Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MA2506 | — |
Alpha gal allergy; Flu like symptoms; Chills; Cold; Diarrhea; Fever; This is a spontaneous report received from a Pharmacist from medical information team. A 58-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Nov2025 as dose number unknown, single (Lot number: MA2506, Expiration Date: 01Oct2026) at the age of 58 years for pneumococcal immunisation, Device Lot Number: MA2506, Device Expiration Date: 01Oct2026. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE; ROSUVASTATIN. The following information was reported: FOOD ALLERGY (non-serious) with onset Nov2025, outcome "unknown", described as "Alpha gal allergy"; CHILLS (non-serious) with onset Nov2025, outcome "unknown"; NASOPHARYNGITIS (non-serious) with onset Nov2025, outcome "unknown", described as "Cold"; DIARRHOEA (non-serious) with onset Nov2025, outcome "unknown", described as "Diarrhea"; PYREXIA (non-serious) with onset Nov2025, outcome "unknown", described as "Fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset Nov2025, outcome "unknown", described as "Flu like symptoms". Additional information: Caller asks if Prevnar 20 vaccine has any animal products or gelatin in the product. Her patient has alpha gal. Pharmacist stated, the patient was saying she had a bad reaction and felt it was more related to alpha gal allergy then flu like symptoms. Pharmacist stated, it sounds like it was cleared up. It started about 8 hours later and was fine now, it was intense for a few hours. Does Prevnar 20 contain animal products. Response: Animal-derived ingredients from avian, bovine, ovine, and caprine are used during the manufacturing process of PREVNAR 20 (pneumococcal 20-valent conjugate) vaccine. There are several stages of purification after these are introduced to the manufacturing process, only residual/trace amounts of animal-derived ingredients could potentially be present in the final product for PREVNAR 20 (pneumococcal 20-valent conjugate) vaccine. Animal-derived ingredients from tallow derivatives (bovine and porcine) in some product contact materials are used in the PREVNAR 20 (pneumococcal 20-valent conjugate) vaccine manufacturing process and the packaging materials. There are several stages of purification after these are introduced to the manufacturing process, so only residual/trace amounts of animal-derived Ingredients could potentially be present in the final product for PREVNAR 20 (pneumococcal 20-valent conjugate) vaccine. Was Prevnar 20 safe for individuals with alpha gal. Response: Explained pfizer does not test product for safety in patients with alpha gal, however, we can provide information on potential allergen ingredients in the product. Does Prevnar 20 contain Gelatin? Response: Gelatin is not used during in the manufacturing process of PREVNAR 20® | pneumococcal 20-valent conjugate vaccine, and gelatin is not an excipient entering in the vaccine composition. However, there are starting materials used in the PREVNAR 20® | pneumococcal 20-valent conjugate vaccine manufacturing process which come into contact with materials derived from animal (avian, bovine, ovine and caprine) during their production process. Pfizer uses controlled manufacturing processes that meet quality standards of the pharmaceutical industry. However, Pfizer does not specifically manufacture or test PREVNAR 20 (pneumococcal 20-valent conjugate vaccine), to be free of Gelatin. Therefore, we cannot guarantee absence of trace amounts. The accuracy of our statement was based upon the final product ingredients. This information may change over time. Please refer back to this page to get the most up-to-date information provided response from website. When paraphrased the concern: Reporter stated that yes, she thought it was not so much, patient thought at first like, flu like symptoms but she said she felt like it was more Alpha-gal but she still explained like chills, cold and diarrhea. It sounds like a fever and then diarrhea. Reporter was informed about the role of Pfizer Drug Safety Department. Age adverse event(s) started: Reporter stated, that would have been sunday, so she wsa 68 years old (Further not clarified appropriately, hence not captured in tab). Height and weight was no reported. Other medical history and concomitant medication: Reporter stated, she was on a anti-depressant and cholesterol medication (Sertraline, so zoloft 50 milligrams, the generic). The patient did not mention any labs in last 2 weeks and reporter stated, not to my knowledge. Patient did not mention anything like that. Date of vaccination: Reporter stated, 16Nov2025, so that would have been that past sunday.
SERTRALINE; ROSUVASTATIN