chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Arrhythmia, Chills, Fatigue, Pyrexia
Clinical narrative: and months of intermittent heart arrhythmia and pain; and months of intermittent heart arrhythmia and pain; severe fever; chills; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Batch/Lot number and expiration date unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes 2" (unspecified if ongoing), notes: diabetes 2; "known allergies: NSAIDs" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), administration date: 2021 (also reported as Feb2021), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), administration date: 2021 (also reported as Mar2021), for COVID-19 immunization. The following information was reported: ARRHYTHMIA (medically significant), ANGINA PECTORIS (medically significant) all with onset 06Oct2021, outcome "recovering" and all described as "and months of intermittent heart arrhythmia and pain"; PYREXIA (non-serious) with onset 06Oct2021, outcome "recovering", described as "severe fever"; CHILLS (non-serious) with onset 06Oct2021, outcome "recovering", described as "chills"; FATIGUE (non-serious) with onset 06Oct2021, outcome "recovering", described as "fatigue". Clinical course: Initial reaction to 3rd dose was severe fever and chills lasting 4-5 days, followed by 3 weeks of major fatigue, and months of intermittent heart arrhythmia and pain. She went to the emergency room for the heart issues. The events were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of arrhythmia, angina pectoris and treatment included propranolol. The patient didn't received other vaccine in four weeks. The patient received other medications in two weeks. There was no  covid prior vaccination or covid tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: She got covid-19 infection; She got covid  19 infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (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) with onset Aug2021, outcome "unknown", described as "she got covid-19 infection"; SUSPECTED COVID-19 (medically significant) with onset Aug2021, outcome "unknown", described as "she got covid  19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Visual acuity reduced, Visual field defect, Visual impairment
Clinical narrative: extreme ocular adverse event, with severe diminution in visual acuity in his right eye.; Vision was dimmer; visual field is extremely distorted; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jan2022 13:30 (Lot number: FJ6369) at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history or known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 10May2021, when the patient was 31 years old, for COVID-19 immunization; bnt162b2 (Dose Number: 1, Batch/Lot No: EW0169, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 19Apr2021, when the patient was 31 years old, for COVID-19 immunization. The day following the 3rd dose on 20Jan2022 at 08:00, the patient woke up suffering from an extreme ocular adverse event, with severe diminution in visual acuity in his right eye. Vision was dimmer, and visual field was extremely distorted. The events "extreme ocular adverse event, with severe diminution in visual acuity in his right eye.", "vision was dimmer" and "visual field is extremely distorted" were evaluated at the physician office visit and serious for being disabling. Therapeutic measures were not taken as a result of visual acuity reduced, visual impairment, visual field defect. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not resolved.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling and pain right axillary lymph nodes tenderness; Swelling and pain right axillary lymph nodes tenderness; tenderness lateral right breast; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jan2022 10:45 (Lot number: 330368D) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 041L20A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 29Jan2021, when the patient was 56 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 037K20A, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 30Dec2020, when the patient was 56 years old, for COVID-19 Immunization. The following information was reported: LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 26Jan2022, outcome "recovering" and all described as "Swelling and pain right axillary lymph nodes tenderness"; BREAST TENDERNESS (non-serious) with onset 26Jan2022, outcome "recovering", described as "tenderness lateral right breast".  Additional information: Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no. The patient had not received any other vaccine within 4 weeks. Patient was not taken any other medications with in 2 Weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. AE resulted in: None of the above.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Laboratory test, Lumbar puncture
