chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood parathyroid hormone, Blood thyroid stimulating hormone, CSF test, Chest X-ray, Computerised tomogram
Clinical narrative: Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Drug screen, Full blood count, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging
Clinical narrative: Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging neck, Metabolic function test, Muscular weakness, Urine analysis
Clinical narrative: Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12
Clinical narrative: Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Decreased appetite, Fatigue, Hepatic enzyme abnormal, Nausea
Clinical narrative: lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3; fatigue; loss of appetite; constipation; nausea; This is a spontaneous report received. A contactable physician reported for a 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 06Feb2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Patient had historical vaccine (at 46-year-old) BNT162B2 on 16Jan2021 for Covid-19 Immunization. Other medical history included, colitis ulcerative, Primary sclerosing cholangitis and allergies from amoxicillin (Allergies to medications, food, or other products: Amoxicillin (prior DILI)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included mesalazine (LIALDA) (within 2 weeks of vaccination), 1.2 g twice a day (BID) taken for colitis ulcerative. The event of patient reported as Patient had PMH significant for quiescent UC on Lialda with recent diagnosis of PSC without history of cholangitis, prior DILI Dec2019 2/2 amoxicillin. Patient had first COVID vaccine (Pfizer) on 16Jan2021 with second on 06Feb2021. Patient works in healthcare and is testing weekly for COVID as part of his job and has been negative. 10 days after first dose he developed fatigue, loss of appetite, constipation and nausea. Patient got the second dose on 06Feb, symptoms persisted so he reached out on 10Feb2021. On 11Feb2021 lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3. No herbals, new meds, NSAIDs, APAP, alcohol. No fevers or chills or pruritus. Full serologic workup negative (viral, etc). Patient had Liver biopsy on 12Feb2021 showed mild cholestasis, mild portal inflammation of lymphs, eos, rare plasma cells and neutrophils. Mild bile ductular proliferation. Trichrome and reticulin with focal portal/periportal fibrosis associated with the bile ducts. Peak labs: bili 3.9 (direct 1.7), alk phos 179, ALT 594, AST 249. Adverse event result the doctor or other healthcare professional office/clinic visit. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. Patient did not received any treatment for the events. The outcome of all events was Unknown.  Follow up information has been requested for Lot/Batch no.; Sender's Comments: The event of hepatic enzyme abnormal is assessed as more likely due to concomitant medication mesalazine. although suspect product  "BNT162B2" role cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Serology test
Clinical narrative: lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3; fatigue; loss of appetite; constipation; nausea; This is a spontaneous report received. A contactable physician reported for a 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 06Feb2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Patient had historical vaccine (at 46-year-old) BNT162B2 on 16Jan2021 for Covid-19 Immunization. Other medical history included, colitis ulcerative, Primary sclerosing cholangitis and allergies from amoxicillin (Allergies to medications, food, or other products: Amoxicillin (prior DILI)). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications included mesalazine (LIALDA) (within 2 weeks of vaccination), 1.2 g twice a day (BID) taken for colitis ulcerative. The event of patient reported as Patient had PMH significant for quiescent UC on Lialda with recent diagnosis of PSC without history of cholangitis, prior DILI Dec2019 2/2 amoxicillin. Patient had first COVID vaccine (Pfizer) on 16Jan2021 with second on 06Feb2021. Patient works in healthcare and is testing weekly for COVID as part of his job and has been negative. 10 days after first dose he developed fatigue, loss of appetite, constipation and nausea. Patient got the second dose on 06Feb, symptoms persisted so he reached out on 10Feb2021. On 11Feb2021 lab data of patient showed ALT 538, AST 238, alk phos 197, Tbili 2.3. No herbals, new meds, NSAIDs, APAP, alcohol. No fevers or chills or pruritus. Full serologic workup negative (viral, etc). Patient had Liver biopsy on 12Feb2021 showed mild cholestasis, mild portal inflammation of lymphs, eos, rare plasma cells and neutrophils. Mild bile ductular proliferation. Trichrome and reticulin with focal portal/periportal fibrosis associated with the bile ducts. Peak labs: bili 3.9 (direct 1.7), alk phos 179, ALT 594, AST 249. Adverse event result the doctor or other healthcare professional office/clinic visit. No covid prior to vaccination, Since the vaccination, the patient has been tested for COVID-19. Patient did not received any treatment for the events. The outcome of all events was Unknown.  Follow up information has been requested for Lot/Batch no.; Sender's Comments: The event of hepatic enzyme abnormal is assessed as more likely due to concomitant medication mesalazine. although suspect product  "BNT162B2" role cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Mental impairment, Nausea, Somnolence
