chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blister, Urticaria
Clinical narrative: blisters and vesicles with rash both forearms; blisters and vesicles with rash both forearms; This is a spontaneous report from a contactable physician. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 00:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (VIVELLE DOT) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported. The patient experienced blisters and vesicles with rash both forearms (rash vesicular) (non-serious) on 15Jan2021 12:30 and blisters and vesicles with rash both forearms (rash vesicular) (non-serious) on 15Jan2021 12:30. Therapeutic measures were taken as a result of blisters and vesicles with rash both forearms (rash vesicular), blisters and vesicles with rash both forearms (rash vesicular). The outcome of the events were reported as Recovered/Resolved with Sequel.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash vesicular
Clinical narrative: blisters and vesicles with rash both forearms; blisters and vesicles with rash both forearms; This is a spontaneous report from a contactable physician. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 00:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (VIVELLE DOT) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported. The patient experienced blisters and vesicles with rash both forearms (rash vesicular) (non-serious) on 15Jan2021 12:30 and blisters and vesicles with rash both forearms (rash vesicular) (non-serious) on 15Jan2021 12:30. Therapeutic measures were taken as a result of blisters and vesicles with rash both forearms (rash vesicular), blisters and vesicles with rash both forearms (rash vesicular). The outcome of the events were reported as Recovered/Resolved with Sequel.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Fatigue, Pyrexia
Clinical narrative: Patient took the vaccine and walked back to his apartment after waiting for around 30 minutes.  He gradually became more fatiqued and decided to shower.  As he came out of the shower, he collapsed and was taken by ambulance to The Hospital as he could not support himself to stand.  He was unable to walk for 3 days and then regained his ability to walk with some difficulty.  Placed in rehab for approximately 8 days.  He is having greater difficulty ambulating since this event and then taking the 2nd dose and having what were covid symptoms.  Temp around 99.0.  Congestion and coughing.    He continues with shortness of breath after 2nd injection reaction taken 2/17/2021.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Patient took the vaccine and walked back to his apartment after waiting for around 30 minutes.  He gradually became more fatiqued and decided to shower.  As he came out of the shower, he collapsed and was taken by ambulance to The Hospital as he could not support himself to stand.  He was unable to walk for 3 days and then regained his ability to walk with some difficulty.  Placed in rehab for approximately 8 days.  He is having greater difficulty ambulating since this event and then taking the 2nd dose and having what were covid symptoms.  Temp around 99.0.  Congestion and coughing.    He continues with shortness of breath after 2nd injection reaction taken 2/17/2021.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Laboratory test, Respiratory tract congestion, Syncope, X-ray
Clinical narrative: Patient took the vaccine and walked back to his apartment after waiting for around 30 minutes.  He gradually became more fatiqued and decided to shower.  As he came out of the shower, he collapsed and was taken by ambulance to The Hospital as he could not support himself to stand.  He was unable to walk for 3 days and then regained his ability to walk with some difficulty.  Placed in rehab for approximately 8 days.  He is having greater difficulty ambulating since this event and then taking the 2nd dose and having what were covid symptoms.  Temp around 99.0.  Congestion and coughing.    He continues with shortness of breath after 2nd injection reaction taken 2/17/2021.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Headache, Muscular weakness, Pain, Pain in extremity
Clinical narrative: sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; Fever; headache; flu like aches; tiredness; This is a spontaneous report from a contactable female consumer (patient) A 70-year-old female patient (non -pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686; Expiration Date: unknown), via unspecified route of administration, anatomical location: - Left arm On 20Jan2021 at single dose for COVID-19 immunisation. The patient Medical history included Slight asthma, fibromyalgia. concomitant medications include Shingrix on 04Jan2021. Patient experienced Fever, headache, flu like aches, tiredness Not concerned about this, had same reaction to shingles vaccine. But six days later sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs. Had a negative reading for covid three days after vaccine. The intensity of the feeling began to decrease after 48 hours but the feeling and weakness is still present..patient was