chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Neck pain
Clinical narrative: Dull pressing pain in the whole right side of his chest; Headache; Pain was radiating up his back and shoulders into his neck; Pain was radiating up his back and shoulders into his neck; Pain was radiating up his back and shoulders into his neck; Third night he started to shiver; he sweat a lot; This is a spontaneous report from a contactable consumer (patient) reported for a himself that. A male patient of an unspecified age received second dose bnt162b2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose bnt162b2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unknown date, the caller stated he had both doses of the vaccine. He stated he had a couple episodes of symptoms after the second dose. He had no problem with the first vaccine. 26 hours after the second shot he experienced dull pressing pain in the whole right side of his chest, kind of a pressure like on the lung spread over the whole area there. He took a TYLENOL and it went away and 10 days later had the same experience but it was the whole chest and the pain was radiating up his back and shoulders into his neck and he started having headache on an unknown date. He took a couple Tylenol and it went away but the next night had he same symptoms and the next couple nights he had the same symptoms and he took a couple Tylenol and went to bed. On the third night he started to shiver, like internal shivering and he couldn't get comfortable for about an hour and 15-20 min. Then he sweat a lot after that on an unknown date. At no time did he have a fever. He called the primary care physician and he suggested he call the cardiologist and had an appointment with him a couple days later. The next day he had symptoms again and he went to the Emergency Room and they performed tests as if he was having a heart attack, because he was having heart attack symptoms, and the tests were all negative. They were going to hold him over night but he had a stress test scheduled the next day so they let him leave and he had that test the next day and everything was negative and they couldn't find anything. Still when he wakes up he has the chest pain and they told him to still take Tylenol. The doctor prescribed nitroglycerin pills and nitroglycerin pain patches. He has not used any of those because the pain is not severe enough. He is reporting these but also wondering if other people have experienced these symptoms and he asked if it is possible that he got the side effects from the shot or is it a coincidence. The outcome of the events were unknown
Age: 33.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Injection site injury, Injection site pain, Joint range of motion decreased
Clinical narrative: Employee requesting influenza vaccine - administered at employee health clinic.  Developed tenderness within 24 hours after injection and persistent shoulder aches and lack of range of motion, persisting to current day.
Age: 33.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Tenderness
Clinical narrative: Employee requesting influenza vaccine - administered at employee health clinic.  Developed tenderness within 24 hours after injection and persistent shoulder aches and lack of range of motion, persisting to current day.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute generalised exanthematous pustulosis, Biopsy skin abnormal, C-reactive protein, Drug eruption, Eosinophils urine
Clinical narrative: rash swelling
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pustule, Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash swelling
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, Skin exfoliation, Swelling, Urine analysis
Clinical narrative: rash swelling
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling
Clinical narrative: rash swelling
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Computerised tomogram head, Computerised tomogram spine, Computerised tomogram thorax, Dehydration
Clinical narrative: Fainted; Fainted; lightheadedness; drop in blood pressure; sweats; clammyness; major chills; shaking; nausea; vomiting; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 15:45 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Medical history included minor history of fainting (4x in 15 years). The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); omeprazole; fish oil, vitamins etc. The patient had no COVID prior to vaccination. The patient felt great initially. Fainted in response to lightheadedness (drop in blood pressure) 4 hours later on 12Mar2021 at 07:30 PM - on a hardwood floor. 7 stitches after an ambulance ride and multiple CT scans. Also had sweats/clammyness, major chills (shaking), and nausea and vomiting over the next 12 hours or so. Spent 2 nights in the hospital to rule out other causes for fainting. The received the following as treatment for the events: stitches, IV to rehydrate and anti-nausea meds. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for two days. The patient tested negative on a COVID-19 test via nasal swab on 12Mar2021. The patient was recovering from the events.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Nausea, Rib fracture
