chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Dizziness, Injection site pain, Pain, Pyrexia
Clinical narrative: sudden drop of blood pressure, blurry vision and dizziness. Fever, body aches and pain in the injection site for 3 days.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: sudden drop of blood pressure, blurry vision and dizziness. Fever, body aches and pain in the injection site for 3 days.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: Throbbing heart/ chest pain ,Lasted for 3 or 4 days
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram ambulatory, Fatigue
Clinical narrative: Symptoms began getting worse within the week after October 8. Including: Leaning down to put down a box, I had to sit down, heart was pounding, needle pain in chest. I would be walking outside and all of a sudden my heart began to race, felt very hot and began sweating. Pins and needles and ache in my chest. Ants and pins all over my body, especially in left leg (which began feeling heavy and going numb if I walked more than about 30min). Constantly feeling like someone was sitting on my chest, hard time taking a full breathe because of it. Feeling completely wiped out, exhausted and out of breathe from doing something simple as going to grocery store, or going under the table to reach down for something. Heart pounding one second, then feeling like I have a faint heart beat the next, and needing to sit down because light headed. My heart going completely out of rhythm on a simple walk outside, that I felt a pulse in my ears and had to hold onto something because I couldn't catch a breathe or my grounding. Fingers swelling after taking a walk outside, hard to close hands to make a fist. Left arm went numb, tingling and feeling very heavy on October 15th, which was the first day I managed to find strength to leave the house because I had a cardiologist appt.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Hypoaesthesia, Limb discomfort, Palpitations
Clinical narrative: Symptoms began getting worse within the week after October 8. Including: Leaning down to put down a box, I had to sit down, heart was pounding, needle pain in chest. I would be walking outside and all of a sudden my heart began to race, felt very hot and began sweating. Pins and needles and ache in my chest. Ants and pins all over my body, especially in left leg (which began feeling heavy and going numb if I walked more than about 30min). Constantly feeling like someone was sitting on my chest, hard time taking a full breathe because of it. Feeling completely wiped out, exhausted and out of breathe from doing something simple as going to grocery store, or going under the table to reach down for something. Heart pounding one second, then feeling like I have a faint heart beat the next, and needing to sit down because light headed. My heart going completely out of rhythm on a simple walk outside, that I felt a pulse in my ears and had to hold onto something because I couldn't catch a breathe or my grounding. Fingers swelling after taking a walk outside, hard to close hands to make a fist. Left arm went numb, tingling and feeling very heavy on October 15th, which was the first day I managed to find strength to leave the house because I had a cardiologist appt.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: Symptoms began getting worse within the week after October 8. Including: Leaning down to put down a box, I had to sit down, heart was pounding, needle pain in chest. I would be walking outside and all of a sudden my heart began to race, felt very hot and began sweating. Pins and needles and ache in my chest. Ants and pins all over my body, especially in left leg (which began feeling heavy and going numb if I walked more than about 30min). Constantly feeling like someone was sitting on my chest, hard time taking a full breathe because of it. Feeling completely wiped out, exhausted and out of breathe from doing something simple as going to grocery store, or going under the table to reach down for something. Heart pounding one second, then feeling like I have a faint heart beat the next, and needing to sit down because light headed. My heart going completely out of rhythm on a simple walk outside, that I felt a pulse in my ears and had to hold onto something because I couldn't catch a breathe or my grounding. Fingers swelling after taking a walk outside, hard to close hands to make a fist. Left arm went numb, tingling and feeling very heavy on October 15th, which was the first day I managed to find strength to leave the house because I had a cardiologist appt.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Cerebrovascular accident
Clinical narrative: Covid vaccine was given 10/9/21. When this provider called patient for other reason (billing), her husband answered and he reported to me that his wife had a "stroke" 2 days after she received her 3rd dose of Covid vaccine and she is currently in SNF.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor, Tremor
