Johnson & Johnson

Pt received vaccine on 03/17/2021. Pt's wife stated that pt never felt well after receiving the vaccine. Per hospital notes, pt lost his balance and fell at home approximately 12 hours prior to admission. By report, he laid on the floor for around 12 hours before emergency services were activated and he was brought to the ED. Primary diagnosis was a closed left hip fracture with other hospital problems of the fall at home, bradycardia, coronary artery disease, hypokalemia, protein calorie malnutrition, type 2 myocardial infarction and essential hypertension.

Janssen COVID-19 Vaccine EUA The vaccine was administered Friday 12th at 1:30 pm Saturday morning, the13th - there was loss of appetite Saturday 5:00 pm - fever of 102.0 was recorded. Administered 2 Tylenol and fever reduced slowly over the next 5-6 hours. Sunday 14th - no apparent symptoms

PNEUMONIA; INJECTION SITE ITCHINESS; RASH AT INJECTION SITE; This spontaneous report received from a consumer concerned a 97 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on 07-APR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient developed an itchy rash at the site of the vaccine, 5 days after receiving the vaccine. Her husband did not said anything and it had started to dry up. Consumer said her husband picked up pneumonia about 3 weeks after the vaccine on 27-APR-2021 and was hospitalized. He was on antibiotics for a long time. might be 2 weeks or more. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pneumonia, injection site itchiness, and rash at injection site. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 - 20210557955-covid-19 vaccine ad26.cov2.s-Pneumonia. This event(s) is considered unassessable. The event(s) 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 event(s).