Johnson & Johnson

STOMACH WAS BOTHERING - THINKING GETTING PERIOD; HEADACHE; SORE ARM AT INJECTION SITE; ADOLESCENT RECEIVED THE JANSSEN COVID 19 VACCINE; OFF LABEL USE; This spontaneous report received from a parent concerned a 14 year old female. The patient's weight was 150 pounds, and height was 170.18 centimeters. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced adolescent received the janssen covid 19 vaccine. On 16-MAY-2021, the subject experienced off label use. On 16-MAY-2021, the subject experienced headache. On 16-MAY-2021, the subject experienced sore arm at injection site. On 17-MAY-2021, the subject experienced stomach was bothering - thinking getting period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of adolescent received the janssen covid 19 vaccine, off label use, stomach was bothering - thinking getting period and sore arm at injection site was not reported. This report was non-serious.

patient presented to Covid vaccination clinic for scheduled second dose of Pfizer. Inadvertently patient received 0.3ml of Janssen vaccine instead of 0.3 ml of Pfizer vaccine. As of 6/23 patient has had fatigue and headache since vaccination. Also has felt warm.