chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue blistering, Urticaria
Clinical narrative: TURNED BRIGHT RED FROM HEAD ALL THE WAY DOWN; LIPS STARTED SWELLING; BLISTERS ON OUTSIDE OF LIPS; BLISTERS ON TONGUE; BODY WENT REALLY HOT (TEMPERATURE WAS LOW GRADE TEMPERATURE OF 99 F); HIVES ON OUTSIDE OF LIPS/HIVES ON TONGUE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the patient experienced turned bright red from head all the way down. On 02-APR-2021, the patient experienced lips started swelling. On 02-APR-2021, the patient experienced blisters on outside of lips. On 02-APR-2021, the patient experienced blisters on tongue. On 02-APR-2021, the patient experienced body went really hot (temperature was low grade temperature of 99 f). On 02-APR-2021, the patient experienced hives on outside of lips/hives on tongue. Laboratory data included: Body temperature (NR: not provided) 99 F. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from turned bright red from head all the way down on 05-APR-2021, and lips started swelling, blisters on outside of lips, blisters on tongue, body went really hot (temperature was low grade temperature of 99 f), and hives on outside of lips/hives on tongue on 04-APR-2021. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain.; Her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain./joint pain had increased; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, administered in Arm Left on 09Apr2021 09:05 (Batch/Lot Number: EW0150) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included urinary retention from 2016 and ongoing, Interstim Implant for Bladder, ongoing electrocardiogram t wave inversion she had the inverted T waves all her life, clarifying she had issues since college, ongoing hypoglycaemia Stated she had hypoglycemia since high school. No further details provided, ongoing gluten sensitivity she had gluten intolerance, and another autoimmune issue referred to as leaky gut, ongoing asthma Stated she was diagnosed with moderate asthma as a child. No further details provided, Lobular carcinoma of breast from Dec2020 to an unknown date Stated she had a lumpectomy on her right breast in Dec2020. diagnosed with a lobular carcinoma that was not cancerous, but considered a high-risk lesion, and was removed. Concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206) via unspecified route administered in Arm Left on 19Mar2021 at 9:48 AM On 10APR2021 DOSE 1, SINGLE for COVID-19 immunization. Reported after her first COVID-19 Vaccine shot, she got sick. She said she had joint pain and body aches, and her arm, and all that stuff. On 10Apr2021 Her second dose was on April 09, and she had mild joint pain then now its progressed to moderate joint pain and her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain. /Joint pain had increased. It was reported that with the 2nd COVID-19 Vaccine shot, she just had joint pain that started the next day (10Apr2021), and the joint pain had continued and increased was reported as worsened. Treatment: Reported she took ginger (clarified as Nature's Way Brand Ginger Root 1.1g capsule), and turmeric (clarified as Solgar Curcumin) for her joint pain, providing: Nature's Way Brand Ginger Root 1.1g capsule UPC Number: # Lot Number: Unknown Expiration Date: Unknown Stated she did not see a Lot Number and Expiration Date listed on the product packaging. Solgar Brand Curcumin (Curcuminoids 48mg) soft gel capsule UPC Number: 3398454708 Lot Number: 485875-04 Expiration Date: Nov2021. Patient underwent lab tests and procedures which included blood test: unknown on Dec2020. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Condition aggravated
Clinical narrative: Her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain.; Her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain./joint pain had increased; This is a spontaneous report from a contactable consumer (patient).  A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, administered in Arm Left on 09Apr2021 09:05 (Batch/Lot Number: EW0150) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included urinary retention from 2016 and ongoing, Interstim Implant for Bladder, ongoing electrocardiogram t wave inversion she had the inverted T waves all her life, clarifying she had issues since college, ongoing hypoglycaemia Stated she had hypoglycemia since high school. No further details provided, ongoing gluten sensitivity she had gluten intolerance, and another autoimmune issue referred to as leaky gut, ongoing asthma Stated she was diagnosed with moderate asthma as a child. No further details provided, Lobular carcinoma of breast from Dec2020 to an unknown date Stated she had a lumpectomy on her right breast in Dec2020. diagnosed with a lobular carcinoma that was not cancerous, but considered a high-risk lesion, and was removed. Concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206) via unspecified route administered in Arm Left on 19Mar2021 at 9:48 AM On 10APR2021 DOSE 1, SINGLE for COVID-19 immunization. Reported after her first COVID-19 Vaccine shot, she got sick. She said she had joint pain and body aches, and her arm, and all that stuff. On 10Apr2021 Her second dose was