chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Magnetic resonance imaging, Urticaria, X-ray
Clinical narrative: she passed out; she had swelling of her lymph nodes; cold chills; cold sweats; threw up; She thought she was going to have a heart attack; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient had minor side effects with the first COVID vaccine.  With the second shot on unspecified date, the patient had swelling of her lymph nodes. A week later from the shot, she passed out. She has never passed out before in her life. This week two days ago, she had cold chills, cold sweats, and threw up. She was in the bathroom from both ends. She thought she was going to have a heart attack. She went to the doctor for a check-up. The patient had a CAT scan, and a heart monitor to rule out a TIA on unspecified date with unknown results. She cannot believe it because she is normally a healthy person. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Hypersomnia, Laboratory test
Clinical narrative: she passed out; she had swelling of her lymph nodes; cold chills; cold sweats; threw up; She thought she was going to have a heart attack; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient had minor side effects with the first COVID vaccine.  With the second shot on unspecified date, the patient had swelling of her lymph nodes. A week later from the shot, she passed out. She has never passed out before in her life. This week two days ago, she had cold chills, cold sweats, and threw up. She was in the bathroom from both ends. She thought she was going to have a heart attack. She went to the doctor for a check-up. The patient had a CAT scan, and a heart monitor to rule out a TIA on unspecified date with unknown results. She cannot believe it because she is normally a healthy person. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Urticaria, X-ray
Clinical narrative: she passed out; she had swelling of her lymph nodes; cold chills; cold sweats; threw up; She thought she was going to have a heart attack; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient had minor side effects with the first COVID vaccine.  With the second shot on unspecified date, the patient had swelling of her lymph nodes. A week later from the shot, she passed out. She has never passed out before in her life. This week two days ago, she had cold chills, cold sweats, and threw up. She was in the bathroom from both ends. She thought she was going to have a heart attack. She went to the doctor for a check-up. The patient had a CAT scan, and a heart monitor to rule out a TIA on unspecified date with unknown results. She cannot believe it because she is normally a healthy person. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Cold sweat, Computerised tomogram, Electrocardiogram ambulatory, Feeling abnormal
Clinical narrative: she passed out; she had swelling of her lymph nodes; cold chills; cold sweats; threw up; She thought she was going to have a heart attack; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient had minor side effects with the first COVID vaccine.  With the second shot on unspecified date, the patient had swelling of her lymph nodes. A week later from the shot, she passed out. She has never passed out before in her life. This week two days ago, she had cold chills, cold sweats, and threw up. She was in the bathroom from both ends. She thought she was going to have a heart attack. She went to the doctor for a check-up. The patient had a CAT scan, and a heart monitor to rule out a TIA on unspecified date with unknown results. She cannot believe it because she is normally a healthy person. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Lymphadenopathy, Vomiting
Clinical narrative: she passed out; she had swelling of her lymph nodes; cold chills; cold sweats; threw up; She thought she was going to have a heart attack; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date as single dose for COVID-19 immunization. The patient had minor side effects with the first COVID vaccine.  With the second shot on unspecified date, the patient had swelling of her lymph nodes. A week later from the shot, she passed out. She has never passed out before in her life. This week two days ago, she had cold chills, cold sweats, and threw up. She was in the bathroom from both ends. She thought she was going to have a heart attack. She went to the doctor for a check-up. The patient had a CAT scan, and a heart monitor to rule out a TIA on unspecified date with unknown results. She cannot believe it because she is normally a healthy person. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angioedema, Swollen tongue
