chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021; aches; shaking; weakness; mucous; This is a spontaneous report from contactable consumer (patient's wife) received from a Pfizer sponsored program report. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 25Feb2021 11:00 at age of 71-year-old (Lot Number: CH6202) at single dose for COVID-19 immunization in Urgent Care. Medical history included diabetes  from 2000 and ongoing. There were no concomitant medications. Prior Vaccinations (within 4 weeks), there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There was no events following prior vaccinations. The patient got the first dose of Pfizer COVID-19 vaccine and got COVID right after on 04Mar2021. The reporter believed they got it from the clinic. The patient was treated with monoclonal antibodies. The doctors have advised patient to take the second dose three months later. The patient received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021. Patient received antibody treatment on 05Mar2021. Patient had a positive PCR test on 17Mar2021. The patient experience aches that started on 28Feb2021 night after the vaccine. On 01Mar2021 he had a very high fever, it went up to 103.5 with paracetamol (TYLENOL). He could not get out of bed. No NDC Lot or expiration known for paracetamol. The patient had shaking, coughing, weakness and mucous which had all improved. He also had diarrhea, had some in morning of 21Mar2021 and it was still persisting. The events were reported as non-serious. The events required a visit to emergency room and physician office. The patient was not hospitalized and treated at Emergency Room with antibodies and sent home. The patient had positive Rapid COVID test and positive PCR COVID test. The patient underwent lab tests and procedures which included body temperature: 103.5 on 01Mar2021, COVID19: positive on 04Mar2021, PCR test: positive on 17Mar2021. The reporter assumed that patient got COVID 19 at the testing site because reporter knew of five other patients of reporter's own doctor who had that same experience in the same week. The outcome of COVID-19 and aches were unknown, outcome of shaking, weakness and mucous were resolving.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021313862 same reporter/product, similar events, different patients.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Secretion discharge, Tremor
Clinical narrative: received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021; aches; shaking; weakness; mucous; This is a spontaneous report from contactable consumer (patient's wife) received from a Pfizer sponsored program report. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 25Feb2021 11:00 at age of 71-year-old (Lot Number: CH6202) at single dose for COVID-19 immunization in Urgent Care. Medical history included diabetes  from 2000 and ongoing. There were no concomitant medications. Prior Vaccinations (within 4 weeks), there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There was no events following prior vaccinations. The patient got the first dose of Pfizer COVID-19 vaccine and got COVID right after on 04Mar2021. The reporter believed they got it from the clinic. The patient was treated with monoclonal antibodies. The doctors have advised patient to take the second dose three months later. The patient received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021. Patient received antibody treatment on 05Mar2021. Patient had a positive PCR test on 17Mar2021. The patient experience aches that started on 28Feb2021 night after the vaccine. On 01Mar2021 he had a very high fever, it went up to 103.5 with paracetamol (TYLENOL). He could not get out of bed. No NDC Lot or expiration known for paracetamol. The patient had shaking, coughing, weakness and mucous which had all improved. He also had diarrhea, had some in morning of 21Mar2021 and it was still persisting. The events were reported as non-serious. The events required a visit to emergency room and physician office. The patient was not hospitalized and treated at Emergency Room with antibodies and sent home. The patient had positive Rapid COVID test and positive PCR COVID test. The patient underwent lab tests and procedures which included body temperature: 103.5 on 01Mar2021, COVID19: positive on 04Mar2021, PCR test: positive on 17Mar2021. The reporter assumed that patient got COVID 19 at the testing site because reporter knew of five other patients of reporter's own doctor who had that same experience in the same week. The outcome of COVID-19 and aches were unknown, outcome of shaking, weakness and mucous were resolving.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021313862 same reporter/product, similar events, different patients.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021; aches; shaking; weakness; mucous; This is a spontaneous report from contactable consumer (patient's wife) received from a Pfizer sponsored program report. A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 25Feb2021 11:00 at age of 71-year-old (Lot Number: CH6202) at single dose for COVID-19 immunization in Urgent Care. Medical history included diabetes  from 2000 and ongoing. There were no concomitant medications. Prior Vaccinations (within 4 weeks), there were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There was no events following prior vaccinations. The patient got the first dose of Pfizer COVID-19 vaccine and got COVID right after on 04Mar2021. The reporter believed they got it from the clinic. The patient was treated with monoclonal antibodies. The doctors have advised patient to take the second dose three months later. The patient received his Pfizer COVID vaccine on 25Feb2021 and tested positive for COVID on 04Mar2021. Patient received antibody treatment on 05Mar2021. Patient had a positive PCR test on 17Mar2021. The patient experience aches that started on 28Feb2021 night after the vaccine. On 01Mar2021 he had a very high fever, it went up to 103.5 with