chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: developed a strong headache; fatigued; fever; a lot of arm pain; dizziness; irritable bowels; loss of appetite; odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains.; This is a spontaneous report received from a contactable consumer reported for herself. A currently 55 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in left arm at single dose for COVID-19 immunization. Medical history included allergies to tree nuts, nonsteroidal antiinflammatory drugs (NSAIDS) and asthma. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included: cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMINS C), (VITAMINS D), (VITAMINS E), probiotic 10, paracetamol (TYLENOL). It was reported about 90 mins after vaccine first dose, patient developed a strong headache (not common for her). She then felt very fatigued and came down with w/a fever that night. The next day (yesterday), the headache was improved still presented but she felt a lot of fatigue and a lot of arm pain (unusual with flu shots, for her). She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. Today (day 2 after vaccine), she was feeling fatigued w/mild headache. Her appetite was very much diminished w/still irritable bowels (loose stools). The reason she was writing was today she also started experiencing an odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains. There was no pain or redness or swelling. Have had no breast issues to date (last mammography was clear-Fall 2018). Have anaphylaxis reactions to NSAIDS and nuts but never to vaccines. Normally, she was very active running, biking & walking daily many miles. Hoping to feel good soon. Treatment was not received for the adverse event. Since the vaccination, the patient has been tested for COVID-19:  Covid Test given after Vaccine. Outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritable bowel syndrome, Mammogram, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: developed a strong headache; fatigued; fever; a lot of arm pain; dizziness; irritable bowels; loss of appetite; odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains.; This is a spontaneous report received from a contactable consumer reported for herself. A currently 55 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date in left arm at single dose for COVID-19 immunization. Medical history included allergies to tree nuts, nonsteroidal antiinflammatory drugs (NSAIDS) and asthma. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medications the patient received within 2 weeks of vaccination included: cetirizine hydrochloride (ZYRTEC), ascorbic acid (VITAMINS C), (VITAMINS D), (VITAMINS E), probiotic 10, paracetamol (TYLENOL). It was reported about 90 mins after vaccine first dose, patient developed a strong headache (not common for her). She then felt very fatigued and came down with w/a fever that night. The next day (yesterday), the headache was improved still presented but she felt a lot of fatigue and a lot of arm pain (unusual with flu shots, for her). She felt some mild dizziness later in the day and irritable bowels throughout the day as well as a loss of appetite. Today (day 2 after vaccine), she was feeling fatigued w/mild headache. Her appetite was very much diminished w/still irritable bowels (loose stools). The reason she was writing was today she also started experiencing an odd ribcage/breast pain on the side of the injection (left side). It feels like deep shooting pains. There was no pain or redness or swelling. Have had no breast issues to date (last mammography was clear-Fall 2018). Have anaphylaxis reactions to NSAIDS and nuts but never to vaccines. Normally, she was very active running, biking & walking daily many miles. Hoping to feel good soon. Treatment was not received for the adverse event. Since the vaccination, the patient has been tested for COVID-19:  Covid Test given after Vaccine. Outcome of events was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram cerebral abnormal, Echocardiogram normal, Electrocardiogram normal, Facial paralysis
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), intramuscular, administered in right arm on 01Apr2021 09:30 as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date (not taking meds for this prior to this event), and strawberries anaphylaxis from an unknown date. It was unknown if the patient has a history of COVID prior vaccination, and unknown if the patient was COVID tested post vaccination. Concomitant medication included acetaminophen as needed for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 11Mar2021, for COVID-19 immunization, and experienced a spike in her BP. The patient was observed for 30 minutes after her second dose of COVID-19 vaccine. She felt fine and left the vaccine clinic. About 2 hours later on 01Apr2021 11:30, she developed numbness, right-sided facial droop, right upper and lower extremity weakness and headache. She presented to the emergency department (ED) and stroke protocols were initiated including offering tPA for clinical stroke, but she declined it. Imaging and further work up were fairly unremarkable. Neurology consult was unclear if was a TIA vs COVID vaccine reaction vs reaction to headache. The final diagnosis was cryptogenic TIA. The patient was hospitalized for the events for 2 days. Treatment for the events included stroke work up, and tPA was offered, but the patient declined. The patient recovered from the events on an unspecified date.   Information about lot/batch number has been requested.; Sender's Comments: Based on the data provided, the causal association between the reported events and BNT162B2 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hemiparesis, Hypoaesthesia, Intracranial aneurysm, Magnetic resonance imaging head normal
