chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Extraocular muscle paresis, Fall, Pain in extremity
Clinical narrative: dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient.  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization.   Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020.  Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization.  On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around.  On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Somnolence
Clinical narrative: dizziness; fall; Swelling in arm; pain in arm; felt sleepy; weakness in the right eye; balance issues (falling into her right side); This is a spontaneous report from a contactable consumer, the patient.  A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263; Expiration Date: May2021), via an unspecified route of administration in the right arm on 02Feb2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization.   Medical history included cancer survivor, type 2 diabetes mellitus, and surgery of the left hand in 2020.  Concomitant medications included the second dose of varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on 12Jan2021 for immunization. The patient previously received the first dose of the varicella zoster vaccine (shingles vaccine) (MANUFACTURER UNKNOWN) on an unknown date for immunization.  On 02Feb2021, the patient experienced swelling and pain in arm and felt sleepy. On 03Feb2021, the patient fell on the table due to dizziness. The patient had to use her cane more to get around.  On an unknown date in Feb2021, the patient had weakness in the right eye and balance issues (falling into her right side). The clinical outcomes of the dizziness, swelling in the arm, and weakness in the right eye were recovering; while that of the pain in the arm was not recovered. The clinical outcomes of the sleepiness, fall, and balance issues (falling into her right side), were unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Joint dislocation, Neuralgic amyotrophy, Neurological symptom, Pain
Clinical narrative: neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most consistent with Parsonage-Turner syndrome.; Worsening including increasing pain extending to all the arm; paresthesias throughout arm and hand,; feeling of dislocated scapula; tightening of the lateral aspect of the chest; sharp pain; The injection was incorrectly done too high and too deep into the joint/bursa.  She developed sharp pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient (daughter) (not preganent) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3302 and Expiration Date unknown) via Intramuscular on 18Jan2021 (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EH9899 and Expiration Date unknown) via Intramuscular on 30Dec2020 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as none. The concomitant medications were not reported. No other vaccine in four weeks. The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain and started with neurological symptoms most consistent with Parsonage-Turner syndrome, which includes pain in the brachial plexus with weakness, paresthesia which might never resolve. This is an autoimmune disorder. Patient was worsening including increasing pain extending to all the arm, paresthesias throughout arm and hand, feeling of dislocated scapula, tightening of the lateral aspect of the chest. Onset date for all events was 18Jan2021 and resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with treatment of oral steroids and nonsteroidal anti-inflammatory drugs (NSAID).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the neurological symptoms, Parsonage-Turner syndrome and other reported events in the clinical context of wrong injection technique due to temporal relationship.  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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Wrong technique in product usage process
Clinical narrative: neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most consistent with Parsonage-Turner syndrome.; Worsening including increasing pain extending to all the arm; paresthesias throughout arm and hand,; feeling of dislocated scapula; tightening of the lateral aspect of the chest; sharp pain; The injection was incorrectly done too high and too deep into the joint/bursa.  She developed sharp pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient (daughter) (not preganent) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3302 and Expiration Date unknown) via Intramuscular on 18Jan2021 (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EH9899 and Expiration Date unknown) via Intramuscular on 30Dec2020 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as none. The concomitant medications were not reported. No other vaccine in four weeks. The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain and started with neurological symptoms most consistent with Parsonage-Turner syndrome, which includes pain in the brachial plexus with weakness, paresthesia which might never resolve. This is an autoimmune disorder. Patient was worsening including increasing pain extending to all the arm, paresthesias throughout arm and hand, feeling of dislocated scapula, tightening of the lateral aspect of the chest. Onset date for all events was 18Jan2021 and resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with treatment of oral steroids and nonsteroidal anti-inflammatory drugs (NSAID).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the neurological symptoms, Parsonage-Turner syndrome and other reported events in the clinical context of wrong injection technique due to temporal relationship.  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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Breath odour, Fatigue, Feeling abnormal, Headache