Clinical narrative: Fainted; Fainted; lightheadedness; drop in blood pressure; sweats; clammyness; major chills; shaking; nausea; vomiting; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 15:45 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Medical history included minor history of fainting (4x in 15 years). The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); omeprazole; fish oil, vitamins etc. The patient had no COVID prior to vaccination. The patient felt great initially. Fainted in response to lightheadedness (drop in blood pressure) 4 hours later on 12Mar2021 at 07:30 PM - on a hardwood floor. 7 stitches after an ambulance ride and multiple CT scans. Also had sweats/clammyness, major chills (shaking), and nausea and vomiting over the next 12 hours or so. Spent 2 nights in the hospital to rule out other causes for fainting. The received the following as treatment for the events: stitches, IV to rehydrate and anti-nausea meds. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for two days. The patient tested negative on a COVID-19 test via nasal swab on 12Mar2021. The patient was recovering from the events.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin laceration, Suture insertion, Syncope, Tremor, Ultrasound Doppler
Clinical narrative: Fainted; Fainted; lightheadedness; drop in blood pressure; sweats; clammyness; major chills; shaking; nausea; vomiting; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 15:45 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Medical history included minor history of fainting (4x in 15 years). The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); omeprazole; fish oil, vitamins etc. The patient had no COVID prior to vaccination. The patient felt great initially. Fainted in response to lightheadedness (drop in blood pressure) 4 hours later on 12Mar2021 at 07:30 PM - on a hardwood floor. 7 stitches after an ambulance ride and multiple CT scans. Also had sweats/clammyness, major chills (shaking), and nausea and vomiting over the next 12 hours or so. Spent 2 nights in the hospital to rule out other causes for fainting. The received the following as treatment for the events: stitches, IV to rehydrate and anti-nausea meds. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for two days. The patient tested negative on a COVID-19 test via nasal swab on 12Mar2021. The patient was recovering from the events.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Cold sweat, Computerised tomogram
Clinical narrative: Fainted; Fainted; lightheadedness; drop in blood pressure; sweats; clammyness; major chills; shaking; nausea; vomiting; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 15:45 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Medical history included minor history of fainting (4x in 15 years). The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); omeprazole; fish oil, vitamins etc. The patient had no COVID prior to vaccination. The patient felt great initially. Fainted in response to lightheadedness (drop in blood pressure) 4 hours later on 12Mar2021 at 07:30 PM - on a hardwood floor. 7 stitches after an ambulance ride and multiple CT scans. Also had sweats/clammyness, major chills (shaking), and nausea and vomiting over the next 12 hours or so. Spent 2 nights in the hospital to rule out other causes for fainting. The received the following as treatment for the events: stitches, IV to rehydrate and anti-nausea meds. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for two days. The patient tested negative on a COVID-19 test via nasal swab on 12Mar2021. The patient was recovering from the events.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Dizziness, Hyperhidrosis, Nausea, SARS-CoV-2 test
Clinical narrative: Fainted; Fainted; lightheadedness; drop in blood pressure; sweats; clammyness; major chills; shaking; nausea; vomiting; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 15:45 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Medical history included minor history of fainting (4x in 15 years). The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); omeprazole; fish oil, vitamins etc. The patient had no COVID prior to vaccination. The patient felt great initially. Fainted in response to lightheadedness (drop in blood pressure) 4 hours later on 12Mar2021 at 07:30 PM - on a hardwood floor. 7 stitches after an ambulance ride and multiple CT scans. Also had sweats/clammyness, major chills (shaking), and nausea and vomiting over the next 12 hours or so. Spent 2 nights in the hospital to rule out other causes for fainting. The received the following as treatment for the events: stitches, IV to rehydrate and anti-nausea meds. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for two days. The patient tested negative on a COVID-19 test via nasal swab on 12Mar2021. The patient was recovering from the events.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: Fainted; Fainted; lightheadedness; drop in blood pressure; sweats; clammyness; major chills; shaking; nausea; vomiting; This is a spontaneous report from a contactable consumer reporting for himself. A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in the left arm on 12Mar2021 15:45 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Medical history included minor history of fainting (4x in 15 years). The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); omeprazole; fish oil, vitamins etc. The patient had no COVID prior to vaccination. The patient felt great initially. Fainted in response to lightheadedness (drop in blood pressure) 4 hours later on 12Mar2021 at 07:30 PM - on a hardwood floor. 