Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
extreme fatigue, stayed in the bed and got up to go to the bathroom; diarrhea; real horrible headache, very dizzy, full blown vertigo, then spiked a low grade fever Tuesday, diarrhea, and then nausea and vomiting; local reaction red and hot to touch, bigger than 2 half a dollars put together, and it got hard, not uncommon for me when I get vaccines; Arm is still red and bruised; Arm is still red and bruised; This spontaneous report was received from a Nurse and refers to a(n) 78-year-old female patient. The patient's medical history included history of gout and anaphylactic reaction to penicillin in 2012. The patient's concurrent conditions included irritable bowel syndrome (IBS), cirrhosis, seasonal asthma, drug hypersensitivity, and allergy to yellow dye in food and any medication. Historical drugs included penicillin. Concomitant medications included metoprolol, potassium chloride, omeprazole (PRILOSEC), acetylsalicylic acid (BABY ASPIRIN), alopurinol, amlodipine and colesevelam. Historical vaccines included pneumococcal vaccine conj 7v (CRM197) (PREVNAR). The patient had second shot of shingles with symptoms. On 07-Jul-2025, the patient was vaccinated with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered intramuscularly (dose, vaccination site, lot # and expiration date were not reported) to prevent pneumococcal pneumonia. On 07-Jul-2025, the patient got sick. On that day (Monday evening), the patient developed a real horrible headache, she was very dizzy, had full blown vertigo (vertigo). On 08-JUL-2025 (Tuesday), the patient spiked a low grade fever, experienced diarrhea, and then nausea and vomiting, extreme fatigue (diarrhoea; fatigue). She stayed in the bed and got up to go to the bathroom and was so nauseated and had a lot of over the counter medicine due to history of stomach issues that she was able to manage. On an unspecified date in July 2025, she had a local reaction which was red and hot to touch, bigger than 2 half a dollars put together, and it got hard (Skin reaction; Erythema). This was not uncommon for her when she get vaccines. The problem was how sick she got. On 12-Jul-2025 (Saturday), the patient got better and came alive. Her headache got better. On 13-Jul-2025 (yesterday), she felt pretty decent and there was no temperature today. The patient was concerned if there was something with her health that contraindicated. The physician was informed and their take was as followed: "the nurse (the patient) said it sounds like maybe she had contracted a virus and or part vaccine reaction and a virus." Additionally, the patient reported the following: "I do have cirrhosis and never had abnormal blood work, never had jaundice or hepatitis, I am 78 years old, second shot of shingles had symptoms but nothing was like this. I am a retired LPN and I am in tune medically, is that a vaccine that needs to be massaged into the muscle, the injector massaged the site after injection, red streaks and bruising and looked like it was going to abscess, she massaged for a while and hard at the physician's. I had normal blood work and no symptoms prior to the shot." Her arm was still red and bruised (contusion). The nurse also asked about contraindications and any other information and was concerned if her history of anaphylaxis to penicillin or her medications interacted, and informed there was no information from the database as she was a retired nurse but wanted to ask her physician for more information. No additional adverse event (AE) and no product quality complaint (PQC) was noted. At the reporting time, the patient was recovering from the reported adverse events with the exception of skin reaction, erythema and contusion, as her arm was still red and bruised. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not applicable. The causal relationship between the reported adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot # is being requested and will be submitted if received. This is one of two cases received from the same reporter and referring to the same patient.
Allergy; Cirrhosis liver; Irritable bowel syndrome; Penicillin allergy; Seasonal asthma
Medical History/Concurrent Conditions: Anaphylactic reaction; Gout
METROPOLOL; POTASSIUM CHLORIDE; PRILOSEC; BABY ASPIRIN 81 MG; ALOPURINOL; AMLODIPINE; VIT D; colesevelam