chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Erythema, Haemorrhage
Clinical narrative: I have a bleeding disorder; bruising after my second shot; I have little red dot all over the part of my hands; dizziness/ I became extremely dizzy; This is a spontaneous report from a consumer (patient) via a Pfizer sponsored program COVAX US support. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0217, Expiration date: not reported, Age at vaccination: 53-year-old) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced bleeding disorder, legs, my arms and my torso broke up in bruises/ broke out with bruising, little red dot all over the part of my hands and dizziness/dizzy. She got her first dose back in June and she has bruising all over her legs, her arms and her torso. She got that a week after she got her first vaccine (Later consumer clarified consumer got bruising after the second shot) and on the second dose all she got was dizziness. She had a bleeding disorder (Further clarification was unknown if consumer had bleeding disorder after getting the vaccine or not) and she was on a blood thinner (Intent: treatment). Her doctor thought, it is best that she get the shot, within one week after taking both shot, on the last shot that we got afterwards (Further clarification was unknown) her legs, her arms and her torso broke up in bruises and she had little red dot all over the part of her hands. Consumer stated, The second dose EW0196 (Clarified as LOT#). Consumer stated, It is 09May1968 (Not clarified). So she broke out with bruising after her second shot. Also after the second shot she became extremely dizzy. Patient stated, So you want people started dying started having this side effect which they already are, the place where I work, most people are having the same bruising. The outcome of events was unknown.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dizziness, Headache, Pain
Clinical narrative: after my 1st shot I got came a contact to Covid virus and I tested Positive; achiness; head was like really swimming, at time when I stand up I get very light headache; Fever; I was still feeling very light headache if I move too fast; Chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable 56-year-old male consumer (Patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0191), dose 1 via an unspecified route of administration on 16Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Other Medication just regular daily Vitamins, don't know D3 (further not clarified, hence not captured in tab). The patient's concomitant medications were not reported. On 27Jul2021, the patient experienced after my 1st shot, the patient got came a contact to covid virus and the patient tested positive, I did another covid check before came in but it tested positive again, on an unspecified date in 2021 fever, chills, achiness, head was like really swimming, at time when the patient stand up and get very light headache, the patient had still feeling very light headache if the patient move too fast. He missed the 2nd Dose and asking if how long he needs to wait to get the 2nd dose, I already gave him the number of the Pfizer medical information department." Therapeutic measures were taken as a result of, headache. Treatment taken in response to adverse events, only thing I took was Tylenol for the headaches may be 200mg, took two. Investigation Assessment Yes. Consumers ask, how long should I wait for my 2nd dose because when they came time for my 3 weeks after the 1st dose, the patient actually contacted Covid, and how long do I wait to take my 2nd shot. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021, sars-cov-2 test was positive on 27Jul2021. The outcome for all events was unknown except headache was recovered on an unspecified date in 2021.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: after my 1st shot I got came a contact to Covid virus and I tested Positive; achiness; head was like really swimming, at time when I stand up I get very light headache; Fever; I was still feeling very light headache if I move too fast; Chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable 56-year-old male consumer (Patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0191), dose 1 via an unspecified route of administration on 16Jul2021 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. Other Medication just regular daily Vitamins, don't know D3 (further not clarified, hence not captured in tab). The patient's concomitant medications were not reported. On 27Jul2021, the patient experienced after my 1st shot, the patient got came a contact to covid virus and the patient tested positive, I did another covid check before came in but it tested positive again, on an unspecified date in 2021 fever, chills, achiness, head was like really swimming, at time when the patient stand up and get very light headache, the patient had still feeling very light headache if the patient move too fast. He missed the 2nd Dose and asking if how long he needs to wait to get the 2nd dose, I already gave him the number of the Pfizer medical information department." Therapeutic measures were taken as a result of, headache. Treatment taken in response to adverse events, only thing I took was Tylenol for the headaches may be 200mg, took two. Investigation Assessment Yes. Consumers ask, how long should I wait for my 2nd dose because when they came time for my 3 weeks after the 1st dose, the patient actually contacted Covid, and how long do I wait to take my 2nd shot. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in 2021, sars-cov-2 test was positive on 27Jul2021. The outcome for all events was unknown except headache was recovered on an unspecified date in 2021.
