chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: Fever; body aches; severe exhaustion; dizziness; sweating; cold chills; shortness of breath; sore swollen throat; sore swollen throat; This is a spontaneous report from a contactable health professional, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL32A) via an unspecified route of administration in the left arm on 18Jan2021 at 16:00 (at the age of 25-years-old) for COVID-19 immunization. Medical history included gastroparesis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included celecoxib (CELEXA), alprazolam (ATARAX), ethinylestradiol/levonorgestrel (AVIANE). The patient did not receive other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient previously took amoxicillin and experienced allergies; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK5730) on 28Dec2020 at 14:30 (at an unspecified age) in the left arm for COVID-19 immunization. On 19Jan2021 at 01:00, the patient experienced fever, body aches, severe exhaustion, dizziness, sweating, cold chills, shortness of breath, sore swollen throat. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Jan2021 with negative results. The clinical outcome of Fever, body aches, severe exhaustion, dizziness, sweating, cold chills, shortness of breath, sore swollen throat was not resolved.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pharyngeal swelling, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; body aches; severe exhaustion; dizziness; sweating; cold chills; shortness of breath; sore swollen throat; sore swollen throat; This is a spontaneous report from a contactable health professional, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL32A) via an unspecified route of administration in the left arm on 18Jan2021 at 16:00 (at the age of 25-years-old) for COVID-19 immunization. Medical history included gastroparesis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included celecoxib (CELEXA), alprazolam (ATARAX), ethinylestradiol/levonorgestrel (AVIANE). The patient did not receive other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient previously took amoxicillin and experienced allergies; and received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EK5730) on 28Dec2020 at 14:30 (at an unspecified age) in the left arm for COVID-19 immunization. On 19Jan2021 at 01:00, the patient experienced fever, body aches, severe exhaustion, dizziness, sweating, cold chills, shortness of breath, sore swollen throat. The patient did not receive any treatment for the events. Since the vaccination, the patient had been tested for COVID-19 via nasal swab on 19Jan2021 with negative results. The clinical outcome of Fever, body aches, severe exhaustion, dizziness, sweating, cold chills, shortness of breath, sore swollen throat was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Fatigue; chills; body aches; headache; This is a spontaneous report from a contactable nurse.  A 49-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Ej1686), in a hospital intramuscularly in the left arm on 18Jan2021 at 09:00 at 49-years-old at a single dose for COVID-19 immunization.  Medical history included type 2 diabetes mellitus (Dm2 controlled) from an unknown date and unknown if ongoing.  Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), Pro tonic (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose -Lot Number: Ek9231, intramuscularly in the left arm) on 28Dec2020 at 49-years-old. On 18Jan2021 at 16:00, the patient experienced fatigue (non-serious), chills (non-serious), body aches (non-serious), headache (non-serious); with no treatment received.  The clinical outcome of the events was not recovered. The patient did not receive any other vaccine in four weeks prior to the COVID-19 vaccine. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination..
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure during pregnancy, Myalgia, Nausea, Off label use
Clinical narrative: Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Nausea; Vomiting; Severe myalgias; Headache; This is a spontaneous report from a contactable physician reporting for herself. A 29-years-old female pregnant patient received the second dose of bnt162b2 (BNT162B2), lot number EL0142, via an unspecified route of administration from 18Jan2021 15:00 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination.  Historical vaccine included first dose of bnt162b2 (BNT162B2), lot number EL1284 in the left arm. The patient's medical history was not reported.  Concomitant medication included multivitamin. The patient previously took  clarithromycin(BIAXIN) and experienced Known allergies: BIAXIN. No other vaccine was given in four weeks. The patient received the vaccine at a hospital. The patient's last menstrual date was 23Nov2020. Her Delivery date is 01Sep2021. Gestational period is 6. The mother was 8 Weeks pregnant at the onset of the event. On 19Jan2021 at 03:00 the patient experienced nausea, vomiting, severe myalgias and headache. Treatment included acetaminophen (TYLENOL) and antiemetic. The clinical outcomes of the events nausea, vomiting, severe myalgias and headache was recovering. The clinical outcome of the event "Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event" was unknown. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Vomiting