Clinical narrative: had both COVID vaccines and the booster dose and developed COVID; had both COVID vaccines and the booster dose and developed COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dementia" (unspecified if ongoing); "cognitive age related impairment", start date: 2017 (unspecified if ongoing); "subdural hematoma" (unspecified if ongoing), notes: 2 years prior; "horrible twisted feet/ bunions and are torched to the side" (unspecified if ongoing). Concomitant medication(s) included: CLINDAMYCIN taken for localised infection (ongoing); PREDNISOLONE taken for localised infection (ongoing); ARICEPT taken for dementia alzheimer's type, start date: 2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "had both COVID vaccines and the booster dose and developed COVID". The patient underwent the following laboratory tests and procedures: computerised tomogram: (24Sep2021) unknown results; laboratory test: (2017) cognitive age related impairment, notes: initial testing; (Mar2021) showed definite change; lumbar puncture: (01Oct2021) leptin lymphocytic meningitis, notes: she was diagnosed with that on 01Oct2021 but those symptoms developed on 22Sep2021; magnetic resonance imaging: (Mar2021) loss of volume in regions, notes: that are pretty commonly associated with Alzheimer's; sars-cov-2 test: (unspecified date) positive, notes: developed COVID. Therapeutic measures were taken as a result of covid-19. Patient has been diagnosed with COVID, she has had both COVID vaccines plus the booster, but she got COVID. The patient basically started with coughing and other symptoms around 20Jan2022 and her doctor prescribed her a steroid, Prednisolone 20 mg and PAXLOVID 4 mg BID for 5 days.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: had both COVID vaccines and the booster dose and developed COVID; had both COVID vaccines and the booster dose and developed COVID; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) at the age of 85 years as dose 3 (booster), single, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dementia" (unspecified if ongoing); "cognitive age related impairment", start date: 2017 (unspecified if ongoing); "subdural hematoma" (unspecified if ongoing), notes: 2 years prior; "horrible twisted feet/ bunions and are torched to the side" (unspecified if ongoing). Concomitant medication(s) included: CLINDAMYCIN taken for localised infection (ongoing); PREDNISOLONE taken for localised infection (ongoing); ARICEPT taken for dementia alzheimer's type, start date: 2021 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "had both COVID vaccines and the booster dose and developed COVID". The patient underwent the following laboratory tests and procedures: computerised tomogram: (24Sep2021) unknown results; laboratory test: (2017) cognitive age related impairment, notes: initial testing; (Mar2021) showed definite change; lumbar puncture: (01Oct2021) leptin lymphocytic meningitis, notes: she was diagnosed with that on 01Oct2021 but those symptoms developed on 22Sep2021; magnetic resonance imaging: (Mar2021) loss of volume in regions, notes: that are pretty commonly associated with Alzheimer's; sars-cov-2 test: (unspecified date) positive, notes: developed COVID. Therapeutic measures were taken as a result of covid-19. Patient has been diagnosed with COVID, she has had both COVID vaccines plus the booster, but she got COVID. The patient basically started with coughing and other symptoms around 20Jan2022 and her doctor prescribed her a steroid, Prednisolone 20 mg and PAXLOVID 4 mg BID for 5 days.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dry mouth, Hypogeusia, Hyposmia, Nasal dryness
Clinical narrative: Chronic dry mouth; Dry nasal passages; Lacks ability to smell; Lacks ability to taste; Has not had a good meal in about 4 weeks; 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 male patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (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: DRY MOUTH (non-serious), outcome "unknown", described as "Chronic dry mouth"; NASAL DRYNESS (non-serious), outcome "unknown", described as "Dry nasal passages"; HYPOSMIA (non-serious), outcome "unknown", described as "Lacks ability to smell"; HYPOGEUSIA (non-serious), outcome "unknown", described as "Lacks ability to taste"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Has not had a good meal in about 4 weeks".  Additional information: Clinical course: It was reported that patient got his first shot on 05Jan2022 since then, he has had chronic dry mouth, and dry nasal passages. He still lacks smell or taste. Overnight his mouth feels dry, like there is dirt in his mouth, and his nasal passages are dry. Patient wants to know if these symptoms will continue and will they go away and anyone else reported these events. Patient was supposed to get his second shot today and the nurse at the vaccine site could not answer his question. He may not get his second shot and has not had a good meal in about four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy bone, Culture, Eye swelling, Localised infection, Ocular hyperaemia