7 stitches after an ambulance ride and multiple CT scans. Also had sweats/clammyness, major chills (shaking), and nausea and vomiting over the next 12 hours or so. Spent 2 nights in the hospital to rule out other causes for fainting. The received the following as treatment for the events: stitches, IV to rehydrate and anti-nausea meds. The events resulted to doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for two days. The patient tested negative on a COVID-19 test via nasal swab on 12Mar2021. The patient was recovering from the events.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: raised bumps formed on my face; Itching over entire body; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right ram on 01Mar2021 15:30 (Lot Number: EM9809) at single dose for COVID-19 immunization. Medical history included none. Concomitant medications included desvenlafaxine succinate (PRISTIQ); vitamin d3; hair skin and nails vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EL3302) at the age of 33 years old in left arm on 01Feb2021 14:00 for COVID-19 immunization. The patient experienced injection site was swollen, red, warm, and firm for 7 days after injection, on 01Mar2021 16:30. Itching over entire body started 03Mar2021 and was ongoing as of 09Mar2021. Raised bumps formed on her face on 06Mar2021 and moved around until 08Mar2021. Was prescribed Hydroxyzine which has not controlled the itching. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 04Mar2021 with result of negative. Patient was not pregnant at the time of vaccination. The adverse events were considered non-serious per reporter. The outcome of the events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: raised bumps formed on my face; Itching over entire body; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right ram on 01Mar2021 15:30 (Lot Number: EM9809) at single dose for COVID-19 immunization. Medical history included none. Concomitant medications included desvenlafaxine succinate (PRISTIQ); vitamin d3; hair skin and nails vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EL3302) at the age of 33 years old in left arm on 01Feb2021 14:00 for COVID-19 immunization. The patient experienced injection site was swollen, red, warm, and firm for 7 days after injection, on 01Mar2021 16:30. Itching over entire body started 03Mar2021 and was ongoing as of 09Mar2021. Raised bumps formed on her face on 06Mar2021 and moved around until 08Mar2021. Was prescribed Hydroxyzine which has not controlled the itching. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 04Mar2021 with result of negative. Patient was not pregnant at the time of vaccination. The adverse events were considered non-serious per reporter. The outcome of the events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Skin disorder, Vaccination site erythema, Vaccination site reaction
Clinical narrative: raised bumps formed on my face; Itching over entire body; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right ram on 01Mar2021 15:30 (Lot Number: EM9809) at single dose for COVID-19 immunization. Medical history included none. Concomitant medications included desvenlafaxine succinate (PRISTIQ); vitamin d3; hair skin and nails vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EL3302) at the age of 33 years old in left arm on 01Feb2021 14:00 for COVID-19 immunization. The patient experienced injection site was swollen, red, warm, and firm for 7 days after injection, on 01Mar2021 16:30. Itching over entire body started 03Mar2021 and was ongoing as of 09Mar2021. Raised bumps formed on her face on 06Mar2021 and moved around until 08Mar2021. Was prescribed Hydroxyzine which has not controlled the itching. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 04Mar2021 with result of negative. Patient was not pregnant at the time of vaccination. The adverse events were considered non-serious per reporter. The outcome of the events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: raised bumps formed on my face; Itching over entire body; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; Injection site was swollen, red, warm, and firm for 7 days after injection.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in right ram on 01Mar2021 15:30 (Lot Number: EM9809) at single dose for COVID-19 immunization. Medical history included none. Concomitant medications included desvenlafaxine succinate (PRISTIQ); vitamin d3; hair skin and nails vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EL3302) at the age of 33 years old in left arm on 01Feb2021 14:00 for COVID-19 immunization. The patient experienced injection site was swollen, red, warm, and firm for 7 days after injection, on 01Mar2021 16:30. Itching over entire body started 03Mar2021 and was ongoing as of 09Mar2021. Raised bumps formed on her face on 06Mar2021 and moved around until 08Mar2021. Was prescribed Hydroxyzine which has not controlled the itching. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Nasal Swab on 04Mar2021 with result of negative. Patient was not pregnant at the time of vaccination. The adverse events were considered non-serious per reporter. The outcome of the events was not recovered.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot
Clinical narrative: The patient is a healthy 33 yo female who reports AE after receipt of COVID vaccine Pfizer BioNTech (ER8730) 24 MAR 2021 and about 10 minutes after receipt experienced lightheadedness, cold sweats and felt unsteady. Staff checked HR and she recalls being told it was OK. She was briefly monitored and in about 10 minutes symptoms were resolved. She denies pruritis, urticaria, oral/face/throat/tongue swelling, red watery eyes, rhinorrhea, SOB, wheezing, cough, CP, n/v/d.  She reports a history of lightheadedness after blood draws. She states she has had them drawn lying down which has resolved the problem.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Cold sweat, Dizziness
Clinical narrative: The patient is a healthy 33 yo female who reports AE after receipt of COVID vaccine Pfizer BioNTech (ER8730) 24 MAR 2021 and about 10 minutes after receipt experienced lightheadedness, cold sweats and felt unsteady. Staff checked HR and she recalls being told it was OK. She was briefly monitored and in about 10 minutes symptoms were resolved. She denies pruritis, urticaria, oral/face/throat/tongue swelling, red watery eyes, rhinorrhea, SOB, wheezing, cough, CP, n/v/d.  She reports a history of lightheadedness after blood draws. She states she has had them drawn lying down which has resolved the problem.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autoimmune haemolytic anaemia
Clinical narrative: Patient presented to the office 3weeks after his first  Pfizer Covid shot (which he got at VA ) with symptoms of fatigue and dizziness. he was found to have acute hemolytic anemia which was progressive ad required hospitalization ( hemoglobin level dropped to 5.5). He was treated with blood transfusions and prednisone with improvement of counts. Luckily , he did not get his second covid shot due to feeling poorly prior to booster dose.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin, Blood iron, Blood lactate dehydrogenase, Blood smear test, Crossmatch
Clinical narrative: Patient presented to the office 3weeks after his first  Pfizer Covid shot (which he got at VA ) with symptoms of fatigue and dizziness. he was found to have acute hemolytic anemia which was progressive ad required hospitalization ( hemoglobin level dropped to 5.5). He was treated with blood transfusions and prednisone with improvement of counts. Luckily , he did not get his second covid shot due to feeling poorly prior to booster dose.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Full blood count, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: Patient presented to the office 3weeks after his first  Pfizer Covid shot (which he got at VA ) with symptoms of fatigue and dizziness. he was found to have acute hemolytic anemia which was progressive ad required hospitalization ( hemoglobin level dropped to 5.5). He was treated with blood transfusions and prednisone with improvement of counts. Luckily , he did not get his second covid shot due to feeling poorly prior to booster dose.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Reticulocyte count, Transfusion, Vitamin B12
Clinical narrative: Patient presented to the office 3weeks after his first  Pfizer Covid shot (which he got at VA ) with symptoms of fatigue and dizziness. he was found to have acute hemolytic anemia which was progressive ad required hospitalization ( hemoglobin level dropped to 5.5). He was treated with blood transfusions and prednisone with improvement of counts. Luckily , he did not get his second covid shot due to feeling poorly prior to booster dose.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: After 3 days he developed 2 new seizures according to him.  Document pending since he was admitted in the hospital. Neurology consult placed. He was placed on keppra, atorvastatin and baby aspirin during the admission.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing.  Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21.  Diagnosed with ITP at Hospital on 03/25/21.  Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21.  Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21.  Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21.  Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Immune thrombocytopenia, Immunoglobulin therapy, Intensive care, Platelet count decreased
Clinical narrative: Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing.  Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21.  Diagnosed with ITP at Hospital on 03/25/21.  Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21.  Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21.  Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21.  Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet transfusion, Rash, Rash erythematous