Clinical narrative: fatigue (sleeping most of the day)/tired; fatigue (sleeping most of the day); headaches; pain in her teeth like she has cavities; a color to her spit like gangrene; bad breath; kidney pain; urinary urgency; foul smell to urine; fever; feeling totally just like she had no blood in her body; as weak as a kitten; could not hardly get out of bed; felt sicker than having the virus; felt like she was going to fall out getting out of bed; making very poor decisions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included SARS-CoV-2 infection (hospitalized for 3 days; quarantined at her assisted living facility for 14 days after discharge), gangrene (small intestine when she was younger), and lives at assisted living facility. The patient's concomitant medications were not reported. The patient experienced fatigue (sleeping most of the day)/tired, headaches, pain in her teeth like she has cavities, a color to her spit like gangrene, bad breath, kidney pain, urinary urgency, foul smell to urine, fever, feeling totally just like she had no blood in her body, as weak as a kitten, could not hardly get out of bed, felt sicker than having the virus, felt like she was going to fall out getting out of bed, and making very poor decisions on an unspecified date. All of the events were reported to have caused hospitalization. The clinical course was reported as follows: The patient received the vaccine five days after quarantine from previous COVID-19 infection. It was reported that she did not test positive for COVID-19 but did come down with the COVID-19 virus and was taken to the hospital immediately previously. She reported that she was currently taking unspecified antibiotics for the previous COVID-19 infection. The patient reports that she felt sicker since she got the vaccine than when she had the virus. She slept for 24 hours a day for 4 to 5 days, and only woke up to use the bathroom and when she got up, it felt like she was going to fall out. She also had a bad headache and just did not feel well. She was having really horrible headaches just prior to going to the hospital, some of the worst headaches she ever had. Her teeth, all of her teeth hurt, they just felt like if she pushed on them too much they would fall out; and it was like she had a toothache everywhere in her mouth. She felt really tired at the time of reporting as well. After she got the vaccine, she started feeling sick and was making very poor decisions about things. The clinical outcome of all of the events was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Loss of personal independence in daily activities, Malaise, Mental impairment, Micturition urgency
Clinical narrative: fatigue (sleeping most of the day)/tired; fatigue (sleeping most of the day); headaches; pain in her teeth like she has cavities; a color to her spit like gangrene; bad breath; kidney pain; urinary urgency; foul smell to urine; fever; feeling totally just like she had no blood in her body; as weak as a kitten; could not hardly get out of bed; felt sicker than having the virus; felt like she was going to fall out getting out of bed; making very poor decisions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included SARS-CoV-2 infection (hospitalized for 3 days; quarantined at her assisted living facility for 14 days after discharge), gangrene (small intestine when she was younger), and lives at assisted living facility. The patient's concomitant medications were not reported. The patient experienced fatigue (sleeping most of the day)/tired, headaches, pain in her teeth like she has cavities, a color to her spit like gangrene, bad breath, kidney pain, urinary urgency, foul smell to urine, fever, feeling totally just like she had no blood in her body, as weak as a kitten, could not hardly get out of bed, felt sicker than having the virus, felt like she was going to fall out getting out of bed, and making very poor decisions on an unspecified date. All of the events were reported to have caused hospitalization. The clinical course was reported as follows: The patient received the vaccine five days after quarantine from previous COVID-19 infection. It was reported that she did not test positive for COVID-19 but did come down with the COVID-19 virus and was taken to the hospital immediately previously. She reported that she was currently taking unspecified antibiotics for the previous COVID-19 infection. The patient reports that she felt sicker since she got the vaccine than when she had the virus. She slept for 24 hours a day for 4 to 5 days, and only woke up to use the bathroom and when she got up, it felt like she was going to fall out. She also had a bad headache and just did not feel well. She was having really horrible headaches just prior to going to the hospital, some of the worst headaches she ever had. Her teeth, all of her teeth hurt, they just felt like if she pushed on them too much they would fall out; and it was like she had a toothache everywhere in her mouth. She felt really tired at the time of reporting as well. After she got the vaccine, she started feeling sick and was making very poor decisions about things. The clinical outcome of all of the events was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal pain, Saliva discolouration, Somnolence, Toothache
Clinical narrative: fatigue (sleeping most of the day)/tired; fatigue (sleeping most of the day); headaches; pain in her teeth like she has cavities; a color to her spit like gangrene; bad breath; kidney pain; urinary urgency; foul smell to urine; fever; feeling totally just like she had no blood in her body; as weak as a kitten; could not hardly get out of bed; felt sicker than having the virus; felt like she was going to fall out getting out of bed; making very poor decisions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included SARS-CoV-2 infection (hospitalized for 3 days; quarantined at her assisted living facility for 14 days after discharge), gangrene (small intestine when she was younger), and lives at assisted living facility. The patient's concomitant medications were not reported. The patient experienced fatigue (sleeping most of the day)/tired, headaches, pain in her teeth like she has cavities, a color to her spit like gangrene, bad breath, kidney pain, urinary urgency, foul smell to urine, fever, feeling totally just like she had no blood in her body, as weak as a kitten, could not hardly get out of bed, felt sicker than having the virus, felt like she was going to fall out getting out of bed, and making very poor decisions on an unspecified date. All of