chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Beta-2 glycoprotein antibody, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M
Clinical narrative: immune complex mediated response due to vaccine; portal vein thrombosis; experienced a 30 pound weight loss (over the past two months); night sweats; intermittent fever of unknown origin; chills; This is a spontaneous report from a contactable health care profession and follow up report from a contactable consumer via Pfizer-sponsored program.  A 74-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ),  via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Not provided) as 2nd dose, single for covid-19 immunisation  .  Medical history included coronary artery,  chronic obstructive pulmonary disease,  chronic kidney disease, type II diabetes mellitus, hyperlipidaemia, hypertension. The patient's concomitant medications were not reported.  The patient experienced immune complex mediated response due to vaccine, portal vein thrombosis,  night sweats, intermittent fever, chills, experienced a 30 pound weight loss (over the past two months) on an unspecified date. The patient underwent lab tests and procedures which included ESR: 101 (elevated), CRP: 225 (elevated), White blood cell count elevated (18 today), Procalcitonin: 1.89 (elevated), Haptoglobin: 380, Quantitative IgG: 1,664 (elevated), Antinuclear Factor 1:320 ANA (at first came out negative then positive), Beta-2glycoprotein IgG: 33.4, Antiphospholipid panel: positive, Tumor marker CA 19-9: 46 (Mildly elevated) all on an unspecified date. Negative Lab results: Negative Cultures, Covid-19, RVP, TB, Hepatitis panel, dsDNA, EBV antigen, CMV, Lyme titers, quantitative IgA and IgM, beta 2 glyco IgA, venous duplex, white cell scan, nuclear scan of bone marrow, PNH panel all on an unspecified date. Reporter inquired Are there any reports on portal vein thrombosis after receiving both doses of the Pfizer Covid-19 vaccine? The clinical course was reported as follows Medical assistant stated that she has been treating a 74 year old male patient who received the first dose of the Pfizer Covid-19 vaccine on 02FEB2021 and the second dose on 24FEB2021 and after two weeks of receiving the second dose the patient  started experiencing night sweats (2-3 times a night), intermittent fever of unknown origin and chills, he experienced a 30 pound weight loss (over the past two months) and portal vein thrombosis, at this point the differential includes an immune complex mediated response due to vaccine. He has been admitted for two weeks (admitted on 20APR2021) and performed rheumatology, oncology, hematology panels and ruled out infectious causes. It was also reported They did a full work up but nothing came up except that PRIVACY has a portal vein thrombosis. They are wondering if it is related to the vaccine and if there are some reports regarding this side effects. First dose of the vaccine was given 02Feb or 03Feb (reporter is not sure). Second dose of the vaccine was given 24Feb2021. The clinical outcome of the events was unknown
Sex: M
Vaccine: COVID19
Symptoms: Bone marrow failure, Bone marrow myelogram abnormal, C-reactive protein increased, COVID-19, Carbohydrate antigen 19-9
Clinical narrative: immune complex mediated response due to vaccine; portal vein thrombosis; experienced a 30 pound weight loss (over the past two months); night sweats; intermittent fever of unknown origin; chills; This is a spontaneous report from a contactable health care profession and follow up report from a contactable consumer via Pfizer-sponsored program.  A 74-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ),  via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Not provided) as 2nd dose, single for covid-19 immunisation  .  Medical history included coronary artery,  chronic obstructive pulmonary disease,  chronic kidney disease, type II diabetes mellitus, hyperlipidaemia, hypertension. The patient's concomitant medications were not reported.  The patient experienced immune complex mediated response due to vaccine, portal vein thrombosis,  night sweats, intermittent fever, chills, experienced a 30 pound weight loss (over the past two months) on an unspecified date. The patient underwent lab tests and procedures which included ESR: 101 (elevated), CRP: 225 (elevated), White blood cell count elevated (18 today), Procalcitonin: 1.89 (elevated), Haptoglobin: 380, Quantitative IgG: 1,664 (elevated), Antinuclear Factor 1:320 ANA (at first came out negative then positive), Beta-2glycoprotein IgG: 33.4, Antiphospholipid panel: positive, Tumor marker CA 19-9: 46 (Mildly elevated) all on an unspecified date. Negative Lab results: Negative Cultures, Covid-19, RVP, TB, Hepatitis panel, dsDNA, EBV antigen, CMV, Lyme titers, quantitative IgA and IgM, beta 2 glyco IgA, venous duplex, white cell scan, nuclear scan of bone marrow, PNH panel all on an unspecified date. Reporter inquired Are there any reports on portal vein thrombosis after receiving both doses of the Pfizer Covid-19 vaccine? The clinical course was reported as follows Medical assistant