Clinical narrative: Went to ER at 10 pm on 03/24/21 with red bumps on feet and legs with difficulty swallowing.  Blood draw showed platelet count <3,000 and transferred to Hospital ICU at 4:30 am on Thursday, 03/25/21.  Diagnosed with ITP at Hospital on 03/25/21.  Received two (2) bags of donor platelets, steroids, and IVIG Treatment on 03/25/21 and 03/26/21.  Following treatment, platelet count rose to 48,000 on 03/26/21 and 03/27/21.  Discharged from hospital on 03/27/21 with follow-up with hematologist scheduled for 04/02/21.  Platelet count on recent blood draw on 03/30/21 showed platelet count at 148,000 with continued treatment using steroids only.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: experiencing neuropathy/peripheral neuropathy; This is a spontaneous report from a contactable pharmacist (patient) via medical information team and Pfizer A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on an unspecified date of Mar2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was nervous about getting the second dose of the Pfizer COVID-19 vaccine after experiencing neuropathy and was unsure of what to do - forego second dose, get the second dose in his right arm, or get a second dose from a different manufacturer. He had the Pfizer vaccine a week ago Monday. Everything was fine for 2 days (unspecified date of Mar2021), then he developed a peripheral neuropathy (his pinky and half of his ring finger became very numb and had paresthesia) in the ulnar nerve of his left arm. He had to go back in 2 weeks to get booster and that he was a little nervous to do that because of the neuropathy that the first dose has caused. Stated that it was his left hand that was affected and that he got the injection in his left arm, and asked should he get vaccine in right arm.(for 2nd dose). The outcome of event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "peripheral neuropathy (his pinky and half of his ring finger became very numb and had paresthesia) in the ulnar nerve of his left arm" and the administration of the COVID-19 vaccine, BNT162B2, considering he plausible temporal association.   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 RA, IEC, as appropriate.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Chills, Death, Fatigue, Feeling abnormal
Clinical narrative: Patient felt fatigued, chills following dose 2 of COVID immunization. The following morning she died suddenly. Family reports apparent collapse on the way to the bathroom, was found down.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Hypersomnia, Syncope
Clinical narrative: Patient felt fatigued, chills following dose 2 of COVID immunization. The following morning she died suddenly. Family reports apparent collapse on the way to the bathroom, was found down.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Sudden death, Syncope
Clinical narrative: Patient felt fatigued, chills following dose 2 of COVID immunization. The following morning she died suddenly. Family reports apparent collapse on the way to the bathroom, was found down.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Seizure, Tremor
Clinical narrative: Focal aware seizure. 2 minutes long, left arm treamoring. 10 minutes later a 5 minute long seizure with the same symptoms. Patient had been stable and seizure free on her meds for 6 months before receiving the vaccine.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Simple partial seizures, Tremor
Clinical narrative: Focal aware seizure. 2 minutes long, left arm treamoring. 10 minutes later a 5 minute long seizure with the same symptoms. Patient had been stable and seizure free on her meds for 6 months before receiving the vaccine.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Resuscitation, Seizure
Clinical narrative: Around 4:50 pm on 03/26/2021 patient had a seizure that lasted approximately 5-10 seconds. Immediately following the seizure it was observed he was not breathing, and no pulse was detected. Emergency services was contacted immediately and medical assistance requested. While patient's spouse was on the phone with emergency services, his daughter transferred him to the floor and immediately started CPR.  Fire arrived first and took over CPR. Paramedics arrived, intubated, started delivering medications (incl. epinephrine and amiodarone) and shocked with AED.  He was transported to the hospital after 40 minutes, once EMS got a steady pulse. He arrested and was revived two more times at the hospital before arresting the third time and time of death was called around 8:30 pm on 03/26/2021.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Cardioversion, Death, Endotracheal intubation, Pulse absent
Clinical narrative: Around 4:50 pm on 03/26/2021 patient had a seizure that lasted approximately 5-10 seconds. Immediately following the seizure it was observed he was not breathing, and no pulse was detected. Emergency services was contacted immediately and medical assistance requested. While patient's spouse was on the phone with emergency services, his daughter transferred him to the floor and immediately started CPR.  Fire arrived first and took over CPR. Paramedics arrived, intubated, started delivering medications (incl. epinephrine and amiodarone) and shocked with AED.  He was transported to the hospital after 40 minutes, once EMS got a steady pulse. He arrested and was revived two more times at the hospital before arresting the third time and time of death was called around 8:30 pm on 03/26/2021.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Around 4:50 pm on 03/26/2021 patient had a seizure that lasted approximately 5-10 seconds. Immediately following the seizure it was observed he was not breathing, and no pulse was detected. Emergency services was contacted immediately and medical assistance requested. While patient's spouse was on the phone with emergency services, his daughter transferred him to the floor and immediately started CPR.  Fire arrived first and took over CPR. Paramedics arrived, intubated, started delivering medications (incl. epinephrine and amiodarone) and shocked with AED.  He was transported to the hospital after 40 minutes, once EMS got a steady pulse. He arrested and was revived two more times at the hospital before arresting the third time and time of death was called around 8:30 pm on 03/26/2021.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulse absent, Respiratory arrest, Seizure