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), intramuscular, administered in right arm on 01Apr2021 09:30 as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date (not taking meds for this prior to this event), and strawberries anaphylaxis from an unknown date. It was unknown if the patient has a history of COVID prior vaccination, and unknown if the patient was COVID tested post vaccination. Concomitant medication included acetaminophen as needed for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 11Mar2021, for COVID-19 immunization, and experienced a spike in her BP. The patient was observed for 30 minutes after her second dose of COVID-19 vaccine. She felt fine and left the vaccine clinic. About 2 hours later on 01Apr2021 11:30, she developed numbness, right-sided facial droop, right upper and lower extremity weakness and headache. She presented to the emergency department (ED) and stroke protocols were initiated including offering tPA for clinical stroke, but she declined it. Imaging and further work up were fairly unremarkable. Neurology consult was unclear if was a TIA vs COVID vaccine reaction vs reaction to headache. The final diagnosis was cryptogenic TIA. The patient was hospitalized for the events for 2 days. Treatment for the events included stroke work up, and tPA was offered, but the patient declined. The patient recovered from the events on an unspecified date.   Information about lot/batch number has been requested.; Sender's Comments: Based on the data provided, the causal association between the reported events and BNT162B2 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler normal
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), intramuscular, administered in right arm on 01Apr2021 09:30 as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date (not taking meds for this prior to this event), and strawberries anaphylaxis from an unknown date. It was unknown if the patient has a history of COVID prior vaccination, and unknown if the patient was COVID tested post vaccination. Concomitant medication included acetaminophen as needed for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 11Mar2021, for COVID-19 immunization, and experienced a spike in her BP. The patient was observed for 30 minutes after her second dose of COVID-19 vaccine. She felt fine and left the vaccine clinic. About 2 hours later on 01Apr2021 11:30, she developed numbness, right-sided facial droop, right upper and lower extremity weakness and headache. She presented to the emergency department (ED) and stroke protocols were initiated including offering tPA for clinical stroke, but she declined it. Imaging and further work up were fairly unremarkable. Neurology consult was unclear if was a TIA vs COVID vaccine reaction vs reaction to headache. The final diagnosis was cryptogenic TIA. The patient was hospitalized for the events for 2 days. Treatment for the events included stroke work up, and tPA was offered, but the patient declined. The patient recovered from the events on an unspecified date.   Information about lot/batch number has been requested.; Sender's Comments: Based on the data provided, the causal association between the reported events and BNT162B2 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Headache, Hypoaesthesia, Imaging procedure, Investigation
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), intramuscular, administered in right arm on 01Apr2021 09:30 as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date (not taking meds for this prior to this event), and strawberries anaphylaxis from an unknown date. It was unknown if the patient has a history of COVID prior vaccination, and unknown if the patient was COVID tested post vaccination. Concomitant medication included acetaminophen as needed for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 11Mar2021, for COVID-19 immunization, and experienced a spike in her BP. The patient was observed for 30 minutes after her second dose of COVID-19 vaccine. She felt fine and left the vaccine clinic. About 2 hours later on 01Apr2021 11:30, she developed numbness, right-sided facial droop, right upper and lower extremity weakness and headache. She presented to the emergency department (ED) and stroke protocols were initiated including offering tPA for clinical stroke, but she declined it. Imaging and further work up were fairly unremarkable. Neurology consult was unclear if was a TIA vs COVID vaccine reaction vs reaction to headache. The final diagnosis was cryptogenic TIA. The patient was hospitalized for the events for 2 days. Treatment for the events included stroke work up, and tPA was offered, but the patient declined. The patient recovered from the events on an unspecified date.   Information about lot/batch number has been requested.; Sender's Comments: Based on the data provided, the causal association between the reported events and BNT162B2 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: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Transient ischaemic attack