Clinical narrative: PT MOTHER REPORTED THAT HER CHILD WAS SHAKING, NAUSIOUS AND SKIN TONE WAS GOING PALE.  TOOK BP WAS 90/67.  CONTACTED EMERGENCY RESPONSE.  UPON ARRIVAL AND EVALUATION BY FIRST RESPONDERS.  PT PARENT WAS ADVISED THAT TRIP TO ER VIA AMBULANCE WAS NOT NECESSARY AT THE TIME.  PARENT WAS ADVISED BY FIRST RESPONDERS TO TAKE PT HOME AND KEEP AN EYE ON HIM.  IF SYMPTOMS WORSEN TO GO TO THE ER
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling hot, Pain in extremity
Clinical narrative: Sore arm with moderate pain, shivering, feel hot but no fever.  Tired. Symptoms occurred about 4 hours after vaccination.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Joint instability, Muscle spasms, Pain in extremity, X-ray
Clinical narrative: I experienced leg and knee pain and some cramping in legs after first shot, same after 2nd shot.  Symptoms lasted few weeks lessening each day.   After 3rd shot, I had extreme pain and cramping in left leg.  Additionally my left knee would buckle under my weight with no warning.  I scheduled an X-ray after the pain with the 1st shot.  No damage was seen in the left knee . However I had the pain for weeks.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: PT ACCIDENTALLY GOT SECOND FLU SHOT, MISCOMMUICATION , ALSO GOT COVID BOOSTER
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient became lightheaded and dizzy approximately 2 minutes following immunization. She was given a cold drink of water and cold compress to help. The patient had been instructed to sit down following immunization and did so. About half an hour later following administration of the vaccine the patient felt well and went home. No additional symptoms such as swelling of the mouth, lips, or throat were abnormal and the patient had normal vital signs.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: She had numbness and tingling in her left leg and foot about 5 minutes after getting her shot and the developed numbness and tingling in her right foot about 10 minutes after the shot
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Cardiac monitoring, Chest pain, Chills, Diarrhoea
Clinical narrative: 10/2/21 patient received covid19 booster vaccine 10/3/21-10/4/21 patient didn't feel well ( headache, chills ) 10/4/21 patient started to feel worse and developed diarrhea and nausea 10/5/21 had doctor appointment and nurse noticed pulse was erratic 10/6/21 went to the doctor for an EKG - was normal but referred patient to the heart institute 10/8/21 at appointment with the cardiac doctor - patient was experiencing chest pains, heart pounding, and bradycardia. A longer EKG was performed and showed a PVC every other beat.  An ambulance was called at the cardiac doctor's appointment and patient was taken to hospital and admitted over the weekend. 10/10/21 Patient was discharged 6:30pm.  Metoprolol was added to patient med list and she is currently wearing a heart monitor.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Headache, Heart rate irregular, Malaise, Nausea
Clinical narrative: 10/2/21 patient received covid19 booster vaccine 10/3/21-10/4/21 patient didn't feel well ( headache, chills ) 10/4/21 patient started to feel worse and developed diarrhea and nausea 10/5/21 had doctor appointment and nurse noticed pulse was erratic 10/6/21 went to the doctor for an EKG - was normal but referred patient to the heart institute 10/8/21 at appointment with the cardiac doctor - patient was experiencing chest pains, heart pounding, and bradycardia. A longer EKG was performed and showed a PVC every other beat.  An ambulance was called at the cardiac doctor's appointment and patient was taken to hospital and admitted over the weekend. 10/10/21 Patient was discharged 6:30pm.  Metoprolol was added to patient med list and she is currently wearing a heart monitor.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: 10/2/21 patient received covid19 booster vaccine 10/3/21-10/4/21 patient didn't feel well ( headache, chills ) 10/4/21 patient started to feel worse and developed diarrhea and nausea 10/5/21 had doctor appointment and nurse noticed pulse was erratic 10/6/21 went to the doctor for an EKG - was normal but referred patient to the heart institute 10/8/21 at appointment with the cardiac doctor - patient was experiencing chest pains, heart pounding, and bradycardia. A longer EKG was performed and showed a PVC every other beat.  An ambulance was called at the cardiac doctor's appointment and patient was taken to hospital and admitted over the weekend. 10/10/21 Patient was discharged 6:30pm.  Metoprolol was added to patient med list and she is currently wearing a heart monitor.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Migraine, Pain
