chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Inflammation; Right ankle had swollen again; His right ankle and knee both were swollen; Inside arms right by the joint started swelling; Bridge of nose was swollen; Left eye was swollen up shut; Extreme facial swelling and was brought to the emergency room and was prescribed with medication to reduce the swelling; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EW0175) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW0162) as dose 1, single for covid-19 immunization. On 02May2021 the patient experienced face swelling and went to the emergency room and prescribed with medication to reduce the swelling. Once it came down, on 11Jun2021, patient left eye was swollen up shut and patient returned to the medical facility and doctors gave him medications to reduce the swelling. On 18Jun2021, the patient's bridge of nose was swollen, 19Jun2021, inside arms right by the joint started swelling, 28Jun2021, patient right ankle and knee both were swollen, then went back to the emergency room and patient was again prescribed with medications for that. It went down for a couple of days, but patient right ankle had swollen again on 15Jul2021. On an unspecified date the patient had inflammation. The event swelling face was serious medically significant. The events facial swelling, joint swelling led the patient to emergency room visit and received treatment. The outcome the event swelling face was recovering, event his right ankle and knee both were swollen was recovered with sequelae on an unspecified date in 2021, and outcome of the other events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Mass, Myocardial infarction
Clinical narrative: her heart is racing and feels like it is going to beat out of her chest. Her nerves are so bad right now she is about to have a heart attack; weird bumps, explained as one red spot in right upper arm; weird bumps, explained as one red spot in right upper arm; Her nerves are so bad; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA6780) via an unspecified route of administration in right upper arm on 15Jul2021 at around 09:00 (at the age of 26-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history (none) and no relevant family medical history. Concomitant medications were not reported. Patient had no vaccines within four weeks of COVID-19 vaccine. Patient had no history of adverse event following vaccination. On 15Jul2021, after receiving first dose of vaccination, patient was breaking out in weird bumps and had one red spot in her right upper arm. She reported that about an hour after the shot she took a magnet and put it to her arm at the place she got the shot and it stuck, the magnet did not move. On 15Jul2021, patient experienced her heart was racing and felt like it was going to beat out of her chest. Her nerves were so bad, she was about to have a heart attack. Patient asked what she should do, should she go to the doctor or the emergency room. Patient did not receive any treatment in response to the event. Outcome of the events were unknown.  Follow-up attempts are completed. No further information was expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine, Blood creatine decreased, SARS-CoV-2 antibody test
Clinical narrative: Decrease in Creatine/creatine has decreased down to 31 mL/minute; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266 and Expiration Date: May2021), via an unknown route of administration, administered in right arm on 19Feb2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing FSGS (focal segmental glomerulosclerosis) a kidney condition, blood pressure, immune system being jeopardized from an unknown date and unknown if ongoing. Concomitant medications included lisinopril taken for blood pressure abnormal, start and stop date were not reported and tacrolimus taken for FSGS (focal segmental glomerulosclerosis) from May2019 and ongoing. The patient previously took first dose of bnt162b2 (Lot number: EL9264 Expiration date: May2021) administered in right arm on 29Jan2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunisation at around 11:00. Patient reported that, decrease in Creatine could have started in February possible. However, she saw the doctor last week (as reported) and this was when she got the creatine result, 31. She has had issues with the kidney for a couple of years. Back in Aug2020 the doctor started talking about the patient starting a shot called Rituximab infusion, but the doctor did not give at the time due to immune system being jeopardized. She confirmed she was unable to break down what FSGS meant as it's a long name. Since seeing the doctor there has been a protein they have always been watching. Now, the creatine is something they are concerned with for the kidneys. She saw the doctor on Thursday 08Jul2021 and the testing was done and got the creatine level of 31 ml/minute. The doctor mentioned would like to get the patient off Tacrolimus and get a third shot of the COVID vaccination. The case was assessed as non-serious. The patient underwent lab tests and procedures which included blood creatine: 32 ml/min on 08Jul2021, blood creatine: 31 ml/min on 08Jul2021 and on an unknown date. Sars-co-v/2 spike AB, QUANT, S- These antibodies were checked, and level was 46. Outcome of event was unknown.   Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Drug ineffective, Feeling abnormal, Suspected COVID-19