Clinical narrative: Around 4:50 pm on 03/26/2021 patient had a seizure that lasted approximately 5-10 seconds. Immediately following the seizure it was observed he was not breathing, and no pulse was detected. Emergency services was contacted immediately and medical assistance requested. While patient's spouse was on the phone with emergency services, his daughter transferred him to the floor and immediately started CPR.  Fire arrived first and took over CPR. Paramedics arrived, intubated, started delivering medications (incl. epinephrine and amiodarone) and shocked with AED.  He was transported to the hospital after 40 minutes, once EMS got a steady pulse. He arrested and was revived two more times at the hospital before arresting the third time and time of death was called around 8:30 pm on 03/26/2021.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Hypoaesthesia, Mobility decreased, Pain, Paraesthesia
Clinical narrative: SIRVA
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral coldness, Shoulder injury related to vaccine administration, X-ray
Clinical narrative: SIRVA
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Shoulder injury related to vaccine administration, Wrong technique in product usage process, X-ray limb
Clinical narrative: SIRVA
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: 3/25/21 sore arm, tired achiness, headache, lite headedness-throughout day & night.    3/26/2021 same as previous day.   3/27/2021 at 6:30 am awaken unable to breath.- Both ears felt closed, throat felt closed.    Immediately took a Benadryl, put Vicks on neck-throat area, used steamer for moist air through nose.   Lasted close to one hour.   3/27/21  most of afternoon & evening extreme tiredness.  3/28/21 morning ok, by afternoon extreme achy tiredness again.  3/29 to present headaches.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Ear discomfort, Fatigue, Headache
Clinical narrative: 3/25/21 sore arm, tired achiness, headache, lite headedness-throughout day & night.    3/26/2021 same as previous day.   3/27/2021 at 6:30 am awaken unable to breath.- Both ears felt closed, throat felt closed.    Immediately took a Benadryl, put Vicks on neck-throat area, used steamer for moist air through nose.   Lasted close to one hour.   3/27/21  most of afternoon & evening extreme tiredness.  3/28/21 morning ok, by afternoon extreme achy tiredness again.  3/29 to present headaches.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Throat tightness
Clinical narrative: 3/25/21 sore arm, tired achiness, headache, lite headedness-throughout day & night.    3/26/2021 same as previous day.   3/27/2021 at 6:30 am awaken unable to breath.- Both ears felt closed, throat felt closed.    Immediately took a Benadryl, put Vicks on neck-throat area, used steamer for moist air through nose.   Lasted close to one hour.   3/27/21  most of afternoon & evening extreme tiredness.  3/28/21 morning ok, by afternoon extreme achy tiredness again.  3/29 to present headaches.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Medical history included High blood pressure/ blood pressure was 170/ 110; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included High blood pressure (indication of concomitant medications, defcort and "blood pressure pill") and 'degenerative' arthritis. Concomitant medications included deflazacort (DEFCORT) taken for high blood pressure, start and stop date were not reported; and piroxicam (FELDENE) taken for 'degenerative' arthritis, start and stop date were not reported. The patient previously took lotrel [amlodipine besilate;benazepril hydrochloride] (has been on Lotrel for 24 years). The patient's doctor changed his blood pressure pill (Unspecified Medication) on Monday and he was supposed to keep an eye on it. Patient lost his sister-in-law's husband Tuesday afternoon so, he didn't think about taking the blood pressure pill on Friday night (Clarification unknown), he got up in midnight and blood pressure was 170/ 110 and it's been running high ever since and he was wondering if this could have anything to do with vaccine.  Information on lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dyspnoea, Lung disorder, Nasal congestion
Clinical narrative: pt has idiopathic anaphylaxis, stayed at pharmacy for 30 minutes for first dose and planned to stay longer for the second dose. after 15-20 minutes after vaccination was administered she felt her lungs were itching and she had a bit of a cough, no difficulty breathing. Pt had brought Benadryl and took 50mg of that, then she used her albuterol inhaler and stayed in the pharmacy area for monitoring. about 5-10 minutes later she was having difficulty breathing, based on discussion with paramedics EpiPen was administered by the patient (personal prescription that she has with her). less than 5 minutes after EpiPen was administered the paramedics arrived. She was assessed by paramedics taken to the hospital but released the same day. She stopped back by the pharmacy later on to let us know she was ok. She was treated by the ED with Medrol and monitoring.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Respiratory tract irritation
