chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Subarachnoid haemorrhage
Clinical narrative: subarachnoid hemorrhage; This is a spontaneous report from a non-contactable consumer (patient). A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Lot Number: EW0151) at the age of 64-years-old as single dose for covid-19 immunisation. Medical history included high blood pressure, high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included flecainide, metoprolol, rosuvastatin, acetylsalicylic acid (BABY ASPIRIN). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 15Mar2021 (Lot Number: EN6207) at the age of 64-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced subarachnoid hemorrhage on 26Apr2021. The event assessed as serious, life threatening illness (immediate risk of death from the event), hospitalization for 42 days, disability or permanent damage. The event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, patient received treatment for the adverse event included life saving and rehabilitation. Outcome of the event was recovered with sequelae. Since the vaccination, the patient had been tested for COVID-19 (covid test type was unknown) in Apr2021: negative.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Blood test, Computerised tomogram, Intensive care, Loss of consciousness
Clinical narrative: subarachnoid hemorrhage; This is a spontaneous report from a non-contactable consumer (patient). A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Lot Number: EW0151) at the age of 64-years-old as single dose for covid-19 immunisation. Medical history included high blood pressure, high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included flecainide, metoprolol, rosuvastatin, acetylsalicylic acid (BABY ASPIRIN). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 15Mar2021 (Lot Number: EN6207) at the age of 64-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced subarachnoid hemorrhage on 26Apr2021. The event assessed as serious, life threatening illness (immediate risk of death from the event), hospitalization for 42 days, disability or permanent damage. The event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, patient received treatment for the adverse event included life saving and rehabilitation. Outcome of the event was recovered with sequelae. Since the vaccination, the patient had been tested for COVID-19 (covid test type was unknown) in Apr2021: negative.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Subarachnoid haemorrhage, X-ray
Clinical narrative: subarachnoid hemorrhage; This is a spontaneous report from a non-contactable consumer (patient). A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Apr2021 (Lot Number: EW0151) at the age of 64-years-old as single dose for covid-19 immunisation. Medical history included high blood pressure, high cholesterol. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications within 2 weeks of vaccination included flecainide, metoprolol, rosuvastatin, acetylsalicylic acid (BABY ASPIRIN). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 15Mar2021 (Lot Number: EN6207) at the age of 64-years-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced subarachnoid hemorrhage on 26Apr2021. The event assessed as serious, life threatening illness (immediate risk of death from the event), hospitalization for 42 days, disability or permanent damage. The event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, patient received treatment for the adverse event included life saving and rehabilitation. Outcome of the event was recovered with sequelae. Since the vaccination, the patient had been tested for COVID-19 (covid test type was unknown) in Apr2021: negative.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Subarachnoid haemorrhage
Clinical narrative: Patient suffered a subarachnoid hemorrhage (Hunt & Hess 5) on the evening of April 26 or the morning of April 27 that, after 3 cerebral angiograms, doctors have not been able to determine the cause of.  His son found him unconscious the afternoon of the 27th.  He spent 2.5 weeks in the ICU, 1 week in the step down unit, and 2.5 weeks in the rehab hospital.  He recently completed 18 weeks of outpatient therapy.  His recovery has been remarkable but he still has some short term memory issues.    I don?t know if the vaccine and subarachnoid hemorrhage are related but I?ve been seeking advice as to whether patient should get a booster and was told to make sure a VAERS report was filed.  It?s possible this is a duplicate since I?ve asked 2 doctors and the facility if a report was filed and have not gotten a definitive answer.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Blood test, Computerised tomogram, Intensive care, Loss of consciousness
Clinical narrative: Patient suffered a subarachnoid hemorrhage (Hunt & Hess 5) on the evening of April 26 or the morning of April 27 that, after 3 cerebral angiograms, doctors have not been able to determine the cause of.  His son found him unconscious the afternoon of the 27th.  He spent 2.5 weeks in the ICU, 1 week in the step down unit, and 2.5 weeks in the rehab hospital.  He recently completed 18 weeks of outpatient therapy.  His recovery has been remarkable but he still has some short term memory issues.    I don?t know if the vaccine and subarachnoid hemorrhage are related but I?ve been seeking advice as to whether patient should get a booster and was told to make sure a VAERS report was filed.  It?s possible this is a duplicate since I?ve asked 2 doctors and the facility if a report was filed and have not gotten a definitive answer.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Subarachnoid haemorrhage, X-ray