Clinical narrative: Within 4 hours of the first dose I started getting a headache, before bed I was fatigued and the headache became a migraine. I woke up with my entire body hurting. The migraine lasted for 4 days, the body aches lasted for approx 10 days. I was still fatigued and could not work my job due to the tiredness, I was affraid to drive in this condition. I did try to work.  Same as the first dose with an added factor, along with the migraines I was vomitting everything I ate or drank for four days. The body aches lasted approx 10 days and the fatigue became worse than the first dosage. I still havent worked my regular job since the second dosage.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Within 4 hours of the first dose I started getting a headache, before bed I was fatigued and the headache became a migraine. I woke up with my entire body hurting. The migraine lasted for 4 days, the body aches lasted for approx 10 days. I was still fatigued and could not work my job due to the tiredness, I was affraid to drive in this condition. I did try to work.  Same as the first dose with an added factor, along with the migraines I was vomitting everything I ate or drank for four days. The body aches lasted approx 10 days and the fatigue became worse than the first dosage. I still havent worked my regular job since the second dosage.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: none
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Flucelvax Quad on 10/15/21  but patient had already gotten  flucelvax Quad 2021 on 8/13/2021.  Duplicate shot given on 10/15/21.  Patient had no symptoms of complaints
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient presented no adverse event for getting  flucelvax vaccine twice
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: No adverse event
Clinical narrative: Pt has no adverse reaction  to flu shot.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Patient complained of metallic taste in mouth a few days after Pfizer Covid vaccine
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Experienced tingling in my body; Extreme dizziness; And falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [05Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech), second single dose intramuscularly on 11Jan2021 (Batch/Lot Number: EL3249) for covid-19 immunisation at age of 48-year-old. Medical history and concomitant medications were none. The patient previously received first single dose of bnt162b2 on 19Dec2020 intramuscularly on right deltoid for COVID-19 immunisation (Batch/Lot Number: EJ1685). The patient experienced tingling in body followed by extreme dizziness and falling and events all being transferred to the emergency room. The patient underwent lab test included electrocardiogram with unknown results.  Outcome of the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events ( Paresthesia, Dizziness, Fall) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chest pain, Crying, Dyspnoea
Clinical narrative: Experienced tingling in my body; Extreme dizziness; And falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [05Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech), second single dose intramuscularly on 11Jan2021 (Batch/Lot Number: EL3249) for covid-19 immunisation at age of 48-year-old. Medical history and concomitant medications were none. The patient previously received first single dose of bnt162b2 on 19Dec2020 intramuscularly on right deltoid for COVID-19 immunisation (Batch/Lot Number: EJ1685). The patient experienced tingling in body followed by extreme dizziness and falling and events all being transferred to the emergency room. The patient underwent lab test included electrocardiogram with unknown results.  Outcome of the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events ( Paresthesia, Dizziness, Fall) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Emotional distress, Fatigue, Fear, Feeling of body temperature change
Clinical narrative: Experienced tingling in my body; Extreme dizziness; And falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [05Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech), second single dose intramuscularly on 11Jan2021 (Batch/Lot Number: EL3249) for covid-19 immunisation at age of 48-year-old. Medical history and concomitant medications were none. The patient previously received first single dose of bnt162b2 on 19Dec2020 intramuscularly on right deltoid for COVID-19 immunisation (Batch/Lot Number: EJ1685). The patient experienced tingling in body followed by extreme dizziness and falling and events all being transferred to the emergency room. The patient underwent lab test included electrocardiogram with unknown results.  Outcome of the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events ( Paresthesia, Dizziness, Fall) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hunger, Laboratory test, Sensory disturbance
Clinical narrative: Experienced tingling in my body; Extreme dizziness; And falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [05Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech), second single dose intramuscularly on 11Jan2021 (Batch/Lot Number: EL3249) for covid-19 immunisation at age of 48-year-old. Medical history and concomitant medications were none. The patient previously received first single dose of bnt162b2 on 19Dec2020 intramuscularly on right deltoid for COVID-19 immunisation (Batch/Lot Number: EJ1685). The patient experienced tingling in body followed by extreme dizziness and falling and events all being transferred to the emergency room. The patient underwent lab test included electrocardiogram with unknown results.  Outcome of the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events ( Paresthesia, Dizziness, Fall) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Somnolence, Vertigo