stated that she has been treating a 74 year old male patient who received the first dose of the Pfizer Covid-19 vaccine on 02FEB2021 and the second dose on 24FEB2021 and after two weeks of receiving the second dose the patient  started experiencing night sweats (2-3 times a night), intermittent fever of unknown origin and chills, he experienced a 30 pound weight loss (over the past two months) and portal vein thrombosis, at this point the differential includes an immune complex mediated response due to vaccine. He has been admitted for two weeks (admitted on 20APR2021) and performed rheumatology, oncology, hematology panels and ruled out infectious causes. It was also reported They did a full work up but nothing came up except that PRIVACY has a portal vein thrombosis. They are wondering if it is related to the vaccine and if there are some reports regarding this side effects. First dose of the vaccine was given 02Feb or 03Feb (reporter is not sure). Second dose of the vaccine was given 24Feb2021. The clinical outcome of the events was unknown
Sex: M
Vaccine: COVID19
Symptoms: Chills, Culture, Cytomegalovirus test negative, Double stranded DNA antibody, Epstein-Barr virus antibody positive
Clinical narrative: immune complex mediated response due to vaccine; portal vein thrombosis; experienced a 30 pound weight loss (over the past two months); night sweats; intermittent fever of unknown origin; chills; This is a spontaneous report from a contactable health care profession and follow up report from a contactable consumer via Pfizer-sponsored program.  A 74-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ),  via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Not provided) as 2nd dose, single for covid-19 immunisation  .  Medical history included coronary artery,  chronic obstructive pulmonary disease,  chronic kidney disease, type II diabetes mellitus, hyperlipidaemia, hypertension. The patient's concomitant medications were not reported.  The patient experienced immune complex mediated response due to vaccine, portal vein thrombosis,  night sweats, intermittent fever, chills, experienced a 30 pound weight loss (over the past two months) on an unspecified date. The patient underwent lab tests and procedures which included ESR: 101 (elevated), CRP: 225 (elevated), White blood cell count elevated (18 today), Procalcitonin: 1.89 (elevated), Haptoglobin: 380, Quantitative IgG: 1,664 (elevated), Antinuclear Factor 1:320 ANA (at first came out negative then positive), Beta-2glycoprotein IgG: 33.4, Antiphospholipid panel: positive, Tumor marker CA 19-9: 46 (Mildly elevated) all on an unspecified date. Negative Lab results: Negative Cultures, Covid-19, RVP, TB, Hepatitis panel, dsDNA, EBV antigen, CMV, Lyme titers, quantitative IgA and IgM, beta 2 glyco IgA, venous duplex, white cell scan, nuclear scan of bone marrow, PNH panel all on an unspecified date. Reporter inquired Are there any reports on portal vein thrombosis after receiving both doses of the Pfizer Covid-19 vaccine? The clinical course was reported as follows Medical assistant stated that she has been treating a 74 year old male patient who received the first dose of the Pfizer Covid-19 vaccine on 02FEB2021 and the second dose on 24FEB2021 and after two weeks of receiving the second dose the patient  started experiencing night sweats (2-3 times a night), intermittent fever of unknown origin and chills, he experienced a 30 pound weight loss (over the past two months) and portal vein thrombosis, at this point the differential includes an immune complex mediated response due to vaccine. He has been admitted for two weeks (admitted on 20APR2021) and performed rheumatology, oncology, hematology panels and ruled out infectious causes. It was also reported They did a full work up but nothing came up except that PRIVACY has a portal vein thrombosis. They are wondering if it is related to the vaccine and if there are some reports regarding this side effects. First dose of the vaccine was given 02Feb or 03Feb (reporter is not sure). Second dose of the vaccine was given 24Feb2021. The clinical outcome of the events was unknown
Sex: M
Vaccine: COVID19
Symptoms: Haptoglobin, Hepatitis viral test, Immune system disorder, Investigation, Lyme disease
Clinical narrative: immune complex mediated response due to vaccine; portal vein thrombosis; experienced a 30 pound weight loss (over the past two months); night sweats; intermittent fever of unknown origin; chills; This is a spontaneous report from a contactable health care profession and follow up report from a contactable consumer via Pfizer-sponsored program.  A 74-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ),  via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Not provided) as 2nd dose, single for covid-19 immunisation  .  Medical history included coronary artery,  chronic obstructive pulmonary disease,  chronic kidney disease, type II diabetes mellitus, hyperlipidaemia, hypertension. The patient's concomitant medications were not reported.  