Clinical narrative: diagnosed with covid; diagnosed with covid; head feels like it is in a cloud and he is very disoriented; head feels like it is in a cloud and he is very disoriented; This is a spontaneous report from a contactable consumer reporting for her friend. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose for COVID-19 immunization, dose 1 on an unspecified date, dose 2 on 28Mar2021 (Lot number was not reported). There was no medical history or family medical history relevant to AE. Prior Vaccinations (within 4 weeks) was none. The patient's concomitant medications were not reported. The patient was diagnosed with COVID in Jul2021 3 or 4 days before 15Jul2021. His symptoms were loss of taste for short period of time, no fever, very very light sore throat, head felt like it was in a cloud and he was very disoriented. On 14Jul2021 he could taste his food and was hoping yesterday was the worst of it. The patient declined any treatment. No Emergency Room or Physician Office was required. No relevant rest. The outcome of events was unknown.  Information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My wife and I got shots in February and both have Covid; My wife and I got shots in February and both have Covid; This is a spontaneous report from a contactable consumer (patient) reported same events for two patients. This is the first of two reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported, expiration date not provided) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said, his wife and he got shots in February and both have COVID on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021902573 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My wife and I got shots in Feb and both have Covid; My wife and I got shots in Feb and both have Covid; This is a spontaneous report from a contactable consumer (patient's husband) reported same events for two patients. This is the second of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported, expiration date not provided) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said, his wife (patient) and he got shots in February and both have COVID on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021902542 Same reporter/drug/AE, different patient
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with covid/SARS-CoV-2 test positive; diagnosed with covid/SARS-CoV-2 test positive; This is a spontaneous report from a contactable consumer. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 on 23Feb2021 and dose 2 on 16Mar2021; both via an unspecified route of administration as single dose for covid-19 immunisation. Age at vaccination was 50 years old. Medical history was none. The patient's concomitant medications were not reported. The patient was diagnosed with covid on 08Jul2021, with symptoms of lethargy, sniffles, and cough. He did not receive treatment for the event. He was not immunocompromised. The event did not require a visit to emergency room or physician office. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, and positive on 08Jul2021. The outcome was unknown.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Fatigue, Flank pain, Malaise
Clinical narrative: SOB; tachypneic; Flank pain; fever; general malaise; body aches; fatigue; R lower leg DVT Diagnosed; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular on 08Jan2021 13:45 (Lot Number: EH9899) as dose 2, single for covid-19 immunisation. Medical history included ophthalmic herpes simplex, irritable bowel syndrome. The patient's concomitant medications were not reported. Known allergies included Skelaxin. The patient was not pregnant. No other vaccine in four weeks. No Other medications in two weeks. The patient previously received first dose of BNT162B2 (lot number EH9899) intramuscular on 18Dec2020 01:45 PM for covid-19 immunisation. The patient had flank pain 29Jan2021 21:00 PM, and then fever started 29Jan2021 and lasted for 8 days, general malaise started on 28Jan2021 21:00 PM, body aches, fatigue. After the fever broke had tachycardia with dyspnea for 2 weeks. She had on observation hospital stay 31Jan2021 to 01Feb2021 and additional ER visits due to illness. Last ER visit was 14Feb2021 SOB and tachypneic. Two COVID tests were negative. R lower leg DVT Diagnosed 26May2021 that started 29Mar2021. Events resulted in Emergency room/department or urgent care. Recovered with lasting effects. No treatment. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered with sequelae.; Sender's Comments: Based on the current available information a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Tachypnoea
