chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Magnetic resonance imaging, Migraine, Monoplegia, Muscle twitching
Clinical narrative: Facial paralysis; Migraines; pressure in my head and behind my eyes; pressure in my head and behind my eyes; chest pain; facial twitching and body twitching; dizziness; feeling of suffocation; left head, face, arm, hand, leg and foot paralysis; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration on the right arm on 08Apr2021 (Lot Number: ER8729) at the age of 45-year-old as single does for COVID-19 immunization. Medical history included COVID and thyroid. Known allergy was none. On 04May2021, the patient performed for COVID test (Nasal Swab) and result was negative. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 18Mar2021 (Lot Number: EN6208) at the age of 45-year-old as single does for COVID-19 immunization. On 04May2021 at 11:30 AM, the patient experienced facial paralysis, migraines, left head, face, arm, hand, leg and foot paralysis. The patient had since been back to withheld Hospital 2 times with facial paralysis, pressure in head and behind eyes, chest pain, facial twitching and body twitching. Waiting for next MRI and MRV, as patient have the feeling of suffocation and dizziness all the time and chest pain was completely fine before receiving the shot. The events resulted in hospitalization for 2 days. Treatment was received for events included CT Scan, MRI, EKG, IV Therapy. The outcome of events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, SARS-CoV-2 test, Suffocation feeling
Clinical narrative: Facial paralysis; Migraines; pressure in my head and behind my eyes; pressure in my head and behind my eyes; chest pain; facial twitching and body twitching; dizziness; feeling of suffocation; left head, face, arm, hand, leg and foot paralysis; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER COVID-19) via an unspecified route of administration on the right arm on 08Apr2021 (Lot Number: ER8729) at the age of 45-year-old as single does for COVID-19 immunization. Medical history included COVID and thyroid. Known allergy was none. On 04May2021, the patient performed for COVID test (Nasal Swab) and result was negative. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the right arm on 18Mar2021 (Lot Number: EN6208) at the age of 45-year-old as single does for COVID-19 immunization. On 04May2021 at 11:30 AM, the patient experienced facial paralysis, migraines, left head, face, arm, hand, leg and foot paralysis. The patient had since been back to withheld Hospital 2 times with facial paralysis, pressure in head and behind eyes, chest pain, facial twitching and body twitching. Waiting for next MRI and MRV, as patient have the feeling of suffocation and dizziness all the time and chest pain was completely fine before receiving the shot. The events resulted in hospitalization for 2 days. Treatment was received for events included CT Scan, MRI, EKG, IV Therapy. The outcome of events was not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: fully vaccinated with PCR test positive CV19 on 8/31/21. Client was primary contact to CV19 positive case and sought testing on 8/30/21. Client is asymptomatic.; fully vaccinated with PCR test positive CV19 on 8/31/21. Client was primary contact to CV19 positive case and sought testing on 8/30/21. Client is asymptomatic.; This is a spontaneous report from a contactable other health professional. A 58-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) dose 2 via intramuscular administered in the arm right on 23Feb2021 (at the age of 58 years old) as dose 2, single and dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) via intramuscular, administered in the arm right on 03Feb2021 (at the age of 58 years old) as dose 1, single both for COVID-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was a clinic. The patient medical history and concomitant medication was not reported. The patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications received within 2 weeks of vaccination was reported as unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. On 28Aug2021, the patient experienced asymptomatic Covid-19. The patient was fully vaccinated with PCR test positive CV19 on 31Aug2021. Patient was primary contact to cv19 positive case and sought testing on 30Aug2021. Patient was asymptomatic. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included PCR test resulted positive on 30Aug2021 Nasal Swab. Treatment received was reported as unknown. The event resulted in Doctor or other healthcare professional office/clinic visit. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization / Disabling /Incapacitating / Congenital anomaly/birth defect). The clinical outcome of the event was recovering. Based on the reported information, a causal relationship between the events and suspected drug cannot be excluded.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Inflammation, Pyrexia