Clinical narrative: left thumb infection; swollen face; extremely red swollen eyes; extremely red swollen eyes; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jun2021 17:30 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "RA", start date: 2001 (ongoing); "surgery", start date: 01Jul2021 (unspecified if ongoing). Concomitant medication(s) included: RINVOQ taken for rheumatoid arthritis (RA), start date: Jul2020, stop date: Jun2021. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: EP7534, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Time: 5.30 pm), administration date: 14May2021, for COVID-19 immunization, reaction(s): "Tired", "headache", "extreme fatigue", "Bad RA flare", "hot,cold", "red face", "In bed 3 days", "joint pain from RA got worse", "joint pain from RA got worse". The following information was reported: LOCALISED INFECTION (hospitalization, medically significant) with onset Jun2021, outcome "not recovered", described as "left thumb infection"; SWELLING FACE (non-serious) with onset 05Jun2021, outcome "recovered" (06Jun2021), described as "swollen face"; OCULAR HYPERAEMIA (non-serious), EYE SWELLING (non-serious) all with onset 05Jun2021, outcome "recovered" (06Jun2021) and all described as "extremely red swollen eyes". The patient was hospitalized for localised infection (hospitalization duration: 6 day(s)). The event "left thumb infection" was evaluated at the physician office visit and emergency room visit. With second dose the patient experienced the following events: next day woke up with swollen face, extremely red swollen eyes, took a diphenhydramine (BENADRYL) and got better by next day. Left thumb infection got worse, went to urgent care on 21Jun2021 took antibiotics for a week, did not work. Rheumatologist sent her to ER on 29Jun2021, bad thumb infection went to trauma unit in another hospital. Wanted to amputate thumb, said no.  Had surgery on 01Jul2021. Took cultures and bone biopsy (unknown results). Treated for infection, in hospital 6 days at home IV with pic in arm with daptomycin. Didn't have problem with infection until after vaccine. Thumb hurt some before, but it could have just been joint pain from RA; stopped RINVOQ. Getting no treatment for RA afraid to suppress immune system.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: left thumb infection; swollen face; extremely red swollen eyes; extremely red swollen eyes; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jun2021 17:30 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. Relevant medical history included: "RA", start date: 2001 (ongoing); "surgery", start date: 01Jul2021 (unspecified if ongoing). Concomitant medication(s) included: RINVOQ taken for rheumatoid arthritis (RA), start date: Jul2020, stop date: Jun2021. Vaccination history included: Bnt162b2 (Dose 1, Batch/lot number: EP7534, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Time: 5.30 pm), administration date: 14May2021, for COVID-19 immunization, reaction(s): "Tired", "headache", "extreme fatigue", "Bad RA flare", "hot,cold", "red face", "In bed 3 days", "joint pain from RA got worse", "joint pain from RA got worse". The following information was reported: LOCALISED INFECTION (hospitalization, medically significant) with onset Jun2021, outcome "not recovered", described as "left thumb infection"; SWELLING FACE (non-serious) with onset 05Jun2021, outcome "recovered" (06Jun2021), described as "swollen face"; OCULAR HYPERAEMIA (non-serious), EYE SWELLING (non-serious) all with onset 05Jun2021, outcome "recovered" (06Jun2021) and all described as "extremely red swollen eyes". The patient was hospitalized for localised infection (hospitalization duration: 6 day(s)). The event "left thumb infection" was evaluated at the physician office visit and emergency room visit. With second dose the patient experienced the following events: next day woke up with swollen face, extremely red swollen eyes, took a diphenhydramine (BENADRYL) and got better by next day. Left thumb infection got worse, went to urgent care on 21Jun2021 took antibiotics for a week, did not work. Rheumatologist sent her to ER on 29Jun2021, bad thumb infection went to trauma unit in another hospital. Wanted to amputate thumb, said no.  Had surgery on 01Jul2021. Took cultures and bone biopsy (unknown results). Treated for infection, in hospital 6 days at home IV with pic in arm with daptomycin. Didn't have problem with infection until after vaccine. Thumb hurt some before, but it could have just been joint pain from RA; stopped RINVOQ. Getting no treatment for RA afraid to suppress immune system.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Illness, Immunisation
Clinical narrative: she gets sick after as she assumed that they are carrier of the virus; she gets sick after as she assumed that they are carrier of the virus; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Batch/Lot number: unknown) at the age of 68 years 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 Number:01), administration date: 19Mar2021, for Covid-19 Immunization; Bnt162b2 (Dose Number:02, she got deathly ill for 2 days), administration date: 11Apr2021, for Covid-19 Immunization, reaction(s): "she got deathly ill for 2 days". The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "booster"; EXPOSURE TO SARS-COV-2 (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "she gets sick after as she assumed that they are carrier of the virus".  