on April 09, and she had mild joint pain then now its progressed to moderate joint pain and her second dose was on April 09 and she had mild joint pain then now its progressed to moderate joint pain. /Joint pain had increased. It was reported that with the 2nd COVID-19 Vaccine shot, she just had joint pain that started the next day (10Apr2021), and the joint pain had continued and increased was reported as worsened. Treatment: Reported she took ginger (clarified as Nature's Way Brand Ginger Root 1.1g capsule), and turmeric (clarified as Solgar Curcumin) for her joint pain, providing: Nature's Way Brand Ginger Root 1.1g capsule UPC Number: # Lot Number: Unknown Expiration Date: Unknown Stated she did not see a Lot Number and Expiration Date listed on the product packaging. Solgar Brand Curcumin (Curcuminoids 48mg) soft gel capsule UPC Number: 3398454708 Lot Number: 485875-04 Expiration Date: Nov2021. Patient underwent lab tests and procedures which included blood test: unknown on Dec2020. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: enlarged heart, fluid on heart/Pericardial Effusion; Swelling of extremities; Nausea; short breath; dizziness; chest pains; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (BNT162B2, Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in arm right on 09Mar2021 13:30 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization.  Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot No: EN6205) administered in arm right on unspecified date as single dose for COVID-19 immunization. On 01Jun2021, the patient experienced enlarged heart, fluid on heart/pericardial effusion, swelling of extremities, nausea, short breath, dizziness, chest pains.  The patient was hospitalized on unspecified date in 2021 to unspecified date in 2021 for 5 days. The patient had scans on unspecified date in 2021 which showed enlarged heart, fluid on heart. The doctor drained over 600 cc of bloody fluid, drained left in another 400 c. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 12Sep2021 the patient had nasal swab with negative result. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measure was taken as a result of the reported events. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nausea, Night sweats, Oedema, Sleep disorder
Clinical narrative: enlarged heart, fluid on heart/Pericardial Effusion; Swelling of extremities; Nausea; short breath; dizziness; chest pains; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (BNT162B2, Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in arm right on 09Mar2021 13:30 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization.  Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot No: EN6205) administered in arm right on unspecified date as single dose for COVID-19 immunization. On 01Jun2021, the patient experienced enlarged heart, fluid on heart/pericardial effusion, swelling of extremities, nausea, short breath, dizziness, chest pains.  The patient was hospitalized on unspecified date in 2021 to unspecified date in 2021 for 5 days. The patient had scans on unspecified date in 2021 which showed enlarged heart, fluid on heart. The doctor drained over 600 cc of bloody fluid, drained left in another 400 c. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 12Sep2021 the patient had nasal swab with negative result. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measure was taken as a result of the reported events. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Investigation, Nausea
Clinical narrative: enlarged heart, fluid on heart/Pericardial Effusion; Swelling of extremities; Nausea; short breath; dizziness; chest pains; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (BNT162B2, Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in arm right on 09Mar2021 13:30 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization.  Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot No: EN6205) administered in arm right on unspecified date as single dose for COVID-19 immunization. On 01Jun2021, the patient experienced enlarged heart, fluid on heart/pericardial effusion, swelling of extremities, nausea, short breath, dizziness, chest pains.  The patient was hospitalized on unspecified date in 2021 to unspecified date in 2021 for 5 days. The patient had scans on unspecified date in 2021 which showed enlarged heart, fluid on heart. The doctor drained over 600 cc of bloody fluid, drained left in another 400 c. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 12Sep2021 the patient had nasal swab with negative result. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measure was taken as a result of the reported events. The outcome of the events was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericardial effusion, SARS-CoV-2 test, Swelling