Clinical narrative: mental fog/bit of fog; foggy; Nausea; very sleepy; tired; Injection site pain/pain to the injection site; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 19Feb2021 08:40 at a single dose for COVID-19 immunisation.  Medical history included atrial fibrillation (Afib) about 10 years ago (2011). Concomitant medication included unspecified medications including blood thinner and Afib medications. The patient takes 6 medications: some of those medications for 40 years, some for a bit less. There were a couple more added for his heart because 10 years ago he had a case of Afib and the doctor who has now retired took him from 3 meds to 6; and has had no issues for the last 10 years. The patient had his first dose on 19Feb2021 at a clinic and was due/scheduled for his second on 12Mar2021. The patient had severe reactions to the first one so he wanted to know if he should accelerate second shot or stay within three weeks. His reaction was for the first two weeks, he had severe nausea, etcetera, which was getting better that week. He gives 20-minute presentations each morning and the participants in the presentation were nice about it but they say that the patient has fog and thought he should see if he should go in sooner as they were worried about him. His only symptoms remaining after two weeks of severe reactions was that he was very sleepy. All that was left was being tired and mentally in a bit of fog (also reported as mental fog). The patient only had pain to the injection site for a day and was not an issue, then it didn't take long for him to start getting extremely tired and have nausea. He says all he knows was that from the sheet listing severe reactions, he had every one during the first couple weeks (unspecified), though he never had a fever. He says this week he felt better and he was starting to eat, this was not normal for him to be tired all the time, but at least he was not sick. He says he didn't treat the pain or nausea, because he was healthy as a horse, and has no problems with a vaccine, shots don't bother him other than having soreness the first day. The patient was just foggy and tired. The patient was recovering from nausea. The patient recovered from injection site pain on 20Feb2021. The patient has not recovered from mental fog/bit of fog and tired. The outcome of the remaining events was unknown.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mental fog/bit of fog; foggy; Nausea; very sleepy; tired; Injection site pain/pain to the injection site; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 19Feb2021 08:40 at a single dose for COVID-19 immunisation.  Medical history included atrial fibrillation (Afib) about 10 years ago (2011). Concomitant medication included unspecified medications including blood thinner and Afib medications. The patient takes 6 medications: some of those medications for 40 years, some for a bit less. There were a couple more added for his heart because 10 years ago he had a case of Afib and the doctor who has now retired took him from 3 meds to 6; and has had no issues for the last 10 years. The patient had his first dose on 19Feb2021 at a clinic and was due/scheduled for his second on 12Mar2021. The patient had severe reactions to the first one so he wanted to know if he should accelerate second shot or stay within three weeks. His reaction was for the first two weeks, he had severe nausea, etcetera, which was getting better that week. He gives 20-minute presentations each morning and the participants in the presentation were nice about it but they say that the patient has fog and thought he should see if he should go in sooner as they were worried about him. His only symptoms remaining after two weeks of severe reactions was that he was very sleepy. All that was left was being tired and mentally in a bit of fog (also reported as mental fog). The patient only had pain to the injection site for a day and was not an issue, then it didn't take long for him to start getting extremely tired and have nausea. He says all he knows was that from the sheet listing severe reactions, he had every one during the first couple weeks (unspecified), though he never had a fever. He says this week he felt better and he was starting to eat, this was not normal for him to be tired all the time, but at least he was not sick. He says he didn't treat the pain or nausea, because he was healthy as a horse, and has no problems with a vaccine, shots don't bother him other than having soreness the first day. The patient was just foggy and tired. The patient was recovering from nausea. The patient recovered from injection site pain on 20Feb2021. The patient has not recovered from mental fog/bit of fog and tired. The outcome of the remaining events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: She has had pneumonia; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age (reported as Age: 75; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration second dose on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on an unspecified date for Covid-19 immunization. It was reported that patient has had pneumonia. The reporter stated that completing the vaccine was emotional relief. You feel like now you probably won't get sick and if you do you have a real low chance of hospitalization and if you do get hospitalized there is a miniscule chance of dying. It was like having a weight lifted off the shoulder as they say. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: Had a reaction in her right knee that put her on a cane; This is a spontaneous report from a contactable nurse (patient)  A76-year-old female nurse received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201, expiration date: 30Jun2021) on 20Feb2021 at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history included Osteoarthritis (diagnosed about 45 years ago). Concomitant medications were not reported. The patient received first dose of BNT162B2 on 30Jan2021. On 22Feb2021 the patient experienced a reaction in her right knee that put her on a cane. The event was considered serious as medically significant. The patient informed the knee was getting considerably better, but she can still feel it.  She can now walk without too much of a problem. At the time of the reporting the patient was recovering from the event.; Sender's Comments: Based on the information provided, the event "Had a reaction in her right knee that put her on a cane" is likely to be an intercurrent event unrelated to the use of suspect product BNT162B2 in this 76-year-old female with underlying osteoarthritis. This case will be reassessed should additional information become 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.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, Urinary tract infection
