chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Pain, Swelling
Clinical narrative: 03/24/2021 Entire back of her neck swelled and a lump on the right side of head in the back, heating pad, and ice would not resolve. Called urgent care, was referred to the hospital and she was not able to get to the hospital for economic reasons was not able to get a cab to the hospital. Refused to call emergency services. Laid in bed for 4-5 days and thought that she may have had a stroke. Had a stroke in the past and felt like she was experiencing a stroke with weakness in legs, arm, and speech. When she was seen by a doctor, she went to see a shoulder doctor MRI was done to show a rip or tear and was in therapy. Working with liver doctor and her liver is not working had NASH.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mass, Muscular weakness, Musculoskeletal discomfort, Speech disorder
Clinical narrative: 03/24/2021 Entire back of her neck swelled and a lump on the right side of head in the back, heating pad, and ice would not resolve. Called urgent care, was referred to the hospital and she was not able to get to the hospital for economic reasons was not able to get a cab to the hospital. Refused to call emergency services. Laid in bed for 4-5 days and thought that she may have had a stroke. Had a stroke in the past and felt like she was experiencing a stroke with weakness in legs, arm, and speech. When she was seen by a doctor, she went to see a shoulder doctor MRI was done to show a rip or tear and was in therapy. Working with liver doctor and her liver is not working had NASH.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Headache, SARS-CoV-2 test, Sinus headache, Sinus pain
Clinical narrative: So I started off having a reaction within the first 24 hours. I had a headache and I've had a headache ever since. I've never had migraines before and thought it was a sinus issue. So I waited 10 days before seeing my doctor. I was initially put on a prednisone pack to see if it was sinus related to see if it would go away. But the headaches I had were pretty nasty, and they didn't get any better. So a week later, I went back to the doctor and they gave me an antibiotic. And they also did a prednisone taper. I was still working at the time and it wasn't getting any better. So in June they scheduled for a CT scan. And it got worse so I ended up in the hospital. And I got a CAT scan there instead which came back and was resulted as unremarkable & normal. And they tried to give me other prescriptions to see if they could help me. At the end of June, I finally got to see the neurologist and it was migraines and tension headaches and was given on Gabapentin and Paroxetine initially, and then they took me off of those and now I'm taking Nortriptyline and Topiramate and a monthly injection Ajovy, as well as Nurtec for break through migraines. Still in a bunch of pain and was put on another prednisone taper in October to break the pain cycle. My head still doesn't seem to like me. Still trying to get my migraines under control. And I've been trying to go a day without a headache since the second vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tension headache, Toothache
Clinical narrative: So I started off having a reaction within the first 24 hours. I had a headache and I've had a headache ever since. I've never had migraines before and thought it was a sinus issue. So I waited 10 days before seeing my doctor. I was initially put on a prednisone pack to see if it was sinus related to see if it would go away. But the headaches I had were pretty nasty, and they didn't get any better. So a week later, I went back to the doctor and they gave me an antibiotic. And they also did a prednisone taper. I was still working at the time and it wasn't getting any better. So in June they scheduled for a CT scan. And it got worse so I ended up in the hospital. And I got a CAT scan there instead which came back and was resulted as unremarkable & normal. And they tried to give me other prescriptions to see if they could help me. At the end of June, I finally got to see the neurologist and it was migraines and tension headaches and was given on Gabapentin and Paroxetine initially, and then they took me off of those and now I'm taking Nortriptyline and Topiramate and a monthly injection Ajovy, as well as Nurtec for break through migraines. Still in a bunch of pain and was put on another prednisone taper in October to break the pain cycle. My head still doesn't seem to like me. Still trying to get my migraines under control. And I've been trying to go a day without a headache since the second vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Magnetic resonance imaging head normal, Migraine, Sinusitis, Tension headache