Clinical narrative: enlarged heart, fluid on heart/Pericardial Effusion; Swelling of extremities; Nausea; short breath; dizziness; chest pains; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (BNT162B2, Lot Number: EP6955), dose 2 via an unspecified route of administration, administered in arm right on 09Mar2021 13:30 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization.  Medical history included high blood pressure. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot No: EN6205) administered in arm right on unspecified date as single dose for COVID-19 immunization. On 01Jun2021, the patient experienced enlarged heart, fluid on heart/pericardial effusion, swelling of extremities, nausea, short breath, dizziness, chest pains.  The patient was hospitalized on unspecified date in 2021 to unspecified date in 2021 for 5 days. The patient had scans on unspecified date in 2021 which showed enlarged heart, fluid on heart. The doctor drained over 600 cc of bloody fluid, drained left in another 400 c. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 12Sep2021 the patient had nasal swab with negative result. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measure was taken as a result of the reported events. The outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Granuloma annulare, Injection site rash, Rash, Stress
Clinical narrative: rash; Granuloma annulare; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW015D), via an unspecified route of administration in Arm Right on 02Apr2021 at 16:00 (at 60 years) as single dose for covid-19 immunisation. Medical history included low thyroid, high cholesterol, menopause, overweight (30 lbs), Mono (at the age of 26 years) and she was told  had EBV antibodies, mild Shingles (at the age of 51 years) and had known allergy to bee stings (not been stung since she was a teenager). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.Concomitant medications were not reported.Previously the patient received two doses of Shingles Vaccine for immunization, on 15Oct2019 (first dose; at 58 years old) and on 11Mar2020 (second dose;at 59 years old); patient also get flu shot every year for immunization and last one was  on 16Oct2021 (at 59 years old). On 12Mar2021 at 16:45 (at 60 years) the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), in left arm for covid-19 immunisation. On an unspecified date in Apr2021 at 12:00 the patient experienced rash and granuloma annulare, that resulted in Doctor or other healthcare professional office/clinic visit.Clinical course was as follows: when the patient got the shots, hardly felt it at the injection site - no side effects, no fever, no nausea. Not much discomfort from either dose. Then 2-3 weeks following the second shot she started to develop a rash, it started on upper arms, near the vaccine site and spread quite a bit. Primary doc initially thought it was an allergic reaction, eventually did biopsy and lab result was Granulome annulare. Now seeing a dermatologist. Prednisone and Elidel not very effective. Rash was extensive. Now she was trying Plaquenil. Patient stated never had any reaction to a vaccination, ever, other than the normal expected discomfort as the vaccine did its job creating antibodies. Final outcome of the events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Biopsy, Granuloma annulare, Rash
Clinical narrative: rash; Granuloma annulare; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW015D), via an unspecified route of administration in Arm Right on 02Apr2021 at 16:00 (at 60 years) as single dose for covid-19 immunisation. Medical history included low thyroid, high cholesterol, menopause, overweight (30 lbs), Mono (at the age of 26 years) and she was told  had EBV antibodies, mild Shingles (at the age of 51 years) and had known allergy to bee stings (not been stung since she was a teenager). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.Concomitant medications were not reported.Previously the patient received two doses of Shingles Vaccine for immunization, on 15Oct2019 (first dose; at 58 years old) and on 11Mar2020 (second dose;at 59 years old); patient also get flu shot every year for immunization and last one was  on 16Oct2021 (at 59 years old). On 12Mar2021 at 16:45 (at 60 years) the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), in left arm for covid-19 immunisation. On an unspecified date in Apr2021 at 12:00 the patient experienced rash and granuloma annulare, that resulted in Doctor or other healthcare professional office/clinic visit.Clinical course was as follows: when the patient got the shots, hardly felt it at the injection site - no side effects, no fever, no nausea. Not much discomfort from either dose. Then 2-3 weeks following the second shot she started to develop a rash, it started on upper arms, near the vaccine site and spread quite a bit. Primary doc initially thought it was an allergic reaction, eventually did biopsy and lab result was Granulome annulare. Now seeing a dermatologist. Prednisone and Elidel not very effective. Rash was extensive. Now she was trying Plaquenil. Patient stated never had any reaction to a vaccination, ever, other than the normal expected discomfort as the vaccine did its job creating antibodies. Final outcome of the events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Paraesthesia, Throat tightness