Clinical narrative: Started having terrible Chills; Very tired; fever; inflammatory response from the vaccine; This is a spontaneous report from a contactable consumer reporting on daughter. A 14-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 23Aug2021 (Batch/Lot Number: FC3182) (at the age of 14 years old) as dose 1, as a single dose for COVID-19 immunisation. Medical history included COVID-19 from Dec2020 to an unknown date, described she was positive for antibody before a week of the Covid-19 vaccination because she had mild cold due to Covid-19 infection back in December. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Aug2021, the patient experienced fever and inflammatory response from the vaccine. On 25Aug2021, the patient was very tired. On 29Aug2021, the patient started having terrible chills. The patient visited the physician's office and treatment was received due to these events. The doctor determined that it was definitely some type of inflammatory response from the vaccine. The patient underwent lab tests and procedures which included body temperature 99-100F on an unspecified date, body temperature 102.4F on 30Aug2021, body temperature 100.3F on 30Aug2021 gave her some more ibuprofen and fever went to be like 100.3, body temperature 102.7F on 30Aug2021 we went to home by the afternoon around 2 and her fever was like 102.7, body temperature 100F on 30Aug2021 gave her some more ibuprofen and it lowered her fever at about 100, body temperature 102F on 30Aug2021 fever got elevated 102 by 8 o'clock, her fever was like 103.3 overnight, body temperature: 103.3F on 30Aug2021 fever got elevated 102 by 8 o'clock, her fever was like 103.3 overnight. The patient took ibuprofen, Motrin and Tylenol as treatment for fever reducing but started again to have fever and becoming difficult to control. The reporter stated that these side effects are actually worse than the Corona Virus right now she has like-Corona virus and now she is going sick for a week and it actually got worse and it didn't get better. She was some better today and hoping that may be the side effects completely go away by tomorrow. The outcome of the events fever, inflammatory response, very tired and chills was not recovered.  Follow-up (02Sep2021), Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Lymphadenopathy, Rash papular, Swelling face
Clinical narrative: Red bumpy rash scattered all over; Swollen lymph nodes; Swollen face and eyes; Swollen face and eyes; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in left arm on 26Aug2021 (at 13 years old) as dose 1, single for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The patient experienced red bumpy rash scattered all over, swollen lymph nodes, and swollen face and eyes, all on 27Aug2021. The events resulted in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. Therapeutic measures such as steroid and antihistamine shot were taken as a result of the events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Drug ineffective, Myalgia, Nasal congestion
Clinical narrative: Break through infection in which he tested positive with covid 19, this past Sunday; Break through infection in which he tested positive with covid 19, this past Sunday; Loss of taste; Low grade fever; Myalgia; congestion; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on Mar2021 (reported as 3rd or 4th week of Mar2021) as dose 1, single and on Apr2021 (reported as 2nd week of Apr2021) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. It was reported that there was a breakthrough infection in which patient was tested positive with COVID-19, this past Sunday before the present report (29Aug2021). He did not know specific dates of when he got his COVID-19 vaccines, but he stated that his first dose was in the 3rd or 4th week of Mar2021 and the second dose was in the 2nd week of Apr2021. They did a rapid COVID test, for which he tested positive on Sunday 29Aug2021. On Thursday 26Aug2021 he started feeling sick, his twin 3rd years old school tested positive, and so it was 4 classes that were quarantined. He started feeling symptoms on this past Thursday 26Aug2021 and therefore provides his awareness date as 26Aug2021. Caller (patient) elaborated on the symptoms he experienced on Thursday 26Aug2021, he had congestion nasally, then on Friday 27Aug2021 a low grade fever. He had myalgia from 26Aug2021 having his body be sore. The congestion was done by Sunday and his nose started clearing. Caller confirmed that on Monday (30Aug2021) it was gone. Fever lasted a day and a half (28Aug2021). Regarding myalgia it was reported that he was sore and tired, just still a little sore. He added that another symptom he had was loss of taste, which started on Saturday (28Aug2021) and it was still ongoing and the same. He had no product details since he was quarantined at the moment, he didn't take his COVID card with him and it was at home, he was not going home yet for the moment. The outcome of the events was resolved on 30Aug2021 for congestion, resolved on 28Aug2021 for low grade fever, resolving for myalgia, not resolved for loss of taste and unknown for the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Break through infection in which he tested positive with covid 19, this past Sunday; Break through infection in which he tested positive with covid 19, this past Sunday; Loss of taste; Low grade fever; Myalgia; congestion; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on Mar2021 (reported as 3rd or 4th week of Mar2021) as dose 1, single and on Apr2021 (reported as 2nd week of Apr2021) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. It was reported that there was a breakthrough infection in which patient was tested positive with COVID-19, this past Sunday before the present report (29Aug2021). He did not know specific dates of when he got his COVID-19 vaccines, but he stated that his first dose was in the 3rd or 4th week of Mar2021 and the second dose was in the 2nd week of Apr2021. They did a rapid COVID test, for which he tested positive on Sunday 29Aug2021. On Thursday 26Aug2021 he