Clinical narrative: So I started off having a reaction within the first 24 hours. I had a headache and I've had a headache ever since. I've never had migraines before and thought it was a sinus issue. So I waited 10 days before seeing my doctor. I was initially put on a prednisone pack to see if it was sinus related to see if it would go away. But the headaches I had were pretty nasty, and they didn't get any better. So a week later, I went back to the doctor and they gave me an antibiotic. And they also did a prednisone taper. I was still working at the time and it wasn't getting any better. So in June they scheduled for a CT scan. And it got worse so I ended up in the hospital. And I got a CAT scan there instead which came back and was resulted as unremarkable & normal. And they tried to give me other prescriptions to see if they could help me. At the end of June, I finally got to see the neurologist and it was migraines and tension headaches and was given on Gabapentin and Paroxetine initially, and then they took me off of those and now I'm taking Nortriptyline and Topiramate and a monthly injection Ajovy, as well as Nurtec for break through migraines. Still in a bunch of pain and was put on another prednisone taper in October to break the pain cycle. My head still doesn't seem to like me. Still trying to get my migraines under control. And I've been trying to go a day without a headache since the second vaccine.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness, Tinnitus
Clinical narrative: 10 days later developed blocked ears; tinnitus; ear infection; Had hearing loss in left ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as dose 1, single, for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient had the Pfizer Covid vaccine on 30Jan2021. 10 days later (09Feb2021), the patient developed blocked ears and tinnitus (the patient had never heard of it). The patient thought he/she had an ear infection. Two courses of antibiotics did nothing to alleviate the issues. The patient saw an ENT and audiologist. The patient had hearing loss in left ear in 2021. Three courses of prednisone were helpful. Hearing was restored. The blocked feeling got better. The patient still has tinnitus. The patient stated, "I know many have suffered the same ailments. Vaccine related." The outcome of the events hearing loss and blocked ears were recovered on an unspecified date in 2021 while tinnitus was not recovered, and ear infection was unknown. The patient had second shot on 20Feb2021.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: 10 days later developed blocked ears; tinnitus; ear infection; Had hearing loss in left ear; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) as dose 1, single, for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient had the Pfizer Covid vaccine on 30Jan2021. 10 days later (09Feb2021), the patient developed blocked ears and tinnitus (the patient had never heard of it). The patient thought he/she had an ear infection. Two courses of antibiotics did nothing to alleviate the issues. The patient saw an ENT and audiologist. The patient had hearing loss in left ear in 2021. Three courses of prednisone were helpful. Hearing was restored. The blocked feeling got better. The patient still has tinnitus. The patient stated, "I know many have suffered the same ailments. Vaccine related." The outcome of the events hearing loss and blocked ears were recovered on an unspecified date in 2021 while tinnitus was not recovered, and ear infection was unknown. The patient had second shot on 20Feb2021.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: pt was seen in ED and diagnosed with COVID; pt refused hospitalization and was dc'd to home; pt presented again today in ED with worsening symptoms; reports altered mental status and O2 sats in 80s @ home, increasing SOB; placed on 100% high flow via NC and alternating between BiPAP; pt's condition continued to deteriorate; placed on comfort care only; pt died in the hosp
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Dyspnoea, General physical health deterioration, Mental status changes
Clinical narrative: pt was seen in ED and diagnosed with COVID; pt refused hospitalization and was dc'd to home; pt presented again today in ED with worsening symptoms; reports altered mental status and O2 sats in 80s @ home, increasing SOB; placed on 100% high flow via NC and alternating between BiPAP; pt's condition continued to deteriorate; placed on comfort care only; pt died in the hosp
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy
Clinical narrative: pt was seen in ED and diagnosed with COVID; pt refused hospitalization and was dc'd to home; pt presented again today in ED with worsening symptoms; reports altered mental status and O2 sats in 80s @ home, increasing SOB; placed on 100% high flow via NC and alternating between BiPAP; pt's condition continued to deteriorate; placed on comfort care only; pt died in the hosp
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hypoaesthesia, Lip swelling