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Antibody test, Asymptomatic COVID-19, Chronic lymphocytic leukaemia, Diabetes mellitus, Drug ineffective
Clinical narrative: Positive for Covid-19; Positive for Covid-19; Borderline diabetic; CLL; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for himself:  An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive for covid-19, borderline diabetic, cll on an unspecified date. Caller stated that he has a caller on the line that reported that had a test for antibodies and it was ok. He does not remember when he had the first and second doses of his Covid-19 vaccine and tested positive with Covid-19, but does not know if it was after the 2 doses. He is 85 years old. Caller asked, Will he get antibodies with the vaccines he has taken. Caller said that when he had the blood test it showed that he had antibodies his doctor said that he had Covid and fought it off.  Caller asked does he get antibodies from the Pfizer Vaccines. He had no symptoms that showed he had Covid-19. Caller said that he believes that he had the antibody test after receiving the Covid-19 vaccines. He said that he has CLL and is compromised health wise, has a couple of other things going on, and is borderline diabetic. The patient underwent lab tests and procedures which included antibody test: it was ok on an unspecified date (Had Covid and fought it off), sars-cov-2 test: positive on an unspecified date. The outcome of event was Borderline diabetic and CLL was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: SARS-CoV-2 test
Clinical narrative: Positive for Covid-19; Positive for Covid-19; Borderline diabetic; CLL; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for himself:  An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive for covid-19, borderline diabetic, cll on an unspecified date. Caller stated that he has a caller on the line that reported that had a test for antibodies and it was ok. He does not remember when he had the first and second doses of his Covid-19 vaccine and tested positive with Covid-19, but does not know if it was after the 2 doses. He is 85 years old. Caller asked, Will he get antibodies with the vaccines he has taken. Caller said that when he had the blood test it showed that he had antibodies his doctor said that he had Covid and fought it off.  Caller asked does he get antibodies from the Pfizer Vaccines. He had no symptoms that showed he had Covid-19. Caller said that he believes that he had the antibody test after receiving the Covid-19 vaccines. He said that he has CLL and is compromised health wise, has a couple of other things going on, and is borderline diabetic. The patient underwent lab tests and procedures which included antibody test: it was ok on an unspecified date (Had Covid and fought it off), sars-cov-2 test: positive on an unspecified date. The outcome of event was Borderline diabetic and CLL was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: International normalised ratio decreased
Clinical narrative: Positive for Covid-19; Positive for Covid-19; Borderline diabetic; CLL; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for himself:  An 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive for covid-19, borderline diabetic, cll on an unspecified date. Caller stated that he has a caller on the line that reported that had a test for antibodies and it was ok. He does not remember when he had the first and second doses of his Covid-19 vaccine and tested positive with Covid-19, but does not know if it was after the 2 doses. He is 85 years old. Caller asked, Will he get antibodies with the vaccines he has taken. Caller said that when he had the blood test it showed that he had antibodies his doctor said that he had Covid and fought it off.  Caller asked does he get antibodies from the Pfizer Vaccines. He had no symptoms that showed he had Covid-19. Caller said that he believes that he had the antibody test after receiving the Covid-19 vaccines. He said that he has CLL and is compromised health wise, has a couple of other things going on, and is borderline diabetic. The patient underwent lab tests and procedures which included antibody test: it was ok on an unspecified date (Had Covid and fought it off), sars-cov-2 test: positive on an unspecified date. The outcome of event was Borderline diabetic and CLL was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Mammogram, Phlebitis, Phlebitis superficial, Ultrasound scan
Clinical narrative: developed pain under left breast; It increased daily and formed a thick cord. The cord grew to extend to center of abdomen. Doctor confirmed it was an inflammed vein; Similar to Mondor's cord of the breast; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 24Feb2021 at 17:00 (at the age of 67-years old) as dose 2, single for covid-19 immunization. Medical history included open angle glaucoma, high cholesterol and chronic migraine The patient had known allergies with codeine, sulfa drugs, red dye used in pills. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EL9264) administered in left arm on 04Feb2021 at 19:00 as dose 1, single for COVID-19 immunization at age of 67-year-old. Concomitant medications included atorvastatin calcium , propranolol, butalbital, caffeine, paracetamol (FIORICETTE)and Vitamin D [colecalciferol]. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Patient developed pain under left breast on 04Mar2021 after 2nd shot. Pain increased daily and formed a thick cord. The cord grew to extend to center of abdomen. Doctor confirmed it was an inflamed vein on 04Mar2021, similar to Mondor's cord of the breast. The patient underwent lab tests and procedures which included mammogram and ultrasound scan with unknown results on an unspecified date. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not taken for the events. The outcome of the events was reported as recovering. The case considered as non-serious. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer-sponsored Regulatory Authority Support. A 79-years-old female patient (reporter's wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration on 05Feb2021 as dose 1, single, and received second dose of BNT162B2 (Batch/Lot number and Expiration date: Unknown),via an unspecified route of administration on 26Feb2021 as dose 2, single; both for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications included infliximab (REMICADE) taken for rheumatoid arthritis, start and stop date were not reported. On an unspecified date, Patient started taking Remicade infusion because of her rheumatoid arthritis every 8 weeks, she took this after she received the second dose vaccine. The reporter asked if the booster dose is available and where they can get it because their immune system is low. Therapeutic measures were taken as a result of rheumatoid arthritis. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Heart rate increased, Malaise, Rash
Clinical narrative: Rashes; Rapid heart rate; Feeling unwell; blisters; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZE-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 27Jul2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced rashes, rapid heart rate, blisters and feeling unwell. She experienced allergic reactions during the 1st dose (taken last 27Jul2021) of Covid-19 vaccine. She said that she experienced blisters or rashes, rapid heart rate, and feeling unwell. She added that her employer requires her to complete the doses of the Covid-19 vaccine but she wanted to have an exemption for it because of the adverse events that happened after the 1st dose. She also mentioned that this concern has been already reported. She wanted to know how to be exempted for not getting the vaccine 2nd shot. The outcome of evens was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: she is a Cancer patient; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER COVID-19 VACCINE) on an unspecified date as dose 1 for covid-19 immunisation. She received the first and second dose of Pfizer Covid-19 vaccine and wanted to get the booster shot. Asked how long it would take for the booster to be effective and was there any statistic showing the effectiveness of the vaccine in immunocompromised persons. The patient states that she is a cancer patient and was not confirmed if it is a pre-existing condition. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Influenza like illness, Oropharyngeal pain, Suspected COVID-19
Clinical narrative: they all tested positive for COVID-19 after their COVID-19 vaccination; they all tested positive for COVID-19 after their COVID-19 vaccination; sore throat; symptoms; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 (at the age of 39 years old) as Dose 2, single for covid-19 immunization. Medical history included multiple sclerosis Diagnosed either in 2010 or 2011, somewhere in there. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunization. The patient concomitant medications were not reported. The patient experienced they all tested positive for covid-19 after their covid-19 vaccination on 03Aug2021, sore throat and symptoms on an unspecified date in Aug2021. You should wait until you have recovered from the infection, show no symptoms and completed any required isolation. Lastly, the interim considerations state that a prior COVID-19 infection may lower the risk of getting infected again (for a certain amount of time) so if vaccine supply is low, some people with a recent COVID-19 infection may choose to wait to receive their first dose of COVID-19 vaccine. You should talk to your doctor or other health care professional about this. Pfizer is independent of these recommendations. Please be sure to discuss any questions about receiving the Pfizer-BioNTech COVID-19 vaccine and if you have COVID-19 or develop COVID-19 after receiving the first dose with your vaccination provider, doctor, or other health care professional." Caller's "daughter tested positive for delta variant of COVID-19 last 03AUG2021 and had Multiple Sclerosis". Caller wanted to know if there is a time period for her daughter to wait before she gets the booster dose of the Pfizer BioNTech COVID-19 vaccine. Caller's daughter got off isolation last Monday, 16AUG2021. The dates for tested positive for the delta variant was reported from date 03 Aug2021 to 16 aug2021.No lot number was provided because caller does not have a copy of her daughter's COVID vaccine record card. The caller mentioned about product complaint due to her daughter having delta variant covid infection. The patient underwent lab test and procedure which included covid-19 result included negative on 02Aug2021 and positive on 03Aug2021. The outcome of the event they all tested positive for COVID-19 after their COVID-19 vaccination was recovered on 16Aug2021 and the outcome of other events was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Infection, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid 19; Tested positive for Covid 19; breakthrough infection; This is a spontaneous report from a contactable consumer (patient) reported for herself.   