chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Erythema, Haemorrhage, Hypersensitivity, Lacrimation increased
Clinical narrative: rash on her throat, her leg, her face; lost her voice completely/ Couldn't talk/She is not able to speak; allergic reaction; face is so red; bottom of the throat is little swollen; eyes are watery; she itched in blood; excessive bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2022 14:15 (Lot number: FJ1611) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Alopecia effluvium" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. The following information was reported: RASH (hospitalization, medically significant) with onset 14Jan2022, outcome "not recovered", described as "rash on her throat, her leg, her face"; APHONIA (hospitalization, medically significant) with onset 13Jan2022, outcome "not recovered", described as "lost her voice completely/ Couldn't talk/She is not able to speak"; HAEMORRHAGE (medically significant) with onset Jan2022, outcome "unknown", described as "excessive bleeding"; HYPERSENSITIVITY (medically significant) with onset 14Jan2022, outcome "unknown", described as "allergic reaction"; ERYTHEMA (medically significant) with onset Jan2022, outcome "not recovered", described as "face is so red"; PHARYNGEAL SWELLING (medically significant) with onset Jan2022, outcome "unknown", described as "bottom of the throat is little swollen"; LACRIMATION INCREASED (medically significant) with onset Jan2022, outcome "unknown", described as "eyes are watery"; PRURITUS (medically significant) with onset Jan2022, outcome "unknown", described as "she itched in blood". The events "rash on her throat, her leg, her face", "lost her voice completely/ couldn't talk/she is not able to speak", "excessive bleeding", "allergic reaction", "face is so red", "bottom of the throat is little swollen", "eyes are watery" and "she itched in blood" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash, aphonia, haemorrhage, hypersensitivity, erythema, pharyngeal swelling, lacrimation increased, pruritus.  Clinical course: Patient was prescribed with dexamethasone and Benadryl for the events. Patient had no prior vaccination (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Rash
Clinical narrative: rash on her throat, her leg, her face; lost her voice completely/ Couldn't talk/She is not able to speak; allergic reaction; face is so red; bottom of the throat is little swollen; eyes are watery; she itched in blood; excessive bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Jan2022 14:15 (Lot number: FJ1611) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Alopecia effluvium" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. The following information was reported: RASH (hospitalization, medically significant) with onset 14Jan2022, outcome "not recovered", described as "rash on her throat, her leg, her face"; APHONIA (hospitalization, medically significant) with onset 13Jan2022, outcome "not recovered", described as "lost her voice completely/ Couldn't talk/She is not able to speak"; HAEMORRHAGE (medically significant) with onset Jan2022, outcome "unknown", described as "excessive bleeding"; HYPERSENSITIVITY (medically significant) with onset 14Jan2022, outcome "unknown", described as "allergic reaction"; ERYTHEMA (medically significant) with onset Jan2022, outcome "not recovered", described as "face is so red"; PHARYNGEAL SWELLING (medically significant) with onset Jan2022, outcome "unknown", described as "bottom of the throat is little swollen"; LACRIMATION INCREASED (medically significant) with onset Jan2022, outcome "unknown", described as "eyes are watery"; PRURITUS (medically significant) with onset Jan2022, outcome "unknown", described as "she itched in blood". The events "rash on her throat, her leg, her face", "lost her voice completely/ couldn't talk/she is not able to speak", "excessive bleeding", "allergic reaction", "face is so red", "bottom of the throat is little swollen", "eyes are watery" and "she itched in blood" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash, aphonia, haemorrhage, hypersensitivity, erythema, pharyngeal swelling, lacrimation increased, pruritus.  Clinical course: Patient was prescribed with dexamethasone and Benadryl for the events. Patient had no prior vaccination (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Seizure