not diagnosed with COVID-19 vaccination. The patient was tested for COVID-19 since the vaccination, (covid test type Nasal swab, covid test date-23Jan2021, covid test result-Negative) The outcome of event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; Fever; headache; flu like aches; tiredness; This is a spontaneous report from a contactable female consumer (patient) A 70-year-old female patient (non -pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686; Expiration Date: unknown), via unspecified route of administration, anatomical location: - Left arm On 20Jan2021 at single dose for COVID-19 immunisation. The patient Medical history included Slight asthma, fibromyalgia. concomitant medications include Shingrix on 04Jan2021. Patient experienced Fever, headache, flu like aches, tiredness Not concerned about this, had same reaction to shingles vaccine. But six days later sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs. Had a negative reading for covid three days after vaccine. The intensity of the feeling began to decrease after 48 hours but the feeling and weakness is still present..patient was not diagnosed with COVID-19 vaccination. The patient was tested for COVID-19 since the vaccination, (covid test type Nasal swab, covid test date-23Jan2021, covid test result-Negative) The outcome of event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Muscular weakness, Pain in extremity
Clinical narrative: sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; Fever; headache; flu like aches; tiredness; This is a spontaneous report from a contactable female consumer (patient) A 70-year-old female patient (non -pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686; Expiration Date: unknown), via unspecified route of administration, anatomical location: - Left arm On 20Jan2021 at single dose for COVID-19 immunisation. The patient Medical history included Slight asthma, fibromyalgia. concomitant medications include Shingrix on 04Jan2021. Patient experienced Fever, headache, flu like aches, tiredness Not concerned about this, had same reaction to shingles vaccine. But six days later sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs. Had a negative reading for covid three days after vaccine. The intensity of the feeling began to decrease after 48 hours but the feeling and weakness is still present..patient was not diagnosed with COVID-19 vaccination. The patient was tested for COVID-19 since the vaccination, (covid test type Nasal swab, covid test date-23Jan2021, covid test result-Negative) The outcome of event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs; Fever; headache; flu like aches; tiredness; This is a spontaneous report from a contactable female consumer (patient) A 70-year-old female patient (non -pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EJ1686; Expiration Date: unknown), via unspecified route of administration, anatomical location: - Left arm On 20Jan2021 at single dose for COVID-19 immunisation. The patient Medical history included Slight asthma, fibromyalgia. concomitant medications include Shingrix on 04Jan2021. Patient experienced Fever, headache, flu like aches, tiredness Not concerned about this, had same reaction to shingles vaccine. But six days later sudden and very intense tingling, burning pain in both legs and feet with weakness in both legs. Had a negative reading for covid three days after vaccine. The intensity of the feeling began to decrease after 48 hours but the feeling and weakness is still present..patient was not diagnosed with COVID-19 vaccination. The patient was tested for COVID-19 since the vaccination, (covid test type Nasal swab, covid test date-23Jan2021, covid test result-Negative) The outcome of event was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Feeling abnormal, Frequent bowel movements, Headache
Clinical narrative: Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headache; nausea; Muscle heaviness; fatigue; brain fog(poor concentration and focus); brain fog(poor concentration and focus); general malaise; Increased bowel movements daily; This is a spontaneous report from a contactable pharmacist (Pharmacist). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: El8982), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as single dose for covid-19 immunisation at Health Clinic or administration facility. Medical history included gastrooesophageal reflux and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included pravastatin taken for an unspecified indication, famotidine, ascorbic acid, betacarotene, colecalciferol, folic acid, minerals nos, retinol, tocopheryl acetate, vitamin b nos (CENTRUM [ASCORBIC ACID;BETACAROTENE;COLECALCIFEROL;FOLIC ACID;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS]), cyanocobalamin (B12), ergocalciferol (VIT D). The patient previously took biaxin and experienced drug hypersensitivity. On 27Jan2021 20:00, the patient experienced lung tightness with burning and pain/lungs were tight, headache, nausea, muscle heaviness, fatigue, brain fog (poor concentration and focus), general malaise and increased bowel movements daily. These symptoms lasted for 7 days. Two of the days my lungs were tight but I did not have shortness of breath. Nausea was everyday. Increased bowel movements daily. I am concerned that these effects lasted for 7 days. Does this put me at risk for serious side effects after the 2nd dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscular weakness, Nausea
