Received Mar 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y013009 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT |
sleep and got rid of her arthritis pain; Patient stated that the itching is intense and has sores all over from the scratching/in turn jacks up pain level.; waves of chills; Patient stated that the itching has been interfering with her sleep; intense full body itching. patient stated that the only place that it doesn't itch is the center of her face, soles of the feet and the "area that would be covered by a bikini bottom; This spontaneous report was received from a consumer and refers to an 81-year-old female patient. The patient's medical history was not provided. The patient's concurrent conditions included breast cancer (reoccurred for the 4th time), stage 3B renal disease, Hashimoto's thyroiditis, allergy to a lot of antibiotics, and bad reactions to many medications. Historical drugs included Antibiotics. Concomitant therapies were not reported. Patient stated that she changed her protocol on blood pressure medication the day before the vaccination since per advice of her nephrologist, the new protocol was stopped, and she went back to the original protocol. On 10-Feb-2025 at 06:00 pm, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (strength, formulation, dose, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as prophylaxis. On unspecified date in 2025, the patient had suddenly experienced intense full body itching (Pruritus). The only place that it did not itch was the center of her face, soles of the feet and the area that would be covered by a bikini bottom. It was stated that the itching was intense and has sores all over from the scratching (Pain). She had to use the rough side of a hand towel to scratch. In addition, the patient had waves of chills, but the chills had subsided over the weeks (Chills). The patient had tried fexofenadine (ALLEGRA), diphenhydramine (BENADRYL), hydrocortisone cream 1%, and triamcinolone (KENALOG). The patient stated that the itching during the day, it sometimes itches but at night it gets much worse. Patient stated that around bedtime and all night long the itching is intense and covers all night. She was prescribed a methylprednisolone (MEDROL pack) and was the first relief that she got and it was not 100%. Therefore, she got better sleep (sleep disorder: recovering) and got rid of her arthritis pain (Arthralgia: recovered). Patient stated that nothing has changed with her itching and chills (not recovered). Patient stated that she will have breast cancer surgery. Patient reported that she had bad lives with chronic pain and unable to mitigate the pain. She stated that the itching had been interfering with her sleep and the level of pain increased. The Patient stated that the pain might emanate from pinch nerves, nerves in the spine. At the reporting time, the patient had not recovered from pruritus, pain, and chills. The causal relationship between the events with pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was considered as related. Lot # is being requested and will be submitted if received.
Adverse reaction to product; Allergy to antibiotic; Breast cancer (It has reoccurred for the 4th time); Hashimoto's thyroiditis; Renal disease