Clinical narrative: Anaphylaxis reaction; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6026) at the age of 71-years-old, via an unspecified route of administration in left arm on 11Mar2021 at 15:30 at 1st dose, single for COVID-19 immunization. Medical history included allergies to fluorescein. Prior to vaccination, the patient diagnosed with COVID-19. Concomitant medications included lisinopril, nebivolol hydrochloride (BYSTOLIC), and amlodipine. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID vaccine at a clinic. On 01Apr2021 at 14:00, she was getting ready to leave for her 2nd shot at 14:00 and realized that her tongue and throat felt strange.  On the way, the patient's husband felt they needed to go to a walk-in emergency center and get checked out. They realized, she was having an anaphylaxis reaction in which she was given an epi shot and ambulance was called. The patient was kept in the emergency room for 3 hours. The event resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered with sequel on an unspecified date in 2021. The event was reported as serious due to being life-threatening.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis reaction; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6026) at the age of 71-years-old, via an unspecified route of administration in left arm on 11Mar2021 at 15:30 at 1st dose, single for COVID-19 immunization. Medical history included allergies to fluorescein. Prior to vaccination, the patient diagnosed with COVID-19. Concomitant medications included lisinopril, nebivolol hydrochloride (BYSTOLIC), and amlodipine. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID vaccine at a clinic. On 01Apr2021 at 14:00, she was getting ready to leave for her 2nd shot at 14:00 and realized that her tongue and throat felt strange.  On the way, the patient's husband felt they needed to go to a walk-in emergency center and get checked out. They realized, she was having an anaphylaxis reaction in which she was given an epi shot and ambulance was called. The patient was kept in the emergency room for 3 hours. The event resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered with sequel on an unspecified date in 2021. The event was reported as serious due to being life-threatening.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Urticaria, Vaccination site erythema
Clinical narrative: Anaphylaxis reaction; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6026) at the age of 71-years-old, via an unspecified route of administration in left arm on 11Mar2021 at 15:30 at 1st dose, single for COVID-19 immunization. Medical history included allergies to fluorescein. Prior to vaccination, the patient diagnosed with COVID-19. Concomitant medications included lisinopril, nebivolol hydrochloride (BYSTOLIC), and amlodipine. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the COVID vaccine at a clinic. On 01Apr2021 at 14:00, she was getting ready to leave for her 2nd shot at 14:00 and realized that her tongue and throat felt strange.  On the way, the patient's husband felt they needed to go to a walk-in emergency center and get checked out. They realized, she was having an anaphylaxis reaction in which she was given an epi shot and ambulance was called. The patient was kept in the emergency room for 3 hours. The event resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered with sequel on an unspecified date in 2021. The event was reported as serious due to being life-threatening.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Immediate post-injection reaction, Pharyngeal paraesthesia
Clinical narrative: Has lost some weight/lost maybe over 10 pounds; anaphylactic reaction; Doesn't want to eat/is afraid to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expire Date: Unknown), via an unspecified route of administration, administered in right Arm on 30Mar2021 as single dose for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not had any AE prior vaccination. No family Medical History Relevant to AE(s) is reported. On an unspecified date, the patient experienced has lost some weight/lost maybe over 10 pounds. Upon follow-up received on 05May2021, On 30Mar2021, the patient experienced anaphylactic reaction and doesn't want to eat/is afraid to eat. The patient underwent lab tests and procedures which included allergy test: unknown and very conclusive. On an unspecified date, outcome of the event anaphylactic reaction was recovered. The outcome of event doesn't want to eat/is afraid to eat was not recovered. The outcome of event has lost some weight/lost maybe over 10 pounds was unknown  Information about batch/lot number available. Further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Erythema, Gastrooesophageal reflux disease, Immediate post-injection reaction
Clinical narrative: Has lost some weight/lost maybe over 10 pounds; anaphylactic reaction; Doesn't want to eat/is afraid to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expire Date: Unknown), via an unspecified route of administration, administered in right Arm on 30Mar2021 as single dose for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not had any AE prior vaccination. No family Medical History Relevant to AE(s) is reported. On an unspecified date, the patient experienced has lost some weight/lost maybe over 10 pounds. Upon follow-up received on 05May2021, On 30Mar2021, the patient experienced anaphylactic reaction and doesn't want to eat/is afraid to eat. The patient underwent lab tests and procedures which included allergy test: unknown and very conclusive. On an unspecified date, outcome of