Clinical narrative: Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event; Nausea; Vomiting; Severe myalgias; Headache; This is a spontaneous report from a contactable physician reporting for herself. A 29-years-old female pregnant patient received the second dose of bnt162b2 (BNT162B2), lot number EL0142, via an unspecified route of administration from 18Jan2021 15:00 (at the age of 29-years-old) as a single dose in the left arm for COVID-19 vaccination.  Historical vaccine included first dose of bnt162b2 (BNT162B2), lot number EL1284 in the left arm. The patient's medical history was not reported.  Concomitant medication included multivitamin. The patient previously took  clarithromycin(BIAXIN) and experienced Known allergies: BIAXIN. No other vaccine was given in four weeks. The patient received the vaccine at a hospital. The patient's last menstrual date was 23Nov2020. Her Delivery date is 01Sep2021. Gestational period is 6. The mother was 8 Weeks pregnant at the onset of the event. On 19Jan2021 at 03:00 the patient experienced nausea, vomiting, severe myalgias and headache. Treatment included acetaminophen (TYLENOL) and antiemetic. The clinical outcomes of the events nausea, vomiting, severe myalgias and headache was recovering. The clinical outcome of the event "Pregnant at the time of vaccination?: Yes/gestational period:6/ mother was 8 Weeks pregnant at the onset of the event" was unknown. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Pyrexia
Clinical narrative: Extreme weakness; gastro issues; she had a low grade fever; This is a spontaneous report from a contactable consumer. This consumer reported for a 73-year-old female patient received first dose of bnt162b2 (COVID 19, Pfizer), via unknown route of administration on Jan2021 at single dose for covid-19 immunisation. Medicla history was unknown. No Known allergies. Concomitant medications included other vaccine in 4 weeks product for Shingles. Facility type vaccine was other. The patient experienced Extreme weakness and gastro issues from Jan2021. She had a low grade fever (100 degrees) from Jan2021. Yesterday she mentioned she is feeling better than the initial reaction but not yet 100%. The outcome of the event was recovering. No treatment received. No COVID prior vaccination. No COVID tested post vaccination.   Information about Lot/Batch number is requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Very strong pins/needles throughout body; This is a spontaneous report from a contactable consumer reporting for self.  A 65-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 12Jan2021 (at the age of 65-years-old) 17:00 as a single dose, left arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, arrythmia, high sugar, and penicillin allergy. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included metoprolol succinate (TOPROL), lisinopril, amlodipine, and esomeprazole sodium  (NEXIUM). On 16Jan2021 at 10:00, the patient experienced very strong pins/needles throughout body. There was no treatment provided for the event. The outcome of the event very strong pins/needles throughout body was not recovered. The patient was not COVID-tested post vaccination.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test abnormal, SARS-CoV-2 antibody test
Clinical narrative: rechecked my antibody levels after my second dose and they are the lowest they have been yet at 0.7; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 from May2020. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899, expiry: unknown) on 18Dec2020 for COVID-19 immunization. The patient had Covid back in May2020 and she had her antibodies checked all along since having Covid. Her antibody levels on a graph show that they decreased a little each time, but she rechecked her antibody levels after her second dose and they are the lowest they have been yet at 0.7 (Jan2021). The outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The physician reported an employee of (institute name) suffered a stroke within a week of taking the Pfizer Covid Vaccine on an unknown date. Dr. (Name) told the physician that he didn't think it was related. The event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Very limited information is currently available.  As the reported stroke occurred within a week of taking the Covid Vaccine, BNT162B2, the Company cannot completely exclude the possible causality between the reported event and the administration of the suspect.   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 RA, IEC, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: intense headaches; Chills; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced intense headaches and chills in Jan2021. Caller stated he received the 1st dose of COVID vaccine on 29Dec2020 and experienced no side effects up until yesterday (Jan2021) wherein he experienced intense headaches and chills. The patient wanted to know if it's normal to experience this a few days after getting the vaccine and if there is a similar case that has been reported. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Condition aggravated, Gastrointestinal disorder, Muscle spasms
