chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blindness, Heart rate increased, Hyperhidrosis, Loss of consciousness
Clinical narrative: loss of sight; passed out; Vertigo; sweats; sore injection site; rapid heart rate; loss of memory; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 12:00 (Lot Number: FC3180) as single dose (at the age of 56-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced loss of sight, passed out, vertigo, sweats, sore injection site, rapid heart rate, and loss of memory; all on 06Aug2021 13:00. The events resulted in Emergency room/department or urgent care. No treatment received for the events. The outcome of the events was not recovered. The events loss of sight and passed out were considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was in the Pharmacy or Drug Store. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: loss of sight; passed out; Vertigo; sweats; sore injection site; rapid heart rate; loss of memory; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Aug2021 12:00 (Lot Number: FC3180) as single dose (at the age of 56-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not diagnosed with COVID prior vaccination. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced loss of sight, passed out, vertigo, sweats, sore injection site, rapid heart rate, and loss of memory; all on 06Aug2021 13:00. The events resulted in Emergency room/department or urgent care. No treatment received for the events. The outcome of the events was not recovered. The events loss of sight and passed out were considered as serious (medically significant).  Facility where the most recent COVID-19 vaccine was administered was in the Pharmacy or Drug Store. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (Other HCP) reported for a 42-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), intramuscular, administered in Arm Left on 26Apr2021 (at the age of 42-years-old) (Batch/Lot Number: EN6207) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It's unknown whether the patient receive any other vaccine in four weeks or within 4 weeks prior to the COVID vaccine, also it was unknown the patient had covid-19 prior vaccination. The patient's Colleague tested positive for COVID on 19Jul2021. The patient was Covid 19 positive (medically significant), The patient underwent lab tests and procedures covid test post vaccination which included sars-cov-2 test (nasal swab): positive on 02Aug2021. The patient received treatment in response to event was unknown. The clinical outcome of events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. Additional information including event onset date, concomitant medications and their indications, concurrent medical conditions, medical history, treatment done, is needed to better assess this report.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Aortic disorder, Echocardiogram
Clinical narrative: enlarged aorta; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER2613), via intramuscular route, administered in left arm on 21Mar2021 at 13:30 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The vaccine was not administered at facility. The patient medical history was not reported. There were no concomitant medications. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205), via intramuscular route, administered in left arm on 28Feb2021 at 15:30 as dose 1, single (at the age of 60-years-old) for COVID-19 immunization and experienced tinnitus. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient never had heart issues prior to vaccine. On an unknown date in Mar2021 (reported as on 2 flights (airplane) within one week after second vaccination), the patient experienced enlarged aorta. The event was assessed as Persistant/significant disability/ incapacity. The event resulted in emergency room and physician office visited. The patient lab test which included echocardiogram was enlarged aorta with 4.2 centimetres on 13Apr2021. No treatment medication was received for the event. It was reported by the patient that follow-up echocardiogram to be done in the next year on an unknown date Apr2022. The patient reported that echocardiogram was 4.5 cm or above surgery may be necessary. The outcome of the event was not resolved at the time of report.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Headache, Heart rate irregular
Clinical narrative: heart is poom, poom, poom, poom; can't breath; light headache; dizzy; don't feel good; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heart is poom, poom, poom, poom, can't breath, light headache, dizzy and don't feel good. Outcome of the events were unknown.  QR Comment: Reporter type could not be probed hence captured by default as consumer or other non-health professional in tab.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 test, Sneezing
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Jan2021 (age at the time of vaccination was 51-year-old) as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 26Jan2021 (age at the time of vaccination was 51-year-old) as dose 2, single for COVID-19 immunization. The patient had no underlying conditions. The patient's concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 on 09Aug21. Symptoms include congestion, fever, sneezing, cough, muscle aches, loss of smell, and loss of taste all on an unspecified date in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 09Aug2021. Outcome of the events was reported as unknown at this time of the report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysmenorrhoea, Gait disturbance, Pain in extremity