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), intramuscular, administered in right arm on 01Apr2021 09:30 as single dose for COVID-19 immunization. Medical history included hypertension from an unknown date (not taking meds for this prior to this event), and strawberries anaphylaxis from an unknown date. It was unknown if the patient has a history of COVID prior vaccination, and unknown if the patient was COVID tested post vaccination. Concomitant medication included acetaminophen as needed for an unspecified indication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in left arm on 11Mar2021, for COVID-19 immunization, and experienced a spike in her BP. The patient was observed for 30 minutes after her second dose of COVID-19 vaccine. She felt fine and left the vaccine clinic. About 2 hours later on 01Apr2021 11:30, she developed numbness, right-sided facial droop, right upper and lower extremity weakness and headache. She presented to the emergency department (ED) and stroke protocols were initiated including offering tPA for clinical stroke, but she declined it. Imaging and further work up were fairly unremarkable. Neurology consult was unclear if was a TIA vs COVID vaccine reaction vs reaction to headache. The final diagnosis was cryptogenic TIA. The patient was hospitalized for the events for 2 days. Treatment for the events included stroke work up, and tPA was offered, but the patient declined. The patient recovered from the events on an unspecified date.   Information about lot/batch number has been requested.; Sender's Comments: Based on the data provided, the causal association between the reported events and BNT162B2 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Dermatitis
Clinical narrative: Drug eruption; Severe inflammatory skin reaction / Inflammatory infiltrate; Interface dermatitis; Photodermatitis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration in the left arm on 27Jan2021 12:00 (Batch/Lot Number: EL9262) at the age of 65 years old, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Concomitant medications was reported as none. No other medications were received within 2 weeks of the BNT162B2 vaccination. On 30Jan2021, the patient experienced severe inflammatory skin reaction eventually covering about 1/3rd of the body and was still active as of 07Apr2021. Lab data included "interface dermatitis with eosinophils, drug eruption and photodermatitis, dermoepidermal junction, inflammatory infiltrate".  The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment included high-dose prednisone. The patient was currently in the 2nd round of treatment. The outcome of events drug eruption, severe inflammatory skin reaction, inflammatory infiltrate, interface dermatitis and photodermatitis was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis, Drug eruption, Laboratory test, Photosensitivity reaction
Clinical narrative: Drug eruption; Severe inflammatory skin reaction / Inflammatory infiltrate; Interface dermatitis; Photodermatitis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration in the left arm on 27Jan2021 12:00 (Batch/Lot Number: EL9262) at the age of 65 years old, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Concomitant medications was reported as none. No other medications were received within 2 weeks of the BNT162B2 vaccination. On 30Jan2021, the patient experienced severe inflammatory skin reaction eventually covering about 1/3rd of the body and was still active as of 07Apr2021. Lab data included "interface dermatitis with eosinophils, drug eruption and photodermatitis, dermoepidermal junction, inflammatory infiltrate".  The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment included high-dose prednisone. The patient was currently in the 2nd round of treatment. The outcome of events drug eruption, severe inflammatory skin reaction, inflammatory infiltrate, interface dermatitis and photodermatitis was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest causing death
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: cardiac arrest causing death
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Discomfort, Mobility decreased
Clinical narrative: it was administered on top of her shoulder and not in her muscle; administered on top of her shoulder and not in her muscle/ person placed the band aid, it was bleeding.; administered on top of her shoulder and not in her muscle/deep inside the shoulder she still has pain; administered on top of her shoulder and not in her muscle/ immobilized arm/ hard to raise her left arm without getting the discomfort; This is a spontaneous report from a contactable consumer (patient). This report was also received from Pfizer sponsored program. A 69-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left (top of her shoulder and not in her muscle) on 07Apr2021 08:40 (Batch/Lot Number: EW0150) as SINGLE DOSE for COVID-19 immunization.  Medical history included dental and was prescribed doxycycline. There were no concomitant medications.  The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE at the left deltoid muscle (given absolutely perfectly) on 17Mar2021 (lot#: EN6207) for COVID-19 immunization and arm was "a little" sore after getting the first dose. It was stated that the previously had flu shot as immunization and part of her arm felt like when she receives a regular flu shot. The patient then received the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE on 07Apr2021 08:40 which was administered on top of her shoulder and not in her muscle. It was also stated the when the vaccine administered on top of her shoulder and not in her muscle, the person placed the band aid as it was bleeding. She also stated that her arm was not fine, it was extremely painful the first night. Part of her arm felt like when she receives a regular flu shot, but deep inside the shoulder she still has pain.  