Clinical narrative: SOB; tachypneic; Flank pain; fever; general malaise; body aches; fatigue; R lower leg DVT Diagnosed; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular on 08Jan2021 13:45 (Lot Number: EH9899) as dose 2, single for covid-19 immunisation. Medical history included ophthalmic herpes simplex, irritable bowel syndrome. The patient's concomitant medications were not reported. Known allergies included Skelaxin. The patient was not pregnant. No other vaccine in four weeks. No Other medications in two weeks. The patient previously received first dose of BNT162B2 (lot number EH9899) intramuscular on 18Dec2020 01:45 PM for covid-19 immunisation. The patient had flank pain 29Jan2021 21:00 PM, and then fever started 29Jan2021 and lasted for 8 days, general malaise started on 28Jan2021 21:00 PM, body aches, fatigue. After the fever broke had tachycardia with dyspnea for 2 weeks. She had on observation hospital stay 31Jan2021 to 01Feb2021 and additional ER visits due to illness. Last ER visit was 14Feb2021 SOB and tachypneic. Two COVID tests were negative. R lower leg DVT Diagnosed 26May2021 that started 29Mar2021. Events resulted in Emergency room/department or urgent care. Recovered with lasting effects. No treatment. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovered with sequelae.; Sender's Comments: Based on the current available information a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Erythema, Paraesthesia, Pyrexia
Clinical narrative: Lightheaded; Arms, upper chest, face, and eyelids became red; Felt tingling all over skin like she was going to get hives; Felt tingling all over skin like she was going to get hives; low grade fever; This is a spontaneous report from a contactable pharmacist.   A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 22Mar2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Mar2020 and hives in the past due to unspecified antibiotic. The patient did not have concomitant medications. Patient was vaccinated on 22Mar2021. Symptoms started the same day at 16:00. Patient felt lightheaded, her arms, upper chest, face, and eyelids became red; she felt tingling over her skin like she was going to get hives. These events were assessed as medically significant. Later in call the caller mentioned the patient also had a low-grade fever (non-serious).  Patient never erupted into hives or had any itching. The patient was treated for diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC). Symptoms lasted about 24 hours and were gone the next day. However, the patient was considered recovered from the events 'lightheaded', 'arms, upper chest, face, and eyelids became red', and 'felt tingling all over skin like she was going to get hives' in Apr2021 (duration of the events was 21 days); the patient had recovered from the event 'low grade fever' on unknown date in 2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 17Apr2021 at single dose to completed COVID-19 immunisation.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events Dizziness, Erythema , Paraesthesia Urticaria 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Lightheaded; Arms, upper chest, face, and eyelids became red; Felt tingling all over skin like she was going to get hives; Felt tingling all over skin like she was going to get hives; low grade fever; This is a spontaneous report from a contactable pharmacist.   A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 22Mar2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 from Mar2020 and hives in the past due to unspecified antibiotic. The patient did not have concomitant medications. Patient was vaccinated on 22Mar2021. Symptoms started the same day at 16:00. Patient felt lightheaded, her arms, upper chest, face, and eyelids became red; she felt tingling over her skin like she was going to get hives. These events were assessed as medically significant. Later in call the caller mentioned the patient also had a low-grade fever (non-serious).  Patient never erupted into hives or had any itching. The patient was treated for diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC). Symptoms lasted about 24 hours and were gone the next day. However, the patient was considered recovered from the events 'lightheaded', 'arms, upper chest, face, and eyelids became red', and 'felt tingling all over skin like she was going to get hives' in Apr2021 (duration of the events was 21 days); the patient had recovered from the event 'low grade fever' on unknown date in 2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9269), via an unknown route administered in the right arm, on 17Apr2021 at single dose to completed COVID-19 immunisation.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events Dizziness, Erythema , Paraesthesia Urticaria 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.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea exertional, Electrocardiogram, Laboratory test, Stress echocardiogram
Clinical narrative: Dyspnea with exertion; This is a spontaneous report from a contactable pharmacist. A 40-year-old male patient received BNT162B2 (Lot Number: EJ1685), dose 2 via an unspecified route of administration, administered in arm right on 08Jan2021 at the age of 40-year-old as single dose for covid-19 immunisation. Medical history included cardiac condition, unspecified; high cholesterol; both from an unknown to an unknown date. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot Number: EJ1685) on 18Dec2021 in right arm for COVID-19 Immunisation. On an unspecified date of Jan2021, 1-2 weeks after the second dose of the Pfizer Covid 19 Vaccine the patient began to experience dyspnea with exertion. It persisted and was not present before he got the vaccine. The patient has a cardiac condition, but stated that this felt different. This case was reported as serious due to medical significant. The event resulted in physician office visit - cardiologist seen for patient's dyspnea with exertion, but no emergency room visit. The patient underwent lab tests and procedures which included chest x-ray: negative in 2021, electrocardiogram (EKG): normal in 2021, stress echocardiogram: negative in 2021, lab work: negative in 2021. The outcome of event was unknown.; Sender's Comments: Based on current information available, the event dyspnea with exertion mostly represented intercurrent condition in this patient with cardiac condition, unrelated to Bnt162b2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Condition aggravated, Gait disturbance, Herpes zoster, Limb discomfort