Clinical narrative: a urinary tract infection after the first dose; diagnosed with cancer cells; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported for her husband, a male patient of unspecified age who received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 09Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The consumer reported that she and her husband (patient) got the first dose of the vaccine last 09Feb2021. She was able to get her second dose last 02Mar2021, but her husband got a urinary tract infection on an unspecified date (in 2021) after the first dose and got hospitalized. He was diagnosed with cancer cells on an unspecified date (in 2021) before the schedule of the second dose. She mentioned that their doctor advised them to get the vaccine before 01Apr2021. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Migraine
Clinical narrative: two migraine headaches - atrial fibrillation; two migraine headaches - atrial fibrillation; This is a spontaneous report from a contactable consumer, the patient.   A 72-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation.  Medical history included stroke and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medications included warfarin (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN); both taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 10:00, the patient experienced two migraine headaches and atrial fibrillation. It was unknown if the patient received any treatment for the events. The clinical outcomes of the two migraine headaches and atrial fibrillation were recovered in Mar2021.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 17Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pneumonia in Feb2021. It was reported that the patient received the vaccine on 17Feb2021 and questioned what would happen if a person has pneumonia after the vaccine, which required antibiotic therapy for 11 days. Therapeutic measures were taken as a result of the event, which included unspecified antibiotic therapy starting 24Feb2021. The clinical outcome of pneumonia was unknown.  The lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Depression, Pain, SARS-CoV-2 test, Suicidal ideation
Clinical narrative: suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient).  A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: suicidal thoughts; Site pain; chills; body aches; tinnitus; depression; This is a spontaneous report from a non-contactable consumer (patient).  A 41-year-old (reported as 42-years-old) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the right arm, on 05Mar2021 at 12:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included pericarditis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications, taken within two weeks of vaccination, included emtricitabine, tenofovir disoproxil fumarate (TRUVADA), omeprazole (PRILOSEC), cetirizine hydrochloride (ZYRTEC), and fluticasone propionate (FLONASE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced suicidal thoughts, site pain, chills, body aches, tinnitus, and depression on 06Mar2021 at 04:00. The patient underwent lab tests and procedures which included nasal swab: negative on 01Jul2020. The clinical outcome of suicidal thoughts, site pain, chills, body aches, tinnitus, and depression was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, SARS-CoV-2 test, Tachycardia, Tremor
Clinical narrative: chest pain; tachycardia; cold sweats; shakes; This is a spontaneous report from a contactable other health professional. A 20-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot number was not reported) administered in arm left on an unspecified date for COVID-19 immunisation. The patient ended up in the hospital with chest pain, tachycardia, shakes and cold sweats, 5 hours after receiving second dose. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of chest pain, tachycardia, shakes and cold sweats due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Renal failure, Vitamin D deficiency
Clinical narrative: Husband has vitamin D deficiency and stage 4 kidney failure; Husband has vitamin D deficiency and stage 4 kidney failure; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported for her husband that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had vitamin D deficiency and stage 4 kidney failure on an unspecified date. It was clarified that husband had first covid vaccine shot than found out about his conditions. The outcome of the event was unknown.   Information on lot/batch number is requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Early miscarriage; This is a spontaneous report from a contactable other health care professional (Patient). A 30-year-old female patient (pregnant, last menstrual date 19Jan2021, Delivery date: 26Oct2021, Gestational period 4 weeks) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9269), via an unspecified route of administration on right arm on 19Feb2021 at 15:15 at the age of 30 years old at a single dose for COVID-19 immunisation at hospital. The patient's medical history included rheumatoid arthritis. There were no known allergies. Concomitant medications included prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced early miscarriage on 01Mar2021. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Pending the limited information on clinical course, the company does not attribute the event early miscarriage to BNT162B2. The detailed document of pregnancy, relevant risk factors, status of rheumatoid arthritis are missing for a medically meaningful assessment.   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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Emotional disorder, Eye swelling, Headache