The patient experienced immune complex mediated response due to vaccine, portal vein thrombosis,  night sweats, intermittent fever, chills, experienced a 30 pound weight loss (over the past two months) on an unspecified date. The patient underwent lab tests and procedures which included ESR: 101 (elevated), CRP: 225 (elevated), White blood cell count elevated (18 today), Procalcitonin: 1.89 (elevated), Haptoglobin: 380, Quantitative IgG: 1,664 (elevated), Antinuclear Factor 1:320 ANA (at first came out negative then positive), Beta-2glycoprotein IgG: 33.4, Antiphospholipid panel: positive, Tumor marker CA 19-9: 46 (Mildly elevated) all on an unspecified date. Negative Lab results: Negative Cultures, Covid-19, RVP, TB, Hepatitis panel, dsDNA, EBV antigen, CMV, Lyme titers, quantitative IgA and IgM, beta 2 glyco IgA, venous duplex, white cell scan, nuclear scan of bone marrow, PNH panel all on an unspecified date. Reporter inquired Are there any reports on portal vein thrombosis after receiving both doses of the Pfizer Covid-19 vaccine? The clinical course was reported as follows Medical assistant stated that she has been treating a 74 year old male patient who received the first dose of the Pfizer Covid-19 vaccine on 02FEB2021 and the second dose on 24FEB2021 and after two weeks of receiving the second dose the patient  started experiencing night sweats (2-3 times a night), intermittent fever of unknown origin and chills, he experienced a 30 pound weight loss (over the past two months) and portal vein thrombosis, at this point the differential includes an immune complex mediated response due to vaccine. He has been admitted for two weeks (admitted on 20APR2021) and performed rheumatology, oncology, hematology panels and ruled out infectious causes. It was also reported They did a full work up but nothing came up except that PRIVACY has a portal vein thrombosis. They are wondering if it is related to the vaccine and if there are some reports regarding this side effects. First dose of the vaccine was given 02Feb or 03Feb (reporter is not sure). Second dose of the vaccine was given 24Feb2021. The clinical outcome of the events was unknown
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Portal vein thrombosis, Procalcitonin, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: immune complex mediated response due to vaccine; portal vein thrombosis; experienced a 30 pound weight loss (over the past two months); night sweats; intermittent fever of unknown origin; chills; This is a spontaneous report from a contactable health care profession and follow up report from a contactable consumer via Pfizer-sponsored program.  A 74-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ),  via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Not provided) as 2nd dose, single for covid-19 immunisation  .  Medical history included coronary artery,  chronic obstructive pulmonary disease,  chronic kidney disease, type II diabetes mellitus, hyperlipidaemia, hypertension. The patient's concomitant medications were not reported.  The patient experienced immune complex mediated response due to vaccine, portal vein thrombosis,  night sweats, intermittent fever, chills, experienced a 30 pound weight loss (over the past two months) on an unspecified date. The patient underwent lab tests and procedures which included ESR: 101 (elevated), CRP: 225 (elevated), White blood cell count elevated (18 today), Procalcitonin: 1.89 (elevated), Haptoglobin: 380, Quantitative IgG: 1,664 (elevated), Antinuclear Factor 1:320 ANA (at first came out negative then positive), Beta-2glycoprotein IgG: 33.4, Antiphospholipid panel: positive, Tumor marker CA 19-9: 46 (Mildly elevated) all on an unspecified date. Negative Lab results: Negative Cultures, Covid-19, RVP, TB, Hepatitis panel, dsDNA, EBV antigen, CMV, Lyme titers, quantitative IgA and IgM, beta 2 glyco IgA, venous duplex, white cell scan, nuclear scan of bone marrow, PNH panel all on an unspecified date. Reporter inquired Are there any reports on portal vein thrombosis after receiving both doses of the Pfizer Covid-19 vaccine? The clinical course was reported as follows Medical assistant stated that she has been treating a 74 year old male patient who received the first dose of the Pfizer Covid-19 vaccine on 02FEB2021 and the second dose on 24FEB2021 and after two weeks of receiving the second dose the patient  started experiencing night sweats (2-3 times a night), intermittent fever of unknown origin and chills, he experienced a 30 pound weight loss (over the past two months) and portal vein thrombosis, at this point the differential includes an immune complex mediated response due to vaccine. He has been admitted for two weeks (admitted on 20APR2021) and performed rheumatology, oncology, hematology panels and ruled out infectious causes. It was also reported They did a full work up but nothing came up except that PRIVACY has a portal vein thrombosis. They are wondering if it is related to the vaccine and if there are some reports regarding this side effects. First dose of the vaccine was given 02Feb or 03Feb (reporter is not sure). Second dose of the vaccine was given 24Feb2021. The clinical outcome of the events was unknown