Clinical narrative: Experienced tingling in my body; Extreme dizziness; And falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [05Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech), second single dose intramuscularly on 11Jan2021 (Batch/Lot Number: EL3249) for covid-19 immunisation at age of 48-year-old. Medical history and concomitant medications were none. The patient previously received first single dose of bnt162b2 on 19Dec2020 intramuscularly on right deltoid for COVID-19 immunisation (Batch/Lot Number: EJ1685). The patient experienced tingling in body followed by extreme dizziness and falling and events all being transferred to the emergency room. The patient underwent lab test included electrocardiogram with unknown results.  Outcome of the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events ( Paresthesia, Dizziness, Fall) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Fall, Paraesthesia
Clinical narrative: Experienced tingling in my body; Extreme dizziness; And falling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on [05Oct2021], this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received bnt162b2 (Pfizer-BioNTech), second single dose intramuscularly on 11Jan2021 (Batch/Lot Number: EL3249) for covid-19 immunisation at age of 48-year-old. Medical history and concomitant medications were none. The patient previously received first single dose of bnt162b2 on 19Dec2020 intramuscularly on right deltoid for COVID-19 immunisation (Batch/Lot Number: EJ1685). The patient experienced tingling in body followed by extreme dizziness and falling and events all being transferred to the emergency room. The patient underwent lab test included electrocardiogram with unknown results.  Outcome of the events was unknown.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events ( Paresthesia, Dizziness, Fall) and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Insomnia, Pain, Speech disorder, Swelling
Clinical narrative: Slept a lot; This is a spontaneous report from a contactable Consumer. This female consumer reported in response to Non-HCP Letter sent in cross-referenced case which included that:  A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 75 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced sleeping a lot. The event not resulted in emergency room and physician office visit and no culture was performed. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Somnolence
Clinical narrative: Slept a lot; This is a spontaneous report from a contactable Consumer. This female consumer reported in response to Non-HCP Letter sent in cross-referenced case which included that:  A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date (at the age of 75 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced sleeping a lot. The event not resulted in emergency room and physician office visit and no culture was performed. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incomplete course of vaccination, Ophthalmological examination, Vision blurred
Clinical narrative: very bad blurred vision; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in left arm on 22Feb2021 at 16:30 (at the age of 64-year-old) as dose number unknown, single for COVID-19 immunization in hospital. Patient was not pregnant at the time of vaccination. Medical history included afib, stroke, heart attack, osteoarthritis, degenerative disc disease, herniated disc, spinal stenosis, fibromyalgia (everything from an unknown date and unknown if ongoing). Concomitant medications included unspecified medication (in two weeks) for an unspecified indication, start and stop date were not reported. Patient previously took (levofloxacin) LEVAQUIN, (duloxetine hydrochloride) CYMBALTA, (acetylcarnitine hydrochloride) NEUROTIN, (dronedarone hydrochloride) MULTAQ, (rivaroxaban) XARELTO, (clopidogrel bisulfate) PLAVIX, (dabigatran etexilate mesilate) PRADAXA, (warfarin sodium) COUMADIN for which the patient had experienced allergy. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Feb2021 at 17:30, the patient experienced very bad blurred vision. The patient reported that an hour after having the shot she had very bad blurred vision while driving in right eye only. It lasted for 45 minutes then cleared up around 20.00 when she put my Restasis eye drops in both eyes. The patient saw Ophthalmology doctor on 10Mar2021 for an already scheduled appointment. Outcome of the event was recovered on 22Feb2021 at 20.00.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: very bad blurred vision; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in left arm on 22Feb2021 at 16:30 (at the age of 64-year-old) as dose number unknown, single for COVID-19 immunization in hospital. Patient was not pregnant at the time of vaccination. Medical history included afib, stroke, heart attack, osteoarthritis, degenerative disc disease, herniated disc, spinal stenosis, fibromyalgia (everything from an unknown date and unknown if ongoing). Concomitant medications included unspecified medication (in two weeks) for an unspecified indication, start and stop date were not reported. Patient previously took (levofloxacin) LEVAQUIN, (duloxetine hydrochloride) CYMBALTA, (acetylcarnitine hydrochloride) NEUROTIN, (dronedarone hydrochloride) MULTAQ, (rivaroxaban) XARELTO, (clopidogrel bisulfate) PLAVIX, (dabigatran etexilate mesilate) PRADAXA, (warfarin sodium) COUMADIN for which the patient had experienced allergy. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 22Feb2021 at 17:30, the patient experienced very bad blurred vision. The patient reported that an hour after having the shot she had very bad blurred vision while driving in right eye only. It lasted for 45 minutes then cleared up around 20.00 when she put my Restasis eye drops in both eyes. The patient saw Ophthalmology doctor on 10Mar2021 for an already scheduled appointment. Outcome of the event was recovered on 22Feb2021 at 20.00.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Hypotension, Skin warm
Clinical narrative: low grade temperature; experienced headache before receiving the vaccine and then the headache worsened afterwards; body aches; the vaccination site her blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) via an unspecified route of administration on 13Mar2021 (at the age of 51 year old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. No reported family history. There were no concomitant medications. She had a headache two days before receiving the vaccine. On 13Mar2021, when she received the vaccine, she had a blood pressure reaction drop at the site. She was fine after a couple of minutes. Then on Sunday, 14Mar2021, her headache got worsened, where it was an intense bad headache. Her headache got went up and down. Also she had body aches that started from 14Mar2021, for 2 weeks straight (full on for the first two weeks), then it became intermittent. On 18Mar2021, she experienced a low grade temperature. It was reported that, she was confused on how to move forward. Patient clarified that she knows some of her symptoms were from the vaccine. At the time of report, she is on week three, and is still having symptoms. Patient has intermittent body aches, but they got little better, but her headache has not left her at all, it got much worse she has ever had, and now it is weaning, and her low-grade temperature was reported as intermittently ongoing. She was trying to find out the best path to take. She was asking should she delay her second dose of the COVID vaccine, and if she can delay then, how long can she delay it for it to still be effective. The outcome of the event Blood pressure dropped was recovered on 13Mar2021, and of body aches was recovering and of other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Food allergy, Headache, Pain, Pyrexia
Clinical narrative: low grade temperature; experienced headache before receiving the vaccine and then the headache worsened afterwards; body aches; the vaccination site her blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) via an unspecified route of administration on 13Mar2021 (at the age of 51 year old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. No reported family history. There were no concomitant medications. She had a headache two days before receiving the vaccine. On 13Mar2021, when she received the vaccine, she had a blood pressure reaction drop at the site. She was fine after a couple of minutes. Then on Sunday, 14Mar2021, her headache got worsened, where it was an intense bad headache. Her headache got went up and down. Also she had body aches that started from 14Mar2021, for 2 weeks straight (full on for the first two weeks), then it became intermittent. On 18Mar2021, she experienced a low grade temperature. It was reported that, she was confused on how to move forward. Patient clarified that she knows some of her symptoms were from the vaccine. At the time of report, she is on week three, and is still having symptoms. Patient has intermittent body aches, but they got little better, but her headache has not left her at all, it got much worse she has ever had, and now it is weaning, and her low-grade temperature was reported as intermittently ongoing. She was trying to find out the best path to take. She was asking should she delay her second dose of the COVID vaccine, and if she can delay then, how long can she delay it for it to still be effective. The outcome of the event Blood pressure dropped was recovered on 13Mar2021, and of body aches was recovering and of other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
Clinical narrative: low grade temperature; experienced headache before receiving the vaccine and then the headache worsened afterwards; body aches; the vaccination site her blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) via an unspecified route of administration on 13Mar2021 (at the age of 51 year old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. No reported family history. There were no concomitant medications. She had a headache two days before receiving the vaccine. On 13Mar2021, when she received the vaccine, she had a blood pressure reaction drop at the site. She was fine after a couple of minutes. Then on Sunday, 14Mar2021, her headache got worsened, where it was an intense bad headache. Her headache got went up and down. Also she had body aches that started from 14Mar2021, for 2 weeks straight (full on for the