She had an immobilized arm which was hard to raise her left arm without getting the discomfort. The discomfort traveled to the top of her shoulder and to the back of her neck. She was happy that this was the last dose but questioning the efficacy of this shot. She does not think that the vaccination provider administered the vaccine correctly. The patient was recovering from the events.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Product administered at inappropriate site, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: it was administered on top of her shoulder and not in her muscle; administered on top of her shoulder and not in her muscle/ person placed the band aid, it was bleeding.; administered on top of her shoulder and not in her muscle/deep inside the shoulder she still has pain; administered on top of her shoulder and not in her muscle/ immobilized arm/ hard to raise her left arm without getting the discomfort; This is a spontaneous report from a contactable consumer (patient). This report was also received from Pfizer sponsored program. A 69-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in arm left (top of her shoulder and not in her muscle) on 07Apr2021 08:40 (Batch/Lot Number: EW0150) as SINGLE DOSE for COVID-19 immunization.  Medical history included dental and was prescribed doxycycline. There were no concomitant medications.  The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE at the left deltoid muscle (given absolutely perfectly) on 17Mar2021 (lot#: EN6207) for COVID-19 immunization and arm was "a little" sore after getting the first dose. It was stated that the previously had flu shot as immunization and part of her arm felt like when she receives a regular flu shot. The patient then received the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE on 07Apr2021 08:40 which was administered on top of her shoulder and not in her muscle. It was also stated the when the vaccine administered on top of her shoulder and not in her muscle, the person placed the band aid as it was bleeding. She also stated that her arm was not fine, it was extremely painful the first night. Part of her arm felt like when she receives a regular flu shot, but deep inside the shoulder she still has pain.  She had an immobilized arm which was hard to raise her left arm without getting the discomfort. The discomfort traveled to the top of her shoulder and to the back of her neck. She was happy that this was the last dose but questioning the efficacy of this shot. She does not think that the vaccination provider administered the vaccine correctly. The patient was recovering from the events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Hypotension, Loss of consciousness, Visual impairment
Clinical narrative: 3:01 - Felt heart racing, called for help, fell unconcious. Upon regaining conciousness, there were 2 people attending to me - BP was very low, heart was racing. I was not able to get up. Had a feeling of extreme 'popping' in my lower arms. Was not able to move. Ambulance was called as BP was low and HR was not coming down. Attendants took me to the ER at 3:18 as I was still not recovered. Started IV in ambulance. Heart was reading PAC also. BP came up to 66. another litre of fluid at the ER. by 6:00 pm BP was 110/79 and I was dismissed.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: 3:01 - Felt heart racing, called for help, fell unconcious. Upon regaining conciousness, there were 2 people attending to me - BP was very low, heart was racing. I was not able to get up. Had a feeling of extreme 'popping' in my lower arms. Was not able to move. Ambulance was called as BP was low and HR was not coming down. Attendants took me to the ER at 3:18 as I was still not recovered. Started IV in ambulance. Heart was reading PAC also. BP came up to 66. another litre of fluid at the ER. by 6:00 pm BP was 110/79 and I was dismissed.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Dysstasia, Hypotension, Loss of consciousness, Mobility decreased
Clinical narrative: 3:01 - Felt heart racing, called for help, fell unconcious. Upon regaining conciousness, there were 2 people attending to me - BP was very low, heart was racing. I was not able to get up. Had a feeling of extreme 'popping' in my lower arms. Was not able to move. Ambulance was called as BP was low and HR was not coming down. Attendants took me to the ER at 3:18 as I was still not recovered. Started IV in ambulance. Heart was reading PAC also. BP came up to 66. another litre of fluid at the ER. by 6:00 pm BP was 110/79 and I was dismissed.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Sensory disturbance, Urine analysis normal
Clinical narrative: 3:01 - Felt heart racing, called for help, fell unconcious. Upon regaining conciousness, there were 2 people attending to me - BP was very low, heart was racing. I was not able to get up. Had a feeling of extreme 'popping' in my lower arms. Was not able to move. Ambulance was called as BP was low and HR was not coming down. Attendants took me to the ER at 3:18 as I was still not recovered. Started IV in ambulance. Heart was reading PAC also. BP came up to 66. another litre of fluid at the ER. by 6:00 pm BP was 110/79 and I was dismissed.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness, Tinnitus
