chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Eye haemorrhage, Hypertension, Interchange of vaccine products
Clinical narrative: Her blood vessel popped in her left eye; dizzy; very not feeling well; blood pressure went so high/up to 189/100; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna vaccine (Moderna LOT: 001J20A , DOSE 1, SINGLE), administration date: 12Jan2021, for Covid-19 immunization, reaction(s): "body ache for 24 hours"; moderna vaccine (LOT: 028L20A, DOSE 2, SINGLE), administration date: 09Feb2021, for Covid-19 immunization, reaction(s): "body ache for 24 hours"; moderna vaccine (LOT: 011F21A, DOSE 3 (BOOSTER), SINGLE), administration date: 09Nov2021, for Covid-19 immunization, reaction(s): "body ache for 24 hours". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown"; HYPERTENSION (medically significant) with onset 27Sep2022, outcome "unknown", described as "blood pressure went so high/up to 189/100"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "Her blood vessel popped in her left eye"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; MALAISE (non-serious), outcome "unknown", described as "very not feeling well". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (27Sep2022) 189/100, notes: Unit: Not Provided. Therapeutic measures were not taken as a result of eye haemorrhage. Clinical course reported as: After she received the Pfizer COVID-19 vaccine she had very bad side effects and her blood pressure went so high. She was taking medication in regards with her blood pressure. Her blood pressure went so high happened last week, after she got the Pfizer COVID-19 vaccine booster. Last Tuesday when she was in the doctor's office, 27Sep2022, the nurse took her blood pressure and it was normal, then she gave her the shot and she came home and her blood pressure had shot up to 189/100 she believes. Her doctor put her to more medication to bring it down. She was very, very not feeling well, she was very dizzy and her blood pressure has not gotten better even with extra medication. Her blood vessel popped in her left eye when her blood pressure goes up, this happened the day before yesterday. For the popped blood vessel in her left eye she has done no treatment, there was nothing she can do. She asked the doctor and there was nothing she could do, just wait until it went away, it absorbed kind of. She stated that her blood pressure went high and it popped a blood vessel in her left eye.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Her blood vessel popped in her left eye; dizzy; very not feeling well; blood pressure went so high/up to 189/100; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna vaccine (Moderna LOT: 001J20A , DOSE 1, SINGLE), administration date: 12Jan2021, for Covid-19 immunization, reaction(s): "body ache for 24 hours"; moderna vaccine (LOT: 028L20A, DOSE 2, SINGLE), administration date: 09Feb2021, for Covid-19 immunization, reaction(s): "body ache for 24 hours"; moderna vaccine (LOT: 011F21A, DOSE 3 (BOOSTER), SINGLE), administration date: 09Nov2021, for Covid-19 immunization, reaction(s): "body ache for 24 hours". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown"; HYPERTENSION (medically significant) with onset 27Sep2022, outcome "unknown", described as "blood pressure went so high/up to 189/100"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "Her blood vessel popped in her left eye"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; MALAISE (non-serious), outcome "unknown", described as "very not feeling well". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (27Sep2022) 189/100, notes: Unit: Not Provided. Therapeutic measures were not taken as a result of eye haemorrhage. Clinical course reported as: After she received the Pfizer COVID-19 vaccine she had very bad side effects and her blood pressure went so high. She was taking medication in regards with her blood pressure. Her blood pressure went so high happened last week, after she got the Pfizer COVID-19 vaccine booster. Last Tuesday when she was in the doctor's office, 27Sep2022, the nurse took her blood pressure and it was normal, then she gave her the shot and she came home and her blood pressure had shot up to 189/100 she believes. Her doctor put her to more medication to bring it down. She was very, very not feeling well, she was very dizzy and her blood pressure has not gotten better even with extra medication. Her blood vessel popped in her left eye when her blood pressure goes up, this happened the day before yesterday. For the popped blood vessel in her left eye she has done no treatment, there was nothing she can do. She asked the doctor and there was nothing she could do, just wait until it went away, it absorbed kind of. She stated that her blood pressure went high and it popped a blood vessel in her left eye.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 4, unknown manufacturer.), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3, unknown manufacturer.), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 06Oct2022, outcome "recovered" (Oct2022). Therapeutic measures were taken as a result of headache.  Additional information: Facility type of vaccine was at pharmacy or drug store. There was no covid prior vaccination and not tested post vaccination. Other vaccine in four weeks was reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Haemorrhage, Head injury, Loss of consciousness, Scar
