Age: 53.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Anaphylactic shock, Injection related reaction, Injection site erythema, Injection site pain, Pain
Clinical narrative: INJECTION RELATED REACTION; WEARING OFF EFFECT; INJECTION SITE REDNESS; INJECTION SITE BURNING; ANAPHYLACTIC SHOCK; PAIN; This spontaneous report received from a patient concerned a 53 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient felt pain a few days before next injection was due. She was going on this way for years. She loved it, and did not want to stop because of this. She had injections burn but insurance, did not want to allow citrate free version. She gets a red spot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown expire: unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (solution for injection, subcutaneous, batch number: 1136781 and expire: Unknown) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. Non-company suspect vaccine included: influenza vaccines (form of admin, route of admin, and batch number: Unknown expire: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unknown dates, the patient experienced reaction to flu injection, feels pain a few days before next injection was due and burning on injection/gets a red spot. On an unspecified date in 2021, the patient experienced pain. On an unspecified date in Mar-2021, the patient experienced anaphylactic shock from covid vaccine. On an unspecified date in 2021, the anaphylactic shock from covid vaccine and pain resolved. COVID-19 VACCINE was also considered suspect. Epinephrine was given and cleared up within a few minutes. She got a reaction to flu injections too. She did not take Humira for 56 days while getting the covid vaccine. Physician said to take a break as long as possible. She went as long as she could, but she was having a lot of pain. The patient was taken Flu injection as a co-suspect drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic shock on an unspecified date in 2021, had not recovered from pain, wearing off effect, and injection site burning, and the outcome of injection related reaction and injection site redness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210661838-covid-19 vaccine ad26.cov2.s -Anaphylactic shock, Pain, Wearing off effect, Injection related reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).20210661838-covid-19 vaccine ad26.cov2.s -injection site burning ,injection site redness. This event(s) is labeled per other facility and is therefore considered potentially related.