chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diagnostic procedure, Optical coherence tomography, Retinal vein occlusion, Visual acuity tests
Clinical narrative: diagnosed with central retinal vein occlusion (CRVO); This is a literature report.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypercoagulable workup" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RETINAL VEIN OCCLUSION (medically significant), outcome "recovering", described as "diagnosed with central retinal vein occlusion (CRVO)". The patient underwent the following laboratory tests and procedures: blood test: did not reveal any primary risk factors, notes: did not reveal any primary risk factors that could have explained her disease process; diagnostic procedure: her symptoms deteriorated, notes: significantly and worsening peripapillary hemorrhage; optical coherence tomography: unknown result; visual acuity tests: unknown result; visual field tests: unknown result. Therapeutic measures were taken as a result of retinal vein occlusion.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event Retinal vein occlusion  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Visual field tests
Clinical narrative: diagnosed with central retinal vein occlusion (CRVO); This is a literature report.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypercoagulable workup" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RETINAL VEIN OCCLUSION (medically significant), outcome "recovering", described as "diagnosed with central retinal vein occlusion (CRVO)". The patient underwent the following laboratory tests and procedures: blood test: did not reveal any primary risk factors, notes: did not reveal any primary risk factors that could have explained her disease process; diagnostic procedure: her symptoms deteriorated, notes: significantly and worsening peripapillary hemorrhage; optical coherence tomography: unknown result; visual acuity tests: unknown result; visual field tests: unknown result. Therapeutic measures were taken as a result of retinal vein occlusion.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  event Retinal vein occlusion  and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Blood grouping, Corneal graft rejection
Clinical narrative: acute corneal epithelial rejection of LR-CLAL; This is a literature report.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "living-related conjunctival limbal allograft" (unspecified if ongoing), notes: 4 years and 7 months previously. The patient's concomitant medications were not reported. The following information was reported: CORNEAL GRAFT REJECTION (medically significant), outcome "unknown", described as "acute corneal epithelial rejection of LR-CLAL". The patient underwent the following laboratory tests and procedures: blood grouping: abo.  Abstract: PURPOSE: The purpose of this study was to report a case of acute corneal epithelial rejection of living-related conjunctival limbal allograft (LR-CLAL) after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. OBSERVATIONS: A 27-year-old woman developed acute epithelial rejection of LRCLAL 2 weeks after receiving the SARS-CoV-2 vaccine. She received the LR-CLAL transplant 4 years and 7 months previously and had a stable clinical course with no history of rejection. She had an ABO blood group and human leukocyte antigen compatible donor, no systemic comorbidities, and no rejection risk factors. CONCLUSIONS: The novel SARS-CoV-2 vaccine upregulates the immune system to produce an adaptive immune response. The SARS-CoV-2 vaccine may potentially be associated with increased risk of rejection in those with ocular surface transplants.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and CORNEAL GRAFT REJECTION  cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder
Clinical narrative: diagnosed with autism at the age of 18 months; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  An 18-month-old male patient received bnt162b2 (COMIRNATY) (Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Dpt (they got DPT MMR when they were 8-9 months old), for immunisation; Mmr (they got DPT MMR when they were 8-9 months old), for immunisation. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "diagnosed with autism at the age of 18 months". Clinical course: Reporter wanted to provide her statement/feedback about the Pfizer covid vaccine for infant (6 months) to 5 years old. She stated there would be a lot of lawsuits in Pfizer's hand if they pushed to give Pfizer covid vaccine to this age group. She stated she and her kids and grandkids took the vaccine but not "extra ones". She stated you didn't know how this vaccine would affect the small children. Her grandchild (patient) was diagnosed with autism at the age of 18 months, he was ok before that, her older children received vaccine and they got sick "sicker than dog" (reporter did not clarify which vaccine). She stated that babies did not need injection. They just needed the regular vaccine MMR, polio, DPT injections, which are tested for long time. she told her granddaughter to not give her grandkids who are 7 and 9, "weird injection" (non-Pfizer injection). All they need was MMR polio, DPT vaccine. She stated she heard in the news about the Pfizer covid vaccine for babies and she got really upset about it. She stated it could cause kids to have autism and cerebral palsy, there was going to be lawsuit on Pfizer. She stated she got her Brand name thyroid medication from Pfizer (agent