Clinical narrative: On my second dose I pass out; I bled so much; hit her head on the cement; scar on my face; 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 73-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EL9265) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot number: unknown), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (hospitalization, medically significant), outcome "unknown", described as "On my second dose I pass out"; HAEMORRHAGE (hospitalization, medically significant), outcome "unknown", described as "I bled so much"; HEAD INJURY (hospitalization), outcome "unknown", described as "hit her head on the cement"; SCAR (non-serious), outcome "unknown", described as "scar on my face". The events required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results.  Clinical course: she already has two vaccines and two boosters. When she got her second Pfizer Covid-19 vaccine, she had to go to an internal medicine doctor because she hit her head on the cement. Was rushed to the hospital by an ambulance and was at the hospital for over 10 hours. She has to get them at the doctors office because her doctor wants to monitor her. Plans on getting the fifth vaccine dose, but wants to know how long it is going to provide protection. Patient mentioned: "I want them to know that I refuse to get it. They can't even give me the information. After first, the second, first booster, second booster, now this one, and they don't know. I don't think any of the vaccines protect, none of them protect us, not one of this". On her second dose she passed out and was in the Hospital for over 10 hours. They had to do a CAT scan, she bled so much, she had a scar on face because of it. She had to be careful, she could not read because they did not know if she had a concussion. she could not do anything, she bled like crazy, her head bounced in the cement after waiting after what they recommend to wait, this happened to her 2 minutes after walking out of the place.
Sex: F
Vaccine: COVID19
Symptoms: Chapped lips, Lip dry
Clinical narrative: dry lips; chapped, dry lips; 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 female patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHAPPED LIPS (non-serious) with onset 2021, outcome "unknown", described as "chapped, dry lips"; LIP DRY (non-serious) with onset 2021, outcome "unknown", described as "dry lips". The events "dry lips" and "chapped, dry lips" required physician office visit. Therapeutic measures were taken as a result of lip dry, chapped lips.  Additional information: The patient received two Pfizer Covid vaccines and two boosters. Her first vaccine was given on 27Feb2021 and a couple of days after this, she began to experience very dry lips.  Dry lips progressed to chapped, dry lips. Nothing she did helped the situation. The patient has seen 4 dermatologists. No one knows the source for the dry lips. The patient wanted to know if there are other reports regarding patients getting dry, chapped lips as an adverse effect of the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: Noticed pinkish area at injection site. Only mildly sensitive when touched directly with finger, otherwise not noticeable. No arm soreness either; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GH9693) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:01, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:02, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:03, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset 06Oct2022, outcome "recovering", described as "Noticed pinkish area at injection site. Only mildly sensitive when touched directly with finger, otherwise not noticeable. No arm soreness either". Therapeutic measures were not taken as a result of vaccination site discolouration.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She explained that she has taken the original vaccine (primary series) and two booster doses of the Pfizer-BioNTech COVID-19 Vaccine and that every dose made her very sick; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "sick"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She explained that she has taken the original vaccine (primary series) and two booster doses of the Pfizer-BioNTech COVID-19 Vaccine and that every dose made her very sick".  Additional information: Transferring agent stated, "She was an Optometrist, described that she had taken four doses of the Pfizer COVID-19 Vaccine and the original primary series and two booster doses and described that the vaccines (COVID-19 Vaccine) make her very sick both the primary and the booster doses. She also mentioned that she took a third booster dose from Moderna (Unspecified Vaccine) and that vaccine didn't make her sick at all. Patient was trying to find a Moderna Bivalent booster to take and did found where they are.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201206645 Same patient/drug/event, different dose;US-PFIZER INC-202201210015 Same patient/drug/event, different dose;