Clinical narrative: Patient has a history of Guillan Baire like symptoms after receiving a Tdap vaccine about 7 years ago. After that vaccine she wasn't able to walk for several months due to numbness and shooting pain. She wasn't sure if she should get the Pfizer vaccine but decided to do it anyway. Two days after receiving the pfizer vaccine she started experiencing numbness in her legs, arm and neck. She also had extreme fatigue and bradychardia. She followed up with neurology and cardiology.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, Fatigue, Hypoaesthesia
Clinical narrative: Patient has a history of Guillan Baire like symptoms after receiving a Tdap vaccine about 7 years ago. After that vaccine she wasn't able to walk for several months due to numbness and shooting pain. She wasn't sure if she should get the Pfizer vaccine but decided to do it anyway. Two days after receiving the pfizer vaccine she started experiencing numbness in her legs, arm and neck. She also had extreme fatigue and bradychardia. She followed up with neurology and cardiology.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, C-reactive protein, Chest pain, Dizziness, Fibrin D dimer
Clinical narrative: UNABLE TO WALK; ISSUES WITH LEGS AND HANDS/ LEGS WERE FULL OF LEAD; DID NOT FEEL RIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced did not feel right. On 02-SEP-2021, the patient experienced issues with legs and hands/ legs were full of lead. On 04-SEP-2021, the patient experienced unable to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from issues with legs and hands/ legs were full of lead, and the outcome of unable to walk and did not feel right was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Haemoglobin, Hypoaesthesia, Impaired driving ability, Laboratory test
Clinical narrative: UNABLE TO WALK; ISSUES WITH LEGS AND HANDS/ LEGS WERE FULL OF LEAD; DID NOT FEEL RIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced did not feel right. On 02-SEP-2021, the patient experienced issues with legs and hands/ legs were full of lead. On 04-SEP-2021, the patient experienced unable to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from issues with legs and hands/ legs were full of lead, and the outcome of unable to walk and did not feel right was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Red blood cell sedimentation rate, Thyroxine, Tremor, Tri-iodothyronine
Clinical narrative: UNABLE TO WALK; ISSUES WITH LEGS AND HANDS/ LEGS WERE FULL OF LEAD; DID NOT FEEL RIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced did not feel right. On 02-SEP-2021, the patient experienced issues with legs and hands/ legs were full of lead. On 04-SEP-2021, the patient experienced unable to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from issues with legs and hands/ legs were full of lead, and the outcome of unable to walk and did not feel right was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Gait disturbance, Muscular weakness
Clinical narrative: UNABLE TO WALK; ISSUES WITH LEGS AND HANDS/ LEGS WERE FULL OF LEAD; DID NOT FEEL RIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-SEP-2021, the patient experienced did not feel right. On 02-SEP-2021, the patient experienced issues with legs and hands/ legs were full of lead. On 04-SEP-2021, the patient experienced unable to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from issues with legs and hands/ legs were full of lead, and the outcome of unable to walk and did not feel right was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: swollen lymph node in left arm pit; Hives on face and neck; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 10Aug2021 18:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation in a pharmacy or drug store. Medical history included asthma and known allergies to tree nuts. No covid prior to vaccination. There were no concomitant medications, no other vaccine in four weeks and no other medications in two weeks. On an unspecified date in 2021, the patient experienced swollen lymph node in left arm pit and hives on face and neck for 7 days after first the dose. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment included antibiotics. The patient recovered from the events in 2021.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Lymphadenopathy, Pain, Swelling
Clinical narrative: swollen lymph node in left arm pit; extreme pain; hot; bruising; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01Sep2021 09:00 (Batch/Lot number was not reported) at the age of 15 years as single dose for covid-19 immunisation. Medical history included asthma and known allergies: tree nuts. Patient had no COVID prior vaccination. There were no concomitant medications. Historical vaccine included the first dose of bnt162b2, via an unspecified route of administration, administered in left arm on 10Aug2021 06:00 PM at the age of 15 years as single dose for covid-19 immunisation and experienced hives on face and neck for 7 days, swollen lymph node in left arm pit for 7 days. Patient was not pregnant. Patient experienced swollen lymph node in left arm pit after second dose. Still swollen, extreme pain, hot, bruising. Not resolved. Adverse event start date was 02Sep2021. Ae resulted in: doctor or other healthcare professional office/clinic visit. Treatment: antibiotics was received. Covid (Nasal Swab) tested post vaccination on 27Sep2021 was negative. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Feeling hot, Lymphadenopathy, Pain, SARS-CoV-2 test