A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208; Expiration Date: Jun2021), dose 2 intramuscular, administered in Arm Left on 17Mar2021 16:00 (at the age of 71-years-old) as a single dose for covid-19 immunization and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198; Expiration Date: Jun2021), dose 1 intramuscular, administered in Arm Left on 24Feb2021 16:00 (at the age of 71-years-old) as a single dose for covid-19 immunization. Medical history included hypertension: Blood pressure high. Concomitant medication(s) included lisinopril taken for hypertension. Since the vaccination, the patient been tested for COVID-19. 5 months later she has a breakthrough infection and has tested positive for Covid 19. The patient tested positive for covid 19 on 18Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Aug2021. No more information available. The adverse event doesn't require to visit emergency room and required to visit physician office for covid-19. Outcome of the event was unknown.   Description of Product Complaint: Calling about the Pfizer BioNTech Covid Vaccine. States that she received her 1st dose on 24Feb2021 and her 2nd dose on 17Mar2021. Now, 5 months later she has a breakthrough infection and has tested positive for Covid 19.   Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Passed out; This is a spontaneous report from a contactable other Health Care Professional. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204 and Expiry date: 30Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:45 (at the age of 69-years-old) as DOSE 2, SINGLE for Covid-19 immunization. Medical history included ongoing diabetes mellitus Verbatim: type two diabetes, breast cancer from an unknown date and unknown if ongoing Verbatim: Breast cancer. She had breast cancer 11 years ago and Taxotere dropped her blood pressure till she collapsed on the floor and came close to passing out, she went down like a rock, this was back in 2010. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Concomitant medication included metformin taken for an unspecified indication, start and stop date were not reported. The patient previously took Taxotere, bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 17Feb2021 at 18:30 for Covid-19 immunization and her arm was fine and did not really get sore. She had no reaction to the first dose it was just a poke in the arm and all was well. On 12Mar2021 the patient passed out. She passed out 45 hours after the second dose. She hit the edge of a chair in the bathroom. She went to the emergency room, she got 4 stitches since it tore the flesh off her left ear to point that cartilage could be seen. She has one doctor saying to get the booster and one doctor saying not to get the booster. She wants the booster and does not have an objection to it but does not want to end up in the ER. At the time she went to ER she explained to the doctor that the same thing happened when she had the medication Taxotere in 2010 and the ER doctor told her she is not blaming Pfizer for this and states she is not blaming anything. She was told later by the infusion center where she would get her port flushed, that there was something that begins with a T acid that is in taxotere and the covid vaccine, states if she puts two and two together, they both have that t acid ingredient in them. The outcome of event was unknown.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Loss of conciousness. 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Body temperature, Migraine, Pyrexia, Rash
Clinical narrative: I lost my vision for about 30 min; broke out in a rash; got a migraine like no migraine I have ever had before; couldn't get out of bed let alone set up without vomiting; had a fever of 101.2; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FA7484), via an unspecified route of administration, administered in right arm on 04Aug2021 at 11:45 as dose 1, single (at the age of 42 years) for covid-19 immunization, at pharmacy or drug store. Medical history included chronic migraines from an unknown date and unknown if ongoing and Drug allergy: Sulfa and Rexalti. Concomitant medications were not reported. The patient previously took rexulti on an unknown date and experienced known allergy. There were no other vaccines in four weeks. The patient did not have covid prior vaccination and did not get tested for Covid post vaccination. The patient reported that, on 18Aug2021, 02 weeks after receiving the first vaccine shot, she broke out in a rash, got a migraine like no migraine she has ever had before, she could not get out of bed let alone set up without vomiting, lost her vision for about 30 minutes and had a fever of 101.2, because of which she had miss work. Adverse events did not result in emergency room or physician office visit. The patient underwent lab tests and procedures which included body temperature: 101.2 on 18Aug2021. There was no corrective treatment received for the events. The outcome for all the events was reported as recovering at the time of report.  