Clinical narrative: shingles; rash; extremely bad pain and ended up in the hospital; The caller's left leg was kind of funny and she felt like she was going to fall; screaming; The shingles pain is so bad she has been in bed and can't walk.; The shingles pain is so bad she has been in bed and can't walk.; Shingles was reported as worsened/ shingles pain was so bad/ extremely bad pain/ tremendous pain that goes down to her elbow; right arm has tremendous pain that goes down to her elbow and wakes her up; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8729; NDC and expiration date unknown) via an unspecified route of administration on 13Apr2021 at 12:00 (at the age of 62-years-old) in right arm as a single dose for covid-19 immunization. Medical history (including illness at time of vaccination) included fibromyalgia diagnosed about 5 years ago, stroke diagnosed 8 year ago, pulmonary hypertension from 03Oct2007 to an unknown date. She also received a shingles shot 8 to 10 years ago and it didn't protect her from shingles this time (unknown lot, NDC, and expiration date for the shingles vaccine). No additional vaccines were administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Family medical history relevant to adverse events was reported as none. No investigation assessment was reported. There were no concomitant medications. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot EP7534; NDC and expiration date unknown) on 23Mar2021 at 12:00 in right arm for covid-19 immunization and experienced pain in right arm and it was killing her. The patient received the second shot on 13Apr2021 at 12:00 and at 03:00 her leg started acting kind of funny and she felt like she was going to fall. She also experienced shingles right after the shot, the same day and shingles pain was so bad that she had been in bed and can't walk. The event shingles required emergency room, physician office visit and hospitalisation. Shingles was reported as worsened. She reported that she was in extremely bad pain and ended up in the hospital and that's when the rash came up. Her right arm had tremendous pain that goes down to her elbow and waked her up because that's how bad it was. The patient was hospitalized within the first week after the second dose of the vaccine. She had been admitted in 3 different hospitals for 6 different times (one was 5 days, one was 6 days, one was 5 days, and one was 2 days), she was admitted to the hospital for pain every time. She was screaming and didn't knew what was going on in her body and didn't realize it was from the shot. Relevant tests were reported as none. The outcome for the events shingles, leg discomfort and vaccination site pain were not recovered and for all other events was unknown  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Screaming, Vaccination site pain
Clinical narrative: shingles; rash; extremely bad pain and ended up in the hospital; The caller's left leg was kind of funny and she felt like she was going to fall; screaming; The shingles pain is so bad she has been in bed and can't walk.; The shingles pain is so bad she has been in bed and can't walk.; Shingles was reported as worsened/ shingles pain was so bad/ extremely bad pain/ tremendous pain that goes down to her elbow; right arm has tremendous pain that goes down to her elbow and wakes her up; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER8729; NDC and expiration date unknown) via an unspecified route of administration on 13Apr2021 at 12:00 (at the age of 62-years-old) in right arm as a single dose for covid-19 immunization. Medical history (including illness at time of vaccination) included fibromyalgia diagnosed about 5 years ago, stroke diagnosed 8 year ago, pulmonary hypertension from 03Oct2007 to an unknown date. She also received a shingles shot 8 to 10 years ago and it didn't protect her from shingles this time (unknown lot, NDC, and expiration date for the shingles vaccine). No additional vaccines were administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Family medical history relevant to adverse events was reported as none. No investigation assessment was reported. There were no concomitant medications. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot EP7534; NDC and expiration date unknown) on 23Mar2021 at 12:00 in right arm for covid-19 immunization and experienced pain in right arm and it was killing her. The patient received the second shot on 13Apr2021 at 12:00 and at 03:00 her leg started acting kind of funny and she felt like she was going to fall. She also experienced shingles right after the shot, the same day and shingles pain was so bad that she had been in bed and can't walk. The event shingles required emergency room, physician office visit and hospitalisation. Shingles was reported as worsened. She reported that she was in extremely bad pain and ended up in the hospital and that's when the rash came up. Her right arm had tremendous pain that goes down to her elbow and waked her up because that's how bad it was. The patient was hospitalized within the first week after the second dose of the vaccine. She had been admitted in 3 different hospitals for 6 different times (one was 5 days, one was 6 days, one was 5 days, and one was 2 days), she was admitted to the hospital for pain every time. She was screaming and didn't knew what was going on in her body and didn't realize it was from the shot. Relevant tests were reported as none. The outcome for the events shingles, leg discomfort and vaccination site pain were not recovered and for all other events was unknown  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: it seemed it kind of knocked him out; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for husband that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got his Pfizer Covid 19 Vaccine, it seemed, it kind of knocked him out. It was also reported that the patient had the Pfizer and he didn't have a problem. The outcome was unknown.   The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Epistaxis, Fatigue, Magnetic resonance imaging
Clinical narrative: Fatigue; Disorientation; Epistaxis; This is a spontaneous report from non-contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Dose 1 on Jan2021 and Dose 2 on Feb2021, both via an unspecified route of administration as single dose for COVID-19 immunisation. Medical history included trigeminal neuralgia and multiple sclerosis. Concomitant medications included certain medications like pregabalin (LYRICA), baclofen, oxcarbazepine (TRILEPTAL), glatiramer acetate (COPAXONE), all for trigeminal neuralgia. The reporter said that they got their Pfizer Cocvid-19 Vaccine in Jan2021 for the first dose, and the end of Feb2021. He had a unique problem that kept reoccurring. She asked if anyone had ever reported extreme epistaxis after the receiving the Covid vaccine. She said that it was profuse. She said that he had no reaction to the shot, but a little fatigue and disorientation. His first episode was on 12Mar2021. He had never had a nose bleed in his life before that. She said that it was like turning on a faucet and he had to go to the ER. They could not stop it after 30 minutes. It was like projecting out of both nostrils. It was all over his face, clothes, and all over the towel on his face. She said that they kept him in the ER from 2300 until 0600 the next day. She said that he had had at least 4-5 incidences since then. She said that it happened in Apr2021, 3 times in May2021, and 3 rimes in Jun2021. The patient had been to the EENT and they scoped his nose and throat. They could see the bleeding and treated him with antibiotics and they still can't figure out where it was coming from. They didn't know. He had an MRI and no tumors, and nothing was shown. It was just a blood thing. The last episode he had was 22Jun2021. She said that she had her vaccine at the same time and had no side effects. Outcome of the event was recovered on 22Jun2021, of the events fatigue and disorientation was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Facial paralysis, Herpes zoster, Herpes zoster oticus
Clinical narrative: Shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date.  Face was paralyzed on left side but is; Shingles erupted after about 10 days of first dose of vaccine. Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date. Face was paralyzed on left side but is; Face was paralyzed on left side; Lost complete hearing in left ear still to this date.  Face was paralyzed on left side but is; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 21May2021 at 03:00 PM (age at the vaccination was 56 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history includes heart attack in November of 2020. No known allergies. Concomitant medication included atorvastatin, prasugrel and acetylsalicylic acid (ASPIRIN LOW); All were taken for an unspecified indication, start and stop date were not reported and the patient received within 2 weeks of vaccination. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Jun2021 at 12:00 AM, the patient experienced shingles erupted after about 10 days of first dose of vaccine.  Shingles then led to Ramsey Hunt Syndrome. Lost complete hearing in left ear still to this date.  Face was paralyzed on left side but is now getting back movement.  Still out of work and dealing with shingles after 6 weeks.  In pain constantly from the shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. For adverse events given medication to try and deal with nerve pain. The serious criteria was reported as disabling/incapacitating. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy; my arm was sore the first day or two; I started getting soreness in my arm again; a bit of numbness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. Patient stated that after the first dose she was perfectly fine, patient arm was sore the first day or two. Patient was scheduled to receive her second dose of the Pfizer COVID-19 vaccine on 29Jul2021. She stated about 2 days ago, she started getting soreness in her arm again and neuropathy, a bit of numbness. Patient consulted a neurologist who told her that what she was experiencing was not related to the vaccine. Patient stated what did they know, it's still new. Patient was asking if she should be concerned and if this was an immune response of the vaccine. Events resulted in physician office visit. Outcome of events was unknown.   