Clinical narrative: Patient suffered a subarachnoid hemorrhage (Hunt & Hess 5) on the evening of April 26 or the morning of April 27 that, after 3 cerebral angiograms, doctors have not been able to determine the cause of.  His son found him unconscious the afternoon of the 27th.  He spent 2.5 weeks in the ICU, 1 week in the step down unit, and 2.5 weeks in the rehab hospital.  He recently completed 18 weeks of outpatient therapy.  His recovery has been remarkable but he still has some short term memory issues.    I don?t know if the vaccine and subarachnoid hemorrhage are related but I?ve been seeking advice as to whether patient should get a booster and was told to make sure a VAERS report was filed.  It?s possible this is a duplicate since I?ve asked 2 doctors and the facility if a report was filed and have not gotten a definitive answer.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: lost parent to Covid; lost parent to Covid; This is a spontaneous report from a non-contactable consumer (daughter). This consumer reported similar events for both parents. This is one of her parents cases. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The daughter recently lost parent to covid and not sure if this was a fresh or the vaccine side effects. The outcome of event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101440331 same drug and AE., different patient; Reported Cause(s) of Death: lost parent to Covid; lost parent to Covid
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness transient, Diplopia, Headache, Neck pain, Rash
Clinical narrative: loss of eye sight for 3 hours and then the eye sight returned and the vision was blurry; his right arm, he developed a rash in that same arm which progressed to a bloody rash; instant pain in the base of the neck and back of the forehead; blurred vision in one eye; double vision; pain in the base of the neck and back of the forehead; his right arm, he developed a rash in that same arm which progressed to a bloody rash; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Not reported), via an unspecified route, administered in right arm on 26Aug2021 (at the age of 55-year-old) as Dose 2, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration, Dose 1, Single on unspecified date for Covid-19 immunization. The patient previously took fenofibrate and had a similar rash developed and reported it developed into an infection under the skin which had to be treated with silver and some other medications. The reporter stated that received his second Comirnaty vaccine dose on 26Aug2021 and was still had major adverse reactions. He reported immediately after receiving the vaccine in his right arm, he developed a rash in that same arm which progressed to a bloody rash on 26Aug2021. He had instant pain in the base of the neck and back of the forehead, blurred vision in one eye, double vision, and loss of eyesight for 3 hours and then the eye sight returned, and the vision was blurry on 26Aug2021. Reporter consider case as non-serious. He reported his doctor had given him steroids. Therapeutic measures were taken as a result of adverse reactions with steroids. At the time of this report, the outcome of event loss of eyesight for 3 hours was recovering, and all other events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Vision blurred
Clinical narrative: loss of eye sight for 3 hours and then the eye sight returned and the vision was blurry; his right arm, he developed a rash in that same arm which progressed to a bloody rash; instant pain in the base of the neck and back of the forehead; blurred vision in one eye; double vision; pain in the base of the neck and back of the forehead; his right arm, he developed a rash in that same arm which progressed to a bloody rash; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Not reported), via an unspecified route, administered in right arm on 26Aug2021 (at the age of 55-year-old) as Dose 2, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration, Dose 1, Single on unspecified date for Covid-19 immunization. The patient previously took fenofibrate and had a similar rash developed and reported it developed into an infection under the skin which had to be treated with silver and some other medications. The reporter stated that received his second Comirnaty vaccine dose on 26Aug2021 and was still had major adverse reactions. He reported immediately after receiving the vaccine in his right arm, he developed a rash in that same arm which progressed to a bloody rash on 26Aug2021. He had instant pain in the base of the neck and back of the forehead, blurred vision in one eye, double vision, and loss of eyesight for 3 hours and then the eye sight returned, and the vision was blurry on 26Aug2021. Reporter consider case as non-serious. He reported his doctor had given him steroids. Therapeutic measures were taken as a result of adverse reactions with steroids. At the time of this report, the outcome of event loss of eyesight for 3 hours was recovering, and all other events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Headache, Rash, Ultrasound Doppler normal