Clinical narrative: SEIZURE; This is a spontaneous report received from a contactable reporter(s) (Physician). Other Case identifier(s): EC-2022-106820.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; perampanel (FYCOMPA), first regimen since Dec2021 (Batch/Lot number: unknown) for 2 weeks at 2 mg 1x/day (2 mg, 1x1d, approx 2 weeks) and second regimen (Batch/Lot number: unknown) at 4 mg 1x/day (4 mg, 1x1d) for seizure. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "SEIZURE". The action taken for perampanel was unknown. The patient started Fycompa approximately 4 weeks ago at 2 mg/day, which was then increased to 4 mg/day and the patient became seizure free. The patient recently received a COVID-19 vaccine (unspecified) after which the patient had a seizure. Physician plans to increase Fycompa to 6 mg/day to stabilize the seizure.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event SEIZURE  and the suspect drug BNT162B2 cannot be 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Daughter tested positive for COVID-19/Experiencing symptoms of low grade fever, chest congestion, cough, nasal congestion.; Daughter tested positive for COVID-19/Experiencing symptoms of low grade fever, chest congestion, cough, nasal congestion.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13 year-old female patient received bnt162b2 (BNT162B2), administration date 10Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 20May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Treated for asthma; "Allergies" (unspecified if ongoing), notes: Treated for asthma and allergies. 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 "Daughter tested positive for COVID-19/Experiencing symptoms of low grade fever, chest congestion, cough, nasal congestion.". The patient has not received the booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Menstruation delayed
Clinical narrative: issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 09:30 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION DELAYED (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious) all with onset 29Nov2021, outcome "not recovered" and all described as "issue with menstrual cycles. Being late and an ungodly amount of blood, clots, and cramps". Therapeutic measures were not taken as a result of menstruation delayed, heavy menstrual bleeding, menstrual disorder, dysmenorrhoea. Additional information: No other vaccine was given in four weeks. The adverse events started on 29Nov2021, 12:00 AM. The patient had no COVID-19 prior to vaccination. It was unknown if patient was tested with COVID-19 post vaccination. The patient has no known allergies, other medical history: none. The patient received Pfizer COVID-19 Vaccine dose 2 on 12Jan2022, 02:30 PM at the right arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old male patient received BNT162B2 (BNT162B2), administered in arm right, administration date 13Dec2021 17:00 (Lot number: FJ1620, Expiration Date: Feb2022) at the age of 16 years as dose 3 (booster), single for COVID-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, single; lot number: EW0186; site: left upper arm; time: 09:00), administration date: 14May2021, when the patient was 15 years old, for COVID-19 immunization; BNT162B2 (dose 2, single; lot number: EW0191; site: maybe right upper arm; time: 09:00), administration date: 03Jun2021, when the patient was 15 years old, for COVID-19 immunization. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 16Dec2021, outcome "unknown", described as "Myocarditis". The patient was hospitalized for myocarditis (start date: 16Dec2021, discharge date: 18Dec2021, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: echocardiogram: myocarditis; electrocardiogram: myocarditis; troponin: myocarditis. Clinical course: The patient had a lot of tests during hospitalization. All of the tests showed myocarditis. The tests included troponin, EKG, and echoes.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Kidney infection, Pollakiuria, Renal pain
Clinical narrative: I am having like a kidney infection; Lot of kidney pain; Have a lot of kidney pain on my left one; Going constantly to the bathroom; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 14Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number Unknown, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: KIDNEY INFECTION (medically significant) with onset 16Jan2022, outcome "unknown", described as "I am having like a kidney infection"; RENAL PAIN (non-serious) with onset 16Jan2022, outcome "not recovered", described as "Lot of kidney pain; Have a lot of kidney pain on my left one"; POLLAKIURIA (non-serious) with onset 16Jan2022, outcome "unknown", described as "Going constantly to the bathroom".  Clinical Information: Consumer stated, "I took the Pfizer on Friday at around 3:30 at my job, the booster and today, I am having a lot of kidney pain and going constantly to the bathroom, I have an infection I think. Is this normal" When probed for the vaccine name, consumer stated, "I took Pfizer, the booster." When further confirmed if consumer took Pfizer Covid-19 booster shot, consumer stated, "Yes, I did took it on Friday and today, I still have a lot of kidney pain on my left one and going constantly to the bathroom. When again confirmed if consumer took Pfizer Covid-19 vaccine, consumer stated, "I took the booster. Consumer's telephone: 'withheld' (not appropriately paraphrased and clarified further, hence not captured in tab. When paraphrased the concern, consumer stated, "Yes, if this is the consequence I am having a lot of kidney pain and I am going to the bathroom, I am having like a kidney infection." Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department. Consumer further stated, "Why is this says to call Pfizer, this number in case we have some problem and you are giving me another number. You didn't help me at all, so why you put this number to call if you have any problem Why did they give this number that you all supposed to help us and you do not know anything, then what is the purpose of giving this number. So, what is the number I have to call. Consumer was provided with the number of Pfizer Medical Information. Consumer stated, "What about today Are they open Consumer was informed that Pfizer Medical Information remains closed on weekends  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for covid./cough, congestion, and exhaustion; positive for covid./cough, congestion, and exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 14 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. No COVID prior vaccination. The patient's relevant medical history and concomitant medications were not reported. It was unknown If there was other vaccine in four weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "not recovered" and all described as "positive for covid./cough, congestion, and exhaustion". The event "positive for covid./cough, congestion, and exhaustion" and "positive for covid./cough, congestion, and exhaustion" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: COVID test type post vaccination: Unknown,. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: positive home covid test 15Jan; positive home covid test 15Jan; awoke with 101.7 F fever; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 (Lot number: FJ614) at the age of 15 years as dose 3 (booster), single, administered in arm left, administration date 05Jun2021 (Lot number: ew0178) as dose 2, single and administration date 13May2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Patient had no known allergies. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "not recovered" and all described as "positive home covid test 15Jan"; PYREXIA (non-serious) with onset 15Jan2022, outcome "not recovered", described as "awoke with 101.7 F fever"; COUGH (non-serious) with onset 15Jan2022, outcome "not recovered", described as "cough". The patient underwent the following laboratory tests and procedures: body temperature: (15Jan2022) 101.7 Fahrenheit; sars-cov-2 test: (15Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, cough and included treatment with Tylenol.  Clinical Course: It was reported that facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination.  Additional Information: On 18Jan2022, product quality complaint conclusion was reported as, the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0169 and lot EW0178 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0169, fill lot EP8700, finished goods lot EW0178, fill lot EP8729 and the bulk formulated drug product EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: positive home covid test 15Jan; positive home covid test 15Jan; awoke with 101.7 F fever; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 (Lot number: FJ614) at the age of 15 years as dose 3 (booster), single, administered in arm left, administration date 05Jun2021 (Lot number: ew0178) as dose 2, single and administration date 13May2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Patient had no known allergies. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "not recovered" and all described as "positive home covid test 15Jan"; PYREXIA (non-serious) with onset 15Jan2022, outcome "not recovered", described as "awoke with 101.7 F fever"; COUGH (non-serious) with onset 15Jan2022, outcome "not recovered", described as "cough". The patient underwent the following laboratory tests and procedures: body temperature: (15Jan2022) 101.7 Fahrenheit; sars-cov-2 test: (15Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia, cough and included treatment with Tylenol.  Clinical Course: It was reported that facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid tested post vaccination.  Additional Information: On 18Jan2022, product quality complaint conclusion was reported as, the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0169 and lot EW0178 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0169, fill lot EP8700, finished goods lot EW0178, fill lot EP8729 and the bulk formulated drug product EP8602. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast atrophy