Information on lot/batch number was available; additional information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Blindness transient cannot be totally excluded.This case will be reassessed once additional information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I lost my vision for about 30 min; broke out in a rash; got a migraine like no migraine I have ever had before; couldn't get out of bed let alone set up without vomiting; had a fever of 101.2; This is a spontaneous report from a contactable other healthcare professional (patient). A 42-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FA7484), via an unspecified route of administration, administered in right arm on 04Aug2021 at 11:45 as dose 1, single (at the age of 42 years) for covid-19 immunization, at pharmacy or drug store. Medical history included chronic migraines from an unknown date and unknown if ongoing and Drug allergy: Sulfa and Rexalti. Concomitant medications were not reported. The patient previously took rexulti on an unknown date and experienced known allergy. There were no other vaccines in four weeks. The patient did not have covid prior vaccination and did not get tested for Covid post vaccination. The patient reported that, on 18Aug2021, 02 weeks after receiving the first vaccine shot, she broke out in a rash, got a migraine like no migraine she has ever had before, she could not get out of bed let alone set up without vomiting, lost her vision for about 30 minutes and had a fever of 101.2, because of which she had miss work. Adverse events did not result in emergency room or physician office visit. The patient underwent lab tests and procedures which included body temperature: 101.2 on 18Aug2021. There was no corrective treatment received for the events. The outcome for all the events was reported as recovering at the time of report.  Information on lot/batch number was available; additional information has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Blindness transient cannot be totally excluded.This case will be reassessed once additional information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Chest pain, Dyspnoea, Palpitations
Clinical narrative: Since abatement I've had transient episodes of bradycardia/palpitations; Since abatement I've had transient episodes of bradycardia/palpitations; Within the week following second injection, chest pain, usually when lying down (supine or prone); I've also experienced shortness of breath issues in approximately the same interval; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0185, Expiration date not reported), via an unspecified route of administration, administered in left arm on 22May2021 at 10:00 (at the age of 33-year-old) as single dose for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was reported as none. The patient known allergies were reported as none. There were no concomitant medications reported. The patient did not receive any other vaccines in four weeks and no other medications in two weeks. Patient historical vaccine includes first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0171) as via an unspecified route of administration in an unspecified anatomical location on 01May2021 (at the age of 33-year-old) as single dose for COVID-19 immunisation at Pharmacy or Drug Store. Patient reported that within the week following second injection, chest pain, usually when lying down (supine or prone). Since abatement had transient episodes of bradycardia/palpitations. He also experienced shortness of breath issues in approximately the same interval on an unspecified date in May2021. Patient had no covid prior vaccination and patient did not tested for covid post vaccination. Patient did not receive any treatment for the events. The outcome of the events was resolved with sequel in 2021.  Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Hypoaesthesia, Nausea, Oropharyngeal pain, Throat irritation
Clinical narrative: anaphylactic reaction; Throat was closing up/tighten, sore and itchy throat; Everything was going numb; Nauseous; sore and itchy throat; sore and itchy throat; This is a spontaneous report from a contactable consumer (patient's mother). A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FC3181), via an unspecified route of administration, administered in left arm on 19Aug2021 at around 15:30 as dose 1, single (at the age of 15 years), for covid-19 immunization, at pharmacy. Vaccine was not administered at military facility. It was told that they should get it, needs to be done, protection when going back to school, doctor recommended it. Medical history was not reported. There were no concomitant medications (Other Products: No). There was no family medical history relevant to adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The patient previously received Flu shot (Vaccination Date: Unknown) and had an allergic reaction to the Flu shot. Caller did not know the date of this vaccine or the NDC, Lot Number, or Expiry date for the vaccine. Caller states that this occurred when her daughter was in Kindergarten. Caller