Age: 22.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Hypoaesthesia, Hypotension, Immunisation, Muscular weakness, Nasopharyngitis
Clinical narrative: feeling weakening in her muscles; Product use for unapproved combination; Booster; found her on the bathroom floor last night; was very very nauseous; wanted to throw up; extreme hypotension; body temperature was a little low; was warm to the touch; really dizzy; shaking; really cold; super weak; her vision was super blurry but not blurry but it was dizziness; numb in her feet and hands and felt numbness in both hands and feet and felt the numbness a little bit in her hands but more in her feet; head hurts a little bit; was kind of tired/really tired and kind of weak; heart was also skipping a beat a few times; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Dec2021 11:30 (Lot number: FL3197) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot: EN6202), administration date: 23Feb2021, when the patient was 21 years old, for COVID-19 Immunization, reaction(s): "maybe really knocked down by the vaccine and it was also how she felt after the 1st and 2nd doses of the Pfizer Covid vaccine", "started feeling weakening in her muscles"; Bnt162b2 (2nd dose, lot: EN6207.), administration date: 16Mar2021, when the patient was 21 years old, for COVID-19 Immunization, reaction(s): "maybe really knocked down by the vaccine and it was also how she felt after the 1st and 2nd doses of the Pfizer Covid vaccine", "started feeling weakening in her muscles". The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021 11:30, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "found her on the bathroom floor last night"; NAUSEA (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "was very very nauseous"; VOMITING (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "wanted to throw up"; HYPOTENSION (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "extreme hypotension"; BODY TEMPERATURE DECREASED (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "body temperature was a little low"; FEELING HOT (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "was warm to the touch"; MUSCULAR WEAKNESS (non-serious) with onset 27Dec2021 16:00, outcome "recovered" (Dec2021), described as "feeling weakening in her muscles"; DIZZINESS (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "really dizzy"; TREMOR (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "shaking"; NASOPHARYNGITIS (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "really cold"; ASTHENIA (non-serious) with onset 27Dec2021, outcome "not recovered", described as "super weak"; VISION BLURRED (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "her vision was super blurry but not blurry but it was dizziness"; HYPOAESTHESIA (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "numb in her feet and hands and felt numbness in both hands and feet and felt the numbness a little bit in her hands but more in her feet"; HEADACHE (non-serious) with onset 27Dec2021, outcome "recovered" (Dec2021), described as "head hurts a little bit"; FATIGUE (non-serious) with onset 27Dec2021, outcome "not recovered", described as "was kind of tired/really tired and kind of weak"; EXTRASYSTOLES (non-serious) with onset Dec2021, outcome "unknown", described as "heart was also skipping a beat a few times"; PRODUCT USE ISSUE (non-serious) with onset 27Dec2021 11:30, outcome "unknown", described as "Product use for unapproved combination". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Dec2021) 74/47; (Dec2021) skipping heart beats, notes: at one point the machine was showing she was skipping heart beats; (Dec2021) recovered pretty well, notes: took a series of blood pressure readings and the patient's blood pressure recovered pretty well; body temperature: (Dec2021) 93 or 96 degrees, notes: was a little low at 93 or 96 degrees; electrocardiogram: (28Dec2021) it was fine, notes: today at 1:00am or 2:00am. Therapeutic measures were taken as a result of syncope, nausea, vomiting, hypotension, body temperature decreased, feeling hot, muscular weakness, dizziness, tremor, nasopharyngitis, asthenia, vision blurred, hypoaesthesia, headache, fatigue, extrasystoles.   Clinical course: Caller states his name is withheld and his daughter received the Pfizer Booster shot yesterday and it has on her patient card CPT # with Pfizer NDC 59267-1000-03 and lot number FL3197 and he will put his daughter on the line and let her speak; states the patient got the Pfizer Booster dose around 11:00am yesterday blood pressure reading of 74/47 and they measured the blood pressure a couple of times and then called the nurse that is on their health plan and the nurse helped the patient through this situation and they almost took the patient to the emergency room but instead pumped a lot of fluids in her and took a short walk outside and got the blood pumping a little bit and replenished her fluids. States they took a series of blood pressure readings and the patient's blood pressure recovered pretty well and it got to within normal range and did a round with an EKG unit and it looked good and said the patient was normal and that was today at 1:00am or 2:00am. The daughter who was the patient was provided with the call recording notification and she provided the rest of the report information. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Caller states she got the flu shot at the exact same time in her other arm and states on 27Dec2021 she had the PFizer Covid booster shot in her right arm on her tricep near the shoulder and it had lot FL3197 and NDC 59267-1000-03 and no expiry date written on her patient card; states she also had the influenza flu shot administered to her left arm on 27Dec2021 but she has no flu shot name or lot number to provide.  States she had the 1st dose of the Pfizer Covid vaccine on 23Feb2021 with lot EN6202 and the 2nd dose of the Pfizer Covid vaccine on 16Mar2021 with lot EN6207 and states her patient card has no expiry date or NDC number written on it for the 1st two doses of the Pfizer Covid vaccine. Caller states her heart was also skipping a beat a few times like when they took the EKG it was fine but when they took her blood pressure at one point the machine was showing she was skipping heart beats.  Caller states it was 11:30am when she got the booster dose and when she got the vaccine but was maybe really knocked down by the vaccine and it was also how she felt after the 1st and 2nd doses of the Pfizer Covid vaccine and after the booster she woke up and was not feeling well. States her symptoms are not ongoing and she just feels way better today and her head hurts a little bit and she took Tylenol for that and was kind of tired and wiped out from everything last night and no nothing really and no numbness or anything today but is really tired and kind of weak. States for the Tylenol was brand and took one last night at 1:30am and took two 500mg at 1:30am and then took two more 500mg this morning at 8:30am or 9:00am and the Tylenol has at lot number that the patient's father said small numbers and caller states the lot is 1DV2110 with expiry date 20Dec2022 and for the UPC number she states she is not seeing that on the bottle or a bar code.  Caller states the facility where she got the Pfizer Booster dose of the covid vaccine was one that her brother got off of withheld and on the calendar of events it was an event at withheld and thought it was a state or county regulated thing.  Additional Vaccines Administered on Same Date of the Pfizer Suspect: states she also had the influenza flu shot administered to her left arm on 27Dec2021 but she has no flu shot name or lot number to provide.  Adverse Event (AE) Details: Caller states it was 11:30am when she got the booster dose and when she got the vaccine and started feeling weakening in her muscles around 4:00-5:00pm but was maybe really knocked down by the vaccine and it was also how she felt after the 1st and 2nd doses of the Pfizer Covid vaccine and after the booster she woke up and was not feeling well and just really dizzy, super weak and shaking, was really cold and her vision was super blurry but not blurry but it was dizziness and was also numb in her feet and hands and felt numbness in both hands and feet and felt the numbness a little bit in her hands but more in her feet.  Adverse Event (AE) Details: Caller states it was 11:30am when she got the booster dose and when she got the vaccine and started feeling weakening in her muscles around 4:00-5:00pm but was maybe really knocked down by the vaccine and it was also how she felt after the 1st and 2nd doses of the Pfizer Covid vaccine and after the booster she woke up and was not feeling well and just really dizzy, super weak and shaking, was really cold and her vision was super blurry but not blurry but it was dizziness and was also numb in her feet and hands and felt numbness in both hands and feet and felt the numbness a little bit in her hands but more in her feet.AE(s) did not require a visit to Emergency Room or Physician Office, but did call the nurse and was getting her input. Prior Vaccinations (within 4 weeks) was None. Description of complaint: Vaccine Supplemental Form completed in additional context. States her symptoms are not ongoing and she just feels way better today and her head hurts a little bit and she took Tylenol for that and was kind of tired and wiped out from everything last night and no nothing really and no numbness or anything today but is really tired and kind of weak. States for the Tylenol is is Kroger brand and took one last night at 1:30am and took two 500mg at 1:30am and then took two more 500mg this morning at 8:30am or 9:00am and the Tylenol has at lot number that the patient's father said is small numbers and caller states the lot is 1DV2110 with expiry date 20Dec2022 and for the UPC number she states she is not seeing that on the bottle or a bar code.