Clinical narrative: right arm pain/right leg/left leg pain; It was hard to walk; Knee pain; cramps because she still bleeds; clarified as she still gets her periods; This is a spontaneous report from a contactable consumer (parent). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in 2021 for COVID-19 immunization. On an unspecified date, the patient experienced the pain first started in the left leg then it would go to the right leg and then back and forth. The last time, it would settle in the right leg. It was hard to walk. Then, she would elevate the leg and it would go away. Then it would come back and settle in the knee. Today, was a good day for her, and she did not have any pain. She also reported pain in right arm. Treatment: She believes she took Ibuprofen, which she also takes to help with cramps because she still bleeds; clarified as she still gets her periods. She is not on any other medications. The patient did not went to the ER but to the physician office for the pain in leg. The doctor gave her a prescription and she went to get it filled. It was inaccurate. She had it and didn't take it. She took it one time and whatever they recommended was the wrong medication. The patient did not know the name of the medication. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke (brain); This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 08Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN , SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stroke (brain) (caused hospitalization) in Aug2021 days after vaccination with outcome of unknown.  The patient was hospitalized due to the event from Aug2021. It was reported that the stroke was a reaction due to the vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow-up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: hand and wrist joint pain; Right elbow pain with movement 24 hours after injection/ followed by hand and wrist joint pain; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself) via COVID-19 portal. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 28Dec2020 at the age of 48 years old (Batch/Lot Number: EL1284, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was  at the hospital. The patient was not pregnant at the time of vaccination. Relevant medical history included hypothyroidism and known allergy to Penicillin (PCN), both from an unknown date and unknown if ongoing. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right elbow pain with movement 24 hours after injection on 29Dec2020, followed by hand and wrist joint pain on an unspecified date. The reporter assessed the events as serious, as they resulted in disability or permanent damage. The patient did not receive any treatment for the events. The patient was not recovered from the events.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Oral mucosal eruption, Pain, Pharyngeal enanthema
Clinical narrative: Passing out; Rash over entire body including inside mouth throat nose and eyes; Rash including inside mouth; Rash including throat; Blurred vision; Headaches; Aching; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (Batch/Lot Number: EW0182), via an unspecified route of administration, administered in arm left on an unspecified date (also reported as on 22Apr2021 09:00 AM) at the age of 44 years as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EW0161) administered in arm left on an unspecified date (also reported as on 22Apr2021). 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, and since the vaccination, the patient has not been tested for COVID-19. On 18May2021 12:00, the patient experienced rash over entire body including inside mouth, throat, nose and eyes; blurred vision, headaches, aching and passing out. No hospitalization prolonged. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included steroids. Outcome of events were not recovered.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vision blurred
Clinical narrative: Passing out; Rash over entire body including inside mouth throat nose and eyes; Rash including inside mouth; Rash including throat; Blurred vision; Headaches; Aching; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (Batch/Lot Number: EW0182), via an unspecified route of administration, administered in arm left on an unspecified date (also reported as on 22Apr2021 09:00 AM) at the age of 44 years as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EW0161) administered in arm left on an unspecified date (also reported as on 22Apr2021). 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, and since the vaccination, the patient has not been tested for COVID-19. On 18May2021 12:00, the patient experienced rash over entire body including inside mouth, throat, nose and eyes; blurred vision, headaches, aching and passing out. No hospitalization prolonged. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included steroids. Outcome of events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: developed generalized pain in finger; developed generalized pain in finger, wrist and elbow joints bilaterally; This is a spontaneous report from a contactable health professional (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hypothyroidism and allergies: PCN. Concomitant medication (other medication in two weeks) included levothyroxine sodium (SYNTHROID). Patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 28Dec2020 (Batch/Lot number: EL1284) for COVID-19 immunization and experienced right elbow pain with movement 24 hours after injection followed by hand and wrist joint pain. The patient developed generalized pain in finger, wrist, and elbow joints bilaterally on an unspecified date, within one week after the second shot. This was followed by generalized joint pain that has been slowly getting worse since. Outcome of the events was not recovered. No treatment was received. Events were reported as serious with seriousness criteria: disabling/incapacitating. 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. Patient has not been tested for COVID-19 since the vaccination.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Pain in fingers, Arthralgia) and the BNT162B2 cannot be excluded. The case will be reassessed once new 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Glioblastoma, Inappropriate schedule of product administration, Magnetic resonance imaging
Clinical narrative: Butterfly Glioblastoma/Stage 4,terminal cancer; first dose on 04Mar2021, second dose on 04Mar2021; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 04Mar2021 14:00 (Lot Number: EN6203), dose 2 via an unspecified route of administration in right arm on 04Mar2021 (Lot Number: EP6955), both at age of 69-year-old at single dose for COVID-19 immunisation. The patient had no medical history. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 01Jul2021, the patient was diagnosed (after MRI) with a butterfly Glioblastoma. Her physician estimated that the tumor was 3 months old, which was completely time coincident with receipt of the Pfizer vaccine! This was Stage 4, terminal cancer. The event "butterfly glioblastoma/stage 4,terminal cancer" onset date was 01Apr2021. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 3 days, Life threatening illness (immediate risk of death from the event). Treatment for the event included radiation and chemotherapy. The outcome of event "butterfly glioblastoma/stage 4,terminal cancer" was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Hypoaesthesia, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Inflammation in my spine/Myelitis; impingement between C6 & C 7; Numbness in my arm and hand; Stabbing pain in my chest and back; Stabbing pain in my chest and back; Muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 03Jun2021 08:30 (Batch/Lot Number: FA6780) as dose 1, single for COVID-19 immunization at physician's office. Medical history included known allergies: some nuts from an unknown date. Concomitant medications included fish oil; cyanocobalamin (B12); and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Jun2021 18:00, it was reported that the patient experienced numbness in my arm and hand within 24 hours of my vaccinations, stabbing pain in my chest and back with muscle spasms throughout my arms and chest. The patient went to the emergency room and was diagnosed with inflammation in my spine/myelitis causing an impingement between C6 & C7. I have had to get an injection so I can work and get some of the feeling back in my arm. The patient had to get PT, Spinal injection, Acupuncture, and Chiro and had multiple doctors appointments to try and get back to functionality. The events resulted in hospitalization for 1 day and required emergency room and physician's office visit and was considered by the reporter as having caused disability or permanent damage. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown results on an unspecified date. The outcome of the events was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis, Spinal cord compression
Clinical narrative: Inflammation in my spine/Myelitis; impingement between C6 & C 7; Numbness in my arm and hand; Stabbing pain in my chest and back; Stabbing pain in my chest and back; Muscle spasms; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 03Jun2021 08:30 (Batch/Lot Number: FA6780) as dose 1, single for COVID-19 immunization at physician's office. Medical history included known allergies: some nuts from an unknown date. Concomitant medications included fish oil; cyanocobalamin (B12); and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Jun2021 18:00, it was reported that the patient experienced numbness in my arm and hand within 24 hours of my vaccinations, stabbing pain in my chest and back with muscle spasms throughout my arms and chest. The patient went to the emergency room and was diagnosed with inflammation in my spine/myelitis causing an impingement between C6 & C7. I have had to get an injection so I can work and get some of the feeling back in my arm. The patient had to get PT, Spinal injection, Acupuncture, and Chiro and had multiple doctors appointments to try and get back to functionality. The events resulted in hospitalization for 1 day and required emergency room and physician's office visit and was considered by the reporter as having caused disability or permanent damage. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown results on an unspecified date. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I went out with my son, who just had 1 shot of his vaccine (he didn't say which one he got)...all got covid; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unspecified date, the patient experienced i went out with my son, who just had 1 shot of his vaccine (he didn't say which one he got). all got covid. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Aug2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre; This is a spontaneous report from a contactable pharmacist. This report was received via a sales representative.   A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation.  The patient's medical history and concomitant medications was not reported. The patient admitted for suspected Guillian Barre, 1 week after receiving the Prevnar vaccine.  The outcome of event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Sender's Comments: Aside from the time association, there is no biological plausibility that the suspected Guillian Barre is causally attributed to PREVNAR 13 use.  More immunological and neurological data would be needed to explore the etiology for the event onset.  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: Overdose
Clinical narrative: 76 patients that received, instead of the 0.3 single dose they received the entire vial of vaccine of the Pfizer COVID-19 vaccine after dilution.; This spontaneous report from a contactable pharmacist reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The pharmacist reported that she had 76 patients received, instead of the 0.3 single dose they received the entire vial of vaccine of the Pfizer covid-19 vaccine after dilution. The pharmacist would like to know if they need to get the second dose of the vaccine. This occurred in Apr2021 (reported as 22 days before 14May2021) and was getting ready to give second dose, but wanted to see if that was still needed. The pharmacist stated age range was from 30 to over 80 years old.The patient did not provide information to the reporter regarding the reported adverse event with the use of the product. The pharmacist did not consider the Pfizer product had a causal effect to the adverse event.  Follow-up (12Aug2021): This is a follow up-spontaneous report from a contactable pharmacist included that: lot/batch number cannot be obtained.  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) :PFIZER INC-2021620745 same reporter/drug/event, different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Myasthenia gravis; This is a spontaneous report from a contactable nurse (patient). A currently 26-year-old female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Dec2020 12:00 (at the age of 25-year-old) (Batch/Lot Number: EH9899) as dose 1, single for covid-19 immunisation. The patient had no medical history, concurrent conditions and past drug history. The patient was not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. On 14Jul2021, the patient experienced myasthenia gravis. Treatment was received for the event which included an unspecified medication. The event resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was not recovered.; Sender's Comments: The causal relationship between bnt162b2 and the event myasthenia gravis cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. The event occurred several months after the vaccination, and the circumstances surrounding the event was not specified. This case will be reassessed once additional information becomes 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: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood cholesterol, Chest pain, Hypersomnia
Clinical narrative: First time she fell asleep for 20 hours; She was only awake for like 4 and half hours and then she got back to sleep and slept for another 12 hours; That seems like a lot of sleep; Chest pain; Back pain; This is a spontaneous report from a contactable consumer. This consumer reported for her 12-year-old female patient (reporter's daughter) that: A 12-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0173), via an unspecified route of administration in Arm left on 03Aug2021 as single dose for covid-19 immunisation. Concomitant medications included multivitamin (Gummy Vitamins). Patient was allergic to sometimes antibiotic. She has had about a year ago, they pricked her finger to test for cholesterol and that was good. Patient did not receive any other vaccine prior to covid vaccine. It was reported that she had a Covid vaccine, the first one on 03Aug2021 and she came home, and she slept for 20 hours, woke up with chest pain and back pain and she stayed up for 4 or more hours and then she fall back asleep and slept for about another 12 hours and then she seems okay. Caller called the doctor and they said to give her 2 children chewable Tylenol. It was the chewable one, it is 160 mg each and she had two. Caller wanted to report it and see if it was safe for her to get the second vaccine on 24Aug2021 and make sure that she was okay because that seems like a lot of sleep, chest pain and reporter was worried. The outcome of the events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: Contracted COVID-19 after I have been vaccinated with both the first and second dose; Contracted COVID-19 after I have been vaccinated with both the first and second dose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient/Pfizer employee).  