Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Swelling armpit; Flu-like symptoms; Muscle aches; increase in blood pressure; increase in heart rate; This non-serious case was reported by a consumer and described the occurrence of local swelling in a 51-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Concurrent medical conditions included lumbar pain, spondylolisthesis, migraine and esophageal acid reflux. Concomitant products included tizanidine hydrochloride, oxycodone;paracetamol, paracetamol (Tylenol), acetylsalicylic acid;magnesium oxide (Migralex) and omeprazole (Omeprazol). On 04-SEP-2025, the patient received RSV vaccine. In SEP-2025, less than a week after receiving RSV vaccine, the patient experienced local swelling (Verbatim: Swelling armpit), influenza-like symptoms (Verbatim: Flu-like symptoms), muscle pain (Verbatim: Muscle aches), increased blood pressure (Verbatim: increase in blood pressure) and heart rate increased (Verbatim: increase in heart rate). The outcome of the local swelling was not resolved and the outcome of the influenza-like symptoms, muscle pain, increased blood pressure and heart rate increased were not reported. It was unknown if the reporter considered the local swelling, influenza-like symptoms, muscle pain, increased blood pressure and heart rate increased to be related to RSV vaccine. It was unknown if the company considered the local swelling, influenza-like symptoms, muscle pain, increased blood pressure and heart rate increased to be related to RSV vaccine. Additional Information: GSK Receipt Date: 06-SEP-2025 The patient self-reported this case for herself. The patient reported she experienced increase in blood pressure and heart rate, severe muscle aches and flu-like symptoms. Also, she did not notice the swelling in her armpit until 2 days after the vaccination. The symptoms were not treated. The batch number was not provided and a request for this information had been made.
Esophageal acid reflux; Lumbar pain; Migraine; Spondylolisthesis
TIZANIDINE HYDROCHLORIDE; OXYCODONE;PARACETAMOL; TYLENOL; MIGRALEX; OMEPRAZOL
Test Date: 202509; Test Name: Blood pressure; Result Unstructured Data: (Test Result:increased,Unit:unknown,Normal Low:,Normal High:); Test Date: 202509; Test Name: Heart rate; Result Unstructured Data: (Test Result:increased,Unit:unknown,Normal Low:,Normal High:)