Sex: M
Vaccine: COVID19
Symptoms: Tuberculosis, Ultrasound Doppler, Weight decreased, White blood cell count, White blood cell scan
Clinical narrative: immune complex mediated response due to vaccine; portal vein thrombosis; experienced a 30 pound weight loss (over the past two months); night sweats; intermittent fever of unknown origin; chills; This is a spontaneous report from a contactable health care profession and follow up report from a contactable consumer via Pfizer-sponsored program.  A 74-years-old male patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ),  via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: Not provided) as 2nd dose, single for covid-19 immunisation  .  Medical history included coronary artery,  chronic obstructive pulmonary disease,  chronic kidney disease, type II diabetes mellitus, hyperlipidaemia, hypertension. The patient's concomitant medications were not reported.  The patient experienced immune complex mediated response due to vaccine, portal vein thrombosis,  night sweats, intermittent fever, chills, experienced a 30 pound weight loss (over the past two months) on an unspecified date. The patient underwent lab tests and procedures which included ESR: 101 (elevated), CRP: 225 (elevated), White blood cell count elevated (18 today), Procalcitonin: 1.89 (elevated), Haptoglobin: 380, Quantitative IgG: 1,664 (elevated), Antinuclear Factor 1:320 ANA (at first came out negative then positive), Beta-2glycoprotein IgG: 33.4, Antiphospholipid panel: positive, Tumor marker CA 19-9: 46 (Mildly elevated) all on an unspecified date. Negative Lab results: Negative Cultures, Covid-19, RVP, TB, Hepatitis panel, dsDNA, EBV antigen, CMV, Lyme titers, quantitative IgA and IgM, beta 2 glyco IgA, venous duplex, white cell scan, nuclear scan of bone marrow, PNH panel all on an unspecified date. Reporter inquired Are there any reports on portal vein thrombosis after receiving both doses of the Pfizer Covid-19 vaccine? The clinical course was reported as follows Medical assistant stated that she has been treating a 74 year old male patient who received the first dose of the Pfizer Covid-19 vaccine on 02FEB2021 and the second dose on 24FEB2021 and after two weeks of receiving the second dose the patient  started experiencing night sweats (2-3 times a night), intermittent fever of unknown origin and chills, he experienced a 30 pound weight loss (over the past two months) and portal vein thrombosis, at this point the differential includes an immune complex mediated response due to vaccine. He has been admitted for two weeks (admitted on 20APR2021) and performed rheumatology, oncology, hematology panels and ruled out infectious causes. It was also reported They did a full work up but nothing came up except that PRIVACY has a portal vein thrombosis. They are wondering if it is related to the vaccine and if there are some reports regarding this side effects. First dose of the vaccine was given 02Feb or 03Feb (reporter is not sure). Second dose of the vaccine was given 24Feb2021. The clinical outcome of the events was unknown
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Henoch-Schonlein purpura, Vasculitis
Clinical narrative: Henoch-Schonlien purpura/nasty rash, severe joint paint and itchy/burning skin; vasculitis; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: Lot Number: EW0164), via an unspecified route of administration, administered in the left arm on 22Apr2021 at 17:00 as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, levonorgestrel (VIENVA); ibuprofen, phenylephrine hydrochloride (manufacturer unknown); montelukast (manufacturer unknown) and loratadine (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19. The patient previously received the first dose of BNT162B2 on 01Apr2021 at 16:00 (lot number: er8733) on the left arm for COVID-19 immunization. On 24Apr2021 the patient experienced Henoch-Schonlien purpura (vasculitis). The patient had a nasty rash, severe joint pains and itchy/burning skin. The patient visited the emergency room/department or urgent care due to the events. The patient was prescribed steroids as treatment for the event. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms, Pain, Walking disability, X-ray of pelvis and hip
Clinical narrative: extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk; could not walk/she was not able to walk; she was not able to walk or sleep for two weeks due to the spasms and pain; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12Apr2021 at 11:30 (Batch/Lot Number: ER8731) as single dose, for covid-19 immunization. Medical history included "gluten" (reported as past drug history), hypothyroidism, fibromyalgia, mitochondrial retrovirus and obese. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included levothyroxine sodium (LEVOXYL), sertraline, colecalciferol (D3), antioxidants and "pregneolon"; all taken from unspecified dates, for unspecified indications. Patient previously took the first dose of BNT162B2 (Batch/lot number: FR2613) on 22Mar2021 in the left arm for COVID-19 immunization. On 15Apr2021 at 10:00 (three days after the second dose), patient had extreme pain from muscle spasms all over her body, but so badly in her left leg from hip down that she could not walk. Her ER visit for pain yielded a script for hydromorphone and cyclobenzaprine. Even with these drugs, she was not able to walk or sleep for two weeks due to the spasms and pain. It has been three weeks since the 2nd dose, and still have limited standing time, due to the after effects. I'd get the vaccine again, but the level of pain was extremely bad.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: developed Bell's Palsy on the right side of my face; This is a spontaneous report from a contactable consumer (patient) This 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EW0164), dose 1, via an unspecified route of administration in the left arm on 16Apr2021 at 14:00 (at the age of 44-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included seizure from an unknown date and unknown if ongoing (Seizure disorder-7 years no seizure, 5 years no medication) and penicillin allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin [erythromycin estolate] and experienced hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 14:00, the patient developed Bell's palsy on the right said of her face. The event resulted in an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab) (03May2021): pending results. Therapeutic measures taken included unspecified steroids and unspecified anti-viral medications. Clinical outcome of the event developed Bell's palsy was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Multiple sclerosis relapse, Pain in extremity, SARS-CoV-2 test
Clinical narrative: MS relapse; Flu-like symptoms; Crawling/could barely walk with the cane; Tired/ very fatigue; Pain began in both legs, mostly my right leg but was severe in left leg also; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 26Feb2021 12:45 (Lot Number: EL3302) as single dose for COVID-19 immunisation. Medical history included Hashimoto's Thyroiditis; Multiple Sclerosis; Gluten Sensitive. The patient was not pregnant at time of vaccination. Concomitant medications included Armour Thyroid, low dose Aspirin and Vitamins (received within 2 weeks of vaccination). Historical Vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 29Jan2021 11:00 (Lot Number: EK4176/6022879) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Benadryl and experienced allergies. The patient, after receiving the vaccine, felt tired and had flu-like symptoms. she got into bed within 2 hours+ over the course of the next 48 hours she was very fatigue and the SEVERE pain began in both legs, mostly her right leg but was severe in left leg also. She eventually contacted 911 and was brought to ER. They did an ultrasound of her right leg and X-ray, found nothing and released her. The pain was still excruciating and she could barely walk with the cane they gave her and brace. The next day she was frozen in bed and contacted 911 and the ambulance took her, per her request to a different hospital. She requested a consult from a neurologist because she feared that she was having a MS relapse which was indeed the case. She was released after being given a percocet and told she can go to a neurologist on her own. The reason why this occurred was being investigated by the hospital. On day 3 Adult Protection was called because the lovely Social Worker in her building found out she was crawling. Adverse events started at 13:00 on 28Feb2021, and they resulted in "Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care". The patient was hospitalized for 2 days. The treatment for events included pain medication and assistance with personal care. The patient did not diagnose with COVID-19 prior to vaccination but she tested it post vaccination with not provided result. Events outcome was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Walking disability, X-ray
Clinical narrative: MS relapse; Flu-like symptoms; Crawling/could barely walk with the cane; Tired/ very fatigue; Pain began in both legs, mostly my right leg but was severe in left leg also; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 26Feb2021 12:45 (Lot Number: EL3302) as single dose for COVID-19 immunisation. Medical history included Hashimoto's Thyroiditis; Multiple Sclerosis; Gluten Sensitive. The patient was not pregnant at time of vaccination. Concomitant medications included Armour Thyroid, low dose Aspirin and Vitamins (received within 2 weeks of vaccination). Historical Vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 29Jan2021 11:00 (Lot Number: EK4176/6022879) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took Benadryl and experienced allergies. The patient, after receiving the vaccine, felt tired and had flu-like symptoms. she got into bed within 2 hours+ over the course of the next 48 hours she was very fatigue and the SEVERE pain began in both legs, mostly her right leg but was severe in left leg also. She eventually contacted 911 and was brought to ER. They did an ultrasound of her right leg and