Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Insomnia, Pain, Pain in extremity, Rash macular
Clinical narrative: COVID-19; RASH ON BOTH LEGS AND ARMS/RED BLOTCHES RASH; COULD NOT SLEEP; BODY ACHES; PAINS IN ARMS AND LEGS; This spontaneous report received from a patient concerned a 68-year-old female. Initial information was processed along with the additional information received on 30-MAR-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received with covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: unknown) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: unknown) dose was not reported, 1 total, administered on 30-NOV-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 30-NOV-2021 (night the patient received the booster), patient had pain in arms and legs the and she could not sleep and had body aches (dose number in series 2). The patient developed red blotches rash within 2 days (02-DEC-2021) of her booster vaccination (dose number in series 2). As the days went by, within 7 days, it was bad enough that patient went to see a doctor on 07-DEC-2021. Patient saw the doctor and the doctor said that this was not a reaction to the shot and she gave her hydrocortisone cream and loratadine (Claritin) once a day. On 14-DEC-2021, patient again saw another doctor and the doctor said that she did not think it was related to the booster shot and recommended for her to see the dermatologist. In less than a week time, 20-DEC- 2021, patient saw the dermatologist and told the dermatologist that she felt that she got it because of the vaccine but the dermatologist mentioned hearing about loss of hair but not that rash. Patient reported that, exactly a month later she got Covid-19 on 30-DEC-2021 but it did not kill her as per caller (dose number in series 2). Patient tested positive with rapid test and also with polymerase chain reaction (PCR) on 30-DEC-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both legs and arms/red blotches rash, and the outcome of could not sleep, body aches, pains in arms and legs and covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000223840. The suspected product quality complaint has been confirmed to be voided. A product quality complaint was reported for the booster only so PQMS 90000223840 was updated to document the investigation for booster dose 30-NOV-2021 (lot number 1855191). Product quality complaint 90000223841 would be voided as a duplicate based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220362290, 20220363110, 20220362527 and 20220362219.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.