paracetamol (TYLENOL). He could not get out of bed. No NDC Lot or expiration known for paracetamol. The patient had shaking, coughing, weakness and mucous which had all improved. He also had diarrhea, had some in morning of 21Mar2021 and it was still persisting. The events were reported as non-serious. The events required a visit to emergency room and physician office. The patient was not hospitalized and treated at Emergency Room with antibodies and sent home. The patient had positive Rapid COVID test and positive PCR COVID test. The patient underwent lab tests and procedures which included body temperature: 103.5 on 01Mar2021, COVID19: positive on 04Mar2021, PCR test: positive on 17Mar2021. The reporter assumed that patient got COVID 19 at the testing site because reporter knew of five other patients of reporter's own doctor who had that same experience in the same week. The outcome of COVID-19 and aches were unknown, outcome of shaking, weakness and mucous were resolving.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021313862 same reporter/product, similar events, different patients.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: I seem to be experiencing slight Bell's Palsy on the right side of my face.; This is a spontaneous report from a contactable nurse reporting for himself. A 35-year-old male patient received the first dose of BNT162B2 (Lot Number: EN6204), intramuscular, administered in left arm on 20Mar2021 14:00 (at the age of 35-year-old) at single dose for COVID-19 immunization. Medical history included autoimmune encephalitis and obesity. No known drug allergies. Concomitant medications included aripiprazole (ABILIFY); clonazepam; propranolol; lithium carbonate (LITHEUM); naltrexone; benzatropine mesilate (COGENTIN); dexmethylphenidate hydrochloride (FOCALIN XR ER); dexamethasone, ofloxacin hydrochloride (FOCALIN); desvenlafaxine succinate (PRISTIQ); amoxicillin trihydrate, clavulanate potassium (AUGMENTIN BD); levothyroxine sodium (TIROSINT); iron (FE 10); probiotics and multivitamins (MV). No other vaccine in four weeks. No Covid prior vaccination nor tested with Covid post vaccination. The patient seems to be experiencing slight bell's palsy on the right side of his face on 22Mar2021 08:30. It was unknown if treatment was received for the event. The outcome of the event was unknown.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the event facial paralysis. 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: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dizziness, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side of face; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 13:00 (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health clinic facility. No other vaccine in four weeks. The patient received the first dose of bnt162b2 (lot not reported) in left arm on 24Feb2021 at 14:00 (at the age of 46-years-old) for COVID-19 immunization. Medical history included known allergies: Sulfa. The patient's concomitant medications were not reported. The patient did not have covid prior vaccination and was covid tested post vaccination by nasal swab on 03Mar2021 with result of negative. The adverse events were swelling in head, headache, dizzy, sore arm, numbness left side of face and Bells palsy, all on 19Mar2021 at 01:00. On day 4, went to hospital no stroke or heart attack was told swelling from vaccine. The events were reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. Treatment for the events included pain meds, nausea meds. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling
Clinical narrative: Bells Palsy; Swelling in head/swelling from vaccine; headache; dizzy; sore arm; numbness left side of face; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration in left arm on 18Mar2021 13:00 (at the age of 46-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a public health clinic facility. No other vaccine in four weeks. The patient received the first dose of bnt162b2 (lot not reported) in left arm on 24Feb2021 at 14:00 (at the age of 46-years-old) for COVID-19 immunization. Medical history included known allergies: Sulfa. The patient's concomitant medications were not reported. The patient did not have covid prior vaccination and was covid tested post vaccination by nasal swab on 03Mar2021 with result of negative. The adverse events were swelling in head, headache, dizzy, sore arm, numbness left side of face and Bells palsy, all on 19Mar2021 at 01:00. On day 4, went to hospital no stroke or heart attack was told swelling from vaccine. The events were reported to have resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 1 day. Treatment for the events included pain meds, nausea meds. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood folate normal, Blood immunoglobulin A, Blood immunoglobulin G normal, Blood immunoglobulin M, Borrelia test negative
Clinical narrative: developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Electrophoresis protein normal, Fatigue, Full blood count normal, Glycosylated haemoglobin
Clinical narrative: developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis viral test negative, Hypoaesthesia, Immunoelectrophoresis, Immunology test, Lymphadenopathy
Clinical narrative: developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Thyroid function test normal, Vitamin B1, Vitamin B12 normal
Clinical narrative: developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin E