X-ray, found nothing and released her. The pain was still excruciating and she could barely walk with the cane they gave her and brace. The next day she was frozen in bed and contacted 911 and the ambulance took her, per her request to a different hospital. She requested a consult from a neurologist because she feared that she was having a MS relapse which was indeed the case. She was released after being given a percocet and told she can go to a neurologist on her own. The reason why this occurred was being investigated by the hospital. On day 3 Adult Protection was called because the lovely Social Worker in her building found out she was crawling. Adverse events started at 13:00 on 28Feb2021, and they resulted in "Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care". The patient was hospitalized for 2 days. The treatment for events included pain medication and assistance with personal care. The patient did not diagnose with COVID-19 prior to vaccination but she tested it post vaccination with not provided result. Events outcome was recovering.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Pleurisy
Clinical narrative: Chest pain; Pleurisy; discomfort in his chest (not in the lung) in the bone muscle around the lung, it feels like he has been punched right in the cardiac plexus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 79-years, on 07Apr2021 10:20 (Lot Number: EW0153) as single dose for covid-19 immunisation. Medical history included ongoing moderate to mild asthma that sometimes bothered him when he tried to sleep and maybe wheezed a bit and he had to use inhalers during the day as he cannot go to sleep if he got a wheeze; diabetes 8 or 10 years ago and he took Insulin for it; he was allergic to aspirin. Family History included that his mother had rheumatoid arthritis. The patient's concomitant medications were not reported. No additional vaccines administered on the same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of the Pfizer COVID-19 vaccine on 07Apr2021, next day (08Apr2021) he started to have discomfort across his chest like a hernia starting on the left (he started to have chest discomfort, like a hurting across the chest starting on the left and now on the right), after being checked on a medical place he was informed that he has Pleurisy, they did a chest X-ray and then they sent the information to the hospital to have a doctor look at it so he had to wait a half hour. Mentioned they wanted to put him on pain medication but he declined because he was allergic to aspirin and he only took Tylenol. He described the sensation as: a discomfort in his chest (not in the lung) in the bone muscle around the lung, it felt like he has been punched right in the cardiac plexus, now was a minor discomfort that won't go away. He cancelled his appointment to receive the second dose of the vaccine (due tomorrow) and wanted to know if he should receive the second dose at all. The patient also experienced Chest pain that started on 08May2021, but now it had shifted, and it was more on the right side. First he noticed it on the left then it moved under his sternum and now almost all of it is on the right side. The pain got up to a certain point and then it had stayed the same. Sitting he isn't feeling it but when he got up out of the chair it was worse. Seemed to be worse when he moved from a relaxed position like getting out of bed. Events of Chest discomfort and Pleurisy resulted in "Physician Office Visit". Events outcome was not recovered.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Influenza like illness, Pyrexia
Clinical narrative: fever 101.50; chilling; little dificult to breath; Like flu symptoms; Like Covid symptoms; very intense coughing for 4 days; This is a spontaneous report from contactable consumer, the patient. A 36-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the right arm on 26Apr2021 at 15:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none, the patient did not receive any other medications within 2 weeks of the vaccine. The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On an unspecified date (reported as 07Apr2021), the patient experienced COVID like symptoms, very intense coughing for 4 days, fever 101.50, chilling, a little difficult to breath, flu-like symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of COVID like symptoms, very intense coughing for 4 days, fever 101.50, chilling, a little difficult to breath, flu-like symptoms was unknown.