Clinical narrative: swollen lymph node in left arm pit; extreme pain; hot; bruising; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01Sep2021 09:00 (Batch/Lot number was not reported) at the age of 15 years as single dose for covid-19 immunisation. Medical history included asthma and known allergies: tree nuts. Patient had no COVID prior vaccination. There were no concomitant medications. Historical vaccine included the first dose of bnt162b2, via an unspecified route of administration, administered in left arm on 10Aug2021 06:00 PM at the age of 15 years as single dose for covid-19 immunisation and experienced hives on face and neck for 7 days, swollen lymph node in left arm pit for 7 days. Patient was not pregnant. Patient experienced swollen lymph node in left arm pit after second dose. Still swollen, extreme pain, hot, bruising. Not resolved. Adverse event start date was 02Sep2021. Ae resulted in: doctor or other healthcare professional office/clinic visit. Treatment: antibiotics was received. Covid (Nasal Swab) tested post vaccination on 27Sep2021 was negative. Outcome of events were not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Asthenia, Cardiac monitoring abnormal, Chest X-ray
Clinical narrative: I started having daily/hourly PVCs; tachycardia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Shortly after receiving the first COVID vaccine, patient started having daily/hourly premature ventricular contractions (PVCs) and tachycardia. After 6 months of treatment and hospitalization, they stopped. It was debilitating. Patient asked doctors for a letter excusing from getting the second shot. Patient was an advocate for the vaccines but had been one of the few to react negatively. The patient had recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Electrocardiogram abnormal, Fear, Impaired quality of life, Impaired work ability
Clinical narrative: I started having daily/hourly PVCs; tachycardia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Shortly after receiving the first COVID vaccine, patient started having daily/hourly premature ventricular contractions (PVCs) and tachycardia. After 6 months of treatment and hospitalization, they stopped. It was debilitating. Patient asked doctors for a letter excusing from getting the second shot. Patient was an advocate for the vaccines but had been one of the few to react negatively. The patient had recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Tachycardia, Ultrasound Doppler, Ventricular extrasystoles
Clinical narrative: I started having daily/hourly PVCs; tachycardia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Shortly after receiving the first COVID vaccine, patient started having daily/hourly premature ventricular contractions (PVCs) and tachycardia. After 6 months of treatment and hospitalization, they stopped. It was debilitating. Patient asked doctors for a letter excusing from getting the second shot. Patient was an advocate for the vaccines but had been one of the few to react negatively. The patient had recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Ventricular extrasystoles
Clinical narrative: I started having daily/hourly PVCs; tachycardia; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Shortly after receiving the first COVID vaccine, patient started having daily/hourly premature ventricular contractions (PVCs) and tachycardia. After 6 months of treatment and hospitalization, they stopped. It was debilitating. Patient asked doctors for a letter excusing from getting the second shot. Patient was an advocate for the vaccines but had been one of the few to react negatively. The patient had recovered from the events.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood electrolytes normal, Deep vein thrombosis, Differential white blood cell count normal, Pain in extremity, Peripheral swelling
Clinical narrative: DVT in left leg; antiphospholipid syndrome; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the of 74-years, dose 3 via an unspecified route of administration, administered in arm left on 26Sep2021 (lot number: FF2587) as dose 3 (booster), single for COVID-19 immunisation.  Medical history included antiphospholipid syndrome. The patient was not pregnant at time of vaccination. No COVID-19 prior vaccination. Concomitant medications included propranolol; acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN); calcium carbonate (TUMS). No other vaccine in four weeks. The patient historically received BNT162B2 for COVID-19 immunisation at the age of 74-years, first single dose in left arm on 30Jan2021 (lot number: EI3248), second single dose in left arm on 20Feb2021 (lot number: EN6201). The patient previously received iodine, nitrofurantoin (MACRODANTIN), nitrofurantoin (FURADANTIN), metronidazole (FLAGYL) and Radi-opaque dye, all experienced allergies. On 29Sep2021, the patient experienced DVT in left leg, beginning 3 days after vaccination; diagnosed in ER. Have antiphospholipid syndrome. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. AE treatment included blood thinners. Outcome of the events was recovering. No COVID-19 tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Red blood cell count normal, Ultrasound scan abnormal