tried to clarify the name of the medication but reporter did not provide name) she stated she did not take generic levothyroxine as it made her hair fall/hair loss. Caller stated none of her children got Pfizer medication that she knew of, they got DPT MMR when they were 8-9 months old. She was 83-84 years old female was in a car accident that ruptured her spleen, they would not give her vaccine not even shingles vaccine. She was very concerned, was crying at times on the phone and upset about small children getting the Pfizer covid vaccine. She stated patient had autism and that was from a vaccine. Reporter asked if they could explain to her how this vaccine wouldn't be unsafe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Full blood count, Full blood count decreased, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Got her menstrual period and this is her 15 days with blood clot and heavy period; Got her menstrual period and this is her 15 days with blood clot and heavy period; Her CBC labs came back low; She can be anemic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Dec2021 09:00 (Lot number: FK5127) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. No covid prior vaccination. Relevant medical history included: "Asthma" (unspecified if ongoing); "Otitis media" (unspecified if ongoing). The patient took concomitant medications. No other vaccine in four weeks. There was other medications in two weeks. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 15Nov2021, when the patient was 10 years old, for COVID-19 Immunization, reaction(s): "After the vaccine she got covid". The following information was reported: HEAVY MENSTRUAL BLEEDING (serious), Menstrual irregular(serious) all with onset 17Dec2021 10:00, outcome "not recovered" and all described as "Got her menstrual period and this is her 15 days with blood clot and heavy period"; FULL BLOOD COUNT DECREASED (serious) with onset 17Dec2021 10:00, outcome "not recovered", described as "Her CBC labs came back low"; ANAEMIA (serious) with onset 17Dec2021 10:00, outcome "not recovered", described as "She can be anemic". The events "got her menstrual period and this is her 15 days with blood clot and heavy period", "got her menstrual period and this is her 15 days with blood clot and heavy period", "got her menstrual period and this is her 15 days with blood clot and heavy period", "her cbc labs came back low" and "she can be anemic" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: full blood count: (17Dec2021) came back low; sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of Menstrual irregular, heavy menstrual bleeding, full blood count decreased, anaemia. The patient was asthmatic, after the vaccine she got covid and she never got it in almost 2 years. A month after the vaccine she got her menstrual period and this is her 15 days with blood clot and heavy period from the first day. Her CBC labs came back low and she can be anemic now if i dont give her all the medications.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Got her menstrual period and this is her 15 days with blood clot and heavy period; Got her menstrual period and this is her 15 days with blood clot and heavy period; Her CBC labs came back low; She can be anemic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 10Dec2021 09:00 (Lot number: FK5127) at the age of 10 years as dose 2 (tris), single for covid-19 immunisation. No covid prior vaccination. Relevant medical history included: "Asthma" (unspecified if ongoing); "Otitis media" (unspecified if ongoing). The patient took concomitant medications. No other vaccine in four weeks. There was other medications in two weeks. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5618, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 15Nov2021, when the patient was 10 years old, for COVID-19 Immunization, reaction(s): "After the vaccine she got covid". The following information was reported: HEAVY MENSTRUAL BLEEDING (serious), Menstrual irregular(serious) all with onset 17Dec2021 10:00, outcome "not recovered" and all described as "Got her menstrual period and this is her 15 days with blood clot and heavy period"; FULL BLOOD COUNT DECREASED (serious) with onset 17Dec2021 10:00, outcome "not recovered", described as "Her CBC labs came back low"; ANAEMIA (serious) with onset 17Dec2021 10:00, outcome "not recovered", described as "She can be anemic". The events "got her menstrual period and this is her 15 days with blood clot and heavy period", "got her menstrual period and this is her 15 days with blood clot and heavy period", "got her menstrual period and this is her 15 days with blood clot and heavy period", "her cbc labs came back low" and "she can be anemic" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: full blood count: (17Dec2021) came back low; sars-cov-2 test: (01Jan2022) positive, notes: Nasal Swab. Therapeutic measures were taken as a result of Menstrual irregular, heavy menstrual bleeding, full blood count decreased, anaemia. The patient was asthmatic, after the vaccine she got covid and she never got it in almost 2 years. A month after the vaccine she got her menstrual period and this is her 15 days with blood clot and heavy period from the first day. Her CBC labs came back low and she can be anemic now if i dont give her all the medications.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Joint lock, Joint stiffness, Muscle strain