The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus; This is a spontaneous report from a non-contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 04May2021 13:15 (at the age of 74 years old) as dose 1 single for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. The patient has no known allergies and no other medical history. The patient has no COVID prior to vaccination. Prior to vaccination, the patient has not been tested for COVID-19. Concomitant medication included atorvastatin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07May2021 09:00, the patient experienced severe tinnitus. The event resulted in Doctor or other healthcare professional office/clinic visit. No treatment was given in response to the event. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased, Condition aggravated, Crohn's disease, Feeding disorder
Clinical narrative: C-Reactive protein blood test went up 30 points; She experienced a flare of her Crohn's Disease she never had in her life; She can't eat or hold anything down; She can't eat or hold anything down; it has gotten worse/ Event: Overactive flare was reported as worsened; overactive flare like she has never experienced in her immune system; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162b2 (COVID-19 vaccine, Solution for injection, Lot No: EW0271), via an unspecified route of administration, administered in Arm Left on 06Jun2021 as 1stdose, single for covid-19 immunisation (age at vaccination is 49 years). Medical history included crohn's disease from 2006 and ongoing. The patient's concomitant medications were not reported. The patient experienced a flare of her crohn's disease she never had in her in 2021, she can't eat or hold anything down in 2021, it has gotten worse/ event: overactive flare was reported as worsened on 2021, c-reactive protein blood test went up 30 points on 11Jun2021. The patient underwent lab tests and procedures which included c-reactive protein went up 30 points on 11Jun2021, C-Reactive Protein went back down the 30 points two weeks later. Patient received one dose of the Pfizer Covid-19 Vaccine. On unspecified date in 2021 she experienced a flare of her Crohn's Disease she never had in her life. She can't eat or hold anything down and it has gotten worse since she received the vaccine. She has had no relief, and no one knows what to do. She has held off receiving the second dose of the vaccine. She was advised to get a spike protein qualitative antibody test. She is asking what do the results mean. Her doctor and the lab could not help reviewing the results with her. She thinks she is going to end up in the hospital if this continues. Patient is asking should I take the second vaccine, having Crohn's Disease is there any information or trials other than immunocompromised people were not involved in the clinical trials and that people immune compromised may have a lower response. History and Investigations about the patient was C-Reactive Protein went back down the 30 points two weeks later. Upon follow-up16Jul2021 spontaneous report; contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details). Outcome of the events were recovered/not resolved except C-Reactive protein blood test went up 30 points was recovered/resolved on unspecified date.  Follow-up (16Jul2021): This is a follow-up spontaneous report. A contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Vomiting
Clinical narrative: C-Reactive protein blood test went up 30 points; She experienced a flare of her Crohn's Disease she never had in her life; She can't eat or hold anything down; She can't eat or hold anything down; it has gotten worse/ Event: Overactive flare was reported as worsened; overactive flare like she has never experienced in her immune system; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162b2 (COVID-19 vaccine, Solution for injection, Lot No: EW0271), via an unspecified route of administration, administered in Arm Left on 06Jun2021 as 1stdose, single for covid-19 immunisation (age at vaccination is 49 years). Medical history included crohn's disease from 2006 and ongoing. The patient's concomitant medications were not reported. The patient experienced a flare of her crohn's disease she never had in her in 2021, she can't eat or hold anything down in 2021, it has gotten worse/ event: overactive flare was reported as worsened on 2021, c-reactive protein blood test went up 30 points on 11Jun2021. The patient underwent lab tests and procedures which included c-reactive protein went up 30 points on 11Jun2021, C-Reactive Protein went back down the 30 points two weeks later. Patient received one dose of the Pfizer Covid-19 Vaccine. On unspecified date in 2021 she experienced a flare of her Crohn's Disease she never had in her life. She can't eat or hold anything down and it has gotten worse since she received the vaccine. She has had no relief, and no one knows what to do. She has held off receiving the second dose of the vaccine. She was advised to get a spike protein qualitative antibody test. She is asking what do the results mean. Her doctor and the lab could not help reviewing the results with her. She thinks she is going to end up in the hospital if this continues. Patient is asking should I take the second vaccine, having Crohn's Disease is there any information or trials other than immunocompromised people were not involved in the clinical trials and that people immune compromised may have a lower response. History and Investigations about the patient was C-Reactive Protein went back down the 30 points two weeks later. Upon follow-up16Jul2021 spontaneous report; contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details). Outcome of the events were recovered/not resolved except C-Reactive protein blood test went up 30 points was recovered/resolved on unspecified date.  