Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | LA |
Left a huge swollen hard area on my arm where the needle; Left a huge swollen hard area on my arm where the needle; body aches; chills; fever; sick; totally down for the next 24 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of RSV vaccine (left arm). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site swelling (Verbatim: Left a huge swollen hard area on my arm where the needle), injection site induration (Verbatim: Left a huge swollen hard area on my arm where the needle), general body pain (Verbatim: body aches), chills (Verbatim: chills), fever (Verbatim: fever), sickness (Verbatim: sick) and unwell (Verbatim: totally down for the next 24 hours). The outcome of the injection site swelling and injection site induration were resolved (duration 5 days) and the outcome of the general body pain, chills, fever, sickness and unwell were resolved (duration 24 hrs). It was unknown if the reporter considered the injection site swelling, injection site induration, general body pain, chills, fever, sickness and unwell to be related to RSV vaccine. It was unknown if the company considered the injection site swelling, injection site induration, general body pain, chills, fever, sickness and unwell to be related to RSV vaccine. Additional Information: K Receipt Date: 06-OCT-2025 The patient decided to get Respiratory Syncytial Virus shot this year. Six hours later, the patient became very sick, had chills, fever, body aches, and was completely down for the next 24 hours. A large, swollen, hard area developed on arm where the needle had gone in, and it lasted for the next five days. The patient stated he/she was so glad it was a one-time shot. The batch number was not provided, and we are unable to contact the reporter.