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: fever 101.50; chilling; little dificult to breath; Like flu symptoms; Like Covid symptoms; very intense coughing for 4 days; This is a spontaneous report from contactable consumer, the patient. A 36-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown), via an unspecified route of administration in the right arm on 26Apr2021 at 15:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none, the patient did not receive any other medications within 2 weeks of the vaccine. The patient did not receive any other vaccinations within 4 weeks prior to the vaccine. On an unspecified date (reported as 07Apr2021), the patient experienced COVID like symptoms, very intense coughing for 4 days, fever 101.50, chilling, a little difficult to breath, flu-like symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of COVID like symptoms, very intense coughing for 4 days, fever 101.50, chilling, a little difficult to breath, flu-like symptoms was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: muscle weakness(generalized)  1/7/2021; This is a spontaneous report received from contactable other healthcare professional. This other healthcare professional reported different events with each dose of the same product; this case refers to dose 1. An 88-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot EJI685 expiry information not provided) as a single dose in the right arm on 05Jan2021 at 14:30 (at 88-years-old) for COVID-19 immunization. History of previous allergies included codeine phosphate, morphine, HCL, peanuts, sulfites, and pethidine hydrochloride (DEMEROL). There were no concomitant medications reported. The patient did not receive any recent vaccines for any other conditions prior to the event; the patient did not receive any recent vaccines for SARS CoV-2 other than Pfizer BioNTech COVID-19 vaccine prior to the event; and the patient did not receive any recent vaccines around the time of Pfizer BioNTech COVID-19 vaccine. On 07Jan2021 the patient experienced muscle weakness(generalized). The outcome of the event muscle weakness(generalized) was unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423227 PFIZER (Same reporter/patient/product, different dose/event)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Measles, Ocular hyperaemia, Pruritus
Clinical narrative: It was itchy like hives but looked like measles; broke out in a rash on trunk that quickly spread from chin to toes that evening; It was itchy like hives but looked like measles.; It was itchy like hives but looked like measles.; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 43-year-old female patient (no Pregnancy at time of Vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 at the age of 43 years old (Lot Number: ER8730) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient never had allergic reaction before. On 08Apr2021 (day 9 post vaccine), the patient's left eye swelled shut and was itchy and red. She assumed she had pink eye and was treated accordingly. It did not go away. On 15Apr2021 (Day 16), she broke out in a rash on trunk that quickly spread from chin to toes that evening. It was itchy like hives but looked like measles. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Eye drops and steroid creams and antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: It was itchy like hives but looked like measles; broke out in a rash on trunk that quickly spread from chin to toes that evening; It was itchy like hives but looked like measles.; It was itchy like hives but looked like measles.; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; left eye swelled shut and was itchy and red; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 43-year-old female patient (no Pregnancy at time of Vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 at the age of 43 years old (Lot Number: ER8730) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient never had allergic reaction before. On 08Apr2021 (day 9 post vaccine), the patient's left eye swelled shut and was itchy and red. She assumed she had pink eye and was treated accordingly. It did not go away. On 15Apr2021 (Day 16), she broke out in a rash on trunk that quickly spread from chin to toes that evening. It was itchy like hives but looked like measles. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Eye drops and steroid creams and antihistamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Road traffic accident
Clinical narrative: involved in a fender bender car accident; The pateint missed the second dose; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program, Pfizer.. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Mar2021, the patient was involved in a fender bender car accident. The patient stated it had nothing to do with the vaccine. The patient missed the second dose on 23Mar2021. The patient stated she read that as long as she got it within 6 weeks she did not have to get the second dose, she stated it has now been 8 weeks since first shot. The patient was hospitalized on 21Mar2021 and was discharged in Mid Apr2021. The outcome of the event was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the current available information, the event  Automobile accident  is most likely related to an intercurrent condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.  ,Linked Report(s) : US-PFIZER INC-2021497247 same reporter, vaccine, events, different patients
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Pemphigoid, SARS-CoV-2 antibody test