Clinical narrative: DVT in left leg; antiphospholipid syndrome; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the of 74-years, dose 3 via an unspecified route of administration, administered in arm left on 26Sep2021 (lot number: FF2587) as dose 3 (booster), single for COVID-19 immunisation.  Medical history included antiphospholipid syndrome. The patient was not pregnant at time of vaccination. No COVID-19 prior vaccination. Concomitant medications included propranolol; acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN); calcium carbonate (TUMS). No other vaccine in four weeks. The patient historically received BNT162B2 for COVID-19 immunisation at the age of 74-years, first single dose in left arm on 30Jan2021 (lot number: EI3248), second single dose in left arm on 20Feb2021 (lot number: EN6201). The patient previously received iodine, nitrofurantoin (MACRODANTIN), nitrofurantoin (FURADANTIN), metronidazole (FLAGYL) and Radi-opaque dye, all experienced allergies. On 29Sep2021, the patient experienced DVT in left leg, beginning 3 days after vaccination; diagnosed in ER. Have antiphospholipid syndrome. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. AE treatment included blood thinners. Outcome of the events was recovering. No COVID-19 tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antiphospholipid syndrome, Deep vein thrombosis
Clinical narrative: DVT in left leg; antiphospholipid syndrome; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the of 74-years, dose 3 via an unspecified route of administration, administered in arm left on 26Sep2021 (lot number: FF2587) as dose 3 (booster), single for COVID-19 immunisation.  Medical history included antiphospholipid syndrome. The patient was not pregnant at time of vaccination. No COVID-19 prior vaccination. Concomitant medications included propranolol; acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN); calcium carbonate (TUMS). No other vaccine in four weeks. The patient historically received BNT162B2 for COVID-19 immunisation at the age of 74-years, first single dose in left arm on 30Jan2021 (lot number: EI3248), second single dose in left arm on 20Feb2021 (lot number: EN6201). The patient previously received iodine, nitrofurantoin (MACRODANTIN), nitrofurantoin (FURADANTIN), metronidazole (FLAGYL) and Radi-opaque dye, all experienced allergies. On 29Sep2021, the patient experienced DVT in left leg, beginning 3 days after vaccination; diagnosed in ER. Have antiphospholipid syndrome. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. AE treatment included blood thinners. Outcome of the events was recovering. No COVID-19 tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging, X-ray
Clinical narrative: Guillen-Barre Syndrome (GBS); This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) at the age of 57-years, via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. Medical history was not reported. No known allergies. No COVID-19 prior vaccination. No other vaccine in four weeks. No other medications in two weeks. The patient historically received first single dose of BNT162B2 (lot number: EL3247) on 25Jan2021 for COVID-19 immunisation (at the age of 57-years). The patient experienced Guillen-Barre Syndrome (GBS) on 26Mar2021. AE resulted in emergency room/department or urgent care, hospitalization for 21 days, disability or permanent damage. AE treatment included medical and rehabilitation. Outcome of the event was not recovered. No COVID-19 tested post vaccination.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillen-Barre Syndrome (GBS); This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) at the age of 57-years, via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. Medical history was not reported. No known allergies. No COVID-19 prior vaccination. No other vaccine in four weeks. No other medications in two weeks. The patient historically received first single dose of BNT162B2 (lot number: EL3247) on 25Jan2021 for COVID-19 immunisation (at the age of 57-years). The patient experienced Guillen-Barre Syndrome (GBS) on 26Mar2021. AE resulted in emergency room/department or urgent care, hospitalization for 21 days, disability or permanent damage. AE treatment included medical and rehabilitation. Outcome of the event was not recovered. No COVID-19 tested post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Headache, Pain in extremity, Palpitations, Panic attack
