Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch."; arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch."; her right arm that received the Pneumonia shot in was hurting; arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch."; This spontaneous report was received from a Consumer or other non-health professional and referred to an 87-years-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included Congestive Heart Failure, and she had a pace maker. Concomitant medications included Metoprolol (Metoprolol fumarate), Losartan (Losartan potassium), Potassium (Potassium chloride), Furosemide (Furosemide sodium), Jardiance (Empagliflozin), Thyroidine (Thyroid), Simvastatinx (Simvastatin), Prolia (Denosumab). On 17-Sep-2025, the patient started therapy with an unspecified Pneumonia Vaccine (Manufacturer unknown) (strength, dose, dose number, frequency, vaccination scheme, and route were not reported), in her right arm, as prophylaxis. On the same date, the patient started therapy with Unspecified Flu Vaccine (strength, dose, dose number, frequency, vaccination scheme, and route were not reported), in her left arm, as prophylaxis. On 24-Sep-2025 ("seven days later"), the patient woke up and her right arm that received the Pneumonia shot in was hurting, she stated that arm had a round red spot, it was blotchy but not raised, it was itchy and "hot to touch." Patient then called the doctor's office on the same day to report and was only told it was a Pneumonia Vaccine from the company that she received in that arm, however she was not provided a brand name. The office advised this patient to take diphenhydramine (BENADRYL) and acetaminophen (TYLENOL), which she did not take. She was also advised to ice it and move her arm around, which she did do; the patient stated that within 24 to 48 hours, on an unknown date in September 2025, the arm was back to normal. At the reporting time, the outcome of the events was recovered. The reporter did not assess the causal relationship between the events and the suspect vaccines.; Reporter's Comments: Keywords : OCL
Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Congestive heart failure
Metoprolol; Losartan; Potassium; Furosemide; Jardiance; Thyroid; Simvastatin; Prolia