started feeling sick, his twin 3rd years old school tested positive, and so it was 4 classes that were quarantined. He started feeling symptoms on this past Thursday 26Aug2021 and therefore provides his awareness date as 26Aug2021. Caller (patient) elaborated on the symptoms he experienced on Thursday 26Aug2021, he had congestion nasally, then on Friday 27Aug2021 a low grade fever. He had myalgia from 26Aug2021 having his body be sore. The congestion was done by Sunday and his nose started clearing. Caller confirmed that on Monday (30Aug2021) it was gone. Fever lasted a day and a half (28Aug2021). Regarding myalgia it was reported that he was sore and tired, just still a little sore. He added that another symptom he had was loss of taste, which started on Saturday (28Aug2021) and it was still ongoing and the same. He had no product details since he was quarantined at the moment, he didn't take his COVID card with him and it was at home, he was not going home yet for the moment. The outcome of the events was resolved on 30Aug2021 for congestion, resolved on 28Aug2021 for low grade fever, resolving for myalgia, not resolved for loss of taste and unknown for the other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive when she had her rapid test today; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration on 22Aug2021 as dose 1, single for COVID- 19 Immunisation. Relevant medical history and concomitant medications were not reported. It was reported that patient tested positive when she had her rapid test on 28Aug2021. Patient asked what she would do if she tested positive after her 2nd dose also. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Aug2021 (Lot Number: IA7484) as single dose (at the age of 42-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blurry vision on an unspecified date. The patient stated that she received her first dose of Comirnaty last week because it was mandated by her workplace. After vaccination she began experiencing blurry vision and an electromagnetic arm where things are sticking to her arm. She was asking what side effects have been reported from Comirnaty and demanding an answer to why her arm is now magnetic. Her concerns as being that last week she had the Pfizer first dose because she is a healthcare worker and obviously it is being mandated and now she is one of those people who is pretty sure that there is metal in her arm because everything magnetic is legit sticking to her and now her vision is getting blurry and she is not too happy. She really doesn't have time to complete a report because she is already on 16 to 18 hour shifts and she is barely going as it is. She is an emergency room technician. Patient stated, "Yeah I am just kind of freaking off that I have noticed over the past weeks almost week, my vision has been getting blurrier like I am having harder timing to see and I am only 42 years old and people help me and then like every time I turn around and I was like wait a minute, what the hell I have got metal that literally sticking to me and I am like what the hell is going on." The outcome of the event was unknown.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Blood bilirubin
Clinical narrative: intractable vomiting; feeling of pins and needles; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; This is a spontaneous report from a contactable Pharmacist. A 20-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 20 years, on 27Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history was none. No COVID prior vaccination. No known allergies. There were no concomitant medications. Patient was admitted to hospital for intractable vomiting and feeling of pins and needles starting after vaccine was given on 27Aug2021. Patient had elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission on 27Aug2021. The patient was hospitalized for 3 days in until 30Aug2021. No other vaccine in four weeks. No other medications in two weeks. AE treatment was fluids. COVID tested post vaccination: Abbott ID Now SARS Cov 2 nasal swab was negative on 29Aug2021. The outcome of the events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the events intractable vomiting, feeling of pins and needles, and elevated LFTs with BNT162b2 can not be fully 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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Blood lactic acid, Blood lactic acid increased, Paraesthesia, SARS-CoV-2 test
Clinical narrative: intractable vomiting; feeling of pins and needles; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; This is a spontaneous report from a contactable Pharmacist. A 20-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 20 years, on 27Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history was none. No COVID prior vaccination. No known allergies. There were no concomitant medications. Patient was admitted to hospital for intractable vomiting and feeling of pins and needles starting after vaccine was given on 27Aug2021. Patient had elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission on 27Aug2021. The patient was hospitalized for 3 days in until 30Aug2021. No other vaccine in four weeks. No other medications in two weeks. AE treatment was fluids. COVID tested post vaccination: Abbott ID Now SARS Cov 2 nasal swab was negative on 29Aug2021. The outcome of the events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the events intractable vomiting, feeling of pins and needles, and elevated LFTs with BNT162b2 can not be fully 