Clinical narrative: GI reaction with spasms; GI reaction with spasms; bloating and uncomfortable like you over eat and have tight pants in; bloating and uncomfortable like you over eat and have tight pants in; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 at 04:30PM in left arm at single dose for COVID-19 immunisation at the age of 57-year-old. Lot number was 59267-1000-01. Medical history included no gall bladder, ongoing bloating and uncomfortable like you over eat and have tight pants in on 11Jan2021 at 02:00PM. Patient was not pregnant. Past drug history included allergy to codeine. Concomitant medications included venlafaxine, verapamil, tocopherol (VITAMIN E), ascorbic acid, biotin, folic acid, iodine, pantothenic acid, pyridoxine hydrochloride, retinol, vitamin b12 nos, vitamin d nos, vitamin e nos, zinc (CENTRUM), atenolol (ALTENOL), zopidem tartrate (ZOLPIDEM). On 11Jan2021 at 02:00PM (also reported: wishing 2 minutes, as reported), inside stomachs and gut, the patient felt it spread over that area (not warm, not painful, weird) and afterwards that night bloating and uncomfortable like you over eat and have tight pants in, then the next day (on 12Jan2021, also reported on 11Jan2021 at 02:00PM, as reported) she had a gastro-intestinal (GI) reaction with spasms that were very painful (something that happens very seldom and the patient was sitting at her desk working so no irritable factors) so she had to take strong meds because this GI spasm was very painful and hurt when you breath, so she took strong medication (hyosymin and mepitab). The patient recovered with lasting effects from abdominal distension, the patient recovered from other events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Upper respiratory tract congestion
Clinical narrative: Still experiencing upper respiratory congestion; She developed COVID 5 days after getting the 1st dose; She developed COVID 5 days after getting the 1st dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age(reported as Age: 66, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed COVID 5 days after getting the 1st dose, she received the 1st dose on 29Dec2020 and due for 2nd dose on 19Jan2021. The patient was still experiencing upper respiratory congestion. She had the initial dose of the vaccine 3 weeks before and a week after her first dose, she developed Covid, she had been exposed so it just so happened, The patient was 14 days out from having COVID. She was scheduled to get the 2nd dose at the time of the report and was wondering if she needed to postpone it. The outcome of event "still experiencing upper respiratory congestion" was not recovered, of other events was unknown.    Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: first dose of bnt162b2 on 01Dec2020, patient was due for their second dose 30Dec2020; first dose of bnt162b2 on 01Dec2020, patient was due for their second dose 30Dec2020; patient had a positive COVID test, contracted Sars-Cov-2; patient had a positive COVID test, contracted Sars-Cov-2; This is a spontaneous report from a contactable Nurse from a Pfizer-sponsored program. A 48-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 01Dec2020 at a single dose for COVID-19 immunization. There was none medical history or concomitant medications. The patient received the vaccine on 01Dec2020, and then on 15Dec2020, patient had a positive COVID test, contracted Sars-Cov-2, and was due for their second dose 30Dec2020.  She was supposed to get her second dose at the end of Dec2020, but she did not return. She stated they were caught in the middle. The patient did return for her second dose with her employer, but they turned her away. The patients second dose was supposed to be on 30Dec2020. Suspect product: Caller does not have the NDC, lot, or expiration date to provide from the first dose that the patient received. There was a Product Complaint. This is a non-serious report. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19  and suspected LOE  due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK9231) at single dose on left arm on 03Jan2021 at 0830AM for COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Medical history was none. Family medical history was none. Relevant test was none. Prior Vaccinations (within 4 weeks) was none. There was no concomitant medication. Patient received 1st dose on 03Jan2021. Yesterday (18Jan2021), she noticed 3 lumps the size of finder tip on her shoulder that were red and itchy.  Across her cleavage, she noticed another 3-4 lumps. She noticed last night, 18Jan2021, three lumps on her shoulder that were really itchy and red and three or four across her cleavage area but not as large. She was just checking, she knew it said could have swollen lymph glands. Patient mentioned she tried to set the phone thing set up where they call you but she could not do it. The shoulder lumps were on her left side and about the size of tip of her little finger. She tried Witch Hazel; she rubbed it on and that soothed it a little at that time. she was scheduled for the second dose of the vaccine on the 25Jan2021.  Patient asked if  this was normal and what could the end result possibly be. The adverse events did not require a visit to physician or ER. The outcome of events was not resolved.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Heart rate, Hyperhidrosis
Clinical narrative: drenching sweated for another 5 hours; diarrhea; rigors; fever to 102.7; tachycardia to 140 which all lasted for 30 minutes; This is a spontaneous report from a contactable physician reporting for self. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included asthma, covid-19 from an unknown date. Patient received first dose of bnt162b2 on 17Dec2020. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), fluticasone propionate (FLOVENT). On 15Jan2021 22:00, 36 hours after second vaccine patient had diarrhea, then rigors, fever to 102.7, tachycardia to 140 which all lasted for 30 minutes. After it stopped had drenching sweated for another 5 hours and more diarrhea. Fever lasted for 1 hour after taking Tylenol and Alleve. Felt back to normal next morning and fine since. No symptoms now. Outcome of events was recovered.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: drenching sweated for another 5 hours; diarrhea; rigors; fever to 102.7; tachycardia to 140 which all lasted for 30 minutes; This is a spontaneous report from a contactable physician reporting for self. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included asthma, covid-19 from an unknown date. Patient received first dose of bnt162b2 on 17Dec2020. Concomitant medication included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), fluticasone propionate (FLOVENT). On 15Jan2021 22:00, 36 hours after second vaccine patient had diarrhea, then rigors, fever to 102.7, tachycardia to 140 which all lasted for 30 minutes. After it stopped had drenching sweated for another 5 hours and more diarrhea. Fever lasted for 1 hour after taking Tylenol and Alleve. Felt back to normal next morning and fine since. No symptoms now. Outcome of events was recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Muscle spasms, Seizure