Clinical narrative: Arrived via EMS squad to ER on 10/01/2021. She states she had "just received her Pfizer COVID 19 vaccination" - 20 minutes post dose, she c/o lip swelling, extremity tingling. Pt did have her EPIPEN on her (that she keeps for other allergies) and administered it into her thigh. She is now reporting no more s/s. Denies any PMHX; except for allergies (see list).   Stayed in ER x 4 hr for monitoring and then discharged to home with more RX for epi-pen. Medications Given: Diphenhdramine 50mg IV ED stat 1litre bolus normal saline IV Pepcid 20mg IV stat Methylprednisolone 125mg x1 IV stat
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia
Clinical narrative: Arrived via EMS squad to ER on 10/01/2021. She states she had "just received her Pfizer COVID 19 vaccination" - 20 minutes post dose, she c/o lip swelling, extremity tingling. Pt did have her EPIPEN on her (that she keeps for other allergies) and administered it into her thigh. She is now reporting no more s/s. Denies any PMHX; except for allergies (see list).   Stayed in ER x 4 hr for monitoring and then discharged to home with more RX for epi-pen. Medications Given: Diphenhdramine 50mg IV ED stat 1litre bolus normal saline IV Pepcid 20mg IV stat Methylprednisolone 125mg x1 IV stat
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Acute myocardial infarction, Acute respiratory failure, Asthenia, COVID-19
Clinical narrative: pt presented to ED with c/o cough, SOB, poor appetite and po intake; positive COVID test and bilateral pneumonia; placed on O2 therapy; DNR; pt's condition did not improved; experienced V Tach and then asystole; pt died in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Cardiac failure congestive, Chest pain, Chronic kidney disease, Cough
Clinical narrative: pt presented to ED with c/o cough, SOB, poor appetite and po intake; positive COVID test and bilateral pneumonia; placed on O2 therapy; DNR; pt's condition did not improved; experienced V Tach and then asystole; pt died in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Hypoxia, Pneumonia, Respiratory tract congestion
Clinical narrative: pt presented to ED with c/o cough, SOB, poor appetite and po intake; positive COVID test and bilateral pneumonia; placed on O2 therapy; DNR; pt's condition did not improved; experienced V Tach and then asystole; pt died in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Ventricular fibrillation
Clinical narrative: pt presented to ED with c/o cough, SOB, poor appetite and po intake; positive COVID test and bilateral pneumonia; placed on O2 therapy; DNR; pt's condition did not improved; experienced V Tach and then asystole; pt died in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac arrest, Cough, Death, Decreased appetite
Clinical narrative: pt presented to ED with c/o cough, SOB, poor appetite and po intake; positive COVID test and bilateral pneumonia; placed on O2 therapy; DNR; pt's condition did not improved; experienced V Tach and then asystole; pt died in the hospital
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypophagia, Pneumonia, Ventricular tachycardia
Clinical narrative: pt presented to ED with c/o cough, SOB, poor appetite and po intake; positive COVID test and bilateral pneumonia; placed on O2 therapy; DNR; pt's condition did not improved; experienced V Tach and then asystole; pt died in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: brought to ED via EMS; tested positive for COVID; lethargic; responds to painful and repeated verbal stimuli but doesn't answer questions; placed on BiPAP and COVID protocol started; COVID pneumonia; observed with worsening tremors/rigors; in respiratory distress despite BiPAP, BP elevated; DNR/DNI; condition declined; BiPAP removed and pt died in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Blood pressure increased, COVID-19, COVID-19 pneumonia, Chills
Clinical narrative: brought to ED via EMS; tested positive for COVID; lethargic; responds to painful and repeated verbal stimuli but doesn't answer questions; placed on BiPAP and COVID protocol started; COVID pneumonia; observed with worsening tremors/rigors; in respiratory distress despite BiPAP, BP elevated; DNR/DNI; condition declined; BiPAP removed and pt died in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, General physical health deterioration, Lethargy, Positive airway pressure therapy, Respiratory distress
Clinical narrative: brought to ED via EMS; tested positive for COVID; lethargic; responds to painful and repeated verbal stimuli but doesn't answer questions; placed on BiPAP and COVID protocol started; COVID pneumonia; observed with worsening tremors/rigors; in respiratory distress despite BiPAP, BP elevated; DNR/DNI; condition declined; BiPAP removed and pt died in the hospital
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Tremor
Clinical narrative: brought to ED via EMS; tested positive for COVID; lethargic; responds to painful and repeated verbal stimuli but doesn't answer questions; placed on BiPAP and COVID protocol started; COVID pneumonia; observed with worsening tremors/rigors; in respiratory distress despite BiPAP, BP elevated; DNR/DNI; condition declined; BiPAP removed and pt died in the hospital
Age: 6.0
