Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Injection site hypersensitivity, Injection site pain, Joint swelling
Clinical narrative: This spontaneous report received from a patient concerned a 62 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis (Non-infectious intermediate, posterior and Panuveitis). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, first dose (1 in 1 once) administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 62 years old. No concomitant medications were reported. The patient received non-company suspect drugs adalimumab (Humira) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported, Citrate free, administered for ankylosing spondylitis non-infectious intermediate, posterior and Panuveitis. On an unspecified date, the patient experienced seven blood clots in leg (thrombosis leg), flare up from stress, swelling in knee joints, condition aggravated, sensitivity after injection in stomach (Injection site hypersensitivity), knee pain, and injection site burns/stings and had an area of pain (Injection site pain). On JAN-2022 (date unspecified), the patient experienced Covid-19 which was coded as suspected Covid-19 infection and suspected clinical vaccination failure. On 09-JUN-2022, Laboratory data included: Magnetic resonance imaging result was unknown. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from suspected Covid-19 infection on 2022 (date unspecified), was recovering from seven blood clots in leg, condition aggravated, and sensitivity after injection in stomach, had not recovered from injection site burns/stings and had an area of pain, and knee pain, and the outcome of flare up from stress, swelling in knee joints and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested. Sender's Comments: V0: 20220639689- COVID-19 VACCINE AD26.COV2.S- SEVEN BLOOD CLOTS IN LEG. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220639689-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.