first two weeks), then it became intermittent. On 18Mar2021, she experienced a low grade temperature. It was reported that, she was confused on how to move forward. Patient clarified that she knows some of her symptoms were from the vaccine. At the time of report, she is on week three, and is still having symptoms. Patient has intermittent body aches, but they got little better, but her headache has not left her at all, it got much worse she has ever had, and now it is weaning, and her low-grade temperature was reported as intermittently ongoing. She was trying to find out the best path to take. She was asking should she delay her second dose of the COVID vaccine, and if she can delay then, how long can she delay it for it to still be effective. The outcome of the event Blood pressure dropped was recovered on 13Mar2021, and of body aches was recovering and of other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature decreased, Headache, Pain
Clinical narrative: low grade temperature; experienced headache before receiving the vaccine and then the headache worsened afterwards; body aches; the vaccination site her blood pressure dropped; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP7534) via an unspecified route of administration on 13Mar2021 (at the age of 51 year old) as dose 1, single for COVID-19 immunisation. Medical history included allergies. No reported family history. There were no concomitant medications. She had a headache two days before receiving the vaccine. On 13Mar2021, when she received the vaccine, she had a blood pressure reaction drop at the site. She was fine after a couple of minutes. Then on Sunday, 14Mar2021, her headache got worsened, where it was an intense bad headache. Her headache got went up and down. Also she had body aches that started from 14Mar2021, for 2 weeks straight (full on for the first two weeks), then it became intermittent. On 18Mar2021, she experienced a low grade temperature. It was reported that, she was confused on how to move forward. Patient clarified that she knows some of her symptoms were from the vaccine. At the time of report, she is on week three, and is still having symptoms. Patient has intermittent body aches, but they got little better, but her headache has not left her at all, it got much worse she has ever had, and now it is weaning, and her low-grade temperature was reported as intermittently ongoing. She was trying to find out the best path to take. She was asking should she delay her second dose of the COVID vaccine, and if she can delay then, how long can she delay it for it to still be effective. The outcome of the event Blood pressure dropped was recovered on 13Mar2021, and of body aches was recovering and of other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin hyperpigmentation, Syncope, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Hives; This is a spontaneous report from a contactable physician. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) intramuscularly, administered in Arm Left on 19Feb2021 17:00 (at the age old 47-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included major depressive disorder from 1990 ongoing (Stable with medication (and dose irrelevant), ADHD (attention deficit hyperactivity disorder) from 1974 ongoing (Stable with medication), Seasonal Allergies, and possible eczema from 1977 ongoing (Cetirizine and Zyrtec) controls symptoms well). Family medical history asthma Father- Asthma, severe seasonal allergies (but respond well to medication), Brother- Moderate to severe seasonal allergies (respond well to medication), Nephew (Brother's son)- Moderate to severe seasonal allergies (respond well to medication). Concomitant medication(s) included PROZAC DURAPAC orally taken for depression from 1995 and ongoing; WELLBUTRIN orally taken for depression from 2013 and ongoing; ADDERALL orally taken for attention deficit hyperactivity disorder from 2019 and ongoing; CETIRIZINE orally taken for allergies from 2019 and ongoing; IBUPROFEN orally taken for headache from 1983 and ongoing as needed. The patient previously took first dose of covid-19 vaccine on 29Jan2021 11:00 for covid-19 immunisation. The patient experienced hives on 19Feb2021 18:00. No treatment received. The outcome of event was recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable physician. A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) intramuscularly, administered in Arm Left on 19Feb2021 17:00 (at the age old 47-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included major depressive disorder from 1990 ongoing (Stable with medication (and dose irrelevant), ADHD (attention deficit hyperactivity disorder) from 1974 ongoing (Stable with medication), Seasonal Allergies, and possible eczema from 1977 ongoing (Cetirizine and Zyrtec) controls symptoms well). Family medical history asthma Father- Asthma, severe seasonal allergies (but respond well to medication), Brother- Moderate to severe seasonal allergies (respond well to medication), Nephew (Brother's son)- Moderate to severe seasonal allergies (respond well to medication). Concomitant medication(s) included PROZAC DURAPAC orally taken for depression from 1995 and ongoing; WELLBUTRIN orally taken for depression from 2013 and ongoing; ADDERALL orally taken for attention deficit hyperactivity disorder from 2019 and ongoing; CETIRIZINE orally taken for allergies from 2019 and ongoing; IBUPROFEN orally taken for headache from 1983 and ongoing as needed. The patient previously took first dose of covid-19 vaccine on 29Jan2021 11:00 for covid-19 immunisation. The patient experienced hives on 19Feb2021 18:00. No treatment received. The outcome of event was recovered.  Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disorientation, Headache, Nausea, Pain