Clinical narrative: heart hurt; her arms swelled up; itchy; headache; nerve pain; big red spot on the arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Sep2021 (Batch/Lot Number: FC3181) at the age of 54 years as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID). Historical vaccine included the first dose of bnt162b2 on 28Aug2021 at the age of 54 years for COVID-19 immunisation and experienced shoulder within the right arm, it was sore for 3 weeks and the joints still hurt, had severe panic attack, thought she was having a heart attack. Patient got her second shot and then her arms swelled up and it was red for 3 weeks and it was still red but swelling had gone down and itchy and patient had a headache every single day and then she felt like her heart hurt and then she had from her hips down to her knee a nerve pain and so it was going on after the second shot from her hip to her knee. When they gave her her second shot, it immediately 'shot' up to her brain, patient felt like immediate headache. So, she did not know if it was the muscle or what but her arm was swollen for 3 weeks and red and now the swelling was going down but it was still big red spot on the arm. They drew blood work yesterday and for her symptoms that she had reaction to the COVID Vaccine. Outcome of arms swelled was recovered in 2021 and the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: heart hurt; her arms swelled up; itchy; headache; nerve pain; big red spot on the arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Sep2021 (Batch/Lot Number: FC3181) at the age of 54 years as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID). Historical vaccine included the first dose of bnt162b2 on 28Aug2021 at the age of 54 years for COVID-19 immunisation and experienced shoulder within the right arm, it was sore for 3 weeks and the joints still hurt, had severe panic attack, thought she was having a heart attack. Patient got her second shot and then her arms swelled up and it was red for 3 weeks and it was still red but swelling had gone down and itchy and patient had a headache every single day and then she felt like her heart hurt and then she had from her hips down to her knee a nerve pain and so it was going on after the second shot from her hip to her knee. When they gave her her second shot, it immediately 'shot' up to her brain, patient felt like immediate headache. So, she did not know if it was the muscle or what but her arm was swollen for 3 weeks and red and now the swelling was going down but it was still big red spot on the arm. They drew blood work yesterday and for her symptoms that she had reaction to the COVID Vaccine. Outcome of arms swelled was recovered in 2021 and the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood test, Erythema, Headache, Neuralgia
Clinical narrative: heart hurt; her arms swelled up; itchy; headache; nerve pain; big red spot on the arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Sep2021 (Batch/Lot Number: FC3181) at the age of 54 years as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID). Historical vaccine included the first dose of bnt162b2 on 28Aug2021 at the age of 54 years for COVID-19 immunisation and experienced shoulder within the right arm, it was sore for 3 weeks and the joints still hurt, had severe panic attack, thought she was having a heart attack. Patient got her second shot and then her arms swelled up and it was red for 3 weeks and it was still red but swelling had gone down and itchy and patient had a headache every single day and then she felt like her heart hurt and then she had from her hips down to her knee a nerve pain and so it was going on after the second shot from her hip to her knee. When they gave her her second shot, it immediately 'shot' up to her brain, patient felt like immediate headache. So, she did not know if it was the muscle or what but her arm was swollen for 3 weeks and red and now the swelling was going down but it was still big red spot on the arm. They drew blood work yesterday and for her symptoms that she had reaction to the COVID Vaccine. Outcome of arms swelled was recovered in 2021 and the other events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Lumbar puncture, Magnetic resonance imaging, Myelitis transverse, Neuropathy peripheral
Clinical narrative: Brain fog; Digestive issues; Huge knot on his left arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the first vaccine dose.   A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in the left arm on 03May2021 at 10:00am (Batch/Lot Number: EW0176, at age 41-years-old at vaccination) as a single dose for COVID-19 immunisation at a pharmacy/drug store. Medical history and concomitant medications were not reported. The patient had no prior vaccinations (within 4 weeks) of the BNT162B2 vaccine. On 03May2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date in May2021 (after the first vaccination), the patient experienced a huge knot on his left arm and it has remained the same. It was hard as a rock. The patent has been having a lot of side effects since the vaccine and one is brain fog which began around 18May2021 at the latest after the first dose of the vaccine and was ongoing and continues to get worse. He has an appointment with a neuropsychologist to undergo testing to see what was going on. He has a lot of digestive issues and was undergoing tests. The digestive issues also began around the same time as the brain fog and was ongoing and worst. Treatment for event digestive issues included taking Linzess 150mg once per day by mouth since 24Sep2021. The outcome of events huge knot on his left arm, brain fog and digestive issues was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101314920 Same patient/reporter; different dose/AE