Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9547 | LA |
severe chills /he was awakened at 5 AM due to chills; where if he let cool air under the blanket then he would get a chill; he had weakness in his legs; pain in his leg muscles; feeling wobbly; threw up; dry heaving; Feels very tired; body aches; feels general malaise; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 66-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Oct2025 as dose 1, 0.3 ml single (Lot number: MY9547, Expiration Date: 15Jun2026), in left arm for covid-19 immunisation, Device Lot Number: MY9547, Device Expiration Date: 15Jun2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 16Oct2025, outcome "unknown", described as "Feels very tired"; PAIN (non-serious) with onset 16Oct2025, outcome "not recovered", described as "body aches"; RETCHING (non-serious) with onset 16Oct2025, outcome "unknown", described as "dry heaving"; GAIT DISTURBANCE (non-serious) with onset 16Oct2025, outcome "unknown", described as "feeling wobbly"; MALAISE (non-serious) with onset 16Oct2025, outcome "not recovered", described as "feels general malaise"; MUSCULAR WEAKNESS (non-serious) with onset 16Oct2025, outcome "recovered" (16Oct2025), described as "he had weakness in his legs"; MYALGIA (non-serious) with onset 16Oct2025, outcome "recovered" (16Oct2025), described as "pain in his leg muscles"; CHILLS (non-serious) with onset 16Oct2025, outcome "recovered" (16Oct2025), described as "severe chills /he was awakened at 5 AM due to chills"; VOMITING (non-serious) with onset 16Oct2025, outcome "unknown", described as "threw up"; TEMPERATURE INTOLERANCE (non-serious) with onset 16Oct2025, outcome "unknown", described as "where if he let cool air under the blanket then he would get a chill". Therapeutic measures were not taken as a result of chills, temperature intolerance, muscular weakness, myalgia, gait disturbance, vomiting, retching, fatigue, pain, malaise. Additional information: The patient is calling about Comirnaty. He got the shot yesterday at pharmacy. He had no issues at the time but last night he was awakened at 5am with severe chills, could not go back to sleep. Getting up this morning he had weakness in his legs and pain in his leg muscles. He was feeling wobbly and had one cup of tea with just milk in it and about 20 minutes later he threw that up and went on to dry heaving. States he has never had a reaction before. He states he does not have chills anymore but does have body aches and feels general malaise, he is tired. He lives in PRIVACY and it's getting cold and he did not have the heat on last night and had to bundle under the covers to stay warm. It was a situation where if he let cool air under the blanket then he would get a chill. The weakness in his legs and pain in leg muscles he is not experiencing as of now but he has not been walking around much since he felt poor. When he exercises the legs and chooses to move from one side of the house to the other that's where he feels the tiredness. The worst part was the throwing up and the dry heaves which he has not had recently since he has not put anything in his stomach. But he just ate a whole bowl of cheerios with milk. He is hoping that stays down. He does not feel nauseous right now but there is a chance he could. Treatment was reported as declines any. He is in general good health and does not have any sort of cancers or diabetes or any of the popular conditions. He wants to know if there is any sort of idea whether this is going to go away magically.