chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: almost faded on the floor a while ago; This is a spontaneous report from a Pfizer Sponsored program Pfizer First Connect from a contactable consumer.  A female patient (wife) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose,via an unspecified route of administration on 31Jan2021 14:45 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Consumer's wife received Covid-19 vaccine first shot earlier today at 2:45pm and almost faded on the floor a while ago. Outcome of event was unknown.  Information about Lot/Batch Number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Blood pressure increased, Blood pressure measurement, Chest discomfort
Clinical narrative: Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Insomnia, Lymphadenopathy, Muscle spasms, Nausea
Clinical narrative: Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Palpitations, Rash macular, SARS-CoV-2 test
Clinical narrative: Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer reporting for herself. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN9581, expiry date: May2021), via an unspecified route of administration on 30Jan2021 (at the age of 74-years-old) at a single dose for COVID-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing. Concomitant medication included glipizide, metformin, apixaban (ELIQUIS), flecainide, omeprazole, simvastatin, losartan, lorazepam, hydralazine. The patient received the Pfizer COVID vaccine on 30Jan2021 and ended up getting hives from it on 30Jan2021. The event started three hours after the injection. The patient received CLARITIN at 10 mg one pill as treatment. The patient underwent lab tests and procedures which included basic metabolic panel (where they check your creatinine, check your A1C, they check your kidneys and they check your back and stuff) with unknown results. The outcome of the event was recovered on 30Jan2021.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood iron, Blood iron decreased, Haemoptysis
Clinical narrative: Coughing blood; I went last Thursday to a COVID testing station and I tested positive; Iron was little bit low; My sugar was a little high that is because I was taking taking a steroid (Unspecified Medication); This is a spontaneous report from a contactable consumer (patient).  A 75-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248), via an unspecified route of administration (on right arm) on Jan2021 (at the age of 75-years-old), single dose for COVID-19 immunization. Medical history included diabetes from an unknown date, bypass (20 years ago). Concomitant medication included apixaban (ELIQUIS), insulin glargine (BASAGLAR). Patient went in for his COVID 'vaccine' (not clear) Shot a week ago and he has a follow up in two more weeks. He went last Thursday to a COVID testing station his wife and him and came back, tested positive. So, he went to my healthcare provider and they gave him some meds (Unspecified Medications) and he was worse than that today. So, he went to the hospital this morning (not clarified further if hospitalized or not), he was coughing up blood and they gave him some medication for that and did some chest x-rays, everything was good. He told his doctor about the COVID Shot another one scheduled in two weeks, the 14th two weeks from today and they recommended that he postpones it for three months. The patient had unspecified lab work done, and showing Iron was little bit low but nothing to be concerned about and his sugar was a little high that is because he was taking taking a steroid (Unspecified Medication). The outcome of the events was unknown.; Sender's Comments: The reported sugar high was due to unspecified concomitant steroid, and was unrelated to the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, X-ray
Clinical narrative: Coughing blood; I went last Thursday to a COVID testing station and I tested positive; Iron was little bit low; My sugar was a little high that is because I was taking taking a steroid (Unspecified Medication); This is a spontaneous report from a contactable consumer (patient).  A 75-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL3248), via an unspecified route of administration (on right arm) on Jan2021 (at the age of 75-years-old), single dose for COVID-19 immunization. Medical history included diabetes from an unknown date, bypass (20 years ago). Concomitant medication included apixaban (ELIQUIS), insulin glargine (BASAGLAR). Patient went in for his COVID 'vaccine' (not clear) Shot a week ago and he has a follow up in two more weeks. He went last Thursday to a COVID testing station his wife and him and came back, tested positive. So, he went to my healthcare provider and they gave him some meds (Unspecified Medications) and he was worse than that today. So, he went to the hospital this morning (not clarified further if hospitalized or not), he was coughing up blood and they gave him some medication for that and did some chest x-rays, everything was good. He told his doctor about the COVID Shot another one scheduled in two weeks, the 14th two weeks from today and they recommended that he postpones it for three months. The patient had unspecified lab work done, and showing Iron was little bit low but nothing to be concerned about and his sugar was a little high that is because he was taking taking a steroid (Unspecified Medication). The outcome of the events was unknown.; Sender's Comments: The reported sugar high was due to unspecified concomitant steroid, and was unrelated to the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318; Expiration date was not reported) on 28Jan2021 (16:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient did not have relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on the left arm on 08Jan2021 (when the patient was 25 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 29Jan2021, the patient had nausea and vomiting. The patient did not receive any treatment for the reported events. The outcome of the events, nausea and vomiting, was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not tested positive post-vaccination.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Influenza, Muscle disorder