Sex: F
Vaccine: COVID19-2
Symptoms: Illness
Clinical narrative: every dose made her very sick; This is a spontaneous report received from a contactable reporter (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "very sick"; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "very sick"; Bnt162b2 (DOSE 3), for Covid-19 immunization, reaction(s): "very sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every dose made her very sick".  Additional information: The reporter was an Optometrist. It was reported that the patient was considering taking Paxlovid. She explained that she had taken four doses of the Pfizer COVID-19 Vaccine and the original primary series and two booster doses and that every dose made her very sick and each one made more sick then the one before. She suspects that this reaction was caused by gluten or an egg-derived ingredient. In order to take Paxlovid, she wanted to make sure that this medication does not contain any gluten. She described to be already very sick from COVID. She also said that she took a third booster dose (last dose) from Moderna, and that vaccine did not make her sick at all. So, the patient was trying to find a Moderna Bivalent booster to take, and she did find where they are. The patient just didn't have time to get the booster before she came down with COVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201206645 Same patient/drug/event, different dose;US-PFIZER INC-202201210013 Same patient/drug/event, different dose;US-PFIZER INC-202201210014 Same patient/drug/event, different dose;
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6201), in left arm, on 29Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: 33030BD) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. No allergies were reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 25Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Sep2022) Positive; (03Oct2022) Negative. Therapeutic measures were taken as a result of covid-19, vaccination failure.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 at 07:00 as dose 1, single (Lot number: EL0142), in left arm, on 13Jan2021 at 07:30 as dose 2, single (Lot number: EL1283), in right arm and on 04Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2569) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02May2022 at 12:00 as dose 4 (booster), single (Lot number: 049L21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. No known allergies. Concomitant medication(s) included: TYLENOL, start date: 27Sep2022, stop date: 03Oct2022; NEURONTIN, start date: 22Sep2022, stop date: 25Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of treatment failure, covid-19 included: COVID-19 Treatment (Brand: Pfizer, Lot number: GF1696) from 27Sep2022 to 01Oct2022 for treatment of COVID-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event vaccination failure and Covid-19  cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Being crushed underneath a train car for 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HAE-type 1" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "Being crushed underneath a train car for 4 days".  Additional information: The patient reported had HAE-type 1 and had all vaccines and boosters. It was reported that second vaccine reaction was like being crushed underneath a train car for 4 days. Hope this info/data was of some value.The patient was afraid to get another booster. The patient didn't had knowledge to knew if could become a fatality.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; PROGESTERON; THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 006B21A), in left arm and on 15Apr2021 as dose 2, single (Lot number: 040B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Lymphocytic Luekemia" (unspecified if ongoing), notes: Other medical history: Chronic Lymphocytic Luekemia; "Known allergies: sulpha drugs" (unspecified if ongoing), notes: Known allergies: sulpha drugs. There were no concomitant medications.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19; Positive, notes: tested positive with a strongly marked line. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 22Sep2022 to 27Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Nasopharyngeal swab, Off label use, SARS-CoV-2 test