the events were reported to have caused hospitalization. The clinical course was reported as follows: The patient received the vaccine five days after quarantine from previous COVID-19 infection. It was reported that she did not test positive for COVID-19 but did come down with the COVID-19 virus and was taken to the hospital immediately previously. She reported that she was currently taking unspecified antibiotics for the previous COVID-19 infection. The patient reports that she felt sicker since she got the vaccine than when she had the virus. She slept for 24 hours a day for 4 to 5 days, and only woke up to use the bathroom and when she got up, it felt like she was going to fall out. She also had a bad headache and just did not feel well. She was having really horrible headaches just prior to going to the hospital, some of the worst headaches she ever had. Her teeth, all of her teeth hurt, they just felt like if she pushed on them too much they would fall out; and it was like she had a toothache everywhere in her mouth. She felt really tired at the time of reporting as well. After she got the vaccine, she started feeling sick and was making very poor decisions about things. The clinical outcome of all of the events was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Urine odour abnormal
Clinical narrative: fatigue (sleeping most of the day)/tired; fatigue (sleeping most of the day); headaches; pain in her teeth like she has cavities; a color to her spit like gangrene; bad breath; kidney pain; urinary urgency; foul smell to urine; fever; feeling totally just like she had no blood in her body; as weak as a kitten; could not hardly get out of bed; felt sicker than having the virus; felt like she was going to fall out getting out of bed; making very poor decisions; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 28Jan2021 at a single dose for COVID-19 immunization. Medical history included SARS-CoV-2 infection (hospitalized for 3 days; quarantined at her assisted living facility for 14 days after discharge), gangrene (small intestine when she was younger), and lives at assisted living facility. The patient's concomitant medications were not reported. The patient experienced fatigue (sleeping most of the day)/tired, headaches, pain in her teeth like she has cavities, a color to her spit like gangrene, bad breath, kidney pain, urinary urgency, foul smell to urine, fever, feeling totally just like she had no blood in her body, as weak as a kitten, could not hardly get out of bed, felt sicker than having the virus, felt like she was going to fall out getting out of bed, and making very poor decisions on an unspecified date. All of the events were reported to have caused hospitalization. The clinical course was reported as follows: The patient received the vaccine five days after quarantine from previous COVID-19 infection. It was reported that she did not test positive for COVID-19 but did come down with the COVID-19 virus and was taken to the hospital immediately previously. She reported that she was currently taking unspecified antibiotics for the previous COVID-19 infection. The patient reports that she felt sicker since she got the vaccine than when she had the virus. She slept for 24 hours a day for 4 to 5 days, and only woke up to use the bathroom and when she got up, it felt like she was going to fall out. She also had a bad headache and just did not feel well. She was having really horrible headaches just prior to going to the hospital, some of the worst headaches she ever had. Her teeth, all of her teeth hurt, they just felt like if she pushed on them too much they would fall out; and it was like she had a toothache everywhere in her mouth. She felt really tired at the time of reporting as well. After she got the vaccine, she started feeling sick and was making very poor decisions about things. The clinical outcome of all of the events was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Polyarthritis, Vaccination site pain
Clinical narrative: headache; Immediate injection location pain; left chest pain/Continuous left chest pain; Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist; This is a spontaneous report from a contactable Other Health Professional (patient). A 31-Year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9262 and Expiration Date unknown) via Intramuscular on 03Feb2021 09:45 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included Hypertension. The concomitant medications was reported as Lisinopril. There is no other vaccine in four weeks. Immediate injection location pain and left chest pain on 03Feb2021 10:00. Continuous left chest pain and headache for about 12 hours on day one. Symptoms similar to migratory arthritis randomly occur from day two to four, mainly in both knees, left groin, and left wrist. The outcome of events was recovering without treatment was given.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Migratory arthritis cannot be excluded.  The case will be reassessed if additional information becomes 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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in her left foot; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021, both at arm left via an unspecified route of administration at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced neuropathy in her left foot on an unspecified date after both doses (the second time worse). The patient outcome of the event was unknown.  The information on the batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Neuropathy peripheral, Off label use