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse events; An expired dose of MMR-II was administered to a patient by accident; This spontaneous report was received from a medical assistant, and refers to a 6 year old patient. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.    Medical assistant reported that on 08-OCT-2021, the patient was accidentaly vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S029581 for prophylaxis, which expired on 22-SEP-2021.  The patient had not had any additional adverse experience as a result of receiving the expired dose.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Neck pain, Swelling
Clinical narrative: significant pain at left shoulder and neck areas; significant pain at left shoulder and neck areas; a minor swelling at left neck area; Appears to be Lymphadenopathy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot number: FC3180, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 27Sep2021 at 15:45 (age at vaccination: 77-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included ezetimibe (ZETIA); amlodipine besilate (NORVASC); levothyroxine sodium (SYNTHROID); magnesium and multivitamins taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN1318, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 07Feb2021 at 15:45 (age at vaccination: 76-year-old) as DOSE 1, SINGLE and second dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6202, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 28Feb2021 at 15:45 (age at vaccination: 77-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received zetia, norvasc, synthroid, magnesium, multivitamin within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had no known allergies. It was reported that about three days after taking the booster shot on 30Sep2021 at 23:00, the patient experienced significant pain at left shoulder and neck areas, the patient noticed a minor swelling at left neck area, it was appeared to be lymphadenopathy as highlighted under rare side effects of the vaccine. The patient was applying warm compress and taking advil/ tylenol as a treatment for adverse events. This case was assessed as non serious. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Lymphadenopathy, Neck pain, Swelling
Clinical narrative: significant pain at left shoulder and neck areas; significant pain at left shoulder and neck areas; a minor swelling at left neck area; Appears to be Lymphadenopathy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot number: FC3180, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 27Sep2021 at 15:45 (age at vaccination: 77-year-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included ezetimibe (ZETIA); amlodipine besilate (NORVASC); levothyroxine sodium (SYNTHROID); magnesium and multivitamins taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN1318, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 07Feb2021 at 15:45 (age at vaccination: 76-year-old) as DOSE 1, SINGLE and second dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6202, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 28Feb2021 at 15:45 (age at vaccination: 77-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received zetia, norvasc, synthroid, magnesium, multivitamin within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had no known allergies. It was reported that about three days after taking the booster shot on 30Sep2021 at 23:00, the patient experienced significant pain at left shoulder and neck areas, the patient noticed a minor swelling at left neck area, it was appeared to be lymphadenopathy as highlighted under rare side effects of the vaccine. The patient was applying warm compress and taking advil/ tylenol as a treatment for adverse events. This case was assessed as non serious. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acquired immunodeficiency syndrome, Blood cholesterol, Blood glucose abnormal, Blood pressure measurement, Body mass index
Clinical narrative: Severe chest pains on left side (a tight squeezing feeling), elevated heart rate over 180, shortness of breath, fatigue ; was diagnosed with pericardial effusion acute. Was prescribed Losartan, Prednisone, Pantoprazole, Potassium Chloride 40mg daily, Magnesium Sulfate IV. Was referred to a Cardiologist.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature normal, Cardiac monitoring, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Severe chest pains on left side (a tight squeezing feeling), elevated heart rate over 180, shortness of breath, fatigue ; was diagnosed with pericardial effusion acute. Was prescribed Losartan, Prednisone, Pantoprazole, Potassium Chloride 40mg daily, Magnesium Sulfate IV. Was referred to a Cardiologist.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Hepatitis, Laboratory test abnormal, Myocarditis
Clinical narrative: Severe chest pains on left side (a tight squeezing feeling), elevated heart rate over 180, shortness of breath, fatigue ; was diagnosed with pericardial effusion acute. Was prescribed Losartan, Prednisone, Pantoprazole, Potassium Chloride 40mg daily, Magnesium Sulfate IV. Was referred to a Cardiologist.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiration abnormal, SARS-CoV-2 test, Traumatic lung injury, Weight, X-ray