Additional information: Caller just wanted to know if she can receive another dose of the booster shot. She mentioned that she has underlying conditions. She said that when her grandchildren visit her, she gets sick after as she assumed that they are carrier of the virus. She also mentioned that, before the vaccine, she got deathly ill for 2 days, but she did not go to the hospital as she did not want to be "put on that machine or whatever". She just wanted to make sure she is protected as she mentioned that every time her grandchildren visits her, she is the only one who gets sick in her family. clarified that she just has a MI regarding receiving a 2nd booster dose, she had no adverse events. She wanted to have another visit with her grandchildren who are 7 years of age and 6 years of age, she calls them her COVID babies because every time they come over to visit, she gets sick after they leave, the next day or two. She declined to complete a report regarding getting sick after her grandbabies leave and stated that she just wants to know if she can get a 2nd booster shot. She did not get sick with the vaccines; she was happy with them, and she would get sick without them. She has not been sick, and she has not had any side effects. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain near my injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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 (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain near my injection site". Additional information: The patient was wondering if having pain near the injection site after booster was normal. The patient received booster on 20Oct2021 and it still hurt several times during the day. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My husband is fully vaccinated and sick with covid-19; My husband is fully vaccinated and sick with covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient 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. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My husband is fully vaccinated and sick with covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Drooling, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Palsy; Mild and not obvious distortion; Tingles or neuropathy like sensation in lips in chin.; Tingles or neuropathy like sensation in lips in chin.; Weakness noted; Occasion drooling since October; numbness left side of face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Oct2021 15:00 (Lot number: FF2593) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Known allergies: Wheat" (unspecified if ongoing), notes: Known allergies: Wheat; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 01Apr2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PALSY (medically significant) with onset 25Oct2021 10:00, outcome "not recovered", described as "Palsy; Mild and not obvious distortion"; NEUROPATHY PERIPHERAL (medically significant), PARAESTHESIA (non-serious) all with onset 25Oct2021 10:00, outcome "not recovered" and all described as "Tingles or neuropathy like sensation in lips in chin."; ASTHENIA (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "Weakness noted"; DROOLING (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "Occasion drooling since October"; HYPOAESTHESIA (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "numbness left side of face". The events "palsy; Mild and not obvious distortion", "tingles or neuropathy like sensation in lips in chin.", "weakness noted", "occasion drooling since october" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) negative, notes: Nasal Swab; (03Feb2021) negative, notes: Nasal Swab. It also reported that since the vaccination, the patient had been tested positive for COVID-19. Therapeutic measures were not taken as a result of bell's palsy, neuropathy peripheral, paraesthesia, asthenia, drooling, hypoaesthesia.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, SARS-CoV-2 test
Clinical narrative: Palsy; Mild and not obvious distortion; Tingles or neuropathy like sensation in lips in chin.; Tingles or neuropathy like sensation in lips in chin.; Weakness noted; Occasion drooling since October; numbness left side of face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Oct2021 15:00 (Lot number: FF2593) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy; "Known allergies: Wheat" (unspecified if ongoing), notes: Known allergies: Wheat; "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8737, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 01Apr2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: PALSY (medically significant) with onset 25Oct2021 10:00, outcome "not recovered", described as "Palsy; Mild and not obvious distortion"; NEUROPATHY PERIPHERAL (medically significant), PARAESTHESIA (non-serious) all with onset 25Oct2021 10:00, outcome "not recovered" and all described as "Tingles or neuropathy like sensation in lips in chin."; ASTHENIA (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "Weakness noted"; DROOLING (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "Occasion drooling since October"; HYPOAESTHESIA (non-serious) with onset 25Oct2021 10:00, outcome "not recovered", described as "numbness left side of face". The events "palsy; Mild and not obvious distortion", "tingles or neuropathy like sensation in lips in chin.", "weakness noted", "occasion drooling since october" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) negative, notes: Nasal Swab; (03Feb2021) negative, notes: Nasal Swab. It also reported that since the vaccination, the patient had been tested positive for COVID-19. Therapeutic measures were not taken as a result of bell's palsy, neuropathy peripheral, paraesthesia, asthenia, drooling, hypoaesthesia.