Received Nov 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUCELVAX) | SEQIRUS, INC. | 1 | 409415 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Z004302 | IM / LA |
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | Z004302 | OT |
| PPV | PNEUMO (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Z004302 | OT |
cellulitis/whole arm from shoulder to elbow was warm to touch and red, swollen/a low grade mild fever/nausea/Rash developed after antibiotics, still experiencing some tenderness and achiness; fatigue; swollen lymph nodes; Product Lot Number Issue; This spontaneous report was received from a Consumer or other non health professional and refers to a 59-year-old female patient. The patient's concurrent conditions included penicillin Allergies. Concomitant therapies and Pertinent Medical History were none. On 10-Oct-2025, the patient started therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (0.5 mL, once, lot # reported as Z004302, expiration date reported as 04-Jul-2026) administered by Intramuscular route (anatomical location of administration was not reported) for prophylaxis. Batch/Lot number Z004302 is an invalid batch/lot number for Pneumococcal Vaccine, Polyvalent (23-valent), but a valid batch/lot number for Pneumococcal 21-valent Conjugate Vaccine for pneumococcal vaccine (Product Lot Number Issue) (0.5ml once, lot Z004302, upon internal validation expiration date was established as 04 Sep 2026) On 10-Oct-2025, within 12 hours after the vaccination, she experienced some side effects. Consumer said her whole arm from shoulder to elbow was warm to touch and red, swollen. The reporter also stated she had a low-grade mild fever, as well as fatigue and nausea that felt "intensified". The consumer was hospitalized overnight and diagnosed with cellulitis and swollen lymph nodes. Magnetic Resonance Imaging was performed with no results reported. From an unknown day in October 2025, the patient received antibiotics and oral antibiotics for ten days after discharge. Rash developed after antibiotics, still experiencing some tenderness and aches. At the reporting time, the patient was recovering from cellulitis, swollen lymph nodes and fatigue. The action taken with pneumococcal vaccine was not applicable. The causal relationship between all events and suspect pneumococcal vaccine was unknown.
Penicillin allergy