Clinical narrative: Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination site pain
Clinical narrative: Chills; Injection site pain; flu; cold; Joint pain; Muscle stagnant; Where they gave me the shot the muscle goes jumping up and down; Not feeling well; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL9262 expiry date not reported, via an unspecified route of administration from 28Jan2021 at single dose for COVID-19 Immunization. Medical history included High blood pressure and Pre-diabetic. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ) 12.5 mg, metformin (METFORMIN) 1000 mg, twice a day, lisinopril (LISINOPRIL) 20 mg at night, pravastatin (PRAVASTATIN) 20 mg, acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (ATROSTAT). The patient experienced joint pain, not feeling well and muscle stagnant; where they gave me the shot the muscle goes jumping up and down all on 29Jan2021 and chills, injection site pain, flu and cold all on unspecified date. Consumer stated, "I am having a joint pain and chills and not feeling well, I had it Thursday evening, I took it Thursday evening. I am not feeling well from that Friday night and last night I mean the joint pain, the muscle pain you know, it's just you have to deal with." Consumer added, "I have been taking pain medicines, Ibuprofen and Tramadol for pain and Mucinex for cold and flu." Therapeutic measures were taken as a result of joint pain, injection site pain, flu and cold. Outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report from a contactable nurse (patient). A 35-year-old non-pregnant female patient received first dose of BNT162B2 (brand=Pfizer), lot no. EK5730, intramuscular (right arm) on 07Jan2021 11:30 at a single dose for COVID-19 immunization at a hospital. The patient had no relevant medical history. She had no known allergies. Concomitant medication included colecalciferol (VITA D). No other vaccine in four weeks. No COVID prior vaccination. The patient experienced injection site pain on 07Jan2021 12:00 PM. No treatment received. No COVID test post vaccination. The patient recovered from injection site pain on an unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: The morning after the vaccine, I woke up with a generalized rash across my abdomen, evenly dispersed across my torso. Nonpruritic.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #: EL9261), intramuscular in the left arm on 25Jan2021 14:00 (at the age of 35-years-old) at single dose for COVID-19 immunization in a hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) and birth control pills. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination. On 26Jan2021 at 06:00 AM, the morning after the vaccine, the patient woke up with a generalized rash across her abdomen, evenly dispersed across her torso. It was nonpruritic. The patient received BENADRYL and CLARITIN as treatment for the event. The patient was not tested for COVID post vaccination. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Diarrhoea, Headache, Myalgia
Clinical narrative: Low fever; Headache; Nausea; Diarrhea; Severe muscle and bone pain; Severe muscle and bone pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a health clinic. Medical history included thrombocytosis Thrombocythemia, Polycythemia Vera, Neuropathy. The patient had non known allergies. Concomitant medication included apixaban (ELIQUIS), colecalciferol (D3), hydroxycarbamide (HYDREA), pregabalin (PREGABALIN) and venlafaxine hydrochloride (EFFEXOR). On 28Jan2021, the patient experienced headache, nausea, diarrhea, severe muscle and bone pain and low fever. The outcome of the events was recovering. The patient did not have COVID-19 prior to vaccination and was not tested for VOCID-19 after the vaccination. There was no treatment for the events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Low fever; Headache; Nausea; Diarrhea; Severe muscle and bone pain; Severe muscle and bone pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in left arm on 28Jan2021 11:00 at a single dose for COVID-19 immunization. Vaccination was done in a health clinic. Medical history included thrombocytosis Thrombocythemia, Polycythemia Vera, Neuropathy. The patient had non known allergies. Concomitant medication included apixaban (ELIQUIS), colecalciferol (D3), hydroxycarbamide (HYDREA), pregabalin (PREGABALIN) and venlafaxine hydrochloride (EFFEXOR). On 28Jan2021, the patient experienced headache, nausea, diarrhea, severe muscle and bone pain and low fever. The outcome of the events was recovering. The patient did not have COVID-19 prior to vaccination and was not tested for VOCID-19 after the vaccination. There was no treatment for the events.   Information on the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, SARS-CoV-2 test, Thirst
Clinical narrative: Dry mouth; excessive thirst; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2, via an unspecified route of administration (Vaccine location: right arm) on 29Jan2021 20:00 at a single dose for COVID-19 immunization at a hospital. Medical history included insomnia, anxiety, sebbhoreic dermatitis, and Covid prior vaccination. Concomitant medications included retinol, dandelion, melatonin, and unspecified multivitamin. No other vaccine in four weeks. On 29Jan2021 11:00 PM, the patient experienced dry mouth/excessive thirst (this is a side effect she has not yet seen listed). Every other symptom was pretty par for the course. No treatment received for the events. No Covid test post vaccination. The patient recovered from both events on an unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: Dizzy; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 29Jan2021 (10:45) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the Public Health Department. Medical history included hypertension (HTN), atrial fibrillation (Afib), diabetes mellitus (DM), migraine and sulfa drug allergy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA), metoprolol, montelukast sodium (SINGULAIR) and other unspecified medications. The patient previously took clarithromycin (MACROBID), and had allergies; and had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3246; Expiration date was not reported) on 08Jan2021 (when the patient was 74 years old) on the right arm for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 29Jan2021 (21:00), the patient was dizzy; and had blurred vision. The patient did not receive any treatment for the reported events. The outcome of the events, 'dizzy' and 'blurred vision', was recovering. The patient was diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate, Heart rate increased, Investigation, Liver function test
