Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: vomited/throwing up; pain was horrible/body aches; running a low grade body temperature; could barely walk; weak; couldn't breathe; chills; shakes; could not function; does not have really much of an appetite; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 10:30 (Lot number: FL3198) at the age of 77 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: for years; "Acid reflux" (unspecified if ongoing), notes: for years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot: EL8982, Dose: Unknown strength/volume/dose injection to upper left shoulder around maybe 09:30.), administration date: 23Jan2021, when the patient was 76 years old, for Covid-19 immunization; Bnt162b2 (Dose: 02, Lot: EN6201, Dose: Unknown strength/volume/dose injection to upper left shoulder around maybe 10:30), administration date: 13Feb2021, when the patient was 76 years old, for Covid-19 immunization, reaction(s): "felt kind of punky like a lot of people do", "body aches", "low temperature", "nauseousness", "little dizzy"; Flu vaccine (she had a regular flu vaccine a month before the third dose/booster dose of the Pfizer Covid-19 Vaccine), administration date: 2021, for Immunization. The following information was reported: VOMITING (non-serious) with onset 06Jan2022, outcome "recovering", described as "vomited/throwing up"; PAIN (non-serious) with onset 06Jan2022, outcome "recovering", described as "pain was horrible/body aches"; BODY TEMPERATURE DECREASED (non-serious) with onset 06Jan2022, outcome "recovering", described as "running a low grade body temperature"; GAIT INABILITY (non-serious) with onset 06Jan2022, outcome "recovering", described as "could barely walk"; ASTHENIA (non-serious) with onset 06Jan2022, outcome "recovering", described as "weak"; DYSPNOEA (non-serious) with onset 06Jan2022, outcome "recovering", described as "couldn't breathe"; CHILLS (non-serious) with onset 06Jan2022, outcome "recovering", described as "chills"; TREMOR (non-serious) with onset 06Jan2022, outcome "recovering", described as "shakes"; MOBILITY DECREASED (non-serious) with onset 06Jan2022, outcome "recovering", described as "could not function"; DECREASED APPETITE (non-serious) with onset 06Jan2022, outcome "recovering", described as "does not have really much of an appetite"; NAUSEA (non-serious) with onset 06Jan2022, outcome "recovering", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, pain, body temperature decreased, nausea.  Additional information: Response: Shared with caller information that there was a significant increase in titers-a way to measure immunity- after having the booster dose. Shared with caller information from the CDC Pfizer is independent of the CDC: "Talk to a doctor about taking over-the-counter medicine, such as ibuprofen, acetaminophen, aspirin (only for people age 18 or older), or antihistamines for any pain and discomfort experienced after getting vaccinated. People can take these medications to relieve side effects after vaccination if they have no other medical reasons that prevent them from taking these medications normally". Treatment disclaimer repeated. Caller asked if vomiting was an uncommon side effect and if it was considered an adverse reaction? Caller said she vomited every half hour would experience relief for two to three minutes, the pain was horrible, and that this episode lasted seven hours. Caller said she has had GERD and acid reflux for years and asked if that might have contributed to her reaction. Response: Shared with caller that others reported a mild vomiting reaction. Shared that vomiting is considered a hypersensitivity reaction. This consumer is the patient who reported having tried to call Pfizer on 09Jan2022, but she thinks she left a message at that time; she did not have any reference number to provide. This report is regarding herself and adverse reaction she had following the booster dose of the Pfizer Covid-19 Vaccine. Her primary purpose of this call was that information; but she did also provide information on adverse reaction she had following the second dose of the Pfizer Covid-19 Vaccine she received. She asked for further information on the incidence and severity of adverse reactions like her own that other people have had or reported with the Pfizer Covid-19 Vaccine she had such as vomiting. She explained that the paperwork she received said to call if she had an adverse reaction. She has talked to other people and think her adverse reaction with the booster dose of the Pfizer Covid-19 Vaccine was a little worse than other people's.  