Clinical narrative: loss of eye sight for 3 hours and then the eye sight returned and the vision was blurry; his right arm, he developed a rash in that same arm which progressed to a bloody rash; instant pain in the base of the neck and back of the forehead; blurred vision in one eye; double vision; pain in the base of the neck and back of the forehead; his right arm, he developed a rash in that same arm which progressed to a bloody rash; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Not reported), via an unspecified route, administered in right arm on 26Aug2021 (at the age of 55-year-old) as Dose 2, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration, Dose 1, Single on unspecified date for Covid-19 immunization. The patient previously took fenofibrate and had a similar rash developed and reported it developed into an infection under the skin which had to be treated with silver and some other medications. The reporter stated that received his second Comirnaty vaccine dose on 26Aug2021 and was still had major adverse reactions. He reported immediately after receiving the vaccine in his right arm, he developed a rash in that same arm which progressed to a bloody rash on 26Aug2021. He had instant pain in the base of the neck and back of the forehead, blurred vision in one eye, double vision, and loss of eyesight for 3 hours and then the eye sight returned, and the vision was blurry on 26Aug2021. Reporter consider case as non-serious. He reported his doctor had given him steroids. Therapeutic measures were taken as a result of adverse reactions with steroids. At the time of this report, the outcome of event loss of eyesight for 3 hours was recovering, and all other events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod sting, Alopecia, Arthritis, Drug hypersensitivity, Fatigue
Clinical narrative: joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days; joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; severe allergic response to foods, histamine and any sugar; severe reaction to bee sting and amoxicillin; severe reaction to bee sting and amoxicillin; severe allergic response to foods, histamine and any sugar; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old female patient received BNT162B2 (Lot EL3248, first dose) solution for injection intramuscular in left arm on 14Jan2021 at 12:15 (at the age of 69-years-old) as a single dose for COVID-19 immunization, amoxicillin, and histamine. The patient was not pregnant at the time of vaccination. Medical history included Previous Br CA (breast cancer) from 1993. Concomitant medication included losartan potassium/ hydrochlorothiazide. On 19Jan2021 at 12:00, the patient experienced joint inflammation leading to severe joint inflammation and swelling for 12 weeks/5days then extreme hair loss, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue, severe allergic response to foods, histamine and any sugar, severe reaction to bee sting and amoxicillin, severe reaction to bee sting and amoxicillin. The events resulted in doctor or other healthcare professional office/clinic visit. Lab tests included ultrasound lower extremities in 2021 with unknown results; COVID test type: Blood test on 28-SEP-2021 was positive covid_test_name_post_vaccination=previous covid and Negative covid test name post vaccination=to R/O other things (case 202101365226). The action taken with amoxicillin and histamines in response to the events was unknown. Treatment for the events included steroids and many office visits. The outcome of the events was not recovered. The patient received second dose of BNT162B2 on 10Feb2021 at 12:00 PM.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Histamine intolerance, Joint swelling, Petechiae, Pruritus
Clinical narrative: joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days; joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; severe allergic response to foods, histamine and any sugar; severe reaction to bee sting and amoxicillin; severe reaction to bee sting and amoxicillin; severe allergic response to foods, histamine and any sugar; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old female patient received BNT162B2 (Lot EL3248, first dose) solution for injection intramuscular in left arm on 14Jan2021 at 12:15 (at the age of 69-years-old) as a single dose for COVID-19 immunization, amoxicillin, and histamine. The patient was not pregnant at the time of vaccination. Medical history included Previous Br CA (breast cancer) from 1993. Concomitant medication included losartan potassium/ hydrochlorothiazide. On 19Jan2021 at 12:00, the patient experienced joint inflammation leading to severe joint inflammation and swelling for 12 weeks/5days then extreme hair loss, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue, severe allergic response to foods, histamine and any sugar, severe reaction to bee sting and amoxicillin, severe reaction to bee sting and amoxicillin. The events resulted in doctor or other healthcare professional office/clinic visit. Lab tests included ultrasound lower extremities in 2021 with unknown results; COVID test type: Blood test on 28-SEP-2021 was positive covid_test_name_post_vaccination=previous covid and Negative covid test name post vaccination=to R/O other things (case 202101365226). The action taken with amoxicillin and histamines in response to the events was unknown. Treatment for the events included steroids and many office visits. The outcome of the events was not recovered. The patient received second dose of BNT162B2 on 10Feb2021 at 12:00 PM.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin burning sensation, Ultrasound scan