Clinical narrative: Increased heart rate/heart rate increased to 200 beats per minute; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose in the left arm for covid-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for two holes in her heart), complete heart valve replacement in Sep2017 (replaced with pig valve), pacemaker in Oct2017 and ongoing, thyroid condition and allergies. Concomitant medications included metoprolol from unspecified date in 2017 and ongoing for thyroid condition, amlodipine from unspecified date in 2017 and ongoing for high blood pressure and clarithromycin (CLARITIN [CLARITHROMYCIN]) from unspecified date in 2017 and ongoing for allergies. No vaccines administered on the same date or within four weeks prior to administration of bnt162b2. The patient experienced increased heart rate, four to five days following first dose on unspecified date. She was asleep when her heart rate increased to 200 beats per minute around 20:00 which woke her. She did not see it coming. She was seen in the emergency room, but not admitted to the hospital in response to this event. They did not know at that time what caused this event. While in the emergency room, the patient was given intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. She recovered completely from this event on unknown date. The patient underwent lab tests and procedures which included: in the emergency room visit, kidneys and heart were tested, x-ray was performed, electrocardiogram (EKG), liver and thyroid tested, all of which came back good; and her heart rhythm was fast, and irregular. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on unspecified date.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, X-ray
Clinical narrative: Increased heart rate/heart rate increased to 200 beats per minute; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on unspecified date at a single dose in the left arm for covid-19 immunization. Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for two holes in her heart), complete heart valve replacement in Sep2017 (replaced with pig valve), pacemaker in Oct2017 and ongoing, thyroid condition and allergies. Concomitant medications included metoprolol from unspecified date in 2017 and ongoing for thyroid condition, amlodipine from unspecified date in 2017 and ongoing for high blood pressure and clarithromycin (CLARITIN [CLARITHROMYCIN]) from unspecified date in 2017 and ongoing for allergies. No vaccines administered on the same date or within four weeks prior to administration of bnt162b2. The patient experienced increased heart rate, four to five days following first dose on unspecified date. She was asleep when her heart rate increased to 200 beats per minute around 20:00 which woke her. She did not see it coming. She was seen in the emergency room, but not admitted to the hospital in response to this event. They did not know at that time what caused this event. While in the emergency room, the patient was given intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. She recovered completely from this event on unknown date. The patient underwent lab tests and procedures which included: in the emergency room visit, kidneys and heart were tested, x-ray was performed, electrocardiogram (EKG), liver and thyroid tested, all of which came back good; and her heart rhythm was fast, and irregular. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on unspecified date.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Electrocardiogram, Heart rate, Heart rate increased
Clinical narrative: Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization.  Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, "pacemaker" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown.   Information on the batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Laboratory test, Liver function test, Thyroid function test, X-ray
Clinical narrative: Increased heart rate following second dose; they took her blood pressure which was 193; she feels a little lightheaded still; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm shoulder (as reported) on 29Jan2021 at single dose for COVID-19 immunization.  Medical history included high blood pressure from 2017 and ongoing, open heart surgery in Aug2017 (for 2 holes in the heart), complete heart valve replacement in Oct2017 and ongoing, "pacemaker" from Oct2017 and ongoing. Concomitant medication included metoprolol for thyroid condition, amlodipine for high blood pressure, clarithromycin (CLARITIN [CLARITHROMYCIN]) for allergies; all from 2017 and ongoing. Patient previously took first dose of BNT16B2 on an unspecified date for COVID-19 immunization and experienced heart rate increased. She was brought to the emergency room and they gave her an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. Family medical history included mother and sister died from lung cancer; father died of pancreatic cancer. Heart rate increased following second dose of Pfizer-BioNTech COVID-19 vaccine administered on 29Jan2021; onset of event was in the afternoon on 30Jan2021 while at work. Her heart kind of jumped, skipped a beat and then just took off; she could feel her body twerking. Her heart rate went up to 193 beats per minute. She went to the nurses station at work, they took her blood pressure which was 193-verified this as same number of bpm of heart rate-documented as provided. That nurse told her she should go to the hospital, so patient