Clinical narrative: Severe chest pains on left side (a tight squeezing feeling), elevated heart rate over 180, shortness of breath, fatigue ; was diagnosed with pericardial effusion acute. Was prescribed Losartan, Prednisone, Pantoprazole, Potassium Chloride 40mg daily, Magnesium Sulfate IV. Was referred to a Cardiologist.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Severe chest pains on left side (a tight squeezing feeling), elevated heart rate over 180, shortness of breath, fatigue ; was diagnosed with pericardial effusion acute. Was prescribed Losartan, Prednisone, Pantoprazole, Potassium Chloride 40mg daily, Magnesium Sulfate IV. Was referred to a Cardiologist.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericardial effusion
Clinical narrative: Severe chest pains on left side (a tight squeezing feeling), elevated heart rate over 180, shortness of breath, fatigue ; was diagnosed with pericardial effusion acute. Was prescribed Losartan, Prednisone, Pantoprazole, Potassium Chloride 40mg daily, Magnesium Sulfate IV. Was referred to a Cardiologist.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Disturbance in attention, Feeling abnormal, Feeling hot, Heart rate
Clinical narrative: tingling in tongue, lips, and inside her mouth; hands were cold; fever; felt weak; breathe deeply; could taste the medicine; something strange in my heart but very slight; concentration and focus is not the same; felt hot inside; Body aches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in right arm on 18Sep2021 (given at about 2-3pm, vaccinated at the same age) (Batch/Lot Number: 301358A) as dose 1, single for covid-19 immunisation. Medical history included Covid from 05Jan2021 to 16Jan2021 and went twice to the hospital because her heart rate dropped to 40 beats a minute. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation on 15Oct2021, and unspecified vitamins. Patient had a reaction to the flu vaccine years ago, it was a fever but nothing else. Patient experienced tingling in tongue, lips, and inside her mouth about 2-4 minutes after getting the dose and lasted 15-25 minutes. Her hands were cold, and she felt hot inside of her. Afterward she felt weak and wanted to scream but started to breathe deeply and like she needed to walk. This lasted about an hour before the reaction passed. She could taste the medicine and felt something strange in heart but very slight, and her concentration and focus is not the same. Treatment: Took 2 Ibuprofen after she had the shot for body aches and fever and Tylenol PM to sleep, but not together. No treatment for other events. COVID test on 04Sep2021, 11Sep2021, 18Sep2021, 22Sep2021, 25Sep2021, 02Oct2021, 09Oct2021, 23Oct2021 all was negative. AE required visit to Physician Office. All events outcome reported as recovered. Case reported as serious due to Life-threatening.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Nervousness, Pain, Paraesthesia oral, Pyrexia
Clinical narrative: tingling in tongue, lips, and inside her mouth; hands were cold; fever; felt weak; breathe deeply; could taste the medicine; something strange in my heart but very slight; concentration and focus is not the same; felt hot inside; Body aches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in right arm on 18Sep2021 (given at about 2-3pm, vaccinated at the same age) (Batch/Lot Number: 301358A) as dose 1, single for covid-19 immunisation. Medical history included Covid from 05Jan2021 to 16Jan2021 and went twice to the hospital because her heart rate dropped to 40 beats a minute. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation on 15Oct2021, and unspecified vitamins. Patient had a reaction to the flu vaccine years ago, it was a fever but nothing else. Patient experienced tingling in tongue, lips, and inside her mouth about 2-4 minutes after getting the dose and lasted 15-25 minutes. Her hands were cold, and she felt hot inside of her. Afterward she felt weak and wanted to scream but started to breathe deeply and like she needed to walk. This lasted about an hour before the reaction passed. She could taste the medicine and felt something strange in heart but very slight, and her concentration and focus is not the same. Treatment: Took 2 Ibuprofen after she had the shot for body aches and fever and Tylenol PM to sleep, but not together. No treatment for other events. COVID test on 04Sep2021, 11Sep2021, 18Sep2021, 22Sep2021, 25Sep2021, 02Oct2021, 09Oct2021, 23Oct2021 all was negative. AE required visit to Physician Office. All events outcome reported as recovered. Case reported as serious due to Life-threatening.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Screaming, Suspected COVID-19