Clinical narrative: developed peripheral neuropathy/ full blown peripheral neuropathy; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6201) via an unspecified route of administration, administered on the left arm on 11Mar2021 09:45 at a single dose for COVID-19 immunisation. The patient's medical history included peripheral neuropathy. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 18Feb2021 for COVID-19 immunization (Lot number: EN6198, at 10:45 AM at the Left arm). On 14Mar2021 the patient developed peripheral neuropathy. Symptoms started a few days after second vaccine. She had had some issues prior that may or may not have started after second vaccine, but they were intermittent. She had full blown peripheral neuropathy since second vaccine. Therapeutic measures were taken as a result of the event which included medication (unspecified). The event resulted to a doctor or other healthcare professional office/clinic visit. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Clinic facility. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the event was not recovered.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle contracture, Musculoskeletal pain, Myalgia, Pyrexia
Clinical narrative: sweat fever out; slight fever; whole body muscle aches; headache.; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medications included losartan (LOSARTAN)m colecalciferol (VITAMIN D), vitamin b complex (VITAMIN B-COMPLEX) and magnesium (MAGNESIUM) all taken for unspecified dates and indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient receive the vaccine on 18Mar2021 and he was okay on Friday. By Saturday morning (20Mar2021 9:30), he felt pain in upper left buttocks like someone sticking with knife followed by muscle contractions in same area that would repeat 2 to three times but was intermittent for 4 hours. He felt ok with no symptoms rest of Saturday. Then on Sunday morning around 4 a.m., the same feeling came back and lasted until Sunday noon (21Mar2021). Then, his whole-body muscle aches that lasted whole Sunday along with headache. On 22Mar2021 (Monday), the patient had still intense whole-body muscle aches all day headache but no buttocks contractions. By night, he slight fever took paracetamol (TYLENOL) and also had sweat fever. By Tuesday morning, the patient still had faint muscle aches slight headache. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient did not receive treatment for the events of  pain in upper left buttocks like someone sticking with knife followed by muscle contractions, whole-body muscle aches, headache and sweat fever.  The patient was recovering from the events and was feeling much better  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Sweating fever
Clinical narrative: sweat fever out; slight fever; whole body muscle aches; headache.; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; felt pain in upper left buttocks like someone sticking me with knife followed by muscle contractions in same area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Arm Left on 18Mar2021 12:00 (Batch/Lot Number: EN6205) as SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medications included losartan (LOSARTAN)m colecalciferol (VITAMIN D), vitamin b complex (VITAMIN B-COMPLEX) and magnesium (MAGNESIUM) all taken for unspecified dates and indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient receive the vaccine on 18Mar2021 and he was okay on Friday. By Saturday morning (20Mar2021 9:30), he felt pain in upper left buttocks like someone sticking with knife followed by muscle contractions in same area that would repeat 2 to three times but was intermittent for 4 hours. He felt ok with no symptoms rest of Saturday. Then on Sunday morning around 4 a.m., the same feeling came back and lasted until Sunday noon (21Mar2021). Then, his whole-body muscle aches that lasted whole Sunday along with headache. On 22Mar2021 (Monday), the patient had still intense whole-body muscle aches all day headache but no buttocks contractions. By night, he slight fever took paracetamol (TYLENOL) and also had sweat fever. By Tuesday morning, the patient still had faint muscle aches slight headache. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. The patient did not receive treatment for the events of  pain in upper left buttocks like someone sticking with knife followed by muscle contractions, whole-body muscle aches, headache and sweat fever.  The patient was recovering from the events and was feeling much better  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast pain, Chills, Erythema, Mastitis
Clinical narrative: sore right breast; chills; body aches; fever of 102.6; more soreness in right breast and a red mark; diagnosed with mastitis; This is a spontaneous report from a contactable consumer (patient reported for self). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), dose 1, via an unspecified route of administration, administered in right arm on 01Mar2021 12:00 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with Covid-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine and did not receive any other medications within 2 weeks of vaccination. The Wednesday after the vaccine, on 03Mar2021 05:30 (also reported as about 36 hours later), patient woke up with a sore right breast. As the day progressed, patient had the chills, body aches, and a fever of 102.6. Patient also noticed more soreness in right breast and a red mark. Patient spoke to OB and was diagnosed with mastitis. The patient was tested for covid post vaccination reported as results of tests and procedures for investigation of the patient on 12Mar2021 as nasal swab: negative. Therapeutic measures were taken as a result of the events reported which included antibiotic. The events were reported as recovered in Mar2021.   Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: sore right breast; chills; body aches; fever of 102.6; more soreness in right breast and a red mark; diagnosed with mastitis; This is a spontaneous report from a contactable consumer (patient reported for self). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), dose 1, via an unspecified route of administration, administered in right arm on 01Mar2021 12:00 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with Covid-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine and did not receive any other medications within 2 weeks of vaccination. The Wednesday after the vaccine, on 03Mar2021 05:30 (also reported as about 36 hours later), patient woke up with a sore right breast. As the day progressed, patient had the chills, body aches, and a fever of 102.6. Patient also noticed more soreness in right breast and a red mark. Patient spoke to OB and was diagnosed with mastitis. The patient was tested for covid post vaccination reported as results of tests and procedures for investigation of the patient on 12Mar2021 as nasal swab: negative. Therapeutic measures were taken as a result of the events reported which included antibiotic. The events were reported as recovered in Mar2021.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation, Pulmonary oedema, SARS-CoV-2 test