Follow-up (16Jul2021): This is a follow-up spontaneous report. A contactable consumer (patient) reported about patient characteristics (Age at time of onset of reaction/event, sex, medical history and concurrent conditions, Patient medical start date, Reactions and events details, drug information, History and Investigations details.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: chest pain; has been running out of breath pretty easily, and is pretty fatigued; has been running out of breath pretty easily, and is pretty fatigued; This is a spontaneous report from a contactable consumer (patient). A 24-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jun2021 (Lot Number: EW0164) at 24 years old as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included unspecified vitamin type. The patient had experienced chest pain on Jun2021. When the chest pain started, he had kind of a very sort of dull and not severe pain. It started within a day or two of the vaccine dose. He had that for a little bit, then it went away, then it came back a couple days ago. He started yesterday, which has happened only twice, to have a sharp pain that ripples across the left side of his chest that lasts for 5-10 seconds and was painful enough for him to stop what he was doing, and it came without warning then went away on its own. He had been running out of breath pretty easily, and was pretty fatigued. He went to urgent care today, and they didn't know what wrong with him, and if it got worse, to go to the emergency room. When he first got the pain in the middle of his chest he went to the chiropractor because he thought he might have a rib out, which indeed it did go away for a while. He didn't know if it could have anything to do with his left side though, the middle of chest, because it seems like two completely different things. He did take Naproxen sodium and the pain went down a bit, he took one last night and the pain went away for a bit. He says that this is an off brand of what might be known as Naprosyn. The dose is 220mg (EXP: Aug2022). He took one liquid gel type capsule by mouth, and his pain was reduced. The patient underwent lab tests and procedures which included COVID-19 molecular test: negative on 16Jul2021. The outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had blood clot; and reporter stated that she didn't ask the if patient had any other symptoms. Reporter stated that she won't provide any further information for the patient for privacy. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, patient had blood clot. Reporter stated that she did not ask them if patient had any other symptoms. She stated that she would not be providing any further information for the patient for privacy. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Dyspnoea, Feeling hot
Clinical narrative: Approximately 3-4 hours after receiving the shot I had stiffness and pain in neck , shoulders, upper back and chest. Also started feeling very hot but did not show fever on thermometer. Approximately 4 1/2 hrs after shot I started having a bit of  difficulty  breathing, and my  lungs feel itchy like they do when I?m about to go into an asthma attack.   It?s now approximately 7 1/2 hrs since shot and I still feel the same.    Have taken albuteral inhaler one time when breathing started to feel difficult but the feeling in my lungs did not and still have not changed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Respiratory tract irritation
Clinical narrative: Approximately 3-4 hours after receiving the shot I had stiffness and pain in neck , shoulders, upper back and chest. Also started feeling very hot but did not show fever on thermometer. Approximately 4 1/2 hrs after shot I started having a bit of  difficulty  breathing, and my  lungs feel itchy like they do when I?m about to go into an asthma attack.   It?s now approximately 7 1/2 hrs since shot and I still feel the same.    Have taken albuteral inhaler one time when breathing started to feel difficult but the feeling in my lungs did not and still have not changed.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dysstasia, Headache, Muscle atrophy, Muscular weakness
Clinical narrative: I gotten the first does in April then the second dose in March. The first dies cause my knees muscles to atrophy so I very weak knees so I have hard time standing up, and I been having frequent headaches. and having some heart discomfort.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Diarrhea, chest pain, fast heartbeat, shortness of breath, severe headache