just left work and walked to the hospital which was a block away from work. She did not feel lightheaded, sick, or pain, just heart racing. She was again seen in the emergency room in response to this event, but was not admitted to the hospital. She was again given an intravenous medication for cardioversion where they stopped her heart and restarted it to get the rhythm back to normal. She does not know the name of the intravenous medication for cardioversion that she was administered. The only thing still ongoing related to this event was that she feels a little lightheaded still. Relevant Tests: All were good. They tested her kidneys, heart did an X-ray, EKG; tested her liver and thyroid and they said everything came back good; They said her heart rhythm was fast, and irregular, but something else was normal-she does not remember what that was. She had no further details or results for testing/investigations to provide at this time. Outcome of increased heart rate was recovered while outcome of the remaining events was unknown.   Information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Middle insomnia, Movement disorder, Pulmonary oedema
Clinical narrative: Lungs were filled with fluid; couldn't breathe; fatigue; woke up in the middle of the night; couldn't lean back; felt like her lung was on fire; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer, the patient.  This 62 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 24Jan2021 for COVID-19 vaccination. Medical history was unknown. Concomitant medication sere unknown. On an unknown date, the patient experienced severe adverse reactions after the 1st dose reported as she woke up in the middle of the night and couldn't breathe/difficulty in breathing and lasted for 4 hours, her lungs were filled with fluid and felt like her lung was on fire, couldn't lean back and had fatigue the next day. The clinical outcome of woke up in the middle of the night couldn't breathe/difficulty in breathing, lungs were filled with fluid, felt like her lung was on fire, couldn't lean back and fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: Lungs were filled with fluid; couldn't breathe; fatigue; woke up in the middle of the night; couldn't lean back; felt like her lung was on fire; This is a spontaneous report from a Pfizer-sponsored program from a contactable female consumer, the patient.  This 62 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 24Jan2021 for COVID-19 vaccination. Medical history was unknown. Concomitant medication sere unknown. On an unknown date, the patient experienced severe adverse reactions after the 1st dose reported as she woke up in the middle of the night and couldn't breathe/difficulty in breathing and lasted for 4 hours, her lungs were filled with fluid and felt like her lung was on fire, couldn't lean back and had fatigue the next day. The clinical outcome of woke up in the middle of the night couldn't breathe/difficulty in breathing, lungs were filled with fluid, felt like her lung was on fire, couldn't lean back and fatigue was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: deathly ill; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case received from a social media via consumer.  This case involves patient (unknown demographics) who experienced deathly ill (illness), while he/she received INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly ill (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that Got deathly ill with the regular flu shot ended up in the hospital, not asking a chance on this one. Medication details and reason for taking the medicine: route of administration: unknown Indication: unknown dose- unknown product name: product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information on the batch number to be requested for this case.
Sex: U
Vaccine: FLU4
Symptoms: Off label use
Clinical narrative: fluzone QIV multi-dose vials, split the .5ml dose into 2 or 3 doses with no AE; Initial information received on 04-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Adult patient who administered fluzone QIV multi-dose vials, split the 0.5ml dose into 2 or 3 doses (off label use), while he/she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious fluzone QIV multi-dose vials, split the .5ml dose into 2 or 3 doses (off label use) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.   No laboratory data was provided.  It was also a case of off label dosing frequency (latency on same day).  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: YF
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired YF-VAX vaccine/ NO AE; Initial information received on 12-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographics) who received 0.5 mL YELLOW FEVER VACCINE - US [YF-VAX] (batch number: UJ090AA and expiry date: 08-Jan-2021 via an unknown at an unknown administration site) (expired product administered) on 10-Feb-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to expired vaccine used (latency: same day).  Caller would like to know if patient needs to revaccinate. The caller stated that he did not have time to provide additional adverse event details at the time of the call, as he was involved in patient care. He stated he would call back with the details. No Still using product.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ActHIB was administered to a patient 1 day after the expiration date/ NO AE; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center.  This case involves a 16-months-old male patient who administered a vaccine HIB (PRP/T) VACCINE [ACT-HIB] 1 day after the expiration date (batch number: UJ147AAC and expiry date: 17-Feb-2021 via an unknown route in right vastus lateralis) (expired product administered) on 18-Feb-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and booster INFLUENZA VACCINE (FLU) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter would like to know if the patient must be revaccinated. vaccine was accidently used the expiration date on the diluent initially which was 22-Apr-2021.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.