Third dose/Booster dose: Adverse reaction: Onset date: 06Jan2022: Onset time: about 6 hours after the third dose of the Pfizer Covid-19 Vaccine was administered she started with body aches; then started running a low grade body temperature which never went over 100 degrees Fahrenheit, temperature was between 99.2 and 100 degrees Fahrenheit for the entire length of her adverse reaction. Then she began throwing up approximately 10 hours after she received the third dose of the Pfizer Covid-19 Vaccine. She was violently throwing up to the point where she could barely walk and that went on for approximately 7 hours. So to caller, this adverse reaction was pretty bad. She was just praying to die, it was really really bad for her. She does not know if Pfizer considers this adverse reaction to be serious. Caller's husband kept saying he was going to take her to the hospital because she was getting so weak that she couldn't breathe; then she clarified that no, breathing wasn't the problem, she did not want to say that; it was the throwing up and the chills and the shakes, her whole body just shaking violently. She could not function. Outcome of adverse reaction only able to be clarified with caller as much better now; all symptoms of adverse reaction started the night of 06Jan2022 and went through probably until about 15:00 on 07Jan2022. Then she took a Zofran which is for nausea and throwing up and that did help calm her stomach. Then she had tried to take Tylenol throughout this episode, but she would just throw it up so it was useless. She is pretty much back to normal now but still does not have really much of an appetite, she had eaten a little bit 09Jan2022 and this morning, 10Jan2022 she had a bowl of cereal so she is getting appetite back. She is drinking a lot of liquids. She would say she is about maybe 60% recovered, no, maybe 80% recovered from adverse reaction. Second dose: Adverse reaction: Onset date: 13Feb2021, onset time unknown. She was down for 1 day due to body aches and low temperature and nauseousness but did not actually vomit, just nauseousness; body aches; felt kind of punky like a lot of people do. She took it real easy the next day. Onset date and time she provided as the same situation as with the Third dose/booster dose adverse reaction: she got the second dose of Pfizer Covid-19 Vaccine in the morning, around 10:30 on 13Feb2021 she thinks. She felt pretty good, a little dizzy, not quite right as day went on. She went to bed, woke up at some point in time with her whole body aching and aching. She went through that for a few hours, finally took a Tylenol that really started helping her to relieve that. She did not feel like that second dose adverse reaction was bad enough to report. She thinks a lot of people experienced that. She recovered completely from this by 2 days point-clarified as the next day: 14Feb2021 she just took it really easy, and by the day after that: 15Feb2021 she was grocery shopping and back to her normal activities. Caller mentioned that she looked on the computer about adverse reactions and they did list nauseousness kind of down a ways but only 1 of them listed vomiting, which was way down on the very bottom, only 2 people reported vomiting. Is that kind of how you look at it, as rare? All caller's friends none of them had vomiting, all just had body aches. She reported that nobody had as severe of a reaction as caller did: Caller declined to complete reports for those patients, clarification of product names/lots/expiries: not provided, caller unwilling to complete report.Caller reported she has a terrible dread of the ER so she kept waiting and waving her husband off, it was the middle of the night so she did not seek any medical attention. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Caller mentioned she had a regular flu vaccine a month before the third dose/booster dose of the Pfizer Covid-19 Vaccine so it was quite a distance between the two. She felt fine and was thinking how lucky she was that she had not been sick for a while. Vaccine brand name/Lot/Expiry: Unknown, caller had none of this information to provide.; she just went to the pharmacy and asked them if this was the one for seniors, they said yes, so she go the flu shot. Date of administration: Unknown other than a month before the third dose/booster dose of the Pfizer Covid-19 Vaccine. Consumer is patient reporting adverse events with Pfizer Covid-19 Vaccine: Third dose/booster dose as well as Second dose. For Third dose/booster dose adverse reaction caller reported she took a Zofran which is for nausea and throwing up and that did help calm her stomach. Then she had tried to take Tylenol throughout this episode, but she would just throw it up so it was useless.  No follow-up attempts are possible. No further information is expected.