodies to see if the patient was responding to the vaccine and no antibodies were detected. They said it was weird and that the patient probably had lingering vaccine side effects that would go away, and in case the Covid-19 test was wrong, the patient was advised to self-isolate. They planned to conduct further thyroid tests and blood work in the future to see if there were any changes. The patient was still having all the symptoms, and on 7/13/2021, developed symptoms that were consistent either kidney stones or kidney infection. The patient planned to see her doctor to have this looked into. Laboratory data included: Thyroid stimulating hormone (NR: not provided) Abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from asthenia, blood pressure increased, chills, condition aggravated, epistaxis, fatigue, headache, heart rate increased, migraine, myalgia, nausea, neuropathy peripheral, pain, paraesthesia, platelet disorder, sars-cov-2 antibody test negative, suspected immunological vaccine failure, vision blurred, blood test abnormal, blood thyroid stimulating hormone abnormal, full blood count abnormal, metabolic function test abnormal, venogram normal, and sars-cov2 test negative. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000187432 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 was received from central complaint vigilance department on 01-Sep-2021. The following information was updated and incorporated into the case narrative: Product quality complaint Investigation result.; Sender's Comments: V2: Follow up information updated in this version includes Product quality complaint investigation result. This information doesn't alter prior causality of previously reported event. 20210751102- Covid-19 vaccine ad26.cov2.s- Neuropathy peripheral. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210751102-covid-19 vaccine ad26.cov2.s-SARS-cov2 antibody test negative. These events are considered unassessable. The events 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 events. 20210751102-covid-19 vaccine ad26.cov2.s-Suspected immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS