chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue; tried to rehydrate; fever 100.3 that lasted for 3 days; Chills; This is a spontaneous report from a contactable consumer reported for herself that. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 69 years). The patient past medical history and concomitant medication was not reported. The patient is calling to order Sildenafil for her mother for her mother's heart failure. She wanted to report a reaction she (the caller) had to the COVID vaccine. The caller confirmed the details provided by the transferring agent. The caller had a mild reaction to the COVID 19 vaccine. She hears about reporting side effects in the recording. It was the Pfizer COVID vaccine. She got both Pfizer doses: first shot: 19Apr2021, ER8733, 31Jul2021, right arm; last shot 10May2021, ER8729, 31Jul2021, left arm She got both doses at (address withheld). On an unspecified date the patient experienced side effects after the second dose. She had a fever 100.3 that lasted for 3 days. She had chills that lasted for 3 days. She just tried to sleep it off and drink it off. She just tried to rehydrate. The fatigue lasted a couple of days. These just happened after the last dose. She went to the internist recently, and her numbers were really good. She has no diabetes. Her numbers were all well under everything. Her husband and 99-year-old mother got both COVID vaccines the same day as her, and neither one of them had a reaction to either dose. Her husband is a big baby, so she is glad he didn't. Two of her former coworkers had the Moderna vaccine and had the same reaction. She thought it was funny because they all worked together for so long. She doesn't want to do a report for them. The patient underwent lab tests and procedures which included body temperature: 100.3 on an unspecified date and investigation: were good on  has no diabetes. were all well under everything. The event outcome was recovered on an unspecified date.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID and had received their COVID vaccines; tested positive for COVID and had received their COVID vaccines; This is a spontaneous report from a contactable Nurse. A 33-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Feb2021 (at the age of 32-year-old) (Lot Number: EL3247; Expiration Date: 31May2021) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) as DOSE 2, SINGLE (at the age of 32-year-old) for covid-19 immunization. The patient past medical history and concomitant medication was not reported. On 01Aug2021, the patient tested positive for COVID and had received their COVID vaccines. This report is from a registered nurse who has a patient that tested positive for COVID and had received his COVID vaccines. She has two people who have tested positive for COVID who had received their COVID vaccines in Jan2021 and Feb2021 on site and she figured it would be better to call about this. Caller says that the patients reported to her because they must if they are sick on site or have COVID symptoms and that all must go through her. The caller didn't test him but he had tested outside and sent the caller the positive reports. The caller received an email that was sent out today and it said she needed to call for the reason being for vaccine failure. The patient had tested positive on Sunday, 01Aug2021. The event outcome was unknown.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on plausible dose event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events. Linked Report(s): US-PFIZER INC-202100996959 same reporter, drug, AE, different patient.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate increased, Palpitations
Clinical narrative: heart arrhythmia; heart pounding; felt like speeding up; This is a spontaneous report from a contactable consumer. This is a spontaneous report from a contactable consumer or other non hcp.   A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EW0187) via an unspecified route of administration, administered in Arm Left on 20May2021 as single dose (at the age of 48-year-old) for COVID-19 immunization. Patient received second dose of vaccine on 10Jun2021 (lot number: EW0191). The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21May2021, the patient experienced heart arrhythmia, heart pounding, felt like speeding up. No treatment was received. The outcome of the events was resolved in unspecified date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Ear pain
Clinical narrative: my jaw bone going to my ears it's hurting; my jaw bone going to my ears it's hurting; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced my jaw bone going to my ears it's hurting. Consumer stated, Pfizer, I had a Pfizer shot. I did not needed a number. Consumer stated, I was just trying to see if anybody complaint of, my jaw bone going to my ears it's hurting and I am just trying to see is that a symptom. The clinical outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium decreased, Blood pressure increased, Blood pressure measurement, Diaphragm muscle weakness
Clinical narrative: Difficulty expanding diaphragm muscles; blood pressure reached 183/132 within 10 minutes (normal is approx. 110/75).; Apparent serum potassium drop; felt muscles weakness begin with legs, then progress through arms and trunk.; flush with hot skin; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 03Aug2021 at 12:15 (at the age of 60-years-old) at dose 1, single for COVID-19 immunization. Medical history included hypokalemic periodic paralysis; and known allergies to penicillin, Fabreze, mango, and cats. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as none. She did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy. Since the vaccination, the patient has not been tested for COVID-19. On 03Aug2021 at 12:30, the patient's serum potassium apparently dropped. She was known to have a rare disorder, hypokalemic periodic paralysis. Within about 5 minutes (as reported), muscle weakness began on her legs, then progressed through her arms and trunk. She had difficulty expanding diaphragm muscles, had flush with hot skin, and her blood pressure (BP) reached 183/132 within 10 minutes (as reported) (normal was approximately 110/75). Primary care doctor on location administered a quick-acting BP lowering medicine. This brought her BP down to 153/80 within 45 minutes. She needed assistance to walk and went to the emergency room (ER) across the street from the vaccination site as per the primary care doctor. Weakness progressed to a moderate degree, mostly in the extremities and diaphragm. Throughout the episode, she continued ingesting electrolyte/potassium water with a total of approximately 2500 mg over 1 hour. This helped stopped the progression of weakness. After approximately 1 hour of observation in the ER, she was able to breathe properly and fully again. Potassium level rebounded to 4.0 within about 1/2. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient was recovering at home with exhaustion (2021). The outcome of the event exhaustion was unknown and recovering for all other events. The events were reported as non-serious.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Muscular weakness
Clinical narrative: Difficulty expanding diaphragm muscles; blood pressure reached 183/132 within 10 minutes (normal is approx. 110/75).; Apparent serum potassium drop; felt muscles weakness begin with legs, then progress through arms and trunk.; flush with hot skin; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 03Aug2021 at 12:15 (at the age of 60-years-old) at dose 1, single for COVID-19 immunization. Medical history included hypokalemic periodic paralysis; and known allergies to penicillin, Fabreze, mango, and cats. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as none. She did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy. Since the vaccination, the patient has not been tested for COVID-19. On 03Aug2021 at 12:30, the patient's serum potassium apparently dropped. She was known to have a rare disorder, hypokalemic periodic paralysis. Within about 5 minutes (as reported), muscle weakness began on her legs, then progressed through her arms and trunk. She had difficulty expanding diaphragm muscles, had flush with hot skin, and her blood pressure (BP) reached 183/132 within 10 minutes (as reported) (normal was approximately 110/75). Primary care doctor on location administered a quick-acting BP lowering medicine. This brought her BP down to 153/80 within 45 minutes. She needed assistance to walk and went to the emergency room (ER) across the street from the vaccination site as per the primary care doctor. Weakness progressed to a moderate degree, mostly in the extremities and diaphragm. Throughout the episode, she continued ingesting electrolyte/potassium water with a total of approximately 2500 mg over 1 hour. This helped stopped the progression of weakness. After approximately 1 hour of observation in the ER, she was able to breathe properly and fully again. Potassium level rebounded to 4.0 within about 1/2. Therapeutic measures were taken as a result of the events. The events required doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient was recovering at home with exhaustion (2021). The outcome of the event exhaustion was unknown and recovering for all other events. The events were reported as non-serious.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got COVID infection and tested positive in july 2021; Got COVID infection and tested positive in july 2021; This is a spontaneous report from a contactable consumer reporting for a female patient. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via intramuscular route of administration on 16Mar2021 as Dose number Unknown, Single for COVID-19 immunization. Medical history included immunosuppression from an unknown date. The patient's concomitant medications included unspecified immune suppressing drugs. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 post vaccination. It was reported that the patient got COVID infection and tested positive on an unspecified date in July2021. The patient underwent lab tests and procedures which included COVID infection (sars-cov-2 test): positive on an unspecified date in July 2021. Adverse events resulted in none of the above. The outcome of events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Both doses have caused irregularities in menstrual cycle(bleeding and early period); Both doses have caused irregularities in menstrual cycle(bleeding and early period); Headache; This is a spontaneous report from a contactable consumer. This 29-year-old female consumer (patient) reported that she received bnt162b2, dose 1 via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) in right arm as SINGLE DOSE for covid-19 immunisation at Pharmacy or Drug Store (also 29-years-old when receiving vaccine). The patient medical history included Complex partial focal epilepsy and birth control. The patient concomitant medications include Probiotic, Womens multi, deblitane. In Jul2021, the patient experienced irregularities in menstrual cycle(bleeding and early period), Heavy menstrual bleeding and headache. The outcome of the event Both doses have caused irregularities in menstrual cycle(bleeding and early period) and Heavy menstrual bleeding was not reported and that of headache was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown), via intramuscular route of administration, administered in left arm on 05Mar2021 (at the age of 63-years-old) as dose 1, single and again received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via intramuscular route of administration, administered in left arm on 26Mar2021 (at the age of 63-years-old) as dose 2, single for COVID-19 immunisation. Patients medical history included HIV positive and high blood pressure. The patient had unknown allergies. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination, but not sure which medications. Since the vaccination, the patient was tested for COVID-19. It was reported that the patient was tested positive for COVID-19 on 24Jul2021, following exposure on 14Jul2021 to others who also tested positive. Fortunately, symptoms were mild slight shortness of breath, mild fever, and congestion on 18Jul2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received antibody treatment, oral steroids antibiotics, an inhaler for the events. There was no hospitalization required for the events. The patient underwent lab test which included SARS-CoV-2 test: Positive Nasal Swab on 24Jul2021. The outcome of the events was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown), via intramuscular route of administration, administered in left arm on 05Mar2021 (at the age of 63-years-old) as dose 1, single and again received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown, expiry date: unknown) via intramuscular route of administration, administered in left arm on 26Mar2021 (at the age of 63-years-old) as dose 2, single for COVID-19 immunisation. Patients medical history included HIV positive and high blood pressure. The patient had unknown allergies. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination, but not sure which medications. Since the vaccination, the patient was tested for COVID-19. It was reported that the patient was tested positive for COVID-19 on 24Jul2021, following exposure on 14Jul2021 to others who also tested positive. Fortunately, symptoms were mild slight shortness of breath, mild fever, and congestion on 18Jul2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received antibody treatment, oral steroids antibiotics, an inhaler for the events. There was no hospitalization required for the events. The patient underwent lab test which included SARS-CoV-2 test: Positive Nasal Swab on 24Jul2021. The outcome of the events was recovering.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Blood cholesterol increased, Dyspepsia, Fatigue
Clinical narrative: No longer able to work; Difficulty sleeping; High Colesterol; Vitamin D Deficiency; Fever Blisters; Indigestion; Low Energy; Low vitamin D3; Fatigue; Migraine; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at the age of 62-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included destroyed gall bladder hence gall bladder removed, attention deficit hyperactivity disorder, Acid reflux (esophageal), hemorrhoids, menopause, UTIs, yeast infections and abnormal mole. Concomitant medications included ocrelizumab (OCREVUS), diphenhydramine hydrochloride (BENADRYL) and melatonin. On an unspecified date in 2021 the patient experienced no longer able to work, migraine, difficulty sleeping, high cholesterol, vitamin D deficiency, fever blisters, indigestion, low Energy, low vitamin D3 and fatigue. On unknown date patient started therapy with Pfizer COVID-19 vaccine for unknown indication. The patient underwent lab tests and procedures which included antibody test: COVID-19 antibodies not detected in blood on 2021. The outcome of the events was unknown. No further information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Job dissatisfaction, Migraine, Oral herpes, Vitamin D decreased
Clinical narrative: No longer able to work; Difficulty sleeping; High Colesterol; Vitamin D Deficiency; Fever Blisters; Indigestion; Low Energy; Low vitamin D3; Fatigue; Migraine; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at the age of 62-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included destroyed gall bladder hence gall bladder removed, attention deficit hyperactivity disorder, Acid reflux (esophageal), hemorrhoids, menopause, UTIs, yeast infections and abnormal mole. Concomitant medications included ocrelizumab (OCREVUS), diphenhydramine hydrochloride (BENADRYL) and melatonin. On an unspecified date in 2021 the patient experienced no longer able to work, migraine, difficulty sleeping, high cholesterol, vitamin D deficiency, fever blisters, indigestion, low Energy, low vitamin D3 and fatigue. On unknown date patient started therapy with Pfizer COVID-19 vaccine for unknown indication. The patient underwent lab tests and procedures which included antibody test: COVID-19 antibodies not detected in blood on 2021. The outcome of the events was unknown. No further information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin D deficiency
Clinical narrative: No longer able to work; Difficulty sleeping; High Colesterol; Vitamin D Deficiency; Fever Blisters; Indigestion; Low Energy; Low vitamin D3; Fatigue; Migraine; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at the age of 62-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included destroyed gall bladder hence gall bladder removed, attention deficit hyperactivity disorder, Acid reflux (esophageal), hemorrhoids, menopause, UTIs, yeast infections and abnormal mole. Concomitant medications included ocrelizumab (OCREVUS), diphenhydramine hydrochloride (BENADRYL) and melatonin. On an unspecified date in 2021 the patient experienced no longer able to work, migraine, difficulty sleeping, high cholesterol, vitamin D deficiency, fever blisters, indigestion, low Energy, low vitamin D3 and fatigue. On unknown date patient started therapy with Pfizer COVID-19 vaccine for unknown indication. The patient underwent lab tests and procedures which included antibody test: COVID-19 antibodies not detected in blood on 2021. The outcome of the events was unknown. No further information was reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Anaesthesia, Arthralgia, Paraesthesia
Clinical narrative: bilateral elbow pain; intermittent anesthesia; paresthesia left hand; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm, on 12Apr2021 (at the age of 48 years old) as dose 2, single for COVID-19 immunisation. Medical history included mild intermittent asthma and COVID-19. The patient's concomitant medications were not reported. The patient previously took cephalexin and experienced an allergy. Historical vaccine included bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 (at the age of 48 years old), via unspecified route of administration, administered in the left arm, as dose 1, single for COVID-19 Immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date in 2021, it was reported that the patient experienced bilateral elbow pain lasting 3 months after second dose associated with intermittent anesthesia/paresthesia left hand. The patient received NSAIDs as the treatment for the events. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Dizziness, Feeling abnormal
Clinical narrative: patient's blood pressure and it was 140 over a 100; not feeling good; felt kind of weird; felt kind of chills; felt like she wanted to faint, she felt little dizzy; This is a spontaneous report from a contactable consumer (patient's husband). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 03Aug2021 (Batch/Lot number was not reported; at the age of 27 years old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia and blood pressure (abnormal). Concomitant medications included duloxetine; pregabalin; labetalol; and other unspecified medication, all for blood pressure. The patient received her first Pfizer vaccine today (on 03Aug2021, pending clarification). The patient told her husband that she was not feeling good and felt kind of weird. The patient also felt kind of chills. So, the patient's husband came and checked the patient's blood pressure and it was 140 over a 100 and pulse was very close to 80. The patient took blood pressure pills at nighttime and it helped some. The patient felt like she wanted to faint, she felt little dizzy earlier she was holding the baby. The patient's husband is wondering whether it was side effects of the vaccine or if was because of her blood pressure condition. The reporter confirmed that the patient experienced the events probably about 05:30, about 2 hours after she received the shot. The patient is still experiencing the events. The patient had not yet recovered from the events.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Malaise
Clinical narrative: patient's blood pressure and it was 140 over a 100; not feeling good; felt kind of weird; felt kind of chills; felt like she wanted to faint, she felt little dizzy; This is a spontaneous report from a contactable consumer (patient's husband). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 03Aug2021 (Batch/Lot number was not reported; at the age of 27 years old) as dose 1, single for COVID-19 immunization. Medical history included fibromyalgia and blood pressure (abnormal). Concomitant medications included duloxetine; pregabalin; labetalol; and other unspecified medication, all for blood pressure. The patient received her first Pfizer vaccine today (on 03Aug2021, pending clarification). The patient told her husband that she was not feeling good and felt kind of weird. The patient also felt kind of chills. So, the patient's husband came and checked the patient's blood pressure and it was 140 over a 100 and pulse was very close to 80. The patient took blood pressure pills at nighttime and it helped some. The patient felt like she wanted to faint, she felt little dizzy earlier she was holding the baby. The patient's husband is wondering whether it was side effects of the vaccine or if was because of her blood pressure condition. The reporter confirmed that the patient experienced the events probably about 05:30, about 2 hours after she received the shot. The patient is still experiencing the events. The patient had not yet recovered from the events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report from a non-contactable other hcp received (Reference: LRN4357235). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included RITUXAN taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced covid-19. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. Additional information including event onset date, concomitant medications and their indications, concurrent medical conditions, medical history, diagnostic test results, treatment done, is needed to better assess this report.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: chest pain; suspicious of myocarditis; This is a spontaneous report. A non-contactable female consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 2 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced chest pain and suspicious of myocarditis (medically significant). The patient got second dose (of bnt162b2) and got chest pain and went to ER who were suspicious of myocarditis. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Headache, Pain
Clinical narrative: Ankylosing spondylitis affected; Aches/pain; Headaches; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No.: 21K-163-3989630-00). A contactable 55-year-old male consumer (patient) reported for himself that:  Solicited report by a consumer of a 55 year old male with events of non-serious Aches/Pain, Headaches and Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit with Humira (Adalimumab). There was no reported medical history. On an unknown date (as reported), the patient experienced Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit. In 2021, the patient experienced Aches/Pain And Headaches. On 12Jul2021, The Patient Experienced Ankylosing Spondylitis Affected By Weather/Patient thought due to biometric pressure weather been little cooler/hurt a little bit. In 2021, The Aches/Pain And Headaches Resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of Aches/Pain, Headaches, Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit unknown onset and Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit onset 12Jul2021 Was Not Provided.  Concomitant Drugs and dates of Administration: Concomitant Drugs Not Reported. Other relevant History: Not reported  Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB) for events pain, headache, ankylosing spondylitis/pain Causality as per reporter (Drug/Vaccine): Not Reported. Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran), for events events pain, headache, ankylosing spondylitis/pain Causality as per reporter (Drug/Vaccine): Not Reported.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Ankylosing Spondylitis and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Gastrooesophageal reflux disease, Myalgia
Clinical narrative: Severe center upper back pain; joint pain; muscle aches; fainting episodes; throat discomfort; weakness; diagnosed with acid reflux; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jun2021 at 10:15 am (Lot Number: EW0179, unknown expiration; at the age of 48 years old) as dose 2, single for COVID-19 immunization.  Medical history reported as none. No known allergies. No past drug history. Concomitant medication included unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736) on 21May2021 at 10:15 am in the left arm at the age of 48 years old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the date of the 2nd shot (on 11Jun2021 at 22:00), the patient experienced joint pain and muscle aches that lasted 1.5 days. Then the patient experienced severe center upper back pain the next day on 12Jun2021 that lasted for a few hours. Two weeks later (in Jun2021), the patient visited emergency room due to near fainting episodes, throat discomfort, and weakness. The patient had followed up with doctor one week later and diagnosed with acid reflux. The patient is taking pantoprazole as treatment for acid reflux. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from events joint pain, muscle aches, and back pain in Jun2021, while recovering from the remaining events. The events were assessed as non-serious.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Presyncope
Clinical narrative: Severe center upper back pain; joint pain; muscle aches; fainting episodes; throat discomfort; weakness; diagnosed with acid reflux; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 11Jun2021 at 10:15 am (Lot Number: EW0179, unknown expiration; at the age of 48 years old) as dose 2, single for COVID-19 immunization.  Medical history reported as none. No known allergies. No past drug history. Concomitant medication included unspecified vitamins. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8736) on 21May2021 at 10:15 am in the left arm at the age of 48 years old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the date of the 2nd shot (on 11Jun2021 at 22:00), the patient experienced joint pain and muscle aches that lasted 1.5 days. Then the patient experienced severe center upper back pain the next day on 12Jun2021 that lasted for a few hours. Two weeks later (in Jun2021), the patient visited emergency room due to near fainting episodes, throat discomfort, and weakness. The patient had followed up with doctor one week later and diagnosed with acid reflux. The patient is taking pantoprazole as treatment for acid reflux. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from events joint pain, muscle aches, and back pain in Jun2021, while recovering from the remaining events. The events were assessed as non-serious.   No follow-up attempts are possible; information about batch number was already obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: positive for COVID with symptoms; This is a spontaneous report from a Pfizer sponsored program contactable consumer or other non hcp. A 16-year-old female patient received bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EW0198)), dose 1 via an unspecified route of administration on 27Jul2021 (age at the time of vaccination was 16-year-old) as dose 1, single for COVID-19 immunisation.The patient's medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced positive for COVID-19 with symptoms. The reported stated that her both daughters got COVID shot and they both tested positive for COVID; unfortunately, they actually took COVID test yesterday and they tested positive dates for her 2 daughters, they were 14 and 16 years old and unfortunately after taking the first dose they experience side effects. The patient had the first day that she got it that night she threw up. She was little nauseated, she threw up she also had, she had body ache. She had not lot of temperature like, she was gone up to maybe 98 point something but that is or 99 but that is it and she has, she said she is been getting to like middle cough and she just doesn't feel good, but my, because they have not felt good. I took them, they got their shot the vaccine on the 27. The reporter think it was the Tuesday or Wednesday of last week and yesterday I took them to get COVID shot and they both tested positive for COVID. So, my question is what I from here on I mean do they tested positive for COVID. The reporter will not be able to, and I need to get some information and that was what I need to do. Otherwise, I would I am sorry about that. Reporter was informed that the Pfizer Medical Information department is the concerned department. Reporter was unwilling to complete the report hence further probing could not be done. Hence, limited information was available over the call. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on 01Aug2021. The outcome of the event was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Mesenteric vein thrombosis
Clinical narrative: Developed blood clot in superior Mesenteric Vein; This is a spontaneous report received from a contactable consumer other non-health care professional (the patient).   A 57-year-old male consumer received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: EN6203; Batch no: not reported) via an unspecified route of administration in left Arm on 16Mar2021 02:00PM (at the age of 57-years-old) as dose 1 and BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: ER8233; Batch no: not reported) via an unspecified route of administration in left Arm on 06Apr2021 11:00 AM (at the age of 57-years-old) both as single for covid-19 immunization at hospital. The patient medical history was not reported. The patient concomitant medication included medications received within 2 weeks of vaccination Omeprazole (PPI) and Atorvastatin both for unspecified indication from unknown date and unknown if ongoing. The patient Known allergies was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unspecified date in 2021, patient developed blood clot in superior Mesenteric Vein. Adverse event result in Emergency room/department or urgent care. Patient was hospitalized for 3 days. Seriousness was reported as serious with hospitalization. The outcome of event was unknown.   Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive on 13Jul; Patient tested positive on 13Jul; This is a spontaneous report from a contactable Health Care Professional. A 26-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955 and Expiry date: Unknown), via intramuscular route administered in left arm on 09Apr2021 at 16:00 as dose 2, single; and received first dose of BNT162B2 (Lot Number: EP6955 and Expiry date: Unknown) via intramuscular route administered in left arm on 19Mar2021 at 16:00 as dose 1, single; both (at the age of 25-years-old) for COVID-19 immunization. Patient had no medical history and no known allergies. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. Since the vaccination, the patient has been tested for COVID-19. On 13Jul2021, Patient tested positive for COVID-19. Adverse event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test (PCR Nasal Swab): positive on 13Jul2021. Therapeutic measures were taken as a result of event. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Vaccination failure, Covid 19 and the suspect drug bnt162b2. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: had pain in the back of my shoulder; had paint in the back of my neck; stiffness; arm pain; Headache; soreness/I have pain where i received the injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number FA7485, expiration date unspecified), via an unspecified route of administration on 02Aug2021 DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took tylenol and experienced nausea. On 02Aug2021, the patient experienced arm pain, headache along with pain/soreness at the injection site with stiffness. On 03Aug2021, the patient developed pain in the back of shoulder and neck. The patient was treated for the events with Excedrin but it did not work. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had pain in the back of my shoulder; had paint in the back of my neck; stiffness; arm pain; Headache; soreness/I have pain where i received the injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number FA7485, expiration date unspecified), via an unspecified route of administration on 02Aug2021 DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took tylenol and experienced nausea. On 02Aug2021, the patient experienced arm pain, headache along with pain/soreness at the injection site with stiffness. On 03Aug2021, the patient developed pain in the back of shoulder and neck. The patient was treated for the events with Excedrin but it did not work. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable other healthcare professional. A 31-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in the left arm on 31Jul2021 (batch/lot number and expiry date unknown) at 31 years of age as dose 1, single for covid-19 immunization in pharmacy or drug store facility. Medical history included anxiety, depression, recently postpartum, sulfa allergies. The patient was not diagnosed with COVID-19, prior to vaccination. The patient's concomitant medications were not reported. The patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Aug2021, the patient experienced hives. The event was reported non-serious. The event resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The patient received antihistamines and prednisone as treatment due to the event. The outcome of the event was recovering.  The lot number for bnt162b2, was not provided and will be requested during follow up.