Clinical narrative: scratch; dose 5 (booster); dose 4: Moderna, dose 5: Pfizer; dose 5 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: AH9702) at the age of 58 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (product: Pfizer , lot number: EP6955, dose number: 1, vaccine location: Left Arm), administration date: 22Mar2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (product: Pfizer, lot number: EP6955, dose number: 2, vaccine location: Left Arm), administration date: 12Apr2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (product: Pfizer, lot number: Ft2590, dose number: 3, vaccine location: Left Arm), administration date: 29Oct2021, when the patient was 57-year-old, for Covid-19 immunization; moderna (product: Moderna, lot number: 033K212A, dose number: 4, vaccine location: Left Arm), administration date: 01Apr2022, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Sep2022, outcome "unknown", described as "dose 4: Moderna, dose 5: Pfizer"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 21Sep2022, outcome "unknown" and all described as "dose 5 (booster)"; SCRATCH (non-serious) with onset 04Oct2022 at 21:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of scratch. Additional information: Patient was tested positive for COVID-19, developed fatigue, scratch through on 04Oct2022. On 05Oct2022, development more cold & Flu-like symptoms and took COVID-19 home test and tested positive. Report of test result to reporter on 05Oct2022. Patient believed to have been exposed to Covid at a school reunion on 01Oct2022. Reportedly, so far, 9 of 13 attendees at the dinner table that night have tested positive for COVID-19.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch
Clinical narrative: scratch; dose 5 (booster); dose 4: Moderna, dose 5: Pfizer; dose 5 (booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: AH9702) at the age of 58 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (product: Pfizer , lot number: EP6955, dose number: 1, vaccine location: Left Arm), administration date: 22Mar2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (product: Pfizer, lot number: EP6955, dose number: 2, vaccine location: Left Arm), administration date: 12Apr2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (product: Pfizer, lot number: Ft2590, dose number: 3, vaccine location: Left Arm), administration date: 29Oct2021, when the patient was 57-year-old, for Covid-19 immunization; moderna (product: Moderna, lot number: 033K212A, dose number: 4, vaccine location: Left Arm), administration date: 01Apr2022, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Sep2022, outcome "unknown", described as "dose 4: Moderna, dose 5: Pfizer"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 21Sep2022, outcome "unknown" and all described as "dose 5 (booster)"; SCRATCH (non-serious) with onset 04Oct2022 at 21:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of scratch. Additional information: Patient was tested positive for COVID-19, developed fatigue, scratch through on 04Oct2022. On 05Oct2022, development more cold & Flu-like symptoms and took COVID-19 home test and tested positive. Report of test result to reporter on 05Oct2022. Patient believed to have been exposed to Covid at a school reunion on 01Oct2022. Reportedly, so far, 9 of 13 attendees at the dinner table that night have tested positive for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, SARS-CoV-2 test, Vaginal haemorrhage
Clinical narrative: Uncontrollable Vaginal bleeding; anemia; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Aug2021 at 12:00 as dose 2, single (Lot number: FF2588) at the age of 34 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies:onion" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Omnicef, reaction(s): "known allergies: omnicef". Vaccination history included: BNT162b2 (Dose Number: 1; Batch/Lot No: EW0172; Location of injection: Arm Left), administration date: 06Aug2021, when the patient was 34-year-old, for COVID-19 immunization. The patient did not receive any other vaccines in four weeks and was not diagnosed with COVID-19 prior vaccination. The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 05Sep2021, outcome "recovered", described as "Uncontrollable Vaginal bleeding"; ANAEMIA (medically significant) with onset 05Sep2021, outcome "recovered", described as "anemia". The events "uncontrollable vaginal bleeding" and "anemia" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: if covid tested post vaccination: Yes. Therapeutic measures were taken as a result of vaginal haemorrhage, anaemia (IV iron, procedure d&c).; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaginal hemorrhage, anemia and the use of suspect product cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 13:45 as dose 5 (booster), single (Lot number: GJ6742) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy multiple" (unspecified if ongoing), notes: Known allergies: yes. Many; "MDS" (unspecified if ongoing); "Greves disease" (unspecified if ongoing); "bone marrow transplant" (unspecified if ongoing); "aplastic anemia" (unspecified if ongoing); "GVHD" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 20Sep2022 as dose 1, single; SYNTHROID; PREMARIN; TACROLIMUS; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Oct2022 at 18:00, outcome "recovering", described as "pain at the injection site"; FATIGUE (non-serious) with onset 05Oct2022 at 21:00, outcome "recovering". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: The reporter both the patient and a Pfizer colleague. Other medications in two weeks: vit. No covid tested post vaccination.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Many grasses for which I take allergy shots" (unspecified if ongoing), notes: Known allergies: Many grasses for which I take allergy shots. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "recovering", described as "Sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210338 same reporter/vaccine/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210306 same reporter/vaccine/event, different patient;