Clinical narrative: joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days; joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; severe allergic response to foods, histamine and any sugar; severe reaction to bee sting and amoxicillin; severe reaction to bee sting and amoxicillin; severe allergic response to foods, histamine and any sugar; This is a spontaneous report from a contactable nurse, the patient. A 69-year-old female patient received BNT162B2 (Lot EL3248, first dose) solution for injection intramuscular in left arm on 14Jan2021 at 12:15 (at the age of 69-years-old) as a single dose for COVID-19 immunization, amoxicillin, and histamine. The patient was not pregnant at the time of vaccination. Medical history included Previous Br CA (breast cancer) from 1993. Concomitant medication included losartan potassium/ hydrochlorothiazide. On 19Jan2021 at 12:00, the patient experienced joint inflammation leading to severe joint inflammation and swelling for 12 weeks/5days then extreme hair loss, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue, severe allergic response to foods, histamine and any sugar, severe reaction to bee sting and amoxicillin, severe reaction to bee sting and amoxicillin. The events resulted in doctor or other healthcare professional office/clinic visit. Lab tests included ultrasound lower extremities in 2021 with unknown results; COVID test type: Blood test on 28-SEP-2021 was positive covid_test_name_post_vaccination=previous covid and Negative covid test name post vaccination=to R/O other things (case 202101365226). The action taken with amoxicillin and histamines in response to the events was unknown. Treatment for the events included steroids and many office visits. The outcome of the events was not recovered. The patient received second dose of BNT162B2 on 10Feb2021 at 12:00 PM.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Day sore arm; The initial case was missing the following minimum criteria: unspecified event. Upon receipt of follow-up#01 information on 26Feb2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a contactable male consumer via Pfizer-sponsored program and in response to consumer letter sent via follow-up letter. An 86-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 15Feb2021 at 11:30 as dose 2, single for COVID-19 immunization (Age at vaccination: 86 years). The patient medical history and concomitant medications were not reported. The patient previously received historical vaccine which included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9262, Expiry date: not reported) via an unspecified route of administration, on 26Jan2021, as dose 1, single (not ongoing; at the age of 86 years old) for COVID-19 immunization. The patient took the Pfizer Covid vaccine and mentioned that he was feeling fine. He wanted to know if it was okay to take a half glass of wine, which was what he did every night, considering his vaccination. On an unspecified date in 2021, the patient experienced day sore arm. The patient also mentioned that his wife also had an injection and around 4 or 5 hours ago mentioned that her arm was starting to hurt and was feeling a bit stiff. He told her that she could take Tylenol or Advil for it. He wanted to know if what he said was correct. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable 65-years-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9264; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization.  Medical history included pain from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced sore arm on 31Jan2021. Patient did not require admission to hospital due to the event (Did not include emergency room visit without further admission). Therapeutic measures were taken as a result of sore arm as patient took ibuprofen. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Weight
Clinical narrative: kind of like flu; minor unwell feeling; The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (01Mar2021), this case now contains all required information to be considered valid.  A 71-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: EM9810), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing vertigo, dizziness, balance problems, visual problems, abdominal problems, weight fluctuation from an unknown date and unknown if ongoing caller mentions his weight changes every time he goes to the doctor. He lost 80lbs in a year, but his weight was starting to go back up. There were no concomitant medications. The patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: EL3246), via an unspecified route of administration in left arm on 21Jan2021 at 13:10 (Age at vaccination 71-years-old), as DOSE 1, SINGLE for covid-19 immunization and experienced nausea, feeling unwell, chills, he supposed that he was dehydrated. The patient experienced minor unwell feeling and kind of like flu on an unspecified date. The patient underwent lab tests and procedures which included weight was lost 80lbs in a year on an unspecified date. The clinical outcome of the events was recovered on unspecified date.   Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Pain in extremity
Clinical narrative: On the day of both shots, arms were sore.; And there was a considerable increase of energy and alertness felt.; This is a spontaneous report from a contactable Nurse (Patient).  A 29-year-old non-pregnant female patient received BNT162B2 (BNT162B2 Formulation: Solution For injection Batch/Lot number: Unknown Expiration Date: Unknown) via intramuscular route of administration, administered in Right Arm on 27Jan2021 10:30 (at the age of 29-year-old) as DOSE 1, SINGLE and received BNT162B2 (BNT162B2 Formulation: Solution For injection Batch/Lot number: Unknown Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 22Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. No COVID prior vaccination and Patient was not tested for COVID-19 post vaccination. Patients Medical history and concomitant medications were not reported. No known allergies. On the day of both shots, arms were sore. And there was a considerable increase of energy and alertness felt on 27Jan2021 10:30. No treatment received. Outcome of both the events was recovered.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat
Clinical narrative: Cold sweats; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), dose 2 via an unspecified route of administration on 24Feb2021 08:30 as dose 2, single for covid-19 immunisation. Medical history included stomach virus from an unknown date and unknown if ongoing. (This consumer got his second Pfizer COVID-19 Vaccine morning of 24Feb2021. Earlier in the week he had a stomach virus) vomiting from 22Feb2021 to 22Feb2021 (the vomiting stopped immediately night of 22Feb2021, never happened again, on 22Feb2021 he had a little vomiting and then some diarrhea like 23Feb2021, nothing serious) diarrhoea from 23Feb2021 and ongoing. The patient's concomitant medications were not reported. The patient previously took BNT162B2, Dose 1 single, for COVID-19 immunization. The patient experienced cold sweats on an unspecified date. He had been taking Pedialyte and he asked if diarrhea was a side effect of the Pfizer COVID-19 Vaccine and if he can take Imodium. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 23Feb2021 16:45 (at the age of 59-year-old) as dose 1, single for COVID-19 immunization, at other facility. The patient medical history included known allergies: Morphine and COVID-19 (if COVID prior vaccination: Yes). There were no concomitant medications. The patient was not tested for COVID-19 post vaccination. No other vaccine received in 4 weeks. On 25Feb2021 09:00, the patient experienced dizziness. It was unknown if the patient received treatment for the event. The outcome of the event was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache
Clinical narrative: Severe headache; extreme fatigue; upset stomach; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: ENG201, expiry date : not reported), via an unspecified route of administration in the left arm on 18Feb2021 08:45 (at the age of 39-years old) as DOSE 2, SINGLE for covid-19 immunisation at a workplace clinic. Medical history included seasonal allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) , Esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Post vaccination, the patient had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: ELI283, expiry date : not reported), via an unspecified route of administration, administered in the left arm on 28Jan2021 15:30 (at the age of 39-years old) as DOSE 1, SINGLE for covid-19 immunisation. No treatment was received for all the reported events. On 19Feb2021 08:00, the patient experienced severe headache, extreme fatigue and upset stomach. The outcome of the event was recovered.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left arm often has a quick pain when I move it a certain way, such al lifting it over my head; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 at 10:30 (at the age of 74-year-old) in left arm as dose 1, single for covid-19 immunization and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot Number: EN6200) via an unspecified route of administration on 24Feb2021 at 10:30 (at the age of 74-year-old) in right arm as dose 2, single for covid-19 immunization. Medical history included high blood pressure (take medication) from an unknown date and unknown if ongoing. No other vaccine in four weeks. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included allopurinol (ALLOPURINOL); amlodipine besilate (AMLODIPINE BESILATE); losartan (LOSARTAN); atorvastatin calcium (ATORVASTATIN CALCIUM) all taken for an unspecified indication, start and stop date were not reported. The patient received his first shot in left arm. Three weeks later his left arm often had a quick pain when he moved it a certain way, such as lifting it over his head. The pain was not severe and usually went away quickly but seemed to get more frequent. The event started from 08Feb2021. The patient did not receive any treatment. The outcome of the event was not resolved.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: little arm soreness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 24Feb2021 09:30 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient who received the first dose of the Pfizer COVID-19 vaccine experienced a little arm soreness on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: little arm soreness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 24Feb2021 09:30 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient who received the first dose of the Pfizer COVID-19 vaccine experienced a little arm soreness on an unspecified date. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Hypoaesthesia, Muscle spasms
Clinical narrative: muscle cramp; Then my eye on that side started twitching; I started feeling numb and getting tingly on my face/Then the numbness and tingling went down my arms and hands.; dizzy; getting tingly/that feeling moved down my neck, /tingling went down my arms and hands; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 24Feb2021 16:00 (at the age of 46-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included mild PVC heart condition and Known allergies: sulfa drugs. Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), cyanocobalamin (B-12), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), vitamin d, vitamin V, zinc and quercetin. The patient previously took reglan and microbid and experienced known allergies. The patients concomitant medications were not reported. The 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. On 24Feb2021 the patient experienced muscle cramp, then my eye on that side started twitching, i started feeling numb and getting tingly on my face/then the numbness and tingling went down my arms and hands, dizzy and getting tingly/that feeling moved down my neck, /tingling went down my arms and hands. It was reported that Apprx 40 mins after getting the vaccine she got a muscle cramp in the left side of her neck (the side she got her shot) and also in her lower abdomen both went away after about 30 mins). Then her eye on that side started twitching. She started feeling numb and getting tingly on my face (nose, cheek bone area, chin, up around her scalp never her lips) and then that feeling moved down my neck, chest and stomach and her back. Then the numbness and tingling went down her arms and hands. She headed to the ER but the feeling was gone before she got there. But then it came back in just her face. After that feeling passed she was dizzy. It lasted about an hour and half total and never came back. She took her BP and pulse after the tingling went away and both were normal. She did not seek medical attention. The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unknown date, heart rate: normal on an unknown date. The outcome of the event muscle cramp was resolved on 24Feb2021, for rest of the events the outcome was resolved on 2021. Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: muscle cramp; Then my eye on that side started twitching; I started feeling numb and getting tingly on my face/Then the numbness and tingling went down my arms and hands.; dizzy; getting tingly/that feeling moved down my neck, /tingling went down my arms and hands; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 24Feb2021 16:00 (at the age of 46-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included mild PVC heart condition and Known allergies: sulfa drugs. Concomitant medications included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), cyanocobalamin (B-12), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), vitamin d, vitamin V, zinc and quercetin. The patient previously took reglan and microbid and experienced known allergies. The patients concomitant medications were not reported. The 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. On 24Feb2021 the patient experienced muscle cramp, then my eye on that side started twitching, i started feeling numb and getting tingly on my face/then the numbness and tingling went down my arms and hands, dizzy and getting tingly/that feeling moved down my neck, /tingling went down my arms and hands. It was reported that Apprx 40 mins after getting the vaccine she got a muscle cramp in the left side of her neck (the side she got her shot) and also in her lower abdomen both went away after about 30 mins). Then her eye on that side started twitching. She started feeling numb and getting tingly on my face (nose, cheek bone area, chin, up around her scalp never her lips) and then that feeling moved down my neck, chest and stomach and her back. Then the numbness and tingling went down her arms and hands. She headed to the ER but the feeling was gone before she got there. But then it came back in just her face. After that feeling passed she was dizzy. It lasted about an hour and half total and never came back. She took her BP and pulse after the tingling went away and both were normal. She did not seek medical attention. The patient underwent lab tests and procedures which included blood pressure measurement: normal on an unknown date, heart rate: normal on an unknown date. The outcome of the event muscle cramp was resolved on 24Feb2021, for rest of the events the outcome was resolved on 2021. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after getting the first shot; This is a spontaneous report from a contactable consumer (patient) via an Agency. A 73-year-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 01Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On Feb2021, patient had a little sore arm after getting the first shot. Patient cousin died from COVID that was why he was scared. Patient want to make sure that he was protected. Patient was scheduled to receive the second dose of the vaccine 4 week after receiving dose 1. Patient stated that he will try his best to get the second dose within 3 weeks. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer via Medical information team. This 90-years-old female consumer reported that:  A 90-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization and patient had no reaction to the first dose. On an unspecified date, the patient experienced headache. It was reported that she developed a headache 3 days after receiving the second dose. She stated that she had no reaction to the first dose. She also stated that the nurse who administered the vaccine told her that she may experience side effects 24-48 hours after receiving the vaccine and the reporter was concerned that she developed a headache past that time frame. She did take Tylenol to help with the headache and it has improved and she considers it a "mild" headache now. Reporter wanted to know if developing a headache 3 days after receiving the vaccine is normal. Therapeutic measures were taken as a result of headache with Tylenol. The outcome of the event was reported as recovering.  No follow-up attempts are possible. Information about lot/ batch no cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: I'm having a lot of pain in my arm into the left side; my hand is numb; hand and arm are tingling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She received her first dose of the Pfizer covid vaccine the day before yesterday. She was having a lot of pain in her arm into the left side Feb2021. For a day and 1/2 now her hand was numb what was causing it? It's kind of scary. Her thumb, hand and arm. It doesn't hurt any more but it's numb, it's tingling. it's crazy. It's like her whole arm and hand was asleep. Her left arm was numb, it hurt for a day and a half. Now her left arm and hand are numb. Her hand and arm are tingling. was that shot that bad with everyone? It hurts. COVID19 Vaccine. Reporter considered events as non-serious. The outcome of I'm having a lot of pain in my arm into the left side was recovered on an unspecified date in Feb2021, my hand is numb, hand and arm are tingling was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.