A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248; Expiration Date: Apr2021), dose 1 via an unspecified route of administration, administered in right arm on 03Mar2021 (at the age of 34-years-old) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 34-years-old) (Batch/Lot number was not reported; Expiration Date: 30Jun2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included lupus. The patient's family medical history included she thought type 2 diabetes run in her family on her father's side. The patient had no prior vaccination (within 4 weeks) other than COVID-19. The patient stated, she was calling because the adverse event reporting site was not working and she need to report an adverse event with the COVID-19 Vaccine. she specified that, in Mar2021, she contracted COVID-19 after she has been vaccinated with both the first and second dose. The consumer stated, any lab test like for COVID, she thought she had a blood test probably. She don't remember the date but the results were positive like it was for monitoring her lupus condition and there was nothing negative about her results. Basically her treatment was going all good. There was nothing. It was normal. The only thing she took was over the counter medication in the form of 'dichlo' and 'diclo' (Further clarification was unknown) and Tylenol PM. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sinus disorder
Clinical narrative: sinus problems; was diagnosed with positive COVID test / few months later has been diagnosed with COVID; was diagnosed with positive COVID test / few months later has been diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Mar2021 as dose 2, single, patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on Mar2021 as dose 1, single both for covid-19 immunisation. Medical history included high blood pressure and diagnosed with small renal cell carcinoma in Feb2021. The patient concomitant medications were not reported. On 10Aug2021, the patient was diagnosed with positive covid test, Rapid PCR was performed. On unspecified date patient experienced headache, fever, cough, wheezing, sinus problems. Patient was diagnosed with small renal cell carcinoma in Feb2021 and had right nephrectomy in Apr2021. The vaccine was recommended before surgery and patient got it before procedure. Now a few months later has been diagnosed with COVID. The patient underwent lab tests and procedures which included PCR sars-cov-2 test: positive on 10Aug2021. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: very bad rash, I had it on all my torso, my arms and my thighs; hives/ welts; Itchy; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0202), intramuscular, administered in right arm on 16Jul2021 (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. Medical history included pacemaker and right hip prosthesis. Concomitant medication included vitamins. On 27Jul2021, the patient woke up with hives, very bad rash. He had it on all of his torso, his arms and his thighs. He waited to see if it will go away and it did not go away and it was extremely itchy. So, he walked as he does not have a car, to a pharmacy and bought some Benadryl antihistamine and brought that back and took at part of the instruction and after about an hour, he had his rash finally started going away, while about 6 to 7 hours or so later, the rash came back and so, he took more Benadryl and then another 7 to 8 hours, the rash came back again. So, he took more Benadryl so this kept on about a day and a half with coming back over and over again and then he ran out of Benadryl. So, he walked back to the pharmacy and bought another big bottle and the rash continued. So, it was continuing for about one week gradually it had become not quite so bad but it still require the Benadryl and at that point, he considered going to the hospital that was in the area. The hospital said unless it was a true medical emergency, he should not come over and he had to be very very sick or they would not even look at him. So, he call a few hospital and they said no, do not go, if the Benadryl makes it go away, then just keep taking the Benadryl. He did not have the rash today. Since the last time he had it, he did not need to take the additional Benadryl and rash continued coming back and it was very bad, it was huge welts, "huge ostium" and everything. He said that he became eligible for 2nd dose on Friday (unspecified date). He further added that if the agent understand why he was nervous about getting the 2nd shot. He stated he does not have lab test, in fact, he has not seen a doctor in the last 6-7 months. The outcome of the event rash was not recovered while the outcome of the other events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My first shot I started experience the rash on my body; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 56-years-old) via an unspecified route of administration on 19May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included hypertension/high blood pressure. Concomitant medication included lisinopril dihydrate (LISINOPRIL [LISINOPRIL DIHYDRATE]) taken for high blood pressure. The patient stated that on her first shot, she started to experience rash on her body. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Thrombophlebitis superficial