Clinical narrative: Bullous Pemphigoid; This is a spontaneous report from a contactable physician. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) in Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included diabetes mellitus and hypertension; both were ongoing. The patient's concomitant medications were not reported. In Mar2021, the patient had bullous pemphigoid. The event was reported as serious (medically significant). Biopsy of the skin was highly suggestive for bullous pemphigoid on 05Apr2021; and COVID-19 antibody test was "qualitative positive" on 26Apr2021. The patient had received steroids (prednisone) and some topical cream as treatment for the event; then was prescribed with doxycycline ointment, doxycycline (oral), along with some other antibiotics, and niacinamide. The event had resulted into an emergency room visit and physician's office visit. The outcome of the event was recovering. The doctor wanted to know if Pfizer recommended the patient get his second COVID-19 Vaccine, since the patient had what appeared to be an autoimmune reaction to the first COVID-19 vaccine. The patient was scheduled for his second COVID-19 vaccine shot on 30Mar2021.  Information on the batch/lot number has been requested.; 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 Bullous pemphigoid 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
Symptoms: Blood alcohol, Blood alcohol increased, Disturbance in attention, Feeling abnormal, Loss of consciousness
Clinical narrative: Blacked out / Unconscious; Not able to concentrate very well; Brain fog; I do not feel well; Alcohol level was elevated; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: EN6208) as a single dose for COVID-19 immunisation. Medical history was not reported. Alcohol use after vaccination was reported. Concomitant medications included vitamins. The patient got the vaccine on the 14Apr2021 (also reported as 15Apr2021), but she guesses it was on Wednesday (14Apr2021). On 16Apr2021 (also reported as 17Apr2021), "two days later or in those 2 days",  she experienced a brain fog. She was not able to concentrate very well.  She didn't feel physically bad just not being able to concentrate. On Friday (16Apr2021), she went to a friend's home and had 2 glasses of wine and she also tasted a cocktail. She didn't have the cocktail, she just tasted a little bit of her cocktail. Something happened, she doesn't know, she was sitting there, having a telephone conversation. All of a sudden she told her friend that she did not feel well and apparently she kind of blacked out. The ambulance came. She doesn't remember any of this because apparently she was unconscious. The ambulance took her to the hospital. Her alcohol level was elevated and this was the part that she doesn't understand because she didn't remember that much. She only had the wine. She was wondering what effect the vaccine had with alcohol because she was not abusing the alcohol. This was very distressful for her because nothing like this has ever happened before. She thinks they treated her with fluids and some kind of a vitamin package like 'banana packer'. The patient stated she was hospitalized from 16Apr2021 to 17Apr2021. The outcome of the events blacked out / unconscious, brain fog, not being able to concentrate, did not feel well and alcohol level was elevated was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Weight
Clinical narrative: Blacked out / Unconscious; Not able to concentrate very well; Brain fog; I do not feel well; Alcohol level was elevated; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: EN6208) as a single dose for COVID-19 immunisation. Medical history was not reported. Alcohol use after vaccination was reported. Concomitant medications included vitamins. The patient got the vaccine on the 14Apr2021 (also reported as 15Apr2021), but she guesses it was on Wednesday (14Apr2021). On 16Apr2021 (also reported as 17Apr2021), "two days later or in those 2 days",  she experienced a brain fog. She was not able to concentrate very well.  She didn't feel physically bad just not being able to concentrate. On Friday (16Apr2021), she went to a friend's home and had 2 glasses of wine and she also tasted a cocktail. She didn't have the cocktail, she just tasted a little bit of her cocktail. Something happened, she doesn't know, she was sitting there, having a telephone conversation. All of a sudden she told her friend that she did not feel well and apparently she kind of blacked out. The ambulance came. She doesn't remember any of this because apparently she was unconscious. The ambulance took her to the hospital. Her alcohol level was elevated and this was the part that she doesn't understand because she didn't remember that much. She only had the wine. She was wondering what effect the vaccine had with alcohol because she was not abusing the alcohol. This was very distressful for her because nothing like this has ever happened before. She thinks they treated her with fluids and some kind of a vitamin package like 'banana packer'. The patient stated she was hospitalized from 16Apr2021 to 17Apr2021. The outcome of the events blacked out / unconscious, brain fog, not being able to concentrate, did not feel well and alcohol level was elevated was unknown.