Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Illness, Nausea, Pain in extremity
Clinical narrative: I am just lying here nauseated/ nausea; right arm started hurting again after second dose which is weird because second dose was given in her left arm; broke into a fever; diarrhea; splitting, blinding headache; panting/ short of breath; dizziness; vertigo; she was so sick; face is broken out like she is a teenager, she has zits on her face which is weird; her body smells funny, weird; constipated; 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 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Sep2021 (Lot number: FC3184, Expiration Date: Oct2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "stroke", start date: 2019 (unspecified if ongoing); "clot on her brain", start date: 2019 (unspecified if ongoing), notes: was a huge clot on her brain in 2019 and it affected her vision.; "affected her vision" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; TURMERIC [CURCUMA LONGA RHIZOME]; ZINC; VITAMIN D3; CALCIUM; POTASSIUM; MAGNESIUM. Vaccination history included: Bnt162b2 (1st dose, Lot: FC3184, Expiry: Oct2021, injection to right arm at unknown time in the afternoon), administration date: 20Aug2021, when the patient was 69 years old, for Covid-19 immunization, reaction(s): "First dose: right arm hurt". The following information was reported: NAUSEA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "I am just lying here nauseated/ nausea"; PAIN IN EXTREMITY (non-serious) with onset 14Sep2021, outcome "not recovered", described as "right arm started hurting again after second dose which is weird because second dose was given in her left arm"; PYREXIA (non-serious) with onset 14Sep2021, outcome "unknown", described as "broke into a fever"; DIARRHOEA (non-serious) with onset 14Sep2021, outcome "recovered" (2021), described as "diarrhea"; HEADACHE (non-serious) with onset 14Sep2021, outcome "unknown", described as "splitting, blinding headache"; DYSPNOEA (non-serious) with onset 14Sep2021, outcome "not recovered", described as "panting/ short of breath"; DIZZINESS (non-serious) with onset 14Sep2021, outcome "not recovered", described as "dizziness"; VERTIGO (non-serious) with onset 14Sep2021, outcome "not recovered", described as "vertigo"; ACNE (non-serious) with onset 2021, outcome "not recovered", described as "face is broken out like she is a teenager, she has zits on her face which is weird"; SKIN ODOUR ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "her body smells funny, weird"; CONSTIPATION (non-serious) with onset 2021, outcome "not recovered", described as "constipated"; ILLNESS (non-serious) with onset Sep2021, outcome "unknown", described as "she was so sick". The events "i am just lying here nauseated/ nausea", "right arm started hurting again after second dose which is weird because second dose was given in her left arm", "broke into a fever", "diarrhea", "splitting, blinding headache", "panting/ short of breath", "dizziness", "vertigo", "face is broken out like she is a teenager, she has zits on her face which is weird", "her body smells funny, weird", "constipated" and "she was so sick" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.  Follow-up (01Oct2021): This is a follow-up spontaneous report from a contactable consumer. This 69-year-old female consumer (patient) reported for herself that:  The patient did not have any other vaccines 4 weeks prior to vaccination. In the afternoon she thinks Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm. Reporter seriousness for Second dose: right arm started hurting again after second dose which is weird because second dose was given in her left arm: Unspecified. Reporter seriousness for Second dose: broke into a fever: Unspecified. Reporter seriousness for Second dose: diarrhea:Unspecified Dates for Second dose: splitting, blinding headache: (From: 14Sep2021 To: Unknown). Reporter seriousness for Second dose: splitting, blinding headache: Unspecified. Reporter seriousness for Second dose: panting: Unspecified. Reporter seriousness for Second dose: short of breath: Unspecified. Reporter seriousness for Second dose: nausea:Unspecified. Reporter seriousness for Second dose: dizziness, vertigo: Unspecified Dates for Second dose: face is broken out like she is a teenager, she has zits on her face which is weird: (From: 2021 To: Ongoing). Reporter seriousness for Second dose: face is broken out like she is a teenager, she has zits on her face which is weird. Reporter seriousness for Second dose: her body smells funny weird: Unspecified Dates for Second dose: constipated: (From: 2021 To: Ongoing) Reporter seriousness for Second dose: constipated: Unspecified.  The patient on the line who called to report her symptoms after her second dose of Pfizer- BioNTech Covid-19 Vaccine. She further clarified her symptoms were so strong, she has been so sick including her having broke into a fever; diarrhea; splitting, blinding headache; panting; short of breath; nausea; dizziness, vertigo; face is broken out like she is a teenager, she has zits on her face which is weird; her body smells funny, weird; constipated. She also reported that after the first dose of Pfizer-BioNTech Covid-19 Vaccine her right arm hurt where the injection was given-and her right arm started hurting again after she got the second dose of Pfizer-BioNTech Covid-19 Vaccine dose which is weird because the second dose was given in her left arm. Reporter: Fax: She does not have fax. Occupation: She was a research toxicologist for 22 years many years ago so she knows these are not real vaccines. First dose: right arm hurt: Time of onset: Unknown. Second dose: right arm started hurting again after second dose which is weird because second dose was given in her left arm: Time of onset: Unknown other than by that night after having the shot-Pfizer-BioNTech Covid-19 Vaccine.  