Clinical narrative: High frequency hearing loss; High pitch ear ringing; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER26L3), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 17:45 as a single dose for COVID-19 immunization. The patient had no medical history and had no known allergies.  The patient did not have COVID prior to the vaccination. There were no concomitant medications and the patient did not have other vaccines in four weeks and did not have other medications in two weeks. The patient has not been tested for COVID post vaccination. The patient experienced high frequency hearing loss and high pitch ear ringing on 26Mar2021 at 05:00. The patient did not receive treatment for the events. The outcome of the events was not recovered. The events were reported with a seriousness criteria of disability.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: High frequency hearing loss; High pitch ear ringing; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER26L3), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 17:45 as a single dose for COVID-19 immunization. The patient had no medical history and had no known allergies.  The patient did not have COVID prior to the vaccination. There were no concomitant medications and the patient did not have other vaccines in four weeks and did not have other medications in two weeks. The patient has not been tested for COVID post vaccination. The patient experienced high frequency hearing loss and high pitch ear ringing on 26Mar2021 at 05:00. The patient did not receive treatment for the events. The outcome of the events was not recovered. The events were reported with a seriousness criteria of disability.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Bell's palsy, Blood test normal, Chills, Computerised tomogram normal
Clinical narrative: partial facial paralysis (eyes, nose, lips); moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing); Progression of symptoms: back pain; chills; fatigue; night sweats without fever; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66-year-old, via an unspecified route of administration, administered in left arm on 09Feb2021 12:00 (Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included hepatitis C (HCV) - Cured (5-years ago), hypertension, mild cholesterol, benign prostatic hyperplasia (BPH), gastrooesophageal reflux disease (GERD), and occasional fever blister on lips. The patient has no known allergies. The patient has no COVID prior vaccination and not tested for COVID post vaccination. Concomitant medications included alfuzosin, atorvastatin, losartan, and pantoprazole. Progression of symptoms: back pain (5 days then resolved), moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing) controlled with Gabapentin 1x daily and frequent Advil, symptoms included chills, fatigue and night sweats without fever, as these resolved, it moved to partial facial paralysis (eyes, nose, lips), 6 days so far. The patient was given IV Immune Globulin and IV Solumedrol in hospital and then Prednizone 40 mg tabs for 7 days (4 days left) as treatment for the events. All events occurred on 26Feb2021 at 20:00 and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 1 day. The outcome of the event back pain was recovered on 03Mar2021 20:00, facial paralysis was not recovered, and for the rest of the events was recovered. The patient received the second dose of BNT162B2 (lot number: EN6203) on 02Mar2021, 12:00 PM, administered at the right arm.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Fatigue, Headache, Immunoglobulin therapy, Magnetic resonance imaging head normal
Clinical narrative: partial facial paralysis (eyes, nose, lips); moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing); Progression of symptoms: back pain; chills; fatigue; night sweats without fever; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66-year-old, via an unspecified route of administration, administered in left arm on 09Feb2021 12:00 (Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included hepatitis C (HCV) - Cured (5-years ago), hypertension, mild cholesterol, benign prostatic hyperplasia (BPH), gastrooesophageal reflux disease (GERD), and occasional fever blister on lips. The patient has no known allergies. The patient has no COVID prior vaccination and not tested for COVID post vaccination. Concomitant medications included alfuzosin, atorvastatin, losartan, and pantoprazole. Progression of symptoms: back pain (5 days then resolved), moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing) controlled with Gabapentin 1x daily and frequent Advil, symptoms included chills, fatigue and night sweats without fever, as these resolved, it moved to partial facial paralysis (eyes, nose, lips), 6 days so far. The patient was given IV Immune Globulin and IV Solumedrol in hospital and then Prednizone 40 mg tabs for 7 days (4 days left) as treatment for the events. All events occurred on 26Feb2021 at 20:00 and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 1 day. The outcome of the event back pain was recovered on 03Mar2021 20:00, facial paralysis was not recovered, and for the rest of the events was recovered. The patient received the second dose of BNT162B2 (lot number: EN6203) on 02Mar2021, 12:00 PM, administered at the right arm.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neck pain, Night sweats, Red blood cell sedimentation rate increased