Clinical narrative: Deep venous thrombosis of the left upper extremity axillary, brachial and ulnar veins; Superficial thrombophlebitis of cephalic and basilic veins of the left upper extremity; This is a spontaneous report from a non-contactable consumer (patient). A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration on 20Jul2021 (at the age of 43-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history, medications within 2 weeks of vaccination and concomitant medications were not reported. Known allergies for penicillin were reported. Prior to vaccination patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 22Jul2021, the patient experienced superficial thrombophlebitis of cephalic and basilic veins of the left upper extremity and deep venous thrombosis of the left upper extremity axillary, brachial and ulnar veins. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had received treatment for event was Eliquis. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heavy menstrual bleeding, Menstrual disorder, Overdose, SARS-CoV-2 test
Clinical narrative: Abnormal menstrual cycle with extremely heavy bleeding/Multiple menstrual cycles were within 2-3 week of each other; Abnormal menstrual cycle with extremely heavy bleeding/Multiple menstrual cycles were within 2-3 week of each other; Patient received Dose 1 and Dose 2 on 20Jan2021.; This is a spontaneous report from a non-contactable consumer (patient herself). A non-pregnant 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in left arm on 20Jan2021 (Batch/Lot Number: E13247) as DOSE 1, SINGLE; and then dose 2 via an unspecified route of administration, administered in left arm on 20Jan2021 (Batch/Lot Number: EM9809) as DOSE 2, SINGLE, for COVID-19 immunization, age at time of vaccination: 39 years. Relevant medical history includes high blood pressure from an unspecified date and almond and penicillin allergy. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination.  The patient previously received erythromycin on unspecified dates and experienced known allergies. On 02Apr2021, the patient experienced abnormal menstrual cycle with extremely heavy bleeding. Required multiple doctors visits. Multiple menstrual cycles were within 2-3 week of each other, ultimately resolving by itself.  Also, very high blood pressure onset at the same time requiring ongoing medication. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. Since the vaccination, the patient has been tested for COVID-19, COVID test post vaccination is Nasal Swab PCR on 12Mar2021 with negative result. The patient recovered from the events abnormal menstrual cycle with extremely heavy bleeding/Multiple menstrual cycles were within 2-3 week of each other on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had received first dose of Covid vaccine and now has Covid; Had received first dose of Covid vaccine and now has Covid; This is a spontaneous report from via a non-contactable male consumer (patient, self-reported).  A male patient of unspecified age received first dose of BNT162B2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had received first dose of Covid vaccine and now has Covid. The patient wanted to know how long he needed to wait to receive the second dose. There a was Product Complaint. Description of Product Complaint included Covid vaccine: Stated that he had received first dose of Covid vaccine and now has Covid. The patient underwent lab tests and procedures which included covid test and resulted positive for covid on an unspecified date in 2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Insomnia, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: 8/10/2021 tested positive for COVID; 8/10/2021 tested positive for COVID; swollen sinuses with very little clear mucus from my nose; insomnia; sinus pressure; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer(patient) reported for herself that: A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6199; Expiration Date: on an unspecified date in Jun2021), dose 2 via an unspecified route of administration on 08Mar2021 (age at vaccination was 55-year-old) as DOSE 2, single dose and dose 1 via an unspecified route of administration on 15Feb2021 (Lot Number: EL9261 and Expiry date was not reported) as DOSE 1, single dose, both for covid-19 immunisation. She was a Pfizer representative vaccinated with first dose 15Feb2021 and the second dose 08Mar2021. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for anxiety, start and stop date were not reported. Although overweight she relatively healthy. she exercises 50 minutes daily. On 04Aug2021 she came home from work early because she was so tired, constantly sneezing, on 05Aug2021 patient experienced sore throat, but she frequently had a sore throat, headache, fatigue/ tired, lots of drainage, sinus pressure, no energy, on 07Aug2021, she was feeling better just lots of congestion, lost taste, lost smell, on 10Aug2021, tested positive for covid, currently her symptoms are swollen sinuses with very little clear mucus from her nose, insomnia. Still having quite, a bit of drainage down my throat, sore throat, insomnia the last 2 nights. On 05Aug2021 and 06Aug2021 stayed in bed most of the days with symptoms listed above. She was able to clean house and steam all her floors. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, sars-cov-2 test: tested again for covid on 09Aug2021, sars-cov-2 test: positive on 10Aug2021. Treatment received for the event insomnia was Ambien PRN. Outcome of the event covid 19 was unknown, sore throat, lots of drainage, swollen sinuses with very little clear mucus from her nose and insomnia was not recovered, and rest of the events was recovered.