Clinical narrative: She contracted COVID-19 5 days after her first vaccination/She received the first vaccine on 19Feb2021, on 24Feb2021 she showed symptoms of COVID-19 and was diagnosed with a COVID-19 test; Swollen lung; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female received received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 19Feb2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient asked if she could receive her 2nd dose of the COVID-19 vaccine (Pfizer-BioNTech) if she contracted COVID-19 5 days after her first vaccination. She received the first vaccine on 19Feb2021, on 24Feb2021 she showed symptoms of COVID-19 and was diagnosed with a COVID-19 test. The patient stated that she was fine at the time of report, she didn't get pneumonia and didn't go to the hospital. She had a swollen lung, but she didn't have pneumonia. She has a history of asthma. Has not experienced fever for 15 days. Her blood oxygenation is 97 or 98% (24Feb2021). She asked if it is possible that receiving the 1st dose of the COVID-19 vaccine (Pfizer-BioNTech) contributed to showing only mild symptoms of COVID-19 and if the 2nd dose was not given 3 weeks after the first, is the COVID-19 vaccine (Pfizer-BioNTech) still effective. The patient recovered from the events.  Information about lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Superior sagittal sinus thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 73-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration in left arm on 10Feb2021 (Batch/Lot Number: EN9581) as a single dose for COVID-19 immunisation. Medical history included hypertension, prolactinoma, hyper cholesterol, and allergies to penicillin. Concomitant medications received within 2 weeks of vaccination included verapamil, lisinopril, atorvastatin, and omeprazole. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) in the left arm on 20Jan2021 01:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was not diagnosed with COVID-19 prior to vaccination. The patient experienced stroke due to blood clot at superior sagittal sinus of brain on 11Mar2021 13:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 6 days. Treatment received for the adverse event included Enoxaparin injections and warfarin. Outcome of events was not recovered. The patient had not been tested for COVID-19 since the vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 10:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization at a clinic. Medical history included asthma, high blood pressure and allergy with Sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) and apple cider vinegar. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at 10:00 in the left arm for covid-19 immunisation. The patient experienced very high fever and excess vomiting about 10 times in 5 hours on 19Mar2021 at 22:00. No treatment was given for the events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female 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 in right arm, on 15Mar2021 at 14:00 (02:00 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. One week after the vaccine on 22Mar2021 at 09:00 AM, the patient had an atrial fibrillation (Afib) event. On 22Mar2021, the patient went to the emergency room (ER) or department or urgent care and ran tests including electrocardiogram (EKG), chest X-ray, and blood work which were all normal. Now, the patient had to go to a cardiologist for further understanding of the reason for AFib event. No treatment was given for the event. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the event.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Malaise, Pneumonia, X-ray
Clinical narrative: Acute bronchitis; Touch of pneumonia; Didn't feel well; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the BNT162B2 vaccine on 04Mar2021. She stated she didn't feel well since then. On 22Mar2021, she went to the doctor, had an X-ray and was advised that she has acute bronchitis and also stated that she may have a touch of pneumonia. She would like to know if she should receive the second dose of the vaccine scheduled on 25Mar2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood blister, Contusion, Petechiae, Platelet count, Vein rupture
Clinical narrative: Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back to feet; Blood blisters; Turned into bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Mar2021 21:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included allergies: anesthesia and thrombocytopenia that developed during childbirth (went away after a few weeks). The doctors said that it may have been a drug reaction. Concomitant medication included omeprazole (PRILOSEC). The patient previously took codeine and experienced allergies -severe nausea. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 08Mar2021 18:00, patient's lower right leg vein popped out about 1/2-3/4" but did not feel anything. It later turned into a bruise. Lots of petechiae from back to feet and blood blisters noticed; large on torso. AE resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for AE. It was also reported that the events caused hospitalization. Platelets were tested last week (unspecified date in 2021) and are on low end of normal range. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Head discomfort