Clinical narrative: partial facial paralysis (eyes, nose, lips); moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing); Progression of symptoms: back pain; chills; fatigue; night sweats without fever; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66-year-old, via an unspecified route of administration, administered in left arm on 09Feb2021 12:00 (Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included hepatitis C (HCV) - Cured (5-years ago), hypertension, mild cholesterol, benign prostatic hyperplasia (BPH), gastrooesophageal reflux disease (GERD), and occasional fever blister on lips. The patient has no known allergies. The patient has no COVID prior vaccination and not tested for COVID post vaccination. Concomitant medications included alfuzosin, atorvastatin, losartan, and pantoprazole. Progression of symptoms: back pain (5 days then resolved), moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing) controlled with Gabapentin 1x daily and frequent Advil, symptoms included chills, fatigue and night sweats without fever, as these resolved, it moved to partial facial paralysis (eyes, nose, lips), 6 days so far. The patient was given IV Immune Globulin and IV Solumedrol in hospital and then Prednizone 40 mg tabs for 7 days (4 days left) as treatment for the events. All events occurred on 26Feb2021 at 20:00 and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 1 day. The outcome of the event back pain was recovered on 03Mar2021 20:00, facial paralysis was not recovered, and for the rest of the events was recovered. The patient received the second dose of BNT162B2 (lot number: EN6203) on 02Mar2021, 12:00 PM, administered at the right arm.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Chills, Facial paralysis, Fatigue, Headache
Clinical narrative: partial facial paralysis (eyes, nose, lips); moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing); Progression of symptoms: back pain; chills; fatigue; night sweats without fever; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66-year-old, via an unspecified route of administration, administered in left arm on 09Feb2021 12:00 (Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included hepatitis C (HCV) - Cured (5-years ago), hypertension, mild cholesterol, benign prostatic hyperplasia (BPH), gastrooesophageal reflux disease (GERD), and occasional fever blister on lips. The patient has no known allergies. The patient has no COVID prior vaccination and not tested for COVID post vaccination. Concomitant medications included alfuzosin, atorvastatin, losartan, and pantoprazole. Progression of symptoms: back pain (5 days then resolved), moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing) controlled with Gabapentin 1x daily and frequent Advil, symptoms included chills, fatigue and night sweats without fever, as these resolved, it moved to partial facial paralysis (eyes, nose, lips), 6 days so far. The patient was given IV Immune Globulin and IV Solumedrol in hospital and then Prednizone 40 mg tabs for 7 days (4 days left) as treatment for the events. All events occurred on 26Feb2021 at 20:00 and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 1 day. The outcome of the event back pain was recovered on 03Mar2021 20:00, facial paralysis was not recovered, and for the rest of the events was recovered. The patient received the second dose of BNT162B2 (lot number: EN6203) on 02Mar2021, 12:00 PM, administered at the right arm.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Night sweats
Clinical narrative: partial facial paralysis (eyes, nose, lips); moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing); Progression of symptoms: back pain; chills; fatigue; night sweats without fever; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66-year-old, via an unspecified route of administration, administered in left arm on 09Feb2021 12:00 (Lot Number: EM9809) as single dose for COVID-19 immunisation. Medical history included hepatitis C (HCV) - Cured (5-years ago), hypertension, mild cholesterol, benign prostatic hyperplasia (BPH), gastrooesophageal reflux disease (GERD), and occasional fever blister on lips. The patient has no known allergies. The patient has no COVID prior vaccination and not tested for COVID post vaccination. Concomitant medications included alfuzosin, atorvastatin, losartan, and pantoprazole. Progression of symptoms: back pain (5 days then resolved), moving to head pain (30 days, back of neck everywhere, but right side worse, could take pulse from throbbing) controlled with Gabapentin 1x daily and frequent Advil, symptoms included chills, fatigue and night sweats without fever, as these resolved, it moved to partial facial paralysis (eyes, nose, lips), 6 days so far. The patient was given IV Immune Globulin and IV Solumedrol in hospital and then Prednizone 40 mg tabs for 7 days (4 days left) as treatment for the events. All events occurred on 26Feb2021 at 20:00 and resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for 1 day. The outcome of the event back pain was recovered on 03Mar2021 20:00, facial paralysis was not recovered, and for the rest of the events was recovered. The patient received the second dose of BNT162B2 (lot number: EN6203) on 02Mar2021, 12:00 PM, administered at the right arm.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hypoaesthesia
Clinical narrative: some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.