Clinical narrative: tingling in tongue, lips, and inside her mouth; hands were cold; fever; felt weak; breathe deeply; could taste the medicine; something strange in my heart but very slight; concentration and focus is not the same; felt hot inside; Body aches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in right arm on 18Sep2021 (given at about 2-3pm, vaccinated at the same age) (Batch/Lot Number: 301358A) as dose 1, single for covid-19 immunisation. Medical history included Covid from 05Jan2021 to 16Jan2021 and went twice to the hospital because her heart rate dropped to 40 beats a minute. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation on 15Oct2021, and unspecified vitamins. Patient had a reaction to the flu vaccine years ago, it was a fever but nothing else. Patient experienced tingling in tongue, lips, and inside her mouth about 2-4 minutes after getting the dose and lasted 15-25 minutes. Her hands were cold, and she felt hot inside of her. Afterward she felt weak and wanted to scream but started to breathe deeply and like she needed to walk. This lasted about an hour before the reaction passed. She could taste the medicine and felt something strange in heart but very slight, and her concentration and focus is not the same. Treatment: Took 2 Ibuprofen after she had the shot for body aches and fever and Tylenol PM to sleep, but not together. No treatment for other events. COVID test on 04Sep2021, 11Sep2021, 18Sep2021, 22Sep2021, 25Sep2021, 02Oct2021, 09Oct2021, 23Oct2021 all was negative. AE required visit to Physician Office. All events outcome reported as recovered. Case reported as serious due to Life-threatening.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cardiac disorder, Disturbance in attention, Dyspnoea, Feeling hot
Clinical narrative: tingling in tongue, lips, and inside her mouth; hands were cold; fever; felt weak; breathe deeply; could taste the medicine; something strange in my heart but very slight; concentration and focus is not the same; felt hot inside; Body aches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in right arm on 18Sep2021 (given at about 2-3pm, vaccinated at the same age) (Batch/Lot Number: 301358A) as dose 1, single for covid-19 immunisation. Medical history included Covid from 05Jan2021 to 16Jan2021 and went twice to the hospital because her heart rate dropped to 40 beats a minute. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation on 15Oct2021, and unspecified vitamins. Patient had a reaction to the flu vaccine years ago, it was a fever but nothing else. Patient experienced tingling in tongue, lips, and inside her mouth about 2-4 minutes after getting the dose and lasted 15-25 minutes. Her hands were cold, and she felt hot inside of her. Afterward she felt weak and wanted to scream but started to breathe deeply and like she needed to walk. This lasted about an hour before the reaction passed. She could taste the medicine and felt something strange in heart but very slight, and her concentration and focus is not the same. Treatment: Took 2 Ibuprofen after she had the shot for body aches and fever and Tylenol PM to sleep, but not together. No treatment for other events. COVID test on 04Sep2021, 11Sep2021, 18Sep2021, 22Sep2021, 25Sep2021, 02Oct2021, 09Oct2021, 23Oct2021 all was negative. AE required visit to Physician Office. All events outcome reported as recovered. Case reported as serious due to Life-threatening.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia oral, Peripheral coldness, Pyrexia, SARS-CoV-2 test
Clinical narrative: tingling in tongue, lips, and inside her mouth; hands were cold; fever; felt weak; breathe deeply; could taste the medicine; something strange in my heart but very slight; concentration and focus is not the same; felt hot inside; Body aches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in right arm on 18Sep2021 (given at about 2-3pm, vaccinated at the same age) (Batch/Lot Number: 301358A) as dose 1, single for covid-19 immunisation. Medical history included Covid from 05Jan2021 to 16Jan2021 and went twice to the hospital because her heart rate dropped to 40 beats a minute. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation on 15Oct2021, and unspecified vitamins. Patient had a reaction to the flu vaccine years ago, it was a fever but nothing else. Patient experienced tingling in tongue, lips, and inside her mouth about 2-4 minutes after getting the dose and lasted 15-25 minutes. Her hands were cold, and she felt hot inside of her. Afterward she felt weak and wanted to scream but started to breathe deeply and like she needed to walk. This lasted about an hour before the reaction passed. She could taste the medicine and felt something strange in heart but very slight, and her concentration and focus is not the same. Treatment: Took 2 Ibuprofen after she had the shot for body aches and fever and Tylenol PM to sleep, but not together. No treatment for other events. COVID test on 04Sep2021, 11Sep2021, 18Sep2021, 22Sep2021, 25Sep2021, 02Oct2021, 09Oct2021, 23Oct2021 all was negative. AE required visit to Physician Office. All events outcome reported as recovered. Case reported as serious due to Life-threatening.