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: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: intractable vomiting; feeling of pins and needles; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission; This is a spontaneous report from a contactable Pharmacist. A 20-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 20 years, on 27Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history was none. No COVID prior vaccination. No known allergies. There were no concomitant medications. Patient was admitted to hospital for intractable vomiting and feeling of pins and needles starting after vaccine was given on 27Aug2021. Patient had elevated LFTs (AST 4343, ALT 2182, Bilirubin 1.6) and lactic acid (2.5) on admission on 27Aug2021. The patient was hospitalized for 3 days in until 30Aug2021. No other vaccine in four weeks. No other medications in two weeks. AE treatment was fluids. COVID tested post vaccination: Abbott ID Now SARS Cov 2 nasal swab was negative on 29Aug2021. The outcome of the events was recovering.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relationship, the association between the events intractable vomiting, feeling of pins and needles, and elevated LFTs with BNT162b2 can not be fully 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Chest discomfort, Head discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: About five minutes after injection my head began to tingle felt heavy.; About five minutes after injection my head began to tingle felt heavy.; Then my tongue felt tingly on both sides.; Developed chest tightness; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration, administered in left arm on 29Jan2021 (at the age of 65 years old) as dose number unknown, single for covid-19 immunisation. Medical history included cardiovascular disease, hypertension, fibromyalgia, asthma, apnea, high cholesterol, hypothyroidism and known allergy to IVP dye, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of the report and vaccination. The patient previously took levofloxacin (LEVAQUIN) and oxybutynin hydrochloride (DITROPAN), and experienced known allergy to both. Patient also had flu shot (date unknown) for immunization and experienced known allergy to it. Patient had other medications in two weeks which were unspecified. The patient had no other vaccine in four weeks. The Covid-19 vaccine was administered in hospital. It was reported that about five minutes after injection on 29Jan2021, patient's head began to tingle felt heavy and then tongue felt tingly on both sides and then developed chest tightness. Adverse events (AEs) resulted in emergency room/department or urgent care, physician office visit hospitalization on unknown dates in 2021 (with reported 1 day hospitalization). Therapeutic measures were taken as a result of the events reported which included Benadryl and steroids. The patient had no Covid prior vaccination and was not tested for Covid post vaccination. The outcome of the events was recovered on an unspecified date in 2021.    The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: right side of my face right here my jaw line it went numb; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration, administered in arm left on 27Aug2021 (Lot Number: EW0165) as dose 1, single for COVID-19 immunisation. There was no medical history. Concomitant medication included valacyclovir taken for an unspecified indication, start and stop date were not reported. The patient stated that she went to get her first vaccine last Friday (27Aug2021) and on the (name withheld), it said to call if she had any reaction or anything and she was here to report this on the right side of her face right here her jaw line it went numb for about 8 hours. The patient confirmed the date of adverse event on 27Aug2021. The event went away 6 hours (also reported) or so after she got the vaccination. She was just calling to report what happened. She was fine. She just wanted to report what happened, it went away after hours. No treatment was received for the event. The outcome of the event was recovered on 27Aug2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Had a reaction to the Covid Vaccine, both arms are going numb and I am concerned, wondered and scared about that; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated, had a reaction to the Covid Vaccine, both arms are going numb and I am concerned, wondered and scared about that on unknown date. Consumer stated, I would like for somebody to know that I got this vaccination 16 hours ago and my arms were numb and I am scared. The outcome of the event was reported as unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Electrocardiogram, Extra dose administered, Heart rate, Heart rate increased
