Report #2858237

Overview

Sex

Female

Age

Age unknown

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (3)

Symptom narrative

My arm is just hurting a lot; Shoulder level where they put the vaccine it hurts; I can hardly move my arm; she couldn't sleep; Fatigue; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 62-year-old female patient (unknown if pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 2 ,single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "My arm is just hurting a lot; Shoulder level where they put the vaccine it hurts; I can hardly move my arm"; INSOMNIA (non-serious), outcome "unknown", described as "she couldn't sleep"; FATIGUE (non-serious), outcome "unknown". Additional information: The caller reported that she had received the new COVID vaccine the previous day and experienced severe pain at the injection site, rated 9 out of 10 on a pain scale. She stated that she had not experienced side effects with prior vaccinations, except for mild shoulder pain after the first and second doses, which resolved on its own. Following the current vaccination, she reported difficulty sleeping due to shoulder pain and consequently felt tired. The patient was 62 years old. In response, information was provided from the attached document and prescribing information, adverse events section 6.1, table 3, which noted that in participants 56 years of age and older after receiving dose 2, the mean duration of pain at the injection site was 2.4 days, with a range of 1 to 36 days. She was referred to her healthcare provider for treatment recommendations and advised to seek medical attention if the pain persisted.The consumer stated that she had received the COVID booster, specifically the Pfizer COVID booster, the previous day. She reported that although she had received all prior immunizations without issues, this time her arm hurt a lot. She questioned whether this particular vaccine strain was stronger than the others, as she could hardly move her arm. She added that she had been applying ice to the site but was uncertain if this reaction was normal or if it would resolve soon.When paraphrased, the consumer stated that her right arm at shoulder level, where the vaccine had been administered, hurt. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500177423 same patient, different doses/events;US-PFIZER INC-202500176839 same patient, different vaccine doses/events;