Clinical narrative: neuropathy in her left foot; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021, both at arm left via an unspecified route of administration at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced neuropathy in her left foot on an unspecified date after both doses (the second time worse). The patient outcome of the event was unknown.  The information on the batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; mild, intermittent neuropathy in left foot; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: Ej1686) via intramuscular on left arm on 22Jan2021 at 09:45 AM, and second dose of BNT162B2 (lot number: Em9810) via unspecified route of administration on left arm on 05Feb2021, both at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient experienced mild, intermittent neuropathy in left foot. She experienced it first time on 29Jan2021 about a week after the first injection. Neuropathy got worse a day after the second dose. No treatment received for the event. No Covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks and no other medications in two weeks. The outcome of the event was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported peripheral neuropathy cannot totally be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Neuropathy peripheral, Off label use
Clinical narrative: first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; mild, intermittent neuropathy in left foot; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: Ej1686) via intramuscular on left arm on 22Jan2021 at 09:45 AM, and second dose of BNT162B2 (lot number: Em9810) via unspecified route of administration on left arm on 05Feb2021, both at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient experienced mild, intermittent neuropathy in left foot. She experienced it first time on 29Jan2021 about a week after the first injection. Neuropathy got worse a day after the second dose. No treatment received for the event. No Covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks and no other medications in two weeks. The outcome of the event was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported peripheral neuropathy cannot totally be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Noninfective encephalitis, Uterine inflammation
Clinical narrative: My brain, uterus and left foot toes became inflamed.; My brain, uterus and left foot toes became inflamed.; My brain, uterus and left foot toes became inflamed.; This is a spontaneous report from a contactable other health care professional (HCP) (patient). A 61-year-old female patient (no pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 02Feb2021 18:30 on left arm at a single dose for covid-19 immunisation. Facility type vaccine was Doctor's office/urgent care. Medical history included chronic kidney disease (CKD), multiple personality disorder (MPD), blood pressure abnormal. Known allergies: several BP meds and cholesterol lowing. If other vaccine in four weeks was no. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), hydroxyurea, alopurinol. Patient experienced her brain, uterus and left foot toes became inflamed on 02Feb2021 19:30. It was like highlighting her problem areas. She was not sure to take the second shot. It happened after an hour after the shot and lasted within 5 minutes. No treatment was received. The outcome of the events was unknown. Events were considered non-serious per reporting other HCP.; Sender's Comments: The event Noninfective encephalitis most likelt an intercurrent condition and unrelated to suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash vesicular
Clinical narrative: vesicular rash that was pink, red, bumpy and painful on fingers on both hands after first and second vaccine; Vesicular rash that was pink, red, bumpy and painful on fingers on both hands after first and second vaccine; This is a spontaneous report from a contactable Other HCP. A 33-year-old female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH) via an unspecified route of administration, the first dose on an unspecified date, then the second dose on 29Jan2021 at a single dose for covid-19 immunisation. There were no medical history and concomitant medications. After the first vaccine, she got a vesicular rash that was pink, red, bumpy, and painful on her fingers. The same thing happened, but worse after the second dose on day 3. The reporter did not know if it was the same fingers both times. She did know it was a few fingers on both hands. The events were reported as medically significant. No other investigation assessment done. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported Rash vesicular and  pain in extremity cannot totally be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Blood pressure abnormal, Blood pressure diastolic, Blood pressure measurement
Clinical narrative: cold and clammy; kept clearing his throat; blood sugar was 245; blood pressure 175/111; Runny nose; it could have been a delayed allergic response; This is a spontaneous report from a contactable nurse reporting for husband. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 10:15 right arm at single dose for protection from virus. Medical history included diabetes from 2005 and ongoing, partial gastrectomy from Jul2016, stroke from 2015, allergic to various things, dementia. Prior Vaccinations (within 4 weeks): None. Patient previously received Shingrix vaccine (first dose) and experienced a similar reaction (have to clear his throat), flu or hepatitis vaccines and not had a reaction. The patient experienced cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose on 04Feb2021 02:00. Clinical course reported as: Her husband had the vaccine at 10:15am. She gave him some Advil. Sixteen hours later at 2:00am her husband was cold, clammy and diaphoretic. He was having to clear his throat. He did have a little dementia and was diabetic. His blood sugar was 245. His blood pressure was 175/111 and he had a runny nose. He did not have any chest pain. He was unable to explain what was happening. She checked his blood pressure again manually and the results were the same. She gave him another blood pressure pill though it was out of the usual time. Gradually his blood pressure came down. The diastolic stayed over 100 for the evening. The systolic came down. She kept trying to read but was unable to find information. She thought it could have been a delayed allergic response. She was going to take him to the hospital but took care off him herself. She gave him a Benadryl and it calmed him down. He was feeling better and was able to fall asleep. Her husband had a Shingrix vaccine (first dose) this summer and had a similar reaction (have to clear his throat). He went to the hospital and they monitored him. They said it was not because of the vaccine. Her husband has not had a reaction in the past to vaccines. He has had every kind of vaccine with no reaction. He has not had a reaction to the flu or hepatitis vaccines. Outcome of events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose was recovered on 04Feb2021. Events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose were reported as serious medically significant. Events cold and clammy and kept clearing his throat was classified as related to suspect vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  to reported events cannot totally be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic, Cold sweat, Hypersensitivity, Oropharyngeal discomfort, Rhinorrhoea