stated her daughter had all of her other vaccines and never had any reactions. There were no prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. The mother reported that, her daughter got the first dose of the Pfizer-BioNTech Covid-19 Vaccine and on the same day on 19Aug2021, experienced anaphylactic reaction (tighten, sore and itchy throat), everything was numb and she was nauseous that lead to them ending up in urgent care and emergency department to be further treated. She explained in detail that, her daughter was taken to the Emergency Room and as a corrective for all the events she was given an EpiPen that helped immediately and her daughter was also given steroids and was monitored, admitted, and treated in the Emergency Room for 5 hours. She said that her daughter was currently sleeping in her bedroom and was doing better, and she had to go pick up more medication for her daughter this morning that she would take for the next 10 days. She stated it was so scary yesterday. Patient Medical was not continuing. No investigation assessment was done. Adverse events resulted in visit to emergency room and physician office. There were no relevant tests. The outcome for all the events was reported as recovering, at the time of report.  Follow-up attempts completed. No further information expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: anaphylactic reaction; Throat was closing up/tighten, sore and itchy throat; Everything was going numb; Nauseous; sore and itchy throat; sore and itchy throat; This is a spontaneous report from a contactable consumer (patient's mother). A 15-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: FC3181), via an unspecified route of administration, administered in left arm on 19Aug2021 at around 15:30 as dose 1, single (at the age of 15 years), for covid-19 immunization, at pharmacy. Vaccine was not administered at military facility. It was told that they should get it, needs to be done, protection when going back to school, doctor recommended it. Medical history was not reported. There were no concomitant medications (Other Products: No). There was no family medical history relevant to adverse events. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The patient previously received Flu shot (Vaccination Date: Unknown) and had an allergic reaction to the Flu shot. Caller did not know the date of this vaccine or the NDC, Lot Number, or Expiry date for the vaccine. Caller states that this occurred when her daughter was in Kindergarten. Caller stated her daughter had all of her other vaccines and never had any reactions. There were no prior vaccinations (within 4 weeks) to the first administration date of the suspect vaccine. The mother reported that, her daughter got the first dose of the Pfizer-BioNTech Covid-19 Vaccine and on the same day on 19Aug2021, experienced anaphylactic reaction (tighten, sore and itchy throat), everything was numb and she was nauseous that lead to them ending up in urgent care and emergency department to be further treated. She explained in detail that, her daughter was taken to the Emergency Room and as a corrective for all the events she was given an EpiPen that helped immediately and her daughter was also given steroids and was monitored, admitted, and treated in the Emergency Room for 5 hours. She said that her daughter was currently sleeping in her bedroom and was doing better, and she had to go pick up more medication for her daughter this morning that she would take for the next 10 days. She stated it was so scary yesterday. Patient Medical was not continuing. No investigation assessment was done. Adverse events resulted in visit to emergency room and physician office. There were no relevant tests. The outcome for all the events was reported as recovering, at the time of report.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Tremor
Clinical narrative: difficulty breathing; Uncontrolled shaking; This is a spontaneous report from a non-contactable consumer or non-healthcare professional (patient).   A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date: not reported), via an unspecified route of administration on an unspecified date in Mar2021 as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No covid prior vaccination and no covid tested post vaccination. On an unspecified date in 2021, the patient experienced uncontrolled shaking and difficulty breathing. The AE resulted in emergency room/department or urgent care. The patient was hospitalized for the events. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Rash
Clinical narrative: Generalized Rash; Patient developed a generalized rash following each dose; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.This consumer or other non hcp reported information for both mother and fetus/baby.This is a Mothers report.A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8783 and Expiry date: Unknown), via an dose 2 intramuscular, administered in Arm Left on 03Apr2021 15:00, at the age of 34-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included abortion spontaneous from an unknown date and unknown if ongoing, live birth from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within prior to the Covid vaccine. The patient received other medications of vaccination. On 03Apr2021 the patient experienced patient developed a generalized rash following each dose. On 08Apr2021 the patient experienced generalized rash. The mother reported she became pregnant while taking bnt162b2.The mother was 32 Weeks pregnant at the onset of the event.The mother was due to deliver on 24May2021.The mother delivered the pregnancy on 24May2021.Therapeutic measures were taken as a result of generalized rash. The outcome of event generalized rash was recovered while the outcome of event patient developed a generalized rash following each dose was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, SARS-CoV-2 test