Clinical narrative: Joints locked; joint lock far more severe; strained muscle; Joint pain and stiffness; Joint pain and stiffness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 09:00 (Lot number: FG3527) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes - Type II" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Iodine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FG3527, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 01Nov2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Joints locked". The following information was reported: JOINT LOCK (disability), outcome "recovered with sequelae", described as "Joints locked"; CONDITION AGGRAVATED (disability), outcome "recovered with sequelae", described as "joint lock far more severe"; MUSCLE STRAIN (disability), outcome "recovered with sequelae", described as "strained muscle"; ARTHRALGIA (disability), JOINT STIFFNESS (disability), outcome "recovered with sequelae" and all described as "Joint pain and stiffness". The events "joints locked", "joint lock far more severe", "strained muscle", "joint pain and stiffness" and "joint pain and stiffness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of joint lock, condition aggravated, muscle strain, arthralgia, joint stiffness.  Additional information: The patient did not receive other prior vaccine in four weeks. The patient had other medications in two weeks Several for Diabetes and No room to list all here. The patient had Adverse events Joints locked up momentarily with 1st dose for about 2 min. The patient received 2nd dose, joint lock far more severe. The Required ER visit which turned out to be a strained muscle. The patient called only assume was caused by the lock-up. The Joint pain and stiffness had lingered to this day. The AE treatment results Muscle relaxer/pain meds in ER. The patient had covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Lymphoma
Clinical narrative: Caller stated that he is immunocompromised; lymphoma; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single(administration date is three weeks after the first dose) and administration date 11Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Patient is under a clinical study program which needing him to take 2 pills 12 hours apart. he is on this study for 7 or 8 years already. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "Caller stated that he is immunocompromised"; LYMPHOMA (medically significant), outcome "unknown", described as "lymphoma". Patient stated that he is somehow immunocompromised because of this and he needs to "keep track of his lymphoma."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder, Condition aggravated, Crying, Facial discomfort, Intentional self-injury
Clinical narrative: Hitting himself, bending fingers and toes; Exacerbating autistic syptoms; Exacerbating autistic syptoms; Crying; Screaming; Pressing face, looking for pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 9 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Dec2021 (Lot number: FL8094) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). Patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The following information was reported: on 29Dec2021, the patient experienced crying, screaming, hitting himself, bending fingers and toes, pressing face, looking for pressure every 15 minutes for about 5 days exacerbating autistic syptoms. Events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 28Jan2022, patient received dose 2 (tris), lot number: FL0007, intramuscular administered in arm left.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine to the reported events can not be excluded. Case will be re-assessed upon the additional information provided. 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: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Screaming
Clinical narrative: Hitting himself, bending fingers and toes; Exacerbating autistic syptoms; Exacerbating autistic syptoms; Crying; Screaming; Pressing face, looking for pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 9 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Dec2021 (Lot number: FL8094) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing). Patient did not have COVID prior vaccination. The patient's concomitant medications were not reported. The following information was reported: on 29Dec2021, the patient experienced crying, screaming, hitting himself, bending fingers and toes, pressing face, looking for pressure every 15 minutes for about 5 days exacerbating autistic syptoms. Events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. On 28Jan2022, patient received dose 2 (tris), lot number: FL0007, intramuscular administered in arm left.; Sender's Comments: Based on available information and temporal relationship, a possible contributory role of BNT162B2 vaccine to the reported events can not be excluded. Case will be re-assessed upon the additional information provided. 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: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Insomnia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: covid test result: Positive / covid test date: 03Feb2022; covid test result: Positive / covid test date: 03Feb2022; Sore Throat; Cough; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 (Lot number: FF8839) at the age of 52 years as dose 3 (booster), single, administration date 05Feb2021 (Lot number: EL3247) as dose 2, single and administration date 14Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP, gout; "gout" (unspecified if ongoing), notes: Other medical history: HBP, gout. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Feb2022, outcome "unknown" and all described as "covid test result: Positive / covid test date: 03Feb2022"; OROPHARYNGEAL PAIN (non-serious) with onset 03Feb2022, outcome "recovering", described as "Sore Throat"; COUGH (non-serious) with onset 03Feb2022, outcome "recovering", described as "Cough"; INSOMNIA (non-serious) with onset 03Feb2022, outcome "recovering", described as "insomnia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of oropharyngeal pain, cough, insomnia. Clinical course: The facility where the COVID-19 vaccine was administered is Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts possible. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: covid test result: Positive / covid test date: 03Feb2022; covid test result: Positive / covid test date: 03Feb2022; Sore Throat; Cough; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 (Lot number: FF8839) at the age of 52 years as dose 3 (booster), single, administration date 05Feb2021 (Lot number: EL3247) as dose 2, single and administration date 14Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: Other medical history: HBP, gout; "gout" (unspecified if ongoing), notes: Other medical history: HBP, gout. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Feb2022, outcome "unknown" and all described as "covid test result: Positive / covid test date: 03Feb2022"; OROPHARYNGEAL PAIN (non-serious) with onset 03Feb2022, outcome "recovering", described as "Sore Throat"; COUGH (non-serious) with onset 03Feb2022, outcome "recovering", described as "Cough"; INSOMNIA (non-serious) with onset 03Feb2022, outcome "recovering", described as "insomnia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of oropharyngeal pain, cough, insomnia. Clinical course: The facility where the COVID-19 vaccine was administered is Workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19.   No follow-up attempts possible. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Joint lock
Clinical narrative: Joints locked; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 08:30 (Lot number: FG3527) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes - Type II" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If covid prior vaccination Yes. The patient took concomitant medications for Diabetes in two weeks. Past drug history included: Iodine, reaction(s): "Allergy".Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  The following information was reported: JOINT LOCK (disability) with onset 01Nov2021 08:30, outcome "recovered with sequelae", described as "Joints locked". The event "joints locked" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of joint lock included muscle relaxer/pain meds in ER. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care, disability or permanent damage. Clinical course: Joints locked up momentarily with 1st dose for about 2 min. 2nd dose, joint lock far more severe. Required ER visit which turned out to be a strained muscle patient was assumed that it cause by the lock-up. Joint pain and stiffness has lingered to this day.  No follow-up attempts are possible, no information is required.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris
Clinical narrative: heart pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 19 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGINA PECTORIS (medically significant), outcome "unknown", described as "heart pain". Clinical course: The reporter reported that the daughter (Patient) had received Covid vaccine and for some time had been complaining of heart pain that she associated at first not with the vaccine that is known to cause Myocarditis and Pericarditis but with energy drinks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Respiratory failure
Clinical narrative: However after receiving the vaccine the blood sugar spiked up; Developed respiratory failure and was placed on a ventilator; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "blood sugar problems" (unspecified if ongoing), notes: patient had all kinds of sugar problems, mild blood sugar problems for 2 years before the vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: May2021, for Covid-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "However after receiving the vaccine the blood sugar spiked up"; RESPIRATORY FAILURE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Developed respiratory failure and was placed on a ventilator". The patient underwent the following laboratory tests and procedures: blood glucose: (2021) spiked up/very high; (2021) stabilized/come down. Therapeutic measures were taken as a result of blood glucose increased, respiratory failure. Clinical course: The patient has had mild blood sugar problems for 2 years before the vaccine, she got a shot once a week. Immediately after the vaccine suddenly her glucose went very high/spiked up. And she developed respiratory distress/respiratory failure and was placed on a ventilator. She never tested positive for Covid. She was never showed pneumonia on X-ray. During the stay in hospital she was treated with antibiotic. Immediately after the vaccine her sugars started to rise. After all these months, her sugar, her insulin requirements have come down quite a bit. Sugar level is now stabilized.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, the causal association between the reported events and the suspect product bnt162b1 cannot be totally excluded. Contribution from underlying medical condition is also considered. The information available in this report is limited and does not allow  a medically meaningful assessment of the case.  In particular, the following relevant information is not available: event onset date, complete medical history, and concomitant medications.  Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: Ringing in ears, primarily the left ear. Saw an ENT on 8/17/21. Diagnosed as tinnitus.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized with COVID while vaccinated including booster
