Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: BRAIN FOG; PAIN AT THE INJECTION SITE; SWELLING UNDER LEFT ARMPIT; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer Inc.) concerned a 65 year old male of an unspecified race and ethnicity. The patient's weight was 90.72 kilograms (vacillates, about 200 or less pounds at the time of reporting), and height was 173 centimeters. The patient's concurrent conditions included: arthritis, penicillin allergy, sulfa based medicines allergy, and horse serum allergy which was diagnosed a long time ago. The patient experienced skin irritation when injected with iodine for some testing (at the age of 20 years). The patient had not experienced anaphylaxis or breathing difficulty. On 06-APR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) 0.5 ml, 1 total administered to left arm for prophylactic vaccination. The age at time of vaccination was 65 years old. On an unspecified date, the patient had experienced pain at the injection site (dose number in series: 1). On 18-DEC-2021 or 19-DEC-2021, the patient contracted covid-19 virus (dose number in series: 1). On an unspecified date in DEC-2021, the patient took a covid-19 virus rapid test which showed that he had covid and experienced symptoms such as body aches, pains, chills and fever, that lasted on and off for about a month (coded as suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series: 1). The patient had taken another covid-19 virus rapid test prior to New Year's which showed negative result. The patient had recovered from flu like symptoms but sense of smell had not returned. On an unspecified date, the patient had also experienced brain fog which the patient had wondered could be a result of his age or covid (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection and brain fog, and the outcome of suspected clinical vaccination failure and pain at the injection site was not reported. On 07-APR-2022 10:00, the patient received non-company suspect vaccine tozinameran (Pfizer covid vaccine) (dose number in series: 2) (form of admin and route of admin were not reported, batch number: FM0698 expiry: UNKNOWN) dose was not reported, administered to left arm for prophylactic vaccination. The patient was not administered with any other vaccine on the same day or prior four weeks. Concomitant medications included naproxen sodium (Aleve) for arthritis, ascorbic acid (Vitamin C), and cyanocobalamin (Vitamin B12).  On 10-APR-2022 around 07:00 to 07:30, the patient while taking a shower had noticed his left armpit feeling off and found through mirror that the lymph node area was swollen the size of right hand (dose number in series: 2). On the morning of 12-APR-2022, the area was still swollen and had not seemed to be lessening. The patient had not visited the physician office or emergency room. The patient had informed the pharmacist. The pharmacist mentioned that it might be a result of a full blown infection of covid that he had and the booster vaccine might have exacerbated. The patient thinks that he had omicron variant covid-19 infection. The patient further stated that he had not noticed any increase in arthritis symptoms after the vaccine. On an unspecified date, the patient experienced pain at the injection site, which was a little more significant when he rolled over at sleep at night and was more painful when compared to the initial dose (dose number in series: 2). The patient had not undergone any tests. The action taken with tozinameran was not applicable. The patient had not recovered from swelling under left armpit and the outcome of pain at the injection site was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000227476.; Sender's Comments: V0:20220441557-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.