Clinical narrative: headache; lethargy; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administrated in right arm on 02Mar2021 14:00 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to animal dander/urine; pollen, dust, etc. On 02Mar2021, the patient experienced headache, and lethargy. On 11Aug2021, the patient underwent lab tests and procedures which included NAAT/RT-PCR nucleic acid, SARS-CoV-2 test: Negative. The treatment was received as a result of adverse events which included 125 mg amoxicillin every 12 hours for 7 days. 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. Since the vaccination, the patient been has tested for COVID-19. The outcome for all the events was recovered on an unspecified date Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body fluid analysis, Pericardial effusion, Pericarditis, SARS-CoV-2 antibody test
Clinical narrative: having so much fluid in his heart/had fluid around his heart; pericarditis; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; tafamidis (VYNDAMAX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at an unspecified dose for an unspecified indication.  Medical history and concomitant medications were not reported.  The patient had the first shot of the Pfizer BioNTech COVID-19 vaccine "on 06Jan2021 or 07Jan2021 or 04Jan2021" and by 17Jan2021, he was rushed to the emergency room because he couldn't breathe. He was having so much fluid in his heart and had to re-do the operation in Feb2021, and "they took biopsies of the fluid and they came back saying it might be pericarditis." She further described that he had fluid around his heart, they thought it was pericarditis and have been treating him all winter. He had a pericardial window and was on medication. The reporter stated that it started Jan2021 after the first shot,  but "it might be too close to the first shot to actually be caused by it". The patient had a pericardial window now which would take the fluid out should it come back again, but would have to go on antibiotics. They did an antibody test last week (as of 20Aug2021) and the patient's came back as negative; so he has an appointment for a third vaccine The outcome of the event(s) was not recovered. The reporter further provided that they are scheduled for a third dose of Moderna and Pfizer because the patient's doctor said that if the Pfizer (vaccine) didn't give him antibodies, they should try Moderna.   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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Muscle Cramping; This is a spontaneous report from a contactable consumer. A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7533), dose 2 intramuscular, administered in Arm Right on 24Mar2021 at 16:40 (at the age of 64 year) as dose 2, single for COVID-19 immunisation. Medical history included leg pain and headache. Patient did not receive prior vaccinations within 4 weeks. Concomitant medication(s) included tramadol taken for leg pain, headache from 19Apr2021 and ongoing; baclofen taken from 01Apr2021; zolpidem taken from 17Mar2021; olmesartan taken from 02Nov2020; diclofenac sodium taken from 06May2020; vitamin b complex taken from 25Feb2020; aspirin [acetylsalicylic acid] taken from 11Jan2020; Dietary Supplement taken from 06May2020. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: BioNTech/EN6204), dose 1 Intramuscular on 03Mar2021 at 16:40 for COVID-19 immunisation and experienced Headache. On 01Apr2021, patient experienced muscle cramping. AE required visit to Physician office. The patient underwent lab tests and procedures on an unspecified date which included MRI and other testing and all was okay. Therapeutic measures were taken as a result of muscle cramping which included treatment Baclofen, couldn't take due to drowsy. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer. This 61-year-old, non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number: EN6208) dose 2 via an unspecified route of administration on 02Apr2021 (at the age of 61-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history included hypertension, high cholesterol, diabetes. The patient past drug therapy included BNT162B2 (Lot number: EN6198, dose number 1) for Covid-19 immunisation start and stop date on 11Mar2021. The patient had no known allergies. The patient concomitant medications included progesterone, citalopram, valsartan, omeprazole for unknown indication on an unspecified date. The patient experienced vertigo on 21May2021. The patient received treatment with meds and IV fluids for adverse event. The patient underwent lab tests and procedures which included CT Scan and MRI with unknown result. The outcome of the event was not recovered.