Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
having body aches/ she couldn't do anything due to the pain of the body aches; Patient woke the next day with her arm very sore; Patient experiencing chills to the point that her lips were chattering; Patient indicated that the liquid "hurt when going in; Size of the welt on her arm is 4 "long and 3.5"/ the injection spot is still raised, red and grew since yesterday; This spontaneous report has been received from a patient of 59-years-old referring to herself. Patient's concomitant medications included "a statin" and multi vitamins. There was no information about medical history or previous drug allergies. On 10-FEB-2025 at 3:00pm, patient was vaccinated as recommended by her HCP with a dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) formulation as default as solution for injection (strength, exact dose, anatomical route of administration, lot # and expiration date was not reported). Patient indicated that the liquid "hurt when going in" (injection site pain). Patient woke the next day (on 11-FEB-2025) with her arm very sore (pain in extremity). She went to work but started experiencing chills to the point that her lips were chattering (chills) and was having body aches (pain), so she decided to go home. By 12-FEB-2025 she "could not do anything" due to the pain of the body aches and chills so she didn't go to work. Patient stated that as of today the chills are gone, but the size of the welt on her arm is 4" long and 3.5" (vaccination site urticaria) wide and she is still experiencing body aches. The injection spot is still raised, still red, and grew since yesterday (12-FEB-2025). Patient had not contacted her HCP because when reading the PI she saw that 1% of people have side effects. She felt she fell in that 1%. Patient felt it was irrelevant to supply HCP contact information but did authorize contact with her. The outcome of the event vaccination site pain and urticaria was considered as not recovered, while for the event pain and injection site pain was unknown. On an unspecified date in February 2025, the patient was recovered from the event chills. The causal relationship between aforementioned adverse events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not reported. Lot number is being requested and will be submitted if received.