Clinical narrative: pt has idiopathic anaphylaxis, stayed at pharmacy for 30 minutes for first dose and planned to stay longer for the second dose. after 15-20 minutes after vaccination was administered she felt her lungs were itching and she had a bit of a cough, no difficulty breathing. Pt had brought Benadryl and took 50mg of that, then she used her albuterol inhaler and stayed in the pharmacy area for monitoring. about 5-10 minutes later she was having difficulty breathing, based on discussion with paramedics EpiPen was administered by the patient (personal prescription that she has with her). less than 5 minutes after EpiPen was administered the paramedics arrived. She was assessed by paramedics taken to the hospital but released the same day. She stopped back by the pharmacy later on to let us know she was ok. She was treated by the ED with Medrol and monitoring.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bell's Palsy; This is a spontaneous report received from a contactable consumer (patient himself). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EN6200) via an unspecified route of administration on 11Mar2021 at 09:00 am at single dose on left arm for COVID-19 immunisation. Patient's medical history included down syndrome and No known allergies. Patient's concomitant medications (other medications in two weeks) included ascorbic acid (VITAMIN-C), glucosamine, chondroitin, vitamin d and IND. Patient previously took historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN6208) on 18Feb2021 at 09:00 am at single dose on right arm for COVID-19 immunisation. Patient developed Bell's Palsy on 21Mar2021 at 12:15 pm. This was 10 days following the 2nd dosage of the Pfizer vaccine. There was no previous health history of Bell's Palsy. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment for adverse event. If covid was present prior vaccination and if covid was tested post vaccination was reported as no. The outcome of event was not recovered.   Information on the lot/batch number is requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event
Clinical narrative: No additional AE.; After patient was admitted to hospital for 'really bad headaches' and while patient was still in hospital, Patient was administered an unspecified Merck-manufactured 'Pneumonia shot' on 06/25/2015; This spontaneous report was received from a female consumer of unknown age referring to herself. The patient's pertinent medical history and concomitant medications were not reported.  On an unspecified date in 2015, the patient had "really bad headaches" which were determined to be "weird migraines" and the patient was hospitalized due to it.   On 25-JUN-2015 (when the patient was still hospitalized), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (reported as unspecified Merck-manufactured pneumonia shot) as prophylaxis (concentration, dosage, route of administration and anatomical location were not reported; lot number K021881 and expiration date was not reported but upon internal validation established as 30-JUL-2016). The patient requested pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prescribing information (product prescribing issue). No adverse events were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional adverse event or product quality complaint.; ROTATEQ administered on 24-MAR-2021 and expired on 22-MAR-2021; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's concomitant medication, pertinent medical history and drug reactions or allergies was provided.  On 24-MAR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml, orally, lot # 1660666, expiry date 22-MAR-2021 for prophylaxis. The vaccine had never undergone a temperature excursion. No additional adverse event or product quality complaint was reported.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported.; second dose administered 2 months after the first dose; This spontaneous report was received from a licensed practical nurse and refers to a 16-moth-old (also reported as 15-month old) patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 24-DEC-2020, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter, lot # S028914 was confirmed to be valid, expiration date 16-SEP-2021 (route and site of administration were not reported) for prophylaxis. On 04-FEB-2021, the patient received the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) 0.5 milliliter, lot # S028914 was confirmed to be valid, expiration date 16-SEP-2021 (route and site of administration were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis
Clinical narrative: Developed cellulitis in the left arm; Upper left shoulder is killing her hurts terribly; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) experienced cellulitis in the left arm/ cellulitis and the upper left shoulder was killing her hurts terribly/arthralgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Feb 2021, approximately five days prior to onset of the event, the patient received a dose of mRNA-1273 (batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient experienced the upper left shoulder pain and a medically significant event, cellulitis in the left arm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events cellulitis in the left arm and the upper left shoulder was killing her hurts terribly was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.