Clinical narrative: pain in left arm, could not lift above head the next day; Nauseated; Headache; ached all over; Chills; felt hot and cold; drowsy; was disoriented; pain in left arm, could not lift above head the next day; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 11Feb2021 (Lot Number: ELIZ83) (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus (Additional Information for Other Conditions: under control, diagnosed 30 years ago), and hypertension. Concomitant medications included labetalol taken for hypertension (taking for about a year). On 12Feb2021, the patient felt nauseated, headache, ached all over, chills, felt hot and cold, drowsy and disoriented, and pain in left arm, could not lift above head the next day (13Feb2021). The patient was drowsy and stayed in bed for at least 3 days, and was disoriented by the end of it. The patient had no intentions of getting the second dose of the vaccine and was asking if the first dose will offer sufficient immunity. The patient was recovering from the events nauseated, drowsy and disoriented while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: pain in left arm, could not lift above head the next day; Nauseated; Headache; ached all over; Chills; felt hot and cold; drowsy; was disoriented; pain in left arm, could not lift above head the next day; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 11Feb2021 (Lot Number: ELIZ83) (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus (Additional Information for Other Conditions: under control, diagnosed 30 years ago), and hypertension. Concomitant medications included labetalol taken for hypertension (taking for about a year). On 12Feb2021, the patient felt nauseated, headache, ached all over, chills, felt hot and cold, drowsy and disoriented, and pain in left arm, could not lift above head the next day (13Feb2021). The patient was drowsy and stayed in bed for at least 3 days, and was disoriented by the end of it. The patient had no intentions of getting the second dose of the vaccine and was asking if the first dose will offer sufficient immunity. The patient was recovering from the events nauseated, drowsy and disoriented while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disorientation, Feeling of body temperature change, Headache, Joint range of motion decreased
Clinical narrative: pain in left arm, could not lift above head the next day; Nauseated; Headache; ached all over; Chills; felt hot and cold; drowsy; was disoriented; pain in left arm, could not lift above head the next day; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 11Feb2021 (Lot Number: ELIZ83) (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus (Additional Information for Other Conditions: under control, diagnosed 30 years ago), and hypertension. Concomitant medications included labetalol taken for hypertension (taking for about a year). On 12Feb2021, the patient felt nauseated, headache, ached all over, chills, felt hot and cold, drowsy and disoriented, and pain in left arm, could not lift above head the next day (13Feb2021). The patient was drowsy and stayed in bed for at least 3 days, and was disoriented by the end of it. The patient had no intentions of getting the second dose of the vaccine and was asking if the first dose will offer sufficient immunity. The patient was recovering from the events nauseated, drowsy and disoriented while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Somnolence
Clinical narrative: pain in left arm, could not lift above head the next day; Nauseated; Headache; ached all over; Chills; felt hot and cold; drowsy; was disoriented; pain in left arm, could not lift above head the next day; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 11Feb2021 (Lot Number: ELIZ83) (at the age of 72 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included type 2 diabetes mellitus (Additional Information for Other Conditions: under control, diagnosed 30 years ago), and hypertension. Concomitant medications included labetalol taken for hypertension (taking for about a year). On 12Feb2021, the patient felt nauseated, headache, ached all over, chills, felt hot and cold, drowsy and disoriented, and pain in left arm, could not lift above head the next day (13Feb2021). The patient was drowsy and stayed in bed for at least 3 days, and was disoriented by the end of it. The patient had no intentions of getting the second dose of the vaccine and was asking if the first dose will offer sufficient immunity. The patient was recovering from the events nauseated, drowsy and disoriented while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.