Clinical narrative: after the third dose, she states that her breasts started shrinking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, for COVID-19 immunization, reaction(s): "After the first shot, she noticed her breasts were growing back"; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: BREAST ATROPHY (non-serious), outcome "unknown", described as "after the third dose, she states that her breasts started shrinking". Therapeutic measures were not taken as a result of breast atrophy.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Breakout in hives up to now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 09:00 (Lot number: 301468) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol, hypertension,, irregular heart rate; "hypertension" (unspecified if ongoing); "irregular heart rate" (unspecified if ongoing). The patient had no known allergies. Concomitant medications (other medications in two weeks) included: CARVEDILOL; ATORVASTATIN; LOSARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 24Feb2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 03Feb2021, when the patient was 60 years old, for Covid-19 immunization. The patient not received any other vaccine in four weeks.  The following information was reported: URTICARIA (hospitalization) with onset 16Oct2021, outcome "not recovered", described as "Breakout in hives up to now". The event "breakout in hives up to now" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of urticaria.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result=Positive / covid test date=Jul/2021; covid test result=Positive / covid test date=Jul/2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 17:30 (Lot number: EN6205) at the age of 57 years as dose 1, single and administered in arm right, administration date 25Mar2021 17:30 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "unknown" and all described as "covid test result=Positive / covid test date=Jul/2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jul2021) positive, notes: Nasal Swab; (Jul2021) negative, notes: Nasal Swab; (17Dec2021) negative, notes: Nasal Swab; (01Jan2022) negative, notes: Nasal Swab; (May2020) negative, notes: Nasal Swab; (Jun2020) negative, notes: Nasal Swab; (Oct2020) negative, notes: Nasal Swab; (Apr2021) negative, notes: Nasal Swab; (Jun2021) negative, notes: Nasal Swab; (Jul2021) positive, notes: Nasal Swab; (16Dec2021) negative, notes: Nasal Swab. No other vaccine in four weeks. No covid prior vaccination. covid tested post vaccination. Conclusion of Previously Completed Investigation (RA): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8727 was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot# EN6205 and ER8727. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Echocardiogram, Electrocardiogram, Heart rate, Laboratory test
Clinical narrative: I had a stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 16:45 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing). No known allergies reported. The patient took concomitant medication included Zquil medications in two weeks. Patient did not have covid prior vaccination. Patient was tested for covid post vaccination. Patient did not receive any other vaccine in four weeks. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 09Sep2021, outcome "recovered with sequelae", described as "I had a stroke". Adverse event: Patient had a stroke 9 days after vaccine. The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "i had a stroke" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; heart rate: (unspecified date) unknown results; laboratory test: (unspecified date) unknown results, notes: Many Tests; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (12Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident included many tests, MRI, EKG, heart monitor, ECHO.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: I had a stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 16:45 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing). No known allergies reported. The patient took concomitant medication included Zquil medications in two weeks. Patient did not have covid prior vaccination. Patient was tested for covid post vaccination. Patient did not receive any other vaccine in four weeks. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, medically significant, life threatening) with onset 09Sep2021, outcome "recovered with sequelae", described as "I had a stroke". Adverse event: Patient had a stroke 9 days after vaccine. The patient was hospitalized for cerebrovascular accident (hospitalization duration: 2 day(s)). The event "i had a stroke" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; heart rate: (unspecified date) unknown results; laboratory test: (unspecified date) unknown results, notes: Many Tests; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (12Oct2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of cerebrovascular accident included many tests, MRI, EKG, heart monitor, ECHO.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bells Palsy, Left side of face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 10:00 (Lot number: FE3594) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Patient had no other vaccine in four weeks. There were no concomitant medications in two weeks. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8736, Expiration date: 31Jul2021, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 11May2021, when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 13Apr2021, when the patient was 28 years old, for COVID-19 Immunization. Patient was not diagnosed with COVID-19, prior to vaccination. On 29Dec2021, patient had been tested for COVID-19 via polymerase chain reaction (PCR) test, result was negative.  