Clinical narrative: Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headache; nausea; Muscle heaviness; fatigue; brain fog(poor concentration and focus); brain fog(poor concentration and focus); general malaise; Increased bowel movements daily; This is a spontaneous report from a contactable pharmacist (Pharmacist). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: El8982), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as single dose for covid-19 immunisation at Health Clinic or administration facility. Medical history included gastrooesophageal reflux and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included pravastatin taken for an unspecified indication, famotidine, ascorbic acid, betacarotene, colecalciferol, folic acid, minerals nos, retinol, tocopheryl acetate, vitamin b nos (CENTRUM [ASCORBIC ACID;BETACAROTENE;COLECALCIFEROL;FOLIC ACID;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS]), cyanocobalamin (B12), ergocalciferol (VIT D). The patient previously took biaxin and experienced drug hypersensitivity. On 27Jan2021 20:00, the patient experienced lung tightness with burning and pain/lungs were tight, headache, nausea, muscle heaviness, fatigue, brain fog (poor concentration and focus), general malaise and increased bowel movements daily. These symptoms lasted for 7 days. Two of the days my lungs were tight but I did not have shortness of breath. Nausea was everyday. Increased bowel movements daily. I am concerned that these effects lasted for 7 days. Does this put me at risk for serious side effects after the 2nd dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Frequent bowel movements, Headache
Clinical narrative: Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headache; nausea; Muscle heaviness; fatigue; brain fog(poor concentration and focus); brain fog(poor concentration and focus); general malaise; Increased bowel movements daily; This is a spontaneous report from a contactable pharmacist (Pharmacist). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: El8982), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as single dose for covid-19 immunisation at Health Clinic or administration facility. Medical history included gastrooesophageal reflux and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included pravastatin taken for an unspecified indication, famotidine, ascorbic acid, betacarotene, colecalciferol, folic acid, minerals nos, retinol, tocopheryl acetate, vitamin b nos (CENTRUM [ASCORBIC ACID;BETACAROTENE;COLECALCIFEROL;FOLIC ACID;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS]), cyanocobalamin (B12), ergocalciferol (VIT D). The patient previously took biaxin and experienced drug hypersensitivity. On 27Jan2021 20:00, the patient experienced lung tightness with burning and pain/lungs were tight, headache, nausea, muscle heaviness, fatigue, brain fog (poor concentration and focus), general malaise and increased bowel movements daily. These symptoms lasted for 7 days. Two of the days my lungs were tight but I did not have shortness of breath. Nausea was everyday. Increased bowel movements daily. I am concerned that these effects lasted for 7 days. Does this put me at risk for serious side effects after the 2nd dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung disorder, Malaise, Muscle discomfort, Nausea, Pleuritic pain
Clinical narrative: Lung tightness with burning and pain/lungs were tight; Lung tightness with burning and pain; Headache; nausea; Muscle heaviness; fatigue; brain fog(poor concentration and focus); brain fog(poor concentration and focus); general malaise; Increased bowel movements daily; This is a spontaneous report from a contactable pharmacist (Pharmacist). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: El8982), via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as single dose for covid-19 immunisation at Health Clinic or administration facility. Medical history included gastrooesophageal reflux and osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included pravastatin taken for an unspecified indication, famotidine, ascorbic acid, betacarotene, colecalciferol, folic acid, minerals nos, retinol, tocopheryl acetate, vitamin b nos (CENTRUM [ASCORBIC ACID;BETACAROTENE;COLECALCIFEROL;FOLIC ACID;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS]), cyanocobalamin (B12), ergocalciferol (VIT D). The patient previously took biaxin and experienced drug hypersensitivity. On 27Jan2021 20:00, the patient experienced lung tightness with burning and pain/lungs were tight, headache, nausea, muscle heaviness, fatigue, brain fog (poor concentration and focus), general malaise and increased bowel movements daily. These symptoms lasted for 7 days. Two of the days my lungs were tight but I did not have shortness of