the event anaphylactic reaction was recovered. The outcome of event doesn't want to eat/is afraid to eat was not recovered. The outcome of event has lost some weight/lost maybe over 10 pounds was unknown  Information about batch/lot number available. Further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: Has lost some weight/lost maybe over 10 pounds; anaphylactic reaction; Doesn't want to eat/is afraid to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expire Date: Unknown), via an unspecified route of administration, administered in right Arm on 30Mar2021 as single dose for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not had any AE prior vaccination. No family Medical History Relevant to AE(s) is reported. On an unspecified date, the patient experienced has lost some weight/lost maybe over 10 pounds. Upon follow-up received on 05May2021, On 30Mar2021, the patient experienced anaphylactic reaction and doesn't want to eat/is afraid to eat. The patient underwent lab tests and procedures which included allergy test: unknown and very conclusive. On an unspecified date, outcome of the event anaphylactic reaction was recovered. The outcome of event doesn't want to eat/is afraid to eat was not recovered. The outcome of event has lost some weight/lost maybe over 10 pounds was unknown  Information about batch/lot number available. Further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test, Anaphylactic reaction, Eating disorder, Weight decreased
Clinical narrative: Has lost some weight/lost maybe over 10 pounds; anaphylactic reaction; Doesn't want to eat/is afraid to eat; This is a spontaneous report from a contactable consumer or other non hcp. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732, Expire Date: Unknown), via an unspecified route of administration, administered in right Arm on 30Mar2021 as single dose for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not had any AE prior vaccination. No family Medical History Relevant to AE(s) is reported. On an unspecified date, the patient experienced has lost some weight/lost maybe over 10 pounds. Upon follow-up received on 05May2021, On 30Mar2021, the patient experienced anaphylactic reaction and doesn't want to eat/is afraid to eat. The patient underwent lab tests and procedures which included allergy test: unknown and very conclusive. On an unspecified date, outcome of the event anaphylactic reaction was recovered. The outcome of event doesn't want to eat/is afraid to eat was not recovered. The outcome of event has lost some weight/lost maybe over 10 pounds was unknown  Information about batch/lot number available. Further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Feeling abnormal, Injection site pain, Pain
Clinical narrative: SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's past medical history included anaphylaxis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with formaldehyde solution. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe arm pain. The action taken with covid-19 vaccine  was not applicable. The outcome of severe arm pain was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's past medical history included anaphylaxis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with formaldehyde solution. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe arm pain. The action taken with covid-19 vaccine  was not applicable. The outcome of severe arm pain was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 155 pounds, and height was 65 inches. The patient's past medical history included anaphylaxis, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with formaldehyde solution. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced severe arm pain. The action taken with covid-19 vaccine  was not applicable. The outcome of severe arm pain was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Myalgia, Nausea
Clinical narrative: The diagnosis was pericarditis.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Apr2021 at 12:30 (lot number: ER8734) at single dose for COVID-19 immunization. The relevant medical history included Sjogren's syndrome and known allergies: Amoxicillin, Penicillin. Concomitant medications included calcium, ascorbic acid (VITAMINS C), vitamin d nos and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously received the first dose of BNT162B2 on 13Mar2021 at the age of 64 years old (Anatomical Location: Arm Left, lot number: EN6204, Administration time=12:30 PM) for Covid-19 immunization. 3 days after receiving dose 2 on 06Apr2021 at 4:00 PM, the patient developed tightness in her chest. She went to the ER and was admitted to the hospital. The diagnosis was pericarditis. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prescribed colchicine and indomethacin. The patient had been hospitalization for 1 day. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab test included nasal swab showed negative on 07Apr2021. The outcome of the events was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis, SARS-CoV-2 test