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: tingling in tongue, lips, and inside her mouth; hands were cold; fever; felt weak; breathe deeply; could taste the medicine; something strange in my heart but very slight; concentration and focus is not the same; felt hot inside; Body aches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received first dose of bnt162b2 (BNT162B2), intramuscular in right arm on 18Sep2021 (given at about 2-3pm, vaccinated at the same age) (Batch/Lot Number: 301358A) as dose 1, single for covid-19 immunisation. Medical history included Covid from 05Jan2021 to 16Jan2021 and went twice to the hospital because her heart rate dropped to 40 beats a minute. Concomitant medication(s) included influenza vaccine (FLU) taken for immunisation on 15Oct2021, and unspecified vitamins. Patient had a reaction to the flu vaccine years ago, it was a fever but nothing else. Patient experienced tingling in tongue, lips, and inside her mouth about 2-4 minutes after getting the dose and lasted 15-25 minutes. Her hands were cold, and she felt hot inside of her. Afterward she felt weak and wanted to scream but started to breathe deeply and like she needed to walk. This lasted about an hour before the reaction passed. She could taste the medicine and felt something strange in heart but very slight, and her concentration and focus is not the same. Treatment: Took 2 Ibuprofen after she had the shot for body aches and fever and Tylenol PM to sleep, but not together. No treatment for other events. COVID test on 04Sep2021, 11Sep2021, 18Sep2021, 22Sep2021, 25Sep2021, 02Oct2021, 09Oct2021, 23Oct2021 all was negative. AE required visit to Physician Office. All events outcome reported as recovered. Case reported as serious due to Life-threatening.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye disorder, Vision blurred, Visual impairment
Clinical narrative: central serous chorioretinopathy; distorted far sight vision, distorted central sight; yellowish vision; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Oct2021 at 13:15 (Lot Number: EW0179, unknown expiration) as dose 2, single at the age of 33 years old for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin c (ascorbic acid). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0179) on 20Sep2021 at 13:15 in the left arm at the age of 33 years old for COVID-19 immunization. No other vaccine in four weeks. No COVID prior to vaccination and has not been tested for COVID post vaccination. The patient experienced distorted far sight vision, distorted central sight, and yellowish vision on 14Oct2021 at 05:30 am. The patient saw an eye specialist and was diagnosed with central serous chorioretinopathy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events.  The patient has not yet recovered from the events.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chorioretinopathy, Metamorphopsia, Xanthopsia
Clinical narrative: central serous chorioretinopathy; distorted far sight vision, distorted central sight; yellowish vision; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Oct2021 at 13:15 (Lot Number: EW0179, unknown expiration) as dose 2, single at the age of 33 years old for COVID-19 immunization. Medical history reported as none. Concomitant medication included vitamin c (ascorbic acid). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EW0179) on 20Sep2021 at 13:15 in the left arm at the age of 33 years old for COVID-19 immunization. No other vaccine in four weeks. No COVID prior to vaccination and has not been tested for COVID post vaccination. The patient experienced distorted far sight vision, distorted central sight, and yellowish vision on 14Oct2021 at 05:30 am. The patient saw an eye specialist and was diagnosed with central serous chorioretinopathy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events.  The patient has not yet recovered from the events.   Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt c/o worsening dyspnea over past week; fever; found to be hypoxic in ED; tested positive for COVID; started on antibiotics, dexamethasone, baricitinib; placed on BiPAP; abrupt change in mental status and became unresponsive; dilated right pupil; found to have a large subdural hematoma with herniation; placed on comfort measures and died in the hosp
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain herniation, COVID-19, Death, Dyspnoea, Hypoxia
Clinical narrative: pt c/o worsening dyspnea over past week; fever; found to be hypoxic in ED; tested positive for COVID; started on antibiotics, dexamethasone, baricitinib; placed on BiPAP; abrupt change in mental status and became unresponsive; dilated right pupil; found to have a large subdural hematoma with herniation; placed on comfort measures and died in the hosp