breath. Nausea was everyday. Increased bowel movements daily. I am concerned that these effects lasted for 7 days. Does this put me at risk for serious side effects after the 2nd dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: all over body rash/body rash; This is a spontaneous report from a contactable consumer (patient reported herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, NDC number/Lot Number/Expiry date: Not Provided) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history included bladder infection (took antibiotics). Concomitant medications were not reported. Caller confirmed that she provided lot number during initial report on online portal. Caller stated that she did already go online and fill out the report questionnaire, because she had gotten an all over body rash. Caller stated that she had been taking an antibiotic prior to getting the first dose of the Covid vaccine, but she quit taking the antibiotic on Saturday, and then received the injection on Monday. Caller stated that she was wondering if that could have been a reason for getting the rash. Caller was also wondering if there was a recommendation for her getting the second dose following the side effects she experienced. Caller stated that she did not write down the reference number she was provided when she submitted her report online. There was no product complaint to report. Requested medical information (could an abx have interacted with the vaccine, recommendations on second dose). Caller would like to know if antibiotics would have had an effect on the Pfizer Covid vaccine. Caller received the Pfizer vaccine on Monday but was taking antibiotics for a bladder infection which she quit on Saturday. She got a body rash which lasted Monday to Tuesday. Caller would like to know whether she should get the 2nd dose of the Covid vaccine knowing the side effect she had from the previous dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Chills, Headache, Pain, Pain in extremity
Clinical narrative: body aches; headache; both arms sore , left arm pit sore; chills; fever; This is a spontaneous report from a contactable consumer(Patient). A 72-years-old female patient received bnt162b2 (Pfizer- BioNTech Covid 19 Vaccine, Lot Number: EL3248 ), dose 1st via an unspecified route of administration, administered in Arm Left on 05Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure , overweight and covid-19 (if covid prior vaccination: Yes). Concomitant medications included Losartan 100 mg, rosuvastatin 10mg, vita C 1000mg. The patient previously took statins and experienced drug hypersensitivity. Patient experience body aches, headache, both arms sore, left arm pit sore, on and off chills and fever all were on 06Feb2021 02:15. Treatment was not received for the adverse event. Patient was not pregnant.  The outcome of the recovering.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: body aches; headache; both arms sore , left arm pit sore; chills; fever; This is a spontaneous report from a contactable consumer(Patient). A 72-years-old female patient received bnt162b2 (Pfizer- BioNTech Covid 19 Vaccine, Lot Number: EL3248 ), dose 1st via an unspecified route of administration, administered in Arm Left on 05Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure , overweight and covid-19 (if covid prior vaccination: Yes). Concomitant medications included Losartan 100 mg, rosuvastatin 10mg, vita C 1000mg. The patient previously took statins and experienced drug hypersensitivity. Patient experience body aches, headache, both arms sore, left arm pit sore, on and off chills and fever all were on 06Feb2021 02:15. Treatment was not received for the adverse event. Patient was not pregnant.  The outcome of the recovering.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; headache; both arms sore , left arm pit sore; chills; fever; This is a spontaneous report from a contactable consumer(Patient). A 72-years-old female patient received bnt162b2 (Pfizer- BioNTech Covid 19 Vaccine, Lot Number: EL3248 ), dose 1st via an unspecified route of administration, administered in Arm Left on 05Feb2021 as single dose for covid-19 immunisation. Medical history included high blood pressure , overweight and covid-19 (if covid prior vaccination: Yes). Concomitant medications included Losartan 100 mg, rosuvastatin 10mg, vita C 1000mg. The patient previously took statins and experienced drug hypersensitivity. Patient experience body aches, headache, both arms sore, left arm pit sore, on and off chills and fever all were on 06Feb2021 02:15. Treatment was not received for the adverse event. Patient was not pregnant.  The outcome of the recovering.