Clinical narrative: The diagnosis was pericarditis.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Apr2021 at 12:30 (lot number: ER8734) at single dose for COVID-19 immunization. The relevant medical history included Sjogren's syndrome and known allergies: Amoxicillin, Penicillin. Concomitant medications included calcium, ascorbic acid (VITAMINS C), vitamin d nos and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously received the first dose of BNT162B2 on 13Mar2021 at the age of 64 years old (Anatomical Location: Arm Left, lot number: EN6204, Administration time=12:30 PM) for Covid-19 immunization. 3 days after receiving dose 2 on 06Apr2021 at 4:00 PM, the patient developed tightness in her chest. She went to the ER and was admitted to the hospital. The diagnosis was pericarditis. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prescribed colchicine and indomethacin. The patient had been hospitalization for 1 day. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab test included nasal swab showed negative on 07Apr2021. The outcome of the events was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Computerised tomogram thorax, Electrocardiogram, Full blood count
Clinical narrative: The diagnosis was pericarditis.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Apr2021 at 12:30 (lot number: ER8734) at single dose for COVID-19 immunization. The relevant medical history included Sjogren's syndrome and known allergies: Amoxicillin, Penicillin. Concomitant medications included calcium, ascorbic acid (VITAMINS C), vitamin d nos and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously received the first dose of BNT162B2 on 13Mar2021 at the age of 64 years old (Anatomical Location: Arm Left, lot number: EN6204, Administration time=12:30 PM) for Covid-19 immunization. 3 days after receiving dose 2 on 06Apr2021 at 4:00 PM, the patient developed tightness in her chest. She went to the ER and was admitted to the hospital. The diagnosis was pericarditis. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prescribed colchicine and indomethacin. The patient had been hospitalization for 1 day. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab test included nasal swab showed negative on 07Apr2021. The outcome of the events was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: The diagnosis was pericarditis.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Apr2021 at 12:30 (lot number: ER8734) at single dose for COVID-19 immunization. The relevant medical history included Sjogren's syndrome and known allergies: Amoxicillin, Penicillin. Concomitant medications included calcium, ascorbic acid (VITAMINS C), vitamin d nos and ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN). The patient previously received the first dose of BNT162B2 on 13Mar2021 at the age of 64 years old (Anatomical Location: Arm Left, lot number: EN6204, Administration time=12:30 PM) for Covid-19 immunization. 3 days after receiving dose 2 on 06Apr2021 at 4:00 PM, the patient developed tightness in her chest. She went to the ER and was admitted to the hospital. The diagnosis was pericarditis. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prescribed colchicine and indomethacin. The patient had been hospitalization for 1 day. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab test included nasal swab showed negative on 07Apr2021. The outcome of the events was recovering.  Follow up attempts are needed. Further information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pruritus, Rash, Rash erythematous
Clinical narrative: Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; severe muscle and joint pain; severe muscle and joint pain; low electrical shock in limbs; hives all over my body which would welt up like measles if I scratched them; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:45 (at 51 years old, not pregnant) (Batch/Lot Number: EP7533) as 2nd dose, single for covid-19 immunisation. Medical history included cholesteatoma from an unknown date (Cholesteatoma as a teen--resolved with modified canal-wall down tympanomastoidectomy. No problems since 1989-1990), Allergy to cephalosporins, Sulfa drugs, strawberries, all from an unknown date. The patient had no concomitant medications. The patient had her first dose of bnt162b2 (Lot numberEN6204) vaccine on Mar2021 12:45 at 51 years old on left arm for COVID-19 Immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, after about 12 hours (reported also as 09Apr2021 22:00), as expected, patient had moderate to severe muscle and joint pain and a sensation of low electrical shock in limbs. No other symptoms and this resolved in 24 hrs. Eight days after dose 2 (reported also as 09Apr2021 22:00), patient developed hives all over the body which would welt up like measles if patient scratched them. Patient tolerated them for 19 days before patient finally sought help from a doctor, who prescribed a short 20mg/2X/day course of prednisone and hives are improving significantly. However, wherever she scratches these hives on her legs,especially right, she developed bruises and petechiae, which "travel" up and down her thigh corresponding to where she scratches. She was in good health, active, and don't bruise easily. Bruising