The following information was reported: BELL'S PALSY (medically significant) with onset 03Jan2022 08:00, outcome "recovering", described as "Bells Palsy, Left side of face". The event "bells palsy, left side of face" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: on 03Jan2022, patient had been for COVID-19 via nasal swab, result was negative and on 05Jan2022, patient had been for COVID-19 via nasal swab, result was negative. Therapeutic measures were taken as a result of bell's palsy and treatment included week of prednisone and anti-viral medication. The investigation results were reported and the investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8737, fill lot EW3426, and the bulk formulated drug product lot EP8586 and lot ER8736, fill lot EP8688, and the bulk formulated drug product lot EP8585. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I keep getting COVID, when I have the vaccine; I keep getting COVID, when I have the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I keep getting COVID, when I have the vaccine". The patient was just wondering why no one was liable for any of the side effects for the COVID-19 Vaccine when patient keep getting COVID, when have the vaccine. Patient was informed about the Role of Pfizer Drug Safety and Pfizer Medical Information Department. As consumer was unwilling to complete the report, further probing could not be done. Hence, limited information available over the call and appropriate response could not be provided over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood testosterone, Blood testosterone decreased, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Low testosterone; Test: Covid-19 Antigen/Result: Positive; Test: Covid-19 Antigen/Result: Positive; cough; Sore throat; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Sep2021 11:30 (Lot number: 301358A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Skin health" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 25Sep2021; RETIN-A taken for skin disorder, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Date: 13Jan2021, Time: 09:30, Anatomical site of injection: Left deltoid, Route of administration: Intrmuscular, Batch/Lot Number: EL3248), administration date: 13Jan2021, for COVID-19 Immunization, reaction(s): "Low testosterone"; Bnt162b2 (Dose: 2, Date: 03Feb2021, Time: 10:00, Anatomical site of injection: Left deltoid, Route of administration: Intrmuscular, Batch/Lot Number: EL9269), administration date: 03Feb2021, for COVID-19 immunization. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), VACCINATION FAILURE (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Test: Covid-19 Antigen/Result: Positive"; COUGH (non-serious) with onset 31Dec2021, outcome "recovered" (07Jan2022), described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "recovering", described as "Sore throat"; BLOOD TESTOSTERONE DECREASED (non-serious), outcome "not recovered", described as "Low testosterone"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "Fatigue". The patient underwent the following laboratory tests and procedures: blood testosterone: (unspecified date) low; sars-cov-2 test: (28Dec2021) negatie; (04Jan2022) positive; (04Jan2022) positive, notes: second confirmatory positive test; (07Jan2022) positive; (08Jan2022) positive; (09Jan2022) negative; (10Jan2022) negative, notes: second confirmatory negative test. Therapeutic measures were taken as a result of cough, oropharyngeal pain, blood testosterone decreased included ibuprofen, Dextromethorphan Br, Guaifenesin, Phenylephrine HCL. Therapeutic measures were not taken as a result of fatigue.  Clinical course: Ondansetron/Zofran oral 30Dec2021-30Dec2021 for post surgery nausea.Cefadroxil oral 31Dec2021-07Jan2022 for post surgery infection prophylaxis.Mucinex Fast-Max severe (Dextromethorphan HBr/Guaifenesin/Phenylephrine HCL) oral 31Dec2021-07Jan2022 for cough.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: Low testosterone; Test: Covid-19 Antigen/Result: Positive; Test: Covid-19 Antigen/Result: Positive; cough; Sore throat; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Sep2021 11:30 (Lot number: 301358A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Skin health" (unspecified if ongoing). Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 25Sep2021; RETIN-A taken for skin disorder, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Date: 13Jan2021, Time: 09:30, Anatomical site of injection: Left deltoid, Route of administration: Intrmuscular, Batch/Lot Number: EL3248), administration date: 13Jan2021, for COVID-19 Immunization, reaction(s): "Low testosterone"; Bnt162b2 (Dose: 2, Date: 03Feb2021, Time: 10:00, Anatomical site of injection: Left deltoid, Route of administration: Intrmuscular, Batch/Lot Number: EL9269), administration date: 03Feb2021, for COVID-19 immunization. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), VACCINATION FAILURE (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Test: Covid-19 Antigen/Result: Positive"; COUGH (non-serious) with onset 31Dec2021, outcome "recovered" (07Jan2022), described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "recovering", described as "Sore throat"; BLOOD TESTOSTERONE DECREASED (non-serious), outcome "not recovered", described as "Low testosterone"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovering", described as "Fatigue". The patient underwent the following laboratory tests and procedures: blood testosterone: (unspecified date) low; sars-cov-2 test: (28Dec2021) negatie; (04Jan2022) positive; (04Jan2022) positive, notes: second confirmatory positive test; (07Jan2022) positive; (08Jan2022) positive; (09Jan2022) negative; (10Jan2022) negative, notes: second confirmatory negative test. Therapeutic measures were taken as a result of cough, oropharyngeal pain, blood testosterone decreased included ibuprofen, Dextromethorphan Br, Guaifenesin, Phenylephrine HCL. Therapeutic measures were not taken as a result of fatigue.  Clinical course: Ondansetron/Zofran oral 30Dec2021-30Dec2021 for post surgery nausea.Cefadroxil oral 31Dec2021-07Jan2022 for post surgery infection prophylaxis.Mucinex Fast-Max severe (Dextromethorphan HBr/Guaifenesin/Phenylephrine HCL) oral 31Dec2021-07Jan2022 for cough.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; Fever; Bad headache; Severe body aches; Sweats; Neck and back pain; Neck and back pain; Nausea; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 13Jan2022 (lot number: FL3197) at the age of 27-years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication included: ESCITALOPRAM taken for anxiety. Vaccination history included: BNT162B2 (as dose 1, single), for COVID-19 immunisation and BNT162B2 (as dose 2, single), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 14Jan2022, outcome "recovering", described as "Flu like symptoms"; PYREXIA (non-serious) with onset 14Jan2022, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 14Jan2022, outcome "recovering", described as "Bad headache"; PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "Severe body aches"; HYPERHIDROSIS (non-serious) with onset 14Jan2022, outcome "recovering", described as "Sweats"; NECK PAIN (non-serious) and BACK PAIN (non-serious) all with onset 14Jan2022, outcome "recovering" and all described as "Neck and back pain"; and NAUSEA (non-serious) with onset 14Jan2022, outcome "recovering", described as "Nausea."  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Fever; Bad headache; Severe body aches; Sweats; Neck and back pain; Neck and back pain; Nausea; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 13Jan2022 (lot number: FL3197) at the age of 27-years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication included: ESCITALOPRAM taken for anxiety. Vaccination history included: BNT162B2 (as dose 1, single), for COVID-19 immunisation and BNT162B2 (as dose 2, single), for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 14Jan2022, outcome "recovering", described as "Flu like symptoms"; PYREXIA (non-serious) with onset 14Jan2022, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 14Jan2022, outcome "recovering", described as "Bad headache"; PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "Severe body aches"; HYPERHIDROSIS (non-serious) with onset 14Jan2022, outcome "recovering", described as "Sweats"; NECK PAIN (non-serious) and BACK PAIN (non-serious) all with onset 14Jan2022, outcome "recovering" and all described as "Neck and back pain"; and NAUSEA (non-serious) with onset 14Jan2022, outcome "recovering", described as "Nausea."  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: left arm paralyzed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MONOPLEGIA (disability, medically significant), outcome "unknown", described as "left arm paralyzed".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested Covid positive; tested Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "tested Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Delirium, Headache, Pyrexia, Rash macular
Clinical narrative: hotspots on random parts of the body that lasted two days; very high temperature which made him delirious; Violent vomiting; very high temperature which made him delirious; bad headache; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (Pfizer Covid Vaccine Boost34- Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown. , Manufacturer unknown), for Covid-19 Immunization. The following information was reported: DELIRIUM (medically significant), PYREXIA (non-serious), outcome "unknown" and all described as "very high temperature which made him delirious"; VOMITING (non-serious), outcome "unknown", described as "Violent vomiting"; HEADACHE (non-serious), outcome "unknown", described as "bad headache"; RASH MACULAR (non-serious), outcome "recovered", described as "hotspots on random parts of the body that lasted two days". The patient underwent the following laboratory tests and procedures: body temperature: very high. No underlying conditions reported by the patient's wife. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.