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: Within 1st 8 minutes my vision became very blurry, i could not focus.; lightheaded; BP was low end 95/54; This is a spontaneous report from a contactable 71-year-old non-pregnant female consumer reported for herself that she started to receive first dose of bnt162b2 (Pfizer-BioNTech EUA, Formulation: Solution for injection, Batch/lot number: EN5318), via an unspecified route of administration on 09Feb2021 09:30, at single dose in left arm for covid-19 immunization. The patient's medical history included type 2 diabetes, mild hypertension and known allergies: Compazine, Phenothiazines, Oxycodone, Loratadine. Concomitant medications included dulaglutide (TRULICITY), canagliflozin (INVOKANA), METFORMIN, LISINOPRIL, and PRAVASTATIN. No other vaccine in four weeks. The patient received the vaccine at hospital. On 09Feb2021 09:45, within 1st 8 minutes her vision became very blurry, she could not focus, and she became lightheaded. The nurse checked her vitals, and they were normal (BP was low end 95/54) After nearly an hour her vision cleared and she was able to stand up and walk. The events were resulted in Doctor or other healthcare professional office/clinic visit. The patient did not take any treatment for the events. The outcome if the events was recovered on an unknown date.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypotension, Vision blurred, Vital capacity
Clinical narrative: Within 1st 8 minutes my vision became very blurry, i could not focus.; lightheaded; BP was low end 95/54; This is a spontaneous report from a contactable 71-year-old non-pregnant female consumer reported for herself that she started to receive first dose of bnt162b2 (Pfizer-BioNTech EUA, Formulation: Solution for injection, Batch/lot number: EN5318), via an unspecified route of administration on 09Feb2021 09:30, at single dose in left arm for covid-19 immunization. The patient's medical history included type 2 diabetes, mild hypertension and known allergies: Compazine, Phenothiazines, Oxycodone, Loratadine. Concomitant medications included dulaglutide (TRULICITY), canagliflozin (INVOKANA), METFORMIN, LISINOPRIL, and PRAVASTATIN. No other vaccine in four weeks. The patient received the vaccine at hospital. On 09Feb2021 09:45, within 1st 8 minutes her vision became very blurry, she could not focus, and she became lightheaded. The nurse checked her vitals, and they were normal (BP was low end 95/54) After nearly an hour her vision cleared and she was able to stand up and walk. The events were resulted in Doctor or other healthcare professional office/clinic visit. The patient did not take any treatment for the events. The outcome if the events was recovered on an unknown date.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: said he wasn't feeling well, took 2 tylenol
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: said he wasn't feeling well, took 2 tylenol
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Very sore injection area; Temperature of 100.4 degree; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date: not available), via an unspecified route of administration in the left arm on 09Feb2021 at 11:15 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation. The patient had no known allergies. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. No covid tested post vaccination. The patient had no other vaccine in four weeks. The patient received other medication in two weeks. On 09Feb2021 at 15:00, the patient experienced very sore injection area for two days. Temperature of 100.4 degree and down to 99 degree after 36 hours. The patient did not receive any treatments for the events. The clinical outcome of the very sore injection area was recovered and Temperature of 100.4 degree was recovering.  Information on lot/batch has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Very sore injection area; Temperature of 100.4 degree; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date: not available), via an unspecified route of administration in the left arm on 09Feb2021 at 11:15 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation. The patient had no known allergies. Prior and post to the vaccination, the patient was not diagnosed with COVID-19. No covid tested post vaccination. The patient had no other vaccine in four weeks. The patient received other medication in two weeks. On 09Feb2021 at 15:00, the patient experienced very sore injection area for two days. Temperature of 100.4 degree and down to 99 degree after 36 hours. The patient did not receive any treatments for the events. The clinical outcome of the very sore injection area was recovered and Temperature of 100.4 degree was recovering.  Information on lot/batch has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Cough, Disturbance in attention, Dysphonia, Fatigue
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Glossodynia, Pain
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Cough, Depression, Dysphonia
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Gingival pain, Headache, Pain, Paraesthesia oral
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Blood glucose, Blood glucose increased, Dysphonia
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Epistaxis, Fatigue, Gingival pain, Glossodynia
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Influenza like illness, Productive cough, SARS-CoV-2 test, Vaginal discharge