Clinical narrative: Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization.  Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship.   Of note, the patient has a medical history of seizure disorder.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization.  Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship.   Of note, the patient has a medical history of seizure disorder.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Became extremely dizzy Monday night, 48 hours after receiving the vaccine.; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL3249), via an unspecified route of administration on 16Jan2021 16:15 at a single dose for covid-19 immunization. The patient's medical history included migraine (migraine headaches) from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included apple cider vinegar, butalbital, caffeine, paracetamol (FIORICET) and multi-vitamin. On 18Jan2021 at 21:15, the patient became extremely dizzy Monday night, 48 hours after receiving the vaccine. The episode was brief and went away, but was very scary, as this has never happened before. The patient did not received treatment for the event. The outcome of the event was recovered in Jan2021. The patient has not had vaccine in four weeks. The patient has not had Covid prior to vaccination and not tested for Covid post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (reporting for herself).  A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date not reported), via an unspecified route of administration on 23Dec2020 as a single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient reported that she received her first dose on "23Dec and on 27Dec tested positive for Covid". The clinical outcome of the events tested positive for Covid was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event "tested positive for Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be completely excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse. A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first shot of the COVID-19 vaccine on 04Jan2021 then tested positive for COVID-19 on 12Jan2021. Patient was concerned whether she should get the second shot of the COVID-19 vaccine as scheduled or should we wait. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (8 days in this case). However, a causal relationship between event "tested positive for Covid-19 " (coded to Drug ineffective / COVID-19) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Vaccination site pain
Clinical narrative: Minor left arm pain at injection site for 24h; malaise for 24h; Left supraclavicular lymphadenopathy (multiple swollen nodes); This is a spontaneous report from a contactable physician reporting for herself. A 32-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL3246), via an unspecified route of administration on 08Jan2021 at 11:45 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included drospirenone, ethinylestradiol (OCELLA) taken for birth control from an unspecified date and unspecified if ongoing (reported as taken in two weeks). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took acetylsalicylic acid (ASPIRIN) from an unspecified date to an unspecified date for an unspecified indication and experienced allergy. On 15Jan2021 at 12:00, the patient experienced "minor left arm pain at injection site for 24h", "malaise for 24h" and "left supraclavicular lymphadenopathy (multiple swollen nodes)". The clinical course was reported as follows: "Minor: left arm pain at injection site for 24h and malaise for 24h, left supraclavicular lymphadenopathy (multiple swollen nodes) noticed 7 days after vaccination and still present 11 days after vaccination." It was unknown whether the patient received treatment for the events. The clinical outcomes of the events "minor left arm pain at injection site for 24h", "malaise for 24h" and "left supraclavicular lymphadenopathy (multiple swollen nodes)" were all not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Ear pain, Fatigue, Headache
Clinical narrative: Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Oropharyngeal pain, Pyrexia, Somnolence
Clinical narrative: Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: mild bilateral tinnitus/the tinnitus has significantly been exacerbated; This is a spontaneous report from a contactable Other Health Professional (patient). This 25-year-old male received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1283 and Expiration date unspecified) on 12Jan2021 13:00 (at 25 years of age) intramuscular into right arm as single dose for COVID-19 immunisation.  Medical history was reported as none. There was no reported allergies to medications, food, or other products.  Prior to vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to BNT162B2.   Concomitant medications were not reported. On 12Jan2021 13:15, the patient experienced mild bilateral tinnitus/the tinnitus has significantly been exacerbated.  Patient started having very mild bilateral tinnitus 15 minutes after Covid Vaccine and was not concerned, however by 18Jan2021 the tinnitus has significantly been exacerbated.  No treatment was provided.   Lab data included Nasal Swab done 19Jan2021 with pending results which was post vaccination.  Outcome of event mild bilateral tinnitus/the tinnitus has significantly been exacerbated was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: lip tingling; This is a spontaneous report from a non-contactable nurse (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date unspecified) on unspecified date as single dose for COVID-19 immunisation.  Medical history included anxiety, heart was pounding, and palms were sweaty long before the shot.   Concomitant medications were not reported. The patient experienced lip tingling on an unspecified date. Tingling lasted moments not even full minute and went away. Patient is asking if lip tingling with no itchiness and no swelling, is considered anything of concern or in someone without any adverse reactions like anaphylaxis. She already talked to her physician/allergist and was told that event was due to anxiety and panic. She wants to get her second dose of the vaccine but the pharmacist at her employer are reluctant to give it.  Outcome of event lip tingling was recovered.   No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: felt a little warmth in the body; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included ongoing arthritis.  Concomitant medication included methotrexate (manufacturer unknown) for arthritis. The patient was taking methotrexate 0.8ml once a week for arthritis and on an unspecified date (reported as Saturday) received the COVID vaccine. He wanted to know if he can resume his therapy with methotrexate before getting the second dose. He stated that he just felt a little warmth in the body on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: fever; lymph node around my ears are still kind of icky/swollen; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on unspecified date in Jan2021 at single dose for covid-19 immunisation.  Medical history included tested positive for the covid virus from 16Dec2020.  The patient's concomitant medications were not reported.  The patient experienced fever and lymph node around ears are still kind of icky and swollen in Jan2021. The outcome of event fever was not recovered; outcome of other event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Head discomfort
Clinical narrative: head heaviness; felt like fainting; chest heaviness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (78 unit unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient wanted to know if she can get the 2nd dose of the vaccine since she was experiencing few side effects, head heaviness, felt like fainting, chest heaviness. The patient was unsure if it was due to vaccine. The outcome of the events head heaviness, felt like fainting, chest heaviness was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swollen arm as a side effect/Right arm swelling; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number (Lot number reported either EL8982, LL8982, or 6L8982), expiration date unknown), via an unspecified route of administration in the right arm on 15Jan2021 at 14:30 to at a single dose for COVID-19 immunisation.  Medical history and family medical history were reported none.  The patient had no prior vaccinations within four weeks.  There were no concomitant medications.  On 15Jan2021, the patient experienced swollen arm as a side effect/ right arm swelling. It was reported that right arm swelling began in the evening. It was also reported that arm was still swollen, but has gotten a little better.  The patient asked how long that will last, how to treat the swelling, and if she can go for the second inoculation. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: fever; myalgias; headaches; This is a spontaneous report from a non-contactable physician (patient, who is a healthcare provider/oncologist). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in left arm on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of PFIZER BIONTECH COVID-19 VACCINE given on 26Dec2020 in the left arm for COVID-19 immunization. She is not pregnant. The patient had no covid prior vaccination. The patient had no covid prior vaccination and she had not tested for covid post vaccination. On 17Jan2021, a day after receiving the second dose, patient said that she was down all day in bed with fever and myalgias and headaches. After taking ibuprofen, she felt better. Therapeutic measure was taken as a result of the events. The outcome of the events was recovered in Jan2021.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Vaccination site pain
Clinical narrative: pain at the injection site; fatigue; spacey; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 22Dec2020 at 15:00 at a single dose in the left arm to prevent Covid. The patient's medical history included ongoing blood pressure high, ongoing cholesterol, ongoing anxiety, and ongoing sleep disorder. Concomitant medications included pravastatin for cholesterol, amlodipine besylate for blood pressure high, lisinopril for blood pressure high, zolpidem tartrate (AMBIEN CR) for sleep, olanzapine for anxiety, all ongoing. On 10Jan2021, the patient noticed feeling fatigue and spacey. On an unspecified date, the patient stated that she did get some pain at the injection site and took Aleve 2 capsules as needed. The patient considered the events fatigue and spacey as non-serious. The outcome of the events fatigue and spacey was recovered on 10Jan2021, while unknown for the other event.