Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood test, Injection site pain, Presyncope, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; ALMOST PASSED OUT; SEVERE INJECTION SITE PAIN; This spontaneous report received from a patient (retired Medical Assistant) concerned 8 decades (early 70s) female of an unspecified race and ethnicity. Initial information was processed along with the additional information received from department on 02-JUN-2022.  The patient's weight was around 86.5-88lbs (pounds) and height was not reported. The patient's pre-existing medical conditions included: The patient was A positive. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported and expiry: unknown) does not reported, 1 total administered on unspecified date for prophylactic vaccination. The batch number was not reported. Per Procedure, no follow up will be requested for this case. No concomitant medications were reported. The patient reported when she had the first shot, she had some issues because of how it was administered. She stated that she, believes that the angle of the injection or something was wrong. Stated, when the needle went in to her arm, it was so painful that she almost passed out (Dose number in series 1). The patient reported that, vaccine administrator said that the pain was due to vaccine. The patient asked her physician for an antibody test after she got her first shot and she had 0 covid antibodies (suspected immunological vaccine failure) (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe injection site pain, almost passed out and suspected immunological vaccine failure was not reported. The patient additionally received booster dose covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported and expiry: unknown) dose not reported, 1 total administered at end of NOV-2021 for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s vaccine (dose number in series 2).  The patient had no pain during second vaccine. Stated she recently had a blood draw (after booster) and she had antibodies. The patient also mentioned she was surprised to see that her husband's and her laboratory values were exactly the same for covid-19 antibodies (8.9), even though her husband got all Moderna. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and severe injection site pain and suspected immunological vaccine failure as not related.  Company causality between covid-19 vaccine ad26.cov2.s and suspected immunological vaccine failure was not related. Company causality between covid-19 vaccine ad26.cov2.s and severe injection site pain was related. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000233703. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the product quality complaint evaluation/investigation performed.; Sender's Comments: V0-20220601295-COVID-19 VACCINE Ad26.COV2.S-Suspected immunological vaccine failure The event(s) has a unknown/unclear 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