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct.; Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct.; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: AH9702) at the age of 57 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 29Oct2021 as dose 3 (booster), single (Lot number: Ft2590), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 033K212A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Oct2022 at 21:00, outcome "not recovered" and all described as "Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (05Oct2022) Positive; (05Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information:  Tested positive for COVID-19, developed fatigue, scratch through (as reported) on 04Oct. On 05Oct, development more cold & Flu-like symptoms and took COVID-19 home test and tested positive. Report of test result to me (name withheld) on 05Oct. [Note: Patient believes to have been exposed to Covid at a school reunion on 01Oct2022. Reportedly, so far, 9 of 13 attendees at the dinner table that night have tested positive for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210241 same patient, different drug/event;
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fall, Illness, SARS-CoV-2 test
Clinical narrative: positive for Covid after one dose vaccine; positive for Covid after one dose vaccine; sick; Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EN6201) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing), notes: AFib; "COVID-19" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid after one dose vaccine"; ILLNESS (non-serious), outcome "unknown", described as "sick"; FALL (non-serious), outcome "unknown", described as "Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down". The events "then went and got the shot for it. afterwards, went back to the doctor because she was falling down" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2021) Positive. Additional information: Had Afib and takes a blood thinner and heart pill to slow the heart down. Takes something else for the heart. The patient had Covid-19 vaccine, she felt sick after receiving them. Patient tested positive for Covid. Had it bad, a long time there, she was really sick. Actually, had Covid before. The first time was down for 6 weeks, probably. Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down. Tested again positive and it was not as bad as the first time, because she had the shot. Has not had any Covid vaccines prior to first time testing positive for Covid. When she was positive for Covid the second time, she had received just one dose of the Covid vaccine, prior.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210424 same patient, different vaccine dose/AE;US-PFIZER INC-202201209676 same patient, different vaccine dose/AE;US-PFIZER INC-202201210236 same patient, different vaccine dose/AE;US-PFIZER INC-202201210237 same patient, different vaccine dose/AE;
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 3 (booster), single (Lot number: GJ6742) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Second dose, lot number=EP6955,), for COVID-19 Immunization; Bnt162b2 (First dose, lot number=EL3247), for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 06Oct2022, outcome "unknown", described as "Muscle ache"; HEADACHE (non-serious) with onset 06Oct2022, outcome "unknown". Therapeutic measures were not taken as a result of headache, myalgia.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 as dose 2, single (Lot number: EK5730), in left arm, on 16Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 16Jun2022 as dose 4 (booster), single (Lot number: FM2593) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypo-Para-Thyroidism" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL, start date: 01Mar2002; ENALAPRIL; PROGESTERONE ABBOTT; CEPHALEXIN [CEFALEXIN]; CALCIUM CITRATE; LORAZEPAM; CALCITRIOL; CHLORTHALIDONE; KLOR-CON; LIPITOR; NATURE MADE VITAMIN D3; TURMERIC [CURCUMA LONGA]; CRANBERRY; METHOCARBAMOL. The patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details (COVID-19 Treatment): PAXLOVID from 03Oct2022 to 05Oct2022.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CIDP" (unspecified if ongoing); "DM2" (unspecified if ongoing); "Known allergies: Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bronchiectasis" (unspecified if ongoing); "Sjogrens disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Sep2020; ADVAIR, start date: Jan2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment (Brand- Pfizer) orally from 26Sep2022 to 01Oct2022 for treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "P.O.T.S" (unspecified if ongoing), notes: Other medical history: P.O.T.S; "Asthma" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; FAMOTIDINE. Past drug history included: Demerol, reaction(s): "Allergy", notes: Known allergies: Demerol. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 25Sep2022 to 29Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.