Clinical narrative: cold and clammy; kept clearing his throat; blood sugar was 245; blood pressure 175/111; Runny nose; it could have been a delayed allergic response; This is a spontaneous report from a contactable nurse reporting for husband. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Feb2021 10:15 right arm at single dose for protection from virus. Medical history included diabetes from 2005 and ongoing, partial gastrectomy from Jul2016, stroke from 2015, allergic to various things, dementia. Prior Vaccinations (within 4 weeks): None. Patient previously received Shingrix vaccine (first dose) and experienced a similar reaction (have to clear his throat), flu or hepatitis vaccines and not had a reaction. The patient experienced cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose on 04Feb2021 02:00. Clinical course reported as: Her husband had the vaccine at 10:15am. She gave him some Advil. Sixteen hours later at 2:00am her husband was cold, clammy and diaphoretic. He was having to clear his throat. He did have a little dementia and was diabetic. His blood sugar was 245. His blood pressure was 175/111 and he had a runny nose. He did not have any chest pain. He was unable to explain what was happening. She checked his blood pressure again manually and the results were the same. She gave him another blood pressure pill though it was out of the usual time. Gradually his blood pressure came down. The diastolic stayed over 100 for the evening. The systolic came down. She kept trying to read but was unable to find information. She thought it could have been a delayed allergic response. She was going to take him to the hospital but took care off him herself. She gave him a Benadryl and it calmed him down. He was feeling better and was able to fall asleep. Her husband had a Shingrix vaccine (first dose) this summer and had a similar reaction (have to clear his throat). He went to the hospital and they monitored him. They said it was not because of the vaccine. Her husband has not had a reaction in the past to vaccines. He has had every kind of vaccine with no reaction. He has not had a reaction to the flu or hepatitis vaccines. Outcome of events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose was recovered on 04Feb2021. Events cold and clammy, kept clearing his throat, blood sugar was 245, blood pressure 175/111, runny nose were reported as serious medically significant. Events cold and clammy and kept clearing his throat was classified as related to suspect vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),  to reported events cannot totally be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dysgeusia, Dysphagia
Clinical narrative: could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself.  This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Musculoskeletal pain, Palpitations
Clinical narrative: could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself.  This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Paralysis, Pyrexia, Rash erythematous, Swollen tongue
Clinical narrative: could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself.  This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: could not lift arm/move body; her tongue started to be tingly; fuzzy feeling; tongue swollen a bit; hives; hard to swallow; weird taste in mouth; a high grade fever over 103, went down on 03Feb2021 to 102, 101, 99, then 98.6; chills uncontrollably; heart racing a bit; joint-muscle pain; headache; dizziness; swollen lymphnodes; red rash on chest/arms/stomach with some hives; This is a spontaneous report from a contactable consumer reporting for herself.  This 42-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN9581) on 02Feb2021 at 10:30, in left arm, for COVID-19 immunisation. The first BNT162B2 vaccine dose was administered on 12Jan2021 at 13:30, lot number EL3246, in left arm, for COVID-19 immunisation. Medical history included heart murmur, acute sinusitis, allergies to acetaminophen/oxycodone (PERCOCET), cephalexin (KEFLEX), codeine, trees, pollen, grass, mold, cats, some dogs. The patient had no COVID prior to vaccination and COVID was not tested after vaccination. Concomitant medications were not reported. The patient received the second vaccine dose on 02Feb2021 at the hospital and was monitored for 30 minutes. Within that time her tongue started to be tingly, she experienced fuzzy feeling, tongue swollen a bit with hives, hard to swallow, weird taste in mouth. The nurse on staff walked her to the ED, she was admitted and treated for allergic reaction to the vaccine and received prednisone for 5 days and diphenhydramine (BENADRYL). Epipen if needed. Later that night, on 02Feb2021, the patient had a high grade fever over 103, chills uncontrollably, heart racing a bit, could not lift arm/move body, joint-muscle pain, headache, dizziness, swollen lymphnodes, hard to swallow, every side effect on sheet just really bad. Her fever eventually went down on 03Feb2021 to 102, 101, 99, then 98.6. She still had all other symptoms not as severe, later that night she had a bit of a red rash on chest/arms/stomach with some hives, swallowing was still a bit hard. She continued to take BENADRYL and steroid. 06Feb2021 was her last day of steroid. As of 06Feb2021 she was feeling a bit better with no fever, swallowing a bit hard but other symptoms were less. The events resulted in Emergency room/department or urgent care. Fever resolved on an unspecified date in Feb2021. The other events were resolving.