Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
collapsed and had to crawl to the bathroom; taste was completely gone; Chills; woke up and was soaked with sweat; had no appetite whatsoever; weak; bad fever; splitting headache; got sick to her stomach; dizzy; very tired; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Sep2025 at 17:00 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "allergy to Oral Sulfa drugs" (unspecified if ongoing), notes: she gets heart flutters if ingested.; "Seasonal Allergies" (ongoing), notes: Does not take anything for her seasonal allergies.; "Arthritis in her knees" (ongoing), notes: Takes Bayer back and body in the evening for her knees.; "slightly dehydrated" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation, on 25Sep2025 as dose number unknown, 0.5 ml single; CAPTOPRIL taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); SIMVASTATIN taken for blood cholesterol increased (ongoing); MIRALAX taken for constipation (ongoing). The patient also took other concomitant therapy. Vaccination history included: Pfizer covid vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "chills"; Moderna covid vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization, reaction(s): "chills". The following information was reported: CHILLS (non-serious) with onset 2025, outcome "unknown"; PYREXIA (non-serious) with onset 2025, outcome "unknown", described as "bad fever"; CIRCULATORY COLLAPSE (medically significant) with onset 2025, outcome "unknown", described as "collapsed and had to crawl to the bathroom"; DIZZINESS (non-serious) with onset 2025, outcome "unknown", described as "dizzy"; NAUSEA (non-serious) with onset 2025, outcome "unknown", described as "got sick to her stomach"; DECREASED APPETITE (non-serious) with onset 2025, outcome "unknown", described as "had no appetite whatsoever"; HEADACHE (non-serious) with onset 2025, outcome "recovered", described as "splitting headache"; AGEUSIA (non-serious) with onset 2025, outcome "recovered", described as "taste was completely gone"; FATIGUE (non-serious) with onset 2025, outcome "unknown", described as "very tired"; ASTHENIA (non-serious) with onset 2025, outcome "unknown", described as "weak"; HYPERHIDROSIS (non-serious) with onset 2025, outcome "unknown", described as "woke up and was soaked with sweat". Therapeutic measures were taken as a result of pyrexia, headache. Clinical course: Caller was a consumer called about the medication Comirnaty and said that it is for 65 years and older. She thought about filing something with the government, but it did not seem the right thing to do. She got the flu vaccine and the Comirnaty vaccine on Thursday around midday. Usually after she gets the vaccines, she has had Pfizer covid vaccines and including Moderna covid vaccines. She usually gets the chills that last a couple of hours and then everything is fine. She got the Comirnaty vaccine around noon and at about 5pm she started getting the chills, but by 9 they were turning into really bad chills that seemed to be a bad fever. She went to bed early and let it go. She must have been running a bad fever and it broke in the middle of the night and she woke up and she was soaked with sweat. When she woke up, she had a splitting headache and she was completely weak and collapsed and had to crawl to the bathroom, and that had never happened before. She got sick to her stomach, but no throwing up. She managed to take some aspirin and crawl back to bed and go to sleep. In the morning it seemed as if the fever had broken, but she had no appetite whatsoever. She forced herself to eat breakfast, but could taste anything, her taste was completely gone. It was odd. She was very tired and very weak, but she got through the day. In the evening, she got the chills again and said that the headache had not gone away. She switched to Excedrin and the headache started to go away. She went to make dinner to see if her taste was coming back, but every time she stood up, after 4-5 minutes, she would feel weak like she was going to collapse. It was like she was not stable. Once she sat down it would go away, but once she stood back up it would come back after a few minutes. She stated she was not exactly dizzy, but she guesses it could be categorized as dizzy. She slept all night and she felt better and said that she is starting to lose track of time. The headache was not entirely gone, but the headache is gone today. She does not feel up to par, she does not feel bad, but not like she normally would. She feels tired and she got a full night sleep. Her taste came back and does not know why it went away. She is back to her usual breakfast routine. She is extremely healthy 78-year-old. She takes high blood pressure medication and cholesterol medication. She has no preexisting conditions. If this happens to someone with a preexisting condition it would be bad. That is why she is calling. Someone she talked to had heard that other people had adverse reactions to the Comirnaty vaccine. She has taken a Pfizer covid vaccine before and this never happened before. There is something in the vaccine that needs to be looked at. She will need to report this to the doctor as part of her health routine. Caller added that she has been on a diet for the last year to lose certain number of pounds. Medical conditions: She is slightly dehydrated and her doctor told her to eat more protein. Lost almost no weight since Jan. Stated that since she was taking in more protein she became constipated and was on Miralax and said that probably made her more dehydrated. Other than being sick as a dog, it was not like she was going to die or anything. She considered that she has been dieting for so long that it could be related to weight loss and then taking Miralax with a diuretic that made her more dehydrated than she was before. She is concerned about other people with preexisting conditions this could affect. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine reported as none. Did any AE require a visit to the Emergency Room or Physician's Office reported as No. Treatment received for the adverse event included: Aspirin and Excedrin. Only thing that ever happened after receiving the previous Covid vaccines was she got the chills after a couple of hours, and then after a couple of hours the chills would go away and then everything would be fine.
Knee arthritis (Takes Bayer back and body in the evening for her knees.); Seasonal allergy (Does not take anything for her seasonal allergies.)
Medical History/Concurrent Conditions: Blood pressure high; Constipation; Dehydration; High cholesterol; Sulfonamide allergy (she gets heart flutters if ingested.)
CAPTOPRIL; HYDROCHLOROTHIAZIDE; SIMVASTATIN; MIRALAX