Clinical narrative: bodychills; headache; heavy sweats; low fever; no appetite; losing weight; lethargic; heavy head; tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (Lot number: En6205), via an unspecified route of administration, administered in left arm on 08Mar2021 11:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. No Covid prior vaccination. Concomitant medications included amlodipine besilate; benazepril; and gemfibrozil. No other vaccine in four weeks. On 08Mar2021 15:00, the patient experienced body chills, headache, heavy sweats, low fever, no appetite, losing weight, lethargic, heavy head and tired. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was hospitalized due to the events on unspecified date. There was no treatment given for the events. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lethargy, Pyrexia, Weight decreased
Clinical narrative: bodychills; headache; heavy sweats; low fever; no appetite; losing weight; lethargic; heavy head; tired; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (Lot number: En6205), via an unspecified route of administration, administered in left arm on 08Mar2021 11:00 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. No Covid prior vaccination. Concomitant medications included amlodipine besilate; benazepril; and gemfibrozil. No other vaccine in four weeks. On 08Mar2021 15:00, the patient experienced body chills, headache, heavy sweats, low fever, no appetite, losing weight, lethargic, heavy head and tired. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was hospitalized due to the events on unspecified date. There was no treatment given for the events. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Muscle disorder, Muscular weakness, Near death experience
Clinical narrative: muscle weakness; melted on the carpet/went to the floor; no muscular control; nearly killed her; haven't been right since; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. An 85-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), dose 2 via an unspecified route of administration on 19Mar2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that she was having hard time to advise her friends to take the Pfizer vaccine after what happened to her. Patient took the second Pfizer shot and nearly killed her on an unknown date in Mar2021.  Patient got it Friday (19Mar2021) and haven't been right since (Mar2021). A day after the shot (20Mar2021), she stated she got up from her bed put her feet and melted on the carpet, had muscle weakness and no control what soever. Patient asked if Pfizer was aware about the side effects of the 2nd dose. Patient further reported the events as follows: The next day, she went to get out of bed and stated she had no muscular control and went to the floor, and stated she never had a problem with flu shots or her first dose of the covid-19 vaccine. She stated she was on hold all day yesterday and never was able to talk to someone. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: began having symptoms of shingles 12 hours after second shot; severe pain; This is a spontaneous report from a contactable consumer.  A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 18Mar2021 12:00 (Batch/Lot Number: EP754) at single dose (at the age of 48 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had no allergies.  The patient previously took BNT162B2, dose 1, (lot number: EN6198) on 25Feb2021 1:30 AM, vaccine location on the left arm. The patient began having symptoms of shingles 12 hours after second shot on 18Mar2021. Urgent Care visit 3 days later and now severe pain because of the shingles. No covid prior vaccination and not tested for covid post vaccination. The patient was hospitalized due to the events. The outcome of the events was not recovered.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: extensive proximal right lower extremity deep vein thrombosis; This is a spontaneous report received from a contactable physician. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, at the age of 68-year-old, on 05Mar2021, as SINGLE DOSE for covid-19 immunisation.  Medical history included hypertension and chronic kidney disease. The patient's concomitant medications were not reported.  The patient experienced extensive proximal right lower extremity deep vein thrombosis (medically significant) on 05Mar2021.  Therapeutic measures taken as a result of extensive proximal right lower extremity deep vein thrombosis included anticoagulation agent. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and has not been tested for COVID-19. Outcome was recovering at the time of the report.  Information about batch/lot number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Erythema, Exophthalmos, Fatigue
Clinical narrative: bulging eyes; Mild allergic reaction; metallic taste in mouth; pounding headache; red ears; face/neck rash; fatigue; dizzy.; Sore arm; This is a spontaneous report from a contactable consumer (patient).   A 62-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Left Arm on 23Mar2021 12:00 (Batch/Lot number was not reported), at the age of 62-years at vaccination, as SINGLE DOSE for COVID-19 immunization.  Medical history included enlarged aorta, high blood pressure, asthma, eggs and corn allergy. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; budesonide (PULMICORT) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin, ferrous sulfate, folic acid, serine (RESCUE) taken for an unspecified indication, start and stop date were not reported. On 23Mar2021 12:00, the patient experienced mild allergic reaction, started with metallic taste in mouth and pounding headache before leaving (pharmacy name withheld) after 15 min wait period, red ears, face/neck rash, "bulging eyes". No respiratory issues. Subsided after <1 hour but still feeling fatigue and dizzy. The patient also had sore arm. Still thrilled to get it. The outcome of the events was recovering.  No treatment was received for the events.  Information on the lot/batch number has been requested.