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Severe pain throughout body; esp head; stomach, and tongue throbbing.; stomach, and tongue throbbing; Extreme weakness; exhaustion; abnormal mentation; cough; hoarseness; gum pain; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 29Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included type one diabetic and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included insulin lispro (HUMALOG), rosuvastatin, tramadol hydrochloride (TRA), levothyroxine and pramlintide acetate (SYMLIN). On 31Jan2021 18:00, The patient experienced severe pain throughout body, esp head, stomach, and tongue throbbing. extreme weakness, exhaustion, abnormal mentation, cough, hoarseness, gum pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Breast pain, Computerised tomogram, Fatigue, Mouth haemorrhage
Clinical narrative: Right breast had bad pain going from breast around to her back; This is a spontaneous report from a Pfizer-sponsored program Pfizer . A contactable female consumer (Patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Woke up Saturday i.e. on 23Jan2021, right breast had bad pain going from breast around to her back. Wanted to know if anyone has had this issue and could it be a side effect. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth injury, Pain
Clinical narrative: Right breast had bad pain going from breast around to her back; This is a spontaneous report from a Pfizer-sponsored program Pfizer . A contactable female consumer (Patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Woke up Saturday i.e. on 23Jan2021, right breast had bad pain going from breast around to her back. Wanted to know if anyone has had this issue and could it be a side effect. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain
Clinical narrative: Right breast had bad pain going from breast around to her back; This is a spontaneous report from a Pfizer-sponsored program Pfizer . A contactable female consumer (Patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Woke up Saturday i.e. on 23Jan2021, right breast had bad pain going from breast around to her back. Wanted to know if anyone has had this issue and could it be a side effect. The outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Increased pain and stiffness/can't rotate head without moderate neck pain; Increased pain and stiffness; Moderate Neck pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269; Expiry Date: Unknown), via an unspecified route of administration on left arm on 07Feb2021 01:15 PM at single dose for covid-19 immunization. Patient had historical vaccine at left arm on 17Jan2021 01:30 PM. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have allergies to medications, food, or other products. Medical history included migraine, hip arthroplasty, neck fusion, hernia repair. Patient's concomitant medications included rosuvastatin calcium (CRESTOR), tramadol (TRAMADOL), antihistamine and nasal inhaler. The patient experienced moderate neck pain on 07Feb2021 22:00, increased pain and stiffness/can't rotate head without moderate neck pain on 08Feb2021, increased pain and stiffness on 08Feb2021. Patient reported event as moderate neck pain on Monday after vaccine on Monday. Increased pain and stiffness started Tuesday late afternoon. Wednesday was an able to rotate head or lift head against gravity without severe pain until Thursday morning. But from Thursday afternoon can't rotate head without moderate neck pain. Patient reported no for seriousness criteria (Results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect). Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. No treatment was received for the adverse event. The outcome of event was recovering.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: Increased pain and stiffness/can't rotate head without moderate neck pain; Increased pain and stiffness; Moderate Neck pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269; Expiry Date: Unknown), via an unspecified route of administration on left arm on 07Feb2021 01:15 PM at single dose for covid-19 immunization. Patient had historical vaccine at left arm on 17Jan2021 01:30 PM. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have allergies to medications, food, or other products. Medical history included migraine, hip arthroplasty, neck fusion, hernia repair. Patient's concomitant medications included rosuvastatin calcium (CRESTOR), tramadol (TRAMADOL), antihistamine and nasal inhaler. The patient experienced moderate neck pain on 07Feb2021 22:00, increased pain and stiffness/can't rotate head without moderate neck pain on 08Feb2021, increased pain and stiffness on 08Feb2021. Patient reported event as moderate neck pain on Monday after vaccine on Monday. Increased pain and stiffness started Tuesday late afternoon. Wednesday was an able to rotate head or lift head against gravity without severe pain until Thursday morning. But from Thursday afternoon can't rotate head without moderate neck pain. Patient reported no for seriousness criteria (Results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect). Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. No treatment was received for the adverse event. The outcome of event was recovering.