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.; Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single, administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date Jan2021 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown, Since the vaccination, Patient was tested for COVID-19. Clinical course: Patient reports testing positive for COVID-19 on 25Jan or 26Jan2022. Patient reports body aches, minor congestion and a cough that is mostly dry but productive at times.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid_test_result=Positive; covid_test_result=Positive; not sleeping well; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 62 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 17Apr2021 (Lot number: EP6955) at the age of 61 years as dose 2, single and administration date 29Mar2021 (Lot number: EP6955) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jan2022, outcome "recovering" and all described as "covid_test_result=Positive"; INSOMNIA (non-serious) with onset 25Jan2022, outcome "recovering", described as "not sleeping well". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive, notes: +AG. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, insomnia.  Clinical information: Unknown if other vaccine in four weeks, covid prior vaccination. adverse event: not aware of exposure risk- but sx of covid runny nowse, cough and fevers body aches not sleeping well 1/25 and test 1/25 + AG. Updated information included: Suspect drug coding, Product Details: Batch and lot tested and found within specifications  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EP6955 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. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions 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 possible. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19 on 25Jan2022 or 26Jan2022. Reports minor symptoms. No additional information was provided by reporter on symptoms.; Patient tested positive for COVID-19 on 1/25 or 1/26/22. Reports minor symptoms. No additional information was provided by reporter on symptoms.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administration date Dec2021 (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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Jan2021, for COVID-19 immunization.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "Patient tested positive for COVID-19 on 25Jan2022 or 26Jan2022. Reports minor symptoms. No additional information was provided by reporter on symptoms."; COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "Patient tested positive for COVID-19 on 1/25 or 1/26/22. Reports minor symptoms. No additional information was provided by reporter on symptoms.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report received from a contactable reporter (Physician) from medical information team and a sales representative.  A 51 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 2021, outcome "recovering", described as "Bell's Palsy". The event "bell's palsy" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: spike protein AB: more than 250. Therapeutic measures were taken as a result of bell's palsy, included steroids. Clinical course was as follows; The reporter was asking for the recommendations from Pfizer for Covid-19 Booster Vaccination for a patient who had Bell's Palsy after 2nd Pfizer-BioNTech Covid-19 vaccination. The patient had symptoms of left eye tearing then facial weakness 12 days after second covid vaccine. Diagnosed (Dx) to have "L Bells palsy" 05Jun2021 at PRIVACY ER. Treated with 2 courses of steroids and had good outcome with still some residual abnormal blinking slower on the left. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A possible contribution role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Bell's Palsy cannot be excluded, considering the temporal relationship.  The case will be reassessed should additional information become available.  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: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Patient with long-COVID myocarditis (1 year) experienced an improvement in symptoms after third dose (booster dose) of Pfizer COVID vaccine.; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Patient with long-COVID myocarditis (1 year); "myocarditis" (unspecified if ongoing), notes: Patient with long-COVID myocarditis (1 year). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Patient with long-COVID myocarditis (1 year) experienced an improvement in symptoms after third dose (booster dose) of Pfizer COVID vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: The toenail fungus was beginning to improve, and has continued to improve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Lot number: EP7533) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "toe fungus" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot number EC9231), administration date: 19Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (second dose, lot number EN9581.), administration date: 02Feb2021, when the patient was 68 years old, for COVID-19 immunization, reaction(s): "After the 2nd vaccine, he had toe nail fungus that started to disappear.", "He got his first COVID vaccine dose on 19Jan2021/his follow up for the second vaccine was 02Feb2021". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The toenail fungus was beginning to improve, and has continued to improve". The event "the toenail fungus was beginning to improve, and has continued to improve" was evaluated at the physician office visit.  Additional Information: After the 2nd vaccine, patient had toe nail fungus that started to disappear. It started on all of his small digits, and he even started to grow new toenails. Patient big toes started to get better as well, and the toe nail fungus is 1/4 gone. He is getting a new nail on his big toes too. He has done nothing different with his medical care or anything. The only thing that changed was the vaccine. He was 68 years old when he started to see improvement, but he just had a birthday so now he is 69. Patient got his first COVID vaccine dose on 19Jan2021 with lot number EC9231, and his follow up for the second vaccine was 02Feb2021, with lot number EN9581. Patient got the COVID booster 18Oct2021 with lot number EP7533. Patient noticed an improvement in his toenail fungus probably 1.5-2 months after the second COVID vaccine. The toenail fungus was beginning to improve, and has continued to improve. Patient rheumatoid arthritis doctor, said her 15 year old young son had the Pfizer vaccines as well, that his toe nail fungus is starting to improve too. Patient doesn't have further information to do a report on him, but he is going to message his doctor the Pfizer safety department number because she said she would report it. Patient has pictures of his toes as well if he gets contacted by Pfizer. Patient has not received any other vaccines  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: I experienced severe erectile dysfunction for 6 months/I received the booster and it came back; 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 19 year-old male patient received 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; Bnt162b2 (Dose 2), for COVID-19 Immunization, reaction(s): "6 months of depression", "severe erectile dysfunction". The following information was reported: ERECTILE DYSFUNCTION (medically significant), outcome "unknown", described as "I experienced severe erectile dysfunction for 6 months/I received the booster and it came back". The patient reported that when he got the second dose of vaccine, he experienced severe erectile dysfunction for 6 months. (Yes 6 months of erectile dysfunction at 19 years of age). He thought it was a coincidence and accepted it. It finally got back to normal after 6 months of depression. He received the booster and it came back.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness at the injection site that permeated to his other arm; fatigue; 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 male patient received bnt162b2 (BNT162B2) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the injection site that permeated to his other arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Nerve injury
Clinical narrative: Pfizer vaccine is a piece of crap, it doesn't prevent COVID; the product doesn't work, its not good; I have got permanent nerve damage in both arms. I don''t need any more nerve damage; 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 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (non-serious), outcome "unknown", described as "Pfizer vaccine is a piece of crap, it doesn't prevent COVID; the product doesn't work, its not good"; NERVE INJURY (non-serious), outcome "unknown", described as "I have got permanent nerve damage in both arms. I don''t need any more nerve damage.  Additional information: The patient reported that the Pfizer vaccine was a piece of crap, it did not prevent COVID. It did not do anything except make the people sick and miserable. Patient's entire family received the COVID Vaccine the two steps by Pfizer. The patient got permanent nerve damage in both arms. Then patient did not need any more nerve damage, The patient got permanent nerve damage from an attack on me (Further not clarified if consumer experienced permanent nerve damage after receiving the COVID Vaccine hence event captured as per verbatim). The patient was sick of this and to hear this on the news, you got a get the booster. The patient reported, no boosters for our family, as they were all high ranked business people. Patient got three family members that are high placed doctors, they are good friends with doctor. They talked at lengths about these vaccines and which being told to people and in spite of being, and in spite of getting these shots we almost lost my one daughter who is '50' (Further clarification unknown). Patient's people are all high rank in business and in medicine and patient had got family that were high ranked FDA officials. Patient read the insider papers on this stuff, this did not do any good (Further clarification unknown), what this country needs to do is cut ties with withheld bring our pharmaceuticals back to withheld where it belongs. patient had got a list of about a 120 people that we heard from (Further clarification unknown). Patient reported that product did not work, it was not good.  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-202200150609 same reporter/drug, different patients/AE.