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient has a red, sore arm since the day after receiving the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received a vaccine that was one day past its beyond use date. No side effects reported.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Inappropriate schedule of product administration
Clinical narrative: heart condition; taken the second dose of the Pfizer COVID-19 vaccine 2 weeks after the first dose of the vaccine (instead of 3 weeks); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition"; "INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "taken the second dose of the Pfizer COVID-19 vaccine 2 weeks after the first dose of the vaccine (instead of 3 weeks)".  Additional Information: Caller was calling from her friend who has a heart condition and has taken the second dose of the Pfizer COVID-19 vaccine 2 weeks after the first dose of the vaccine (instead of 3 weeks). Caller would like to know if it would cause any effect. DSU: AE realized after the call.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Parent insisted on the patient receiving the pediatric vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Condition aggravated, Herpes virus infection, Illness, Infectious mononucleosis
Clinical narrative: I've been constantly sick since getting the COVID-19 vaccines. I've had constant cold sores around my mouth; sinus infection; now I have mono and a viral infection. It also made my herpes worse.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Sinusitis, Viral infection
Clinical narrative: I've been constantly sick since getting the COVID-19 vaccines. I've had constant cold sores around my mouth; sinus infection; now I have mono and a viral infection. It also made my herpes worse.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: All was fine until December 22nd, when I developed shingles. Visited doctor on January 3, 2022 to get it confirmed.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred  after 2nd vaccine; breakthrough case admission
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid ptosis
Clinical narrative: Right eye droop noticeable next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 02Feb2022 18:15 (Lot number: F55603) at the age of 15 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Lupus" (unspecified if ongoing). No Known allergies. No Covid prior vaccination, no Covid tested post vaccination. No other vaccine in four weeks. Concomitant medication(s) included: PREDNISONE. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: EWO173, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 13Aug2021, when the patient was 15 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot Number: EWO173, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 23Jul2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: EYELID PTOSIS (disability) with onset 03Feb2022 23:45, outcome "not recovered", described as "Right eye droop noticeable next day". Therapeutic measures were not taken as a result of eyelid ptosis.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Joint swelling, Myalgia, Rash
Clinical narrative: Severe joint swelling, pain and minimal ROM. Associated facial rash and muscular pain
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Blood magnesium normal, Blood potassium decreased, Chest X-ray normal, Computerised tomogram thorax abnormal
Clinical narrative: Had syncopal episode while at work 1 day after first COVID vaccine
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Drug screen positive, Electrocardiogram T wave amplitude decreased, Electrocardiogram abnormal, Fibrin D dimer increased, Full blood count
Clinical narrative: Had syncopal episode while at work 1 day after first COVID vaccine
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin decreased, International normalised ratio decreased, Metabolic function test, Myocardial necrosis marker normal, Pregnancy test urine negative
Clinical narrative: Had syncopal episode while at work 1 day after first COVID vaccine
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Splenomegaly, Syncope, Urine analysis, Urine leukocyte esterase positive
Clinical narrative: Had syncopal episode while at work 1 day after first COVID vaccine
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 3rd vaccine; breakthrough case admission
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Obstructive pancreatitis, Surgery
Clinical narrative: Patient presented to ED on 11/27/21 for stomach pain. Patient fully vaccinated with Moderna on 3/11/21, 4/8/21, and boosted on 11/23/21. Patient diagnosed with acute gallstone pancreatitis. Transferred and admitted to acute care surgery on 11/26/21. Following surgery, patient was discharged 12/1/21.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the parent.  A male patient(teen) received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization; Bnt162b2 (Dose:2), for COVID-19 immunization. The following information was reported: MYOCARDITIS (hospitalization), outcome "unknown", described as "Myocarditis". Patient was hospitalized with myocarditis several days after vaccination. The reporter said that the booster shot could have killed the patient.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: UNK, UNK