has not resolved over about 23 days, but has not gotten worse. Patient has no other symptoms. Perhaps this is a very mild case of thrombocytopenia. The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. All the events start date was reported as 09Apr2021 22:00 (for clarification). The outcome of the vaccines was recovering. The patient underwent lab tests and procedures which included Weekly spit test--work: negative on 11Mar2021; negative on 18Mar2021; negative on 25Mar2021; negative on 08Apr2021; negative on 19Apr2021; pending on 28Apr2021. Device used Date : 02May2021  Information about Lot/batch number was available. Further information was expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; severe muscle and joint pain; severe muscle and joint pain; low electrical shock in limbs; hives all over my body which would welt up like measles if I scratched them; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:45 (at 51 years old, not pregnant) (Batch/Lot Number: EP7533) as 2nd dose, single for covid-19 immunisation. Medical history included cholesteatoma from an unknown date (Cholesteatoma as a teen--resolved with modified canal-wall down tympanomastoidectomy. No problems since 1989-1990), Allergy to cephalosporins, Sulfa drugs, strawberries, all from an unknown date. The patient had no concomitant medications. The patient had her first dose of bnt162b2 (Lot numberEN6204) vaccine on Mar2021 12:45 at 51 years old on left arm for COVID-19 Immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, after about 12 hours (reported also as 09Apr2021 22:00), as expected, patient had moderate to severe muscle and joint pain and a sensation of low electrical shock in limbs. No other symptoms and this resolved in 24 hrs. Eight days after dose 2 (reported also as 09Apr2021 22:00), patient developed hives all over the body which would welt up like measles if patient scratched them. Patient tolerated them for 19 days before patient finally sought help from a doctor, who prescribed a short 20mg/2X/day course of prednisone and hives are improving significantly. However, wherever she scratches these hives on her legs,especially right, she developed bruises and petechiae, which "travel" up and down her thigh corresponding to where she scratches. She was in good health, active, and don't bruise easily. Bruising has not resolved over about 23 days, but has not gotten worse. Patient has no other symptoms. Perhaps this is a very mild case of thrombocytopenia. The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. All the events start date was reported as 09Apr2021 22:00 (for clarification). The outcome of the vaccines was recovering. The patient underwent lab tests and procedures which included Weekly spit test--work: negative on 11Mar2021; negative on 18Mar2021; negative on 25Mar2021; negative on 08Apr2021; negative on 19Apr2021; pending on 28Apr2021. Device used Date : 02May2021  Information about Lot/batch number was available. Further information was expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Thrombocytopenia, Urticaria
Clinical narrative: Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; severe muscle and joint pain; severe muscle and joint pain; low electrical shock in limbs; hives all over my body which would welt up like measles if I scratched them; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:45 (at 51 years old, not pregnant) (Batch/Lot Number: EP7533) as 2nd dose, single for covid-19 immunisation. Medical history included cholesteatoma from an unknown date (Cholesteatoma as a teen--resolved with modified canal-wall down tympanomastoidectomy. No problems since 1989-1990), Allergy to cephalosporins, Sulfa drugs, strawberries, all from an unknown date. The patient had no concomitant medications. The patient had her first dose of bnt162b2 (Lot numberEN6204) vaccine on Mar2021 12:45 at 51 years old on left arm for COVID-19 Immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, after about 12 hours (reported also as 09Apr2021 22:00), as expected, patient had moderate to severe muscle and joint pain and a sensation of low electrical shock in limbs. No other symptoms and this resolved in 24 hrs. Eight days after dose 2 (reported also as 09Apr2021 22:00), patient developed hives all over the body which would welt up like measles if patient scratched them. Patient tolerated them for 19 days before patient finally sought help from a doctor, who prescribed a short 20mg/2X/day course of prednisone and hives are improving significantly. However, wherever she scratches these hives on her legs,especially right, she developed bruises and petechiae, which "travel" up and down her thigh corresponding to where she scratches. She was in good health, active, and don't bruise easily. Bruising has not resolved over about 23 days, but has not gotten worse. Patient has no other symptoms. Perhaps this is a very mild case of thrombocytopenia. The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. All the events start date was reported as 09Apr2021 22:00 (for clarification). The outcome of the vaccines was recovering. The patient underwent lab tests and procedures which included Weekly spit test--work: negative on 11Mar2021; negative on 18Mar2021; negative on 25Mar2021; negative on 08Apr2021; negative on 19Apr2021; pending on 28Apr2021. Device used Date : 02May2021  Information about Lot/batch number was available. Further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear discomfort, Tinnitus