Second dose: broke into a fever: Time of onset: Unknown other than by that night after having the shot- Pfizer-BioNTech Covid-19 Vaccine. Second dose: diarrhea: Time of onset: Unknown other than immediately after she had the shot-Pfizer-BioNTech Covid-19 Vaccine. Outcome: Now she does not have diarrhea, that diminished after the first week, further details of outcome unknown. Second dose: splitting, blinding headache: Time of onset: Unknown other than immediately after she had the shot-Pfizer-BioNTech Covid-19 Vaccine. Second dose: panting: Time of onset: Unknown other than by that night after having the shot-Pfizer-BioNTech Covid-19 Vaccine. Second dose: short of breath: Time of onset: Unknown other than by that night after having the shot-Pfizer- BioNTech Covid-19 Vaccine. Second dose: nausea: Time of onset: Unknown other than immediately after she had the shot-Pfizer-BioNTech Covid-19 Vaccine. Second dose: dizziness, vertigo: Time of onset: Unknown other than immediately after she had the shot-Pfizer-BioNTech Covid-19 Vaccine. Second dose: face is broken out like she is a teenager, she has zits on her face which is weird: Time of onset: Unknown. Date of onset unknown other than in 2021 after second dose was adminsitered on 14Sep2021. Second dose: her body smells funny, weird: Time of onset: Unknown. Date of onset unknown other than in 2021 after second dose was adminsitered on 14Sep2021. Her body smells funny, weird. You can tell when your body chemistry changes, it smells weird. She takes showers regularly and she can tell when theres a body change. She feels like a GMO. Second dose: constipated: Time of onset: Time of onset: Unknown. Date of onset unknown other than in 2021 after second dose was adminsitered on 14Sep2021. Now shes constipated and she eats her oatmeal and her fruit every morning. Her diet has not changed. She does not eat junk food or eat out. They make their own food there, she and her husband are both retired. Pfizer-BioNTech Covid- 19 Vaccine: First dose: 20Aug2021 Lot: FC3184 NDC: Unknown, this is not on the CDC Vaccine record card. Expiry: Oct2021 Dose: Unknown strength/volume/dose injection to right arm at unknown time in the afternoon she thinks. Second dose: 14Sep2021 Lot: FC3184 Expiry: Oct2021 NDC: Unknown, this is not on the CDC Vaccine record card. Dose: Unknown strength/volume/dose injection to left arm at unknown time in the afternoon she thinks. Caller verified that both doses had the same Lot and Expiry date. Second dose completed her prescribed therapy. She doesnt care what they say she is not getting any more doses. The patient specified that there are no relevant concomitant products or other medical conditions to provide for this report. She mentioned separately that she had to get some glasses because it is pretty small print on CDC vaccine record card, that her eyes are not great. She had a stroke 2 years ago that they think was from COVID-it was a huge clot on her brain in 2019 and it affected her vision. She was doing perfectly. She just takes a regimen of regular vitamins that she takes very day to boost your immune system, Vitamin C,Turmeric, Zinc, Vitamin D3, Calcium Potassium, Magnesium; just your normal vitamins you take when you get older. Nothing different. She was not sick prior to getting this jab of Pfizer-BioNTech Covid-19 Vaccine, she does not call it a vaccine because it isnt a real vaccine because real vaccines take much longer than that to make. Testing/investigations: She had such a bad reaction that they wanted her tested again; so she was retested on 23Sep2021. She clarified that the testing she is referring to is 1 COVID Rapid Test and 1 COVID PCR Test that were both performed on 23Sep2021 and both had negative results. Patients Physician Assistant wanted patient to have a chest xray performed 01Oct2021, to make sure there was no congestion or anything-that was performed 01Oct2021 and the results were perfectly fine. She clarified that those are the only tests that she has had performed since receiving Pfizer-BioNTech Covid-19 Vaccine doses. She clarified that her terminology regarding being retested was referring to COVID tests that she had performed prior to having been administered Pfizer-BioNTech Covid-19 Vaccine. She does not usually get flu vaccine, and is sure not getting another Pfizer-BioNTech Covid-19 Vaccine. She asked if Pfizer-BioNTech Covid-19 Vaccine has graphite in it. Apparently there was some contaminant in some of these lots of graphite and a few other things, she is not sure what all it was. She clarified she does not have the Lot numbers to provide, declined to provide any further details regarding those products including clarification of product names/lots/ndcs/expiries. She is really kind of tired of being on the phone. She was up for quite a few hours today and wants to end this call and rest because she is a little nauseous. She did go to the doctor today, she wanted to see her because her symptoms were so strong and she was so sick.  Follow-up (13Oct2021): This follow-up consists of no new safety information.  Follow-up (25Oct2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101308723 same patient/drug, different dose/event