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right forearm pain, continuing to present
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, COVID-19, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: I'm not sure this adverse event even properly applies. I have been contacted by phone and asked to fill this form out, but it doesn't seem to be describing the right situation. I have both of my vaccinations and my booster and masked and was careful and still got Covid-19. Immediately following having Covid-19, I got pericarditis. I got a phone call asking me to fill out this form.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Pericarditis, SARS-CoV-2 test positive
Clinical narrative: I'm not sure this adverse event even properly applies. I have been contacted by phone and asked to fill this form out, but it doesn't seem to be describing the right situation. I have both of my vaccinations and my booster and masked and was careful and still got Covid-19. Immediately following having Covid-19, I got pericarditis. I got a phone call asking me to fill out this form.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Laboratory test, Product preparation issue, Troponin
Clinical narrative: C/O CHEST PAIN AFTER VACCINE, ALSO GIVEN TO MUCH DILUENT C VACCINE
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: said superficial blood clots/red spots all over the back lower area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "said superficial blood clots". The event "said superficial blood clots/red spots all over the back lower area" was evaluated at the physician office visit and emergency room visit. Clinical details: Patient got the Pfizer vaccine about 2 months ago. Right after taking the vaccine his feet had red spots all over the back lower area. The reporter thought could be blood clots. Patient thought may be reaction from vaccine but didn't want to worry about it. About 2-3 weeks later. He went to urgent care. Primary, dermatologist, hematologist and podiatrist who finally said superficial blood clots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Lymphadenopathy, Migraine, Pain
Clinical narrative: Swollen lymph nodes in left armpit and neck that lasted a week and triggered multiple migraine attacks due to the soreness from the swelling.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Electrocardiogram, Heart rate increased
Clinical narrative: Three later I felt a rapid heartbeat. My resting heart rate was at 130 for about 4 hours. It continue about 3 weeks , each day it will happen about 10 times. Also gradually heart issues, is was not as bad as my rapid heart beat. I had a phone consultation with different doctor and he recommended an EKG and the result looked fine. I am still dealing with this issues but is not as often as it was.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Distractibility, Tinnitus
Clinical narrative: Approx close to midnite on Feb 14th I started getting a highpitched buzzing/whistling noise in my ears. Sounded like inside head, not an exterior type of noise. It has not stopped. Today is the 6th day, it is very distracting.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Event occurred after 2nd vaccine; breakthrough case admission
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Asthenia, Chest X-ray, Fibrin D dimer increased, Full blood count
Clinical narrative: Fever, body aches, generalized weakness.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Metabolic function test, Pain, Pyrexia
Clinical narrative: Fever, body aches, generalized weakness.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin
Clinical narrative: Fever, body aches, generalized weakness.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: fainted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 2020, outcome "unknown", described as "fainted".  Clinical Course: Patient got 1st dose of vaccination on Apr2020. After receiving the 1st dose patient fainted and primary care doctor told to contact to Pfizer before taking the 2nd shot. So patient wanted to know was this common phenomenon or it was a rare case. The 2nd dose was very important to the patient's job and for future travel so patient was seeking advise. The patient took the vaccine in the evening around 6PM and drank spinach juice in morning and ate 1/2 lb chicken breast in afternoon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: fainted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant) with onset 2020, outcome "unknown", described as "fainted".  Clinical Course: Patient got 1st dose of vaccination on Apr2020. After receiving the 1st dose patient fainted and primary care doctor told to contact to Pfizer before taking the 2nd shot. So patient wanted to know was this common phenomenon or it was a rare case. The 2nd dose was very important to the patient's job and for future travel so patient was seeking advise. The patient took the vaccine in the evening around 6PM and drank spinach juice in morning and ate 1/2 lb chicken breast in afternoon.  The lot number for bnt162b2 was not provided and will be requested during follow up.