Clinical narrative: all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Nausea, Rash, Skin disorder
Clinical narrative: all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site pain, Vaccination site swelling
Clinical narrative: all face including eyes swollen and red; all face including eyes swollen and red; skin got creepy, dry, itchy; injection site pain and was swollen a lot; little dizziness; nausea; Muscle pain more on back side of shoulder towards neck-unbearable pain; headache; neck disfigured; rash; injection site pain; brain fog big time - disorientated, felt like brain getting damage; I'm desperate; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Formulation: solution for injection, Lot no: EN5318) via intramuscular at left arm on 19Feb2021 at 03:10 (at the age of 75-years-old) at single dose for covid-19 immunisation (at hospital). Patient medical history not reported. Concomitant medications included levothyroxine; 0.075 mg once daily for hypothyroid since 20 years; ongoing and trazodone 100 mg 1 tab daily since 20 years; ongoing. On 19Feb2021 the patient experienced injection site pain and was swollen a lot, little dizziness, nausea, muscle pain more on back side of shoulder towards neck-unbearable pain, headache, all face including eyes swollen and red, all face including eyes swollen and red, skin got creepy, dry, itchy, brain fog big time - disorientated, felt like brain getting damage, she was desperate, skin got creepy, dry and itchy. my face and neck was disfigured that don't want my children and grant children see my face. Rash-swelling, itchy and flaky skin, got a little better on 01Mar, but I still have creepy skin, flackey, itchy around eye and eyelids were swollen and dry and felt like have stones rolling in my eyes and my brain fog was very bad. I want to know if my skin will ever get better. Patent took vit-d and all the vit. Covid. Patient received treatment as OTC, Tylenol, ibuprofen, aleve. No covid prior vaccination. The reporter reported seriousness criteria as non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: SLE; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 27Feb2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient suffered from systemic lupus erythematosus (SLE) and has had both Pfizer COVID-19 vaccines but did not have the usual side effects from any of the doses. The patient did not develop a fever nor any flu-like symptoms which were commonly reported. The patient wanted to find out if the patient developed any amount of immunity. The patient was willing to participate in a clinical trial if there was one in the local area for patients with autoimmune disorders. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Currently she has a flare up of RA; This is a spontaneous report received from a Pfizer sponsored program via contactable Other Healthcare Professional. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unknown route of administration on 01Mar2021 at single dose for covid-19 immunization. Medical history included Rheumatoid arthritis. Concomitant medication was not reported. Reporter stated ""I am an Internist- part of the team treating a newly diagnosed Rheumatoid arthritis patient. She received her 1st of Pfizer COVID vaccine on Mar 1. Currently (Mar2021) she has a flare up of RA and has severe joint inflammation and pain. She was prescribed steroid medication to begin 2 weeks after the 2nd dose of COVID vaccine. But her inflammation, swelling and pain are severe. Please let me know what affect the steroids have on antibody formation to the covid vaccine, and the timing for 2nd dose."" The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on known on available information and disease profile of Rheumatoid arthritis, the event Rheumatoid arthritis is not considered related to the using of BNT162B2 but more likely related to diseases progression.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: tingling/numbness in left hand, traveled up the arm; Tingling/numbness in left hand, traveled up the arm/ Skin on jaw went numb for an hour/ recurring along with all over the body; lips began to go numb; left wrist felt as if it was filled with fluid with no visible swelling; Pain on the back of the left hand is intense and unrelenting.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration, on 17Mar2021 at 3:00 PM (at the age of 36-years-old, not pregnant) as a single dose in the left arm for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks administered. On 18Mar2021 at 3:45 PM, the patient experienced tingling/numbness in left hand, traveled up the arm, lips began to go numb. The left wrist felt as if it was filled with fluid with no visible swelling. This has traveled all over various parts of the body. Skin on jaw went numb for an hour. Hand numbness was recurring along with all over the body at differing times. Pain on the back of the left hand is intense and unrelenting. The adverse events reported resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day on an unspecified date in 2021. The treatment administered for the reported events were Benadryl and Pepcid via intravenous (IV) route. The outcome of the events was not recovered.