Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Booster; Booster dose/third dose: got really, really sick; Booster dose/third dose: severe chills; Booster dose/third dose: fever; Booster dose/third dose: severe body aches; Booster dose/third dose: her bones hurt like in her thighs; Booster dose/third dose: Where the injection was administered in her right arm shoulder was very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 13:00 (Lot number: FH8030) at the age of 56 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Lot: ER8731, NDC: Unknown, not on the CDC vaccine record card., Expiry: 31Jul2021, Lot/Expiry information was on sticker on the CDC vaccine record card., Dose: 0.3mL injection to right arm shoulder, Administered at a mega site.), administration date: 23Apr2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "First dose: some mild soreness in right arm shoulder"; Bnt162b2 (DOSE: 2, Second dose: Date administered: 14May2021, Lot: EW0173, NDC: Unknown, not on the CDC vaccine record card., Expiry: 31Aug2021, Lot/Expiry information was on sticker on the CDC vaccine record card., Dose: 0.3mL injection to right arm shoulder, Administered at a mega site., mega site that was run., When went to mega site 0.3mL for first and second vaccine), administration date: 14May2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Second dose: some soreness in the right arm shoulder."; Bnt162b2 (DOSE: 2), administration date: 14May2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "Second dose: body aches". The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 13:00, outcome "unknown", described as "Booster"; ILLNESS (non-serious) with onset 26Nov2021, outcome "recovered" (30Nov2021), described as "Booster dose/third dose: got really, really sick"; CHILLS (non-serious) with onset 26Nov2021, outcome "recovered" (30Nov2021), described as "Booster dose/third dose: severe chills"; PYREXIA (non-serious) with onset 26Nov2021, outcome "recovered" (30Nov2021), described as "Booster dose/third dose: fever"; PAIN (non-serious) with onset 26Nov2021, outcome "recovered" (30Nov2021), described as "Booster dose/third dose: severe body aches"; BONE PAIN (non-serious) with onset 26Nov2021, outcome "recovered" (30Nov2021), described as "Booster dose/third dose: her bones hurt like in her thighs"; INJECTION SITE PAIN (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "Booster dose/third dose: Where the injection was administered in her right arm shoulder was very sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, chills, pyrexia.  Additional information: Dosage text: Unknown strength/volume/dose injection to right arm shoulder at time of appointment: 13:00. Dates for First dose: some mild soreness in right arm shoulder: (From: 24Apr2021 To: 25Apr2021). Dates for Second dose: some soreness in the right arm shoulder.: (From: 15 May 2021 To: 16May2021). Dates for Second dose: body aches: (From: 15May2021 To: 16May2021).Additional Context: This consumer is the patient who called regarding the booster dose of Pfizer Covid-19 Vaccine she was administered. She got really, really sick for 4 days so she just wanted to get some feedback. She did call her doctor when it happened. Now its like, she believes in vaccinations, but she is really super afraid to get a booster again. She wouldn't say she had adverse reaction, it falls over into side effects categories. She is fine now, recovered completely from all events, but she is very nervous about getting any additional booster doses of the Pfizer Covid-19 Vaccine and wanted some feedback from Pfizer about these events and future booster doses of the Pfizer Covid-19 Vaccine. Reporter: Address/Fax/Email: Unknown. Caller mentioned being in (withheld) state, but did not verify this as part of her address. After being administered the booster dose of Pfizer Covid-19 Vaccine caller reported: Onset dates 26Nov2021, onset times unknown: got really, really sick; severe chills like she has never had in her life, she felt like she was almost convulsing, could not keep her body still. She took Advil which seemed to calm it down a bit. Even though she was on Advil and Tylenol for 4 days she had a fever of 101 degrees Fahrenheit while on those medications. She also had severe body aches and like her bones hurt like in her thighs.  Onset date: Unknown if 26Nov2021 or 27Nov2021. Onset time unknown. Where the injection was administered in her right arm shoulder was very sore- she would say event lasted for a full week until unknown date in 2021 and she recovered completely; this event with the arm was expected, that was the least of her worries. After being administered the first dose of Pfizer Covid-19 Vaccine caller reported: Onset date of 24Apr2021 at unknown onset time: some mild soreness in right arm shoulder, which was nothing to worry about. She recovered completely by 25Apr2021. After being administered the second dose of Pfizer Covid-19 Vaccine caller reported: Onset date of 15May2021 at unknown onset time: some soreness in the right arm shoulder. Onset date of 15May2021, onset time: unknown other than a full 12 hours after administration of second dose of Pfizer Covid-19 Vaccine: body aches which were not severe. She took 1 Advil for these events and the Advil cured her, she was back to normal, over the body aches; She recovered completely from these events by 16May2021. Thats why she felt really positive about getting the booster dose later. Pfizer Covid-19 Vaccine: Caller initially reported product name as the Booster; then clarified the Pfizer Booster, then clarified as Pfizer for Booster Covid-19 Vaccine; finally clarified as Pfizer Covid-19 Vaccine, with her primary report purpose regarding the booster dose of the Pfizer Covid-19 Vaccine. Regarding testing/treatment/medical interventions caller reported the only other relevant information was that she had a telemed appointment with her doctor because she did not feel well enough to go to his office relative to the events experienced with the booster dose of the Pfizer Covid-19 Vaccine. Tylenol: Strength: 500mg each Lot: ALA071 Expiry: Jul2023 NDC: Unknown, did not find this information on packaging. UPC: 300450488282 While looking for the Advil Liquigels Lot/NDC/UPC/Expiry caller reported that the print is so small, wanted to see if she still had the cardboard box which might be bigger, but she did not have the box; might have to get the old magnifying glass: then provided as: Advil Liquigels: Strength: 200mg each Lot: R75211 Expiry: Sep2022 UPC/NDC: Unknown, caller did not see this information on the bottle, and did not have outer packaging/cardboard box any longer. It says Distributed by Pfizer (name withheld), (state withheld)- she did not realize Pfizer made Advil. No emergency Room visit. Physician Office Telemed visit only with events Booster dose/third dose: got really, really sick; Booster dose/third dose: severe chills; Booster dose/third dose: fever; Booster dose/third dose: severe body aches; Booster dose/third dose: her bones hurt like in her thighs; Booster dose/third dose: Where the injection was administered in her right arm shoulder was very sore. Not hospitalized. No prior vaccinations (within 4 weeks). She had never even had a flu shot and never had any adverse events following prior immunizations. No underlying health issues, she was a relatively healthy person. No family medical history relevant to ae. No relevant tests. Reporter mentioned her family and friends all got the Pfizer booster and did relatively well so thats why she herself was really shocked at how sick she got. She has concerns about getting any future booster doses of Pfizer Covid-19 Vaccine. Her doctor had a suggestion about maybe getting antibody test first before the next booster. Caller did not want to report further information regarding her family and friends that all got the Pfizer booster: lots/ndcs/expiries: not provided, caller did not want to report further information. Is there a Product Complaint: Yes Description of Product Complaint: Consumer was the patient reporting adverse events with Pfizer Covid-19 Vaccine. During that report caller mentioned treatment of those events where she mentioned: Even though she was on Advil and Tylenol for 4 days she had a fever of 101 degrees Fahrenheit while on those medications.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101886117 similar report from same reporter;US-PFIZER INC-202101886121 similar report from same reporter