Clinical narrative: PRESSURE IN EAR; SEVERE TINNITUS; STRUGGLE TO SLEEP; BODY ACHES; ILL FEELING; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of ear infection or tinnitus. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pressure in ear. On 12-APR-2021, the subject experienced severe tinnitus. On 12-APR-2021, the subject experienced struggle to sleep. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced ill feeling. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from severe tinnitus, and the outcome of ill feeling, fever, body aches, pressure in ear and struggle to sleep was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Insomnia, Malaise, Pain, Pyrexia
Clinical narrative: PRESSURE IN EAR; SEVERE TINNITUS; STRUGGLE TO SLEEP; BODY ACHES; ILL FEELING; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of ear infection or tinnitus. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pressure in ear. On 12-APR-2021, the subject experienced severe tinnitus. On 12-APR-2021, the subject experienced struggle to sleep. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced ill feeling. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from severe tinnitus, and the outcome of ill feeling, fever, body aches, pressure in ear and struggle to sleep was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: PRESSURE IN EAR; SEVERE TINNITUS; STRUGGLE TO SLEEP; BODY ACHES; ILL FEELING; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of ear infection or tinnitus. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pressure in ear. On 12-APR-2021, the subject experienced severe tinnitus. On 12-APR-2021, the subject experienced struggle to sleep. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced ill feeling. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from severe tinnitus, and the outcome of ill feeling, fever, body aches, pressure in ear and struggle to sleep was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Rash
Clinical narrative: swollen lymph nodes, bad rash in breasts; bad rash in breasts; This is a spontaneous report from a contactable consumer. This 47-year-old Female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 05Apr2021 13:15 (Batch/Lot Number: ER8727) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine includes Covid-19 immunization first dose (lot number: EN6208) administered in left arm on 15Mar2021. On 07Apr2021 the patient experienced swollen lymph nodes and bad rash in breasts. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: swollen lymph nodes, bad rash in breasts; bad rash in breasts; This is a spontaneous report from a contactable consumer. This 47-year-old Female consumer (patient) reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 05Apr2021 13:15 (Batch/Lot Number: ER8727) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine includes Covid-19 immunization first dose (lot number: EN6208) administered in left arm on 15Mar2021. On 07Apr2021 the patient experienced swollen lymph nodes and bad rash in breasts. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac monitoring, Chest pain, Dizziness, Electrocardiogram
Clinical narrative: high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation.  Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Magnetic resonance imaging, Menstruation irregular, Palpitations, Throat tightness
Clinical narrative: high blood pressure; chest pains; cold sore; dizzy / lightheaded; vision is blurry; tingling in hands and feet; Memory loss; experienced early period with clotting which stopped in 2-3 days then started faint spotting; Throat closure sensations; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 03Apr2021 (Batch/Lot Number: Er8734) as single dose at the age of 40-year-old for covid-19 immunisation.  Medical history included allergy to amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date the patient experienced early period with clotting which stopped in 2-3 days then started faint spotting again a day later, high blood pressure, cold sore, dizzy / lightheaded, vision is blurry, chest pains, tingling in hands and feet, memory loss. On 03Apr2021 18:00 the patient experienced throat closure sensations. The course of events was as follows: Throat closure sensations, high blood pressure, chest pains, cold sore, dizzy / lightheaded, early period with clotting which stopped in 2-3 days then started faint spotting again a day later. After 25 days, I am still dizzy and have tingling in hands and feet. Memory loss, and vision is blurry. The adverse events resulted in Doctor visit, Emergency room/department or urgent care. The events early period with clotting and started faint spotting again a day later, throat closure sensations were considered medically significant. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.