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mental status changes, Mydriasis, Positive airway pressure therapy, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: pt c/o worsening dyspnea over past week; fever; found to be hypoxic in ED; tested positive for COVID; started on antibiotics, dexamethasone, baricitinib; placed on BiPAP; abrupt change in mental status and became unresponsive; dilated right pupil; found to have a large subdural hematoma with herniation; placed on comfort measures and died in the hosp
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subdural haematoma, Unresponsive to stimuli
Clinical narrative: pt c/o worsening dyspnea over past week; fever; found to be hypoxic in ED; tested positive for COVID; started on antibiotics, dexamethasone, baricitinib; placed on BiPAP; abrupt change in mental status and became unresponsive; dilated right pupil; found to have a large subdural hematoma with herniation; placed on comfort measures and died in the hosp
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Enteritis, Hepatic enzyme increased
Clinical narrative: I am still not feeling well; high levels of troponin; I was diagnosed with enteritis which is inflammation of the small intestine; transaminitis having high liver enzymes; feeling pain in my left side of the neck; I fainted; I felt a burning sensation in my stomach; I felt dizziness; shortness of breath; I began to vomit all over; pain in my left arm; chills; sweats; chest pains; palpitations; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 11Oct2021 (Batch/Lot Number: FE3592) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient medical history was not reported. It was unknown if patient had known allergies. There were no concomitant medications. On 11Oct2021, immediately after receiving the first dose of the Pfizer vaccine, patient felt a burning sensation in her stomach which she have never experienced before. She felt dizziness and shortness of breath. She fainted then she began to vomit all over (name withheld). She felt pain in her left arm, chills, and sweats. The next day (12Oct2021), she continued to have the burning sensation in her stomach. She also started feeling pain in her left side of the neck along with her left arm pain. Further in the week (Oct2021), she started feeling chest pains/palpitations. She felt the burning sensation in her stomach for a week. She released something green/dark in color in her stool. A Doctor said it appeared to be mucus. She have been to the hospital 5 times since she had the vaccine. On 17Oct2021, she was told that she had high levels of troponin and had to have her heart monitored, she was diagnosed with enteritis which is inflammation of the small intestine, transaminitis having high liver enzymes. And as of today (21Oct2021), she was still not feeling well. The events were considered as serious resulting to disability or permanent damage. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Transaminases increased, Ultrasound scan
Clinical narrative: I am still not feeling well; high levels of troponin; I was diagnosed with enteritis which is inflammation of the small intestine; transaminitis having high liver enzymes; feeling pain in my left side of the neck; I fainted; I felt a burning sensation in my stomach; I felt dizziness; shortness of breath; I began to vomit all over; pain in my left arm; chills; sweats; chest pains; palpitations; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; I released something green/dark in color in my stool. A doctor said it appeared to be mucus; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 11Oct2021 (Batch/Lot Number: FE3592) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no other vaccine in four weeks. The patient had no covid prior to vaccination and has not been tested for covid post vaccination. The patient medical history was not reported. It was unknown if patient had known allergies. There were no concomitant medications. On 11Oct2021, immediately after receiving the first dose of the Pfizer vaccine, patient felt a burning sensation in her stomach which she have never experienced before. She felt dizziness and shortness of breath. She fainted then she began to vomit all over (name withheld). She felt pain in her left arm, chills, and sweats. The next day (12Oct2021), she continued to have the burning sensation in her stomach. She also started feeling pain in her left side of the neck along with her left arm pain. Further in the week (Oct2021), she started feeling chest pains/palpitations. She felt the burning sensation in her stomach for a week. She released something green/dark in color in her stool. A Doctor said it appeared to be mucus. She have been to the hospital 5 times since she had the vaccine. On 17Oct2021, she was told that she had high levels of troponin and had to have her heart monitored, she was diagnosed with enteritis which is inflammation of the small intestine, transaminitis having high liver enzymes. And as of today (21Oct2021), she was still not feeling well. The events were considered as serious resulting to disability or permanent damage. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from the events.  Follow-up attempts are completed. No further information is expected.