Clinical narrative: received his third Covid 19 vaccine; received his third Covid 19 vaccine; fluttering heart; fast-beating/heart rate as high as 220 beats per minute; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Aug2021 (Batch/Lot Number: TC3182) at 72 years of age as dose 3, single for COVID-19 immunisation. Medical history included compromised kidneys, Trigeminy, and Paroxysmal atrial tachycardia. The patient takes unspecified medications for years. Historical vaccination included bnt162b2 received by the patient on 06Jan2021 as dose 1, single (Lot number EL1284) and on 27Jan2021 as dose 2, single (Lot number EL9262); both at 72 years of age for COVID-19 immunization. He is a physician who called about the COVID-19 vaccine. He received his third COVID-19 vaccine, his booster on 26Aug2021. Within 24 hours (Aug2021), he had feelings of a fast beating, fluttering heart. He knew this can be an expected side effect and he's asking about how long it's expected to last. He reported he has a history of compromised kidneys, trigeminy, and paroxysmal atrial tachycardia. He's trying to trace his side effects to something and can't. His history with cardiac issues was usually short-lived and he hasn't experienced those cardiac issues in a while. He was followed by a cardiologist. His fast beating, fluttering heart is not incapacitating, he usually has a warning that his heart rate is going up, so he stops what he's doing and sits or lays down until it resolves. His fast beating, fluttering heart hasn't gotten worse but it is persisting. He's checked an electrocardiogram on his Apple watch and it's normal but he has seen his heart rate as high as 220 beats per minute. He checked his heart rate recently and it was 89 beats per minute. He doesn't think his side effects have required any additional care. Outcome of 'fluttering heart' and 'fast-beating/heart rate as high as 220 beats per minute' was not recovered.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events Cardiac flutter, heart rate increased and the suspect drug BNT162B2.  Consider also possible contributory effects from patient's pre-existing risk factors, namely, Trigeminy, and Paroxysmal atrial tachycardia.  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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: received his third Covid 19 vaccine; received his third Covid 19 vaccine; fluttering heart; fast-beating/heart rate as high as 220 beats per minute; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Aug2021 (Batch/Lot Number: TC3182) at 72 years of age as dose 3, single for COVID-19 immunisation. Medical history included compromised kidneys, Trigeminy, and Paroxysmal atrial tachycardia. The patient takes unspecified medications for years. Historical vaccination included bnt162b2 received by the patient on 06Jan2021 as dose 1, single (Lot number EL1284) and on 27Jan2021 as dose 2, single (Lot number EL9262); both at 72 years of age for COVID-19 immunization. He is a physician who called about the COVID-19 vaccine. He received his third COVID-19 vaccine, his booster on 26Aug2021. Within 24 hours (Aug2021), he had feelings of a fast beating, fluttering heart. He knew this can be an expected side effect and he's asking about how long it's expected to last. He reported he has a history of compromised kidneys, trigeminy, and paroxysmal atrial tachycardia. He's trying to trace his side effects to something and can't. His history with cardiac issues was usually short-lived and he hasn't experienced those cardiac issues in a while. He was followed by a cardiologist. His fast beating, fluttering heart is not incapacitating, he usually has a warning that his heart rate is going up, so he stops what he's doing and sits or lays down until it resolves. His fast beating, fluttering heart hasn't gotten worse but it is persisting. He's checked an electrocardiogram on his Apple watch and it's normal but he has seen his heart rate as high as 220 beats per minute. He checked his heart rate recently and it was 89 beats per minute. He doesn't think his side effects have required any additional care. Outcome of 'fluttering heart' and 'fast-beating/heart rate as high as 220 beats per minute' was not recovered.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events Cardiac flutter, heart rate increased and the suspect drug BNT162B2.  Consider also possible contributory effects from patient's pre-existing risk factors, namely, Trigeminy, and Paroxysmal atrial tachycardia.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Allergic reaction to excipient
Clinical narrative: allergy to PEG in Covid vaccine; This is a spontaneous report from a contactable consumer via medical information team . This consumer reported similar events for two patients (including himself). This is second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for covid-19 immunization.  This vaccine contains Polyethylene Glycol (PEG). The patient medical history and concomitant medications were not reported. The patient experienced allergy to PEG in covid vaccine on an unspecified date. Treatment for the event was not reported. The outcome for the event was unknown.  The lot number for the BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101096598 same reporter, drug, event/ different patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: extreme diarrhea; nausea; vomiting bile; feeling sick.; This is a spontaneous report from a contactable other HCP and a consumer from a program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (at the age of 61 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included methotrexate, XELJANZ. The patient experienced extreme diarrhea on 22Aug2021, nausea on 22Aug2021, vomiting bile on 22Aug2021, feeling sick on 22Aug2021. Patient reported adverse event of extreme diarrhea, nausea, vomiting bile starting 22Aug2021, and lasted a few days. Patient reported negative COVID-19 test. Patient stated she stopped taking her Xeljanz and MTX for 1 week due to feeling sick. The outcome of the events was recovered in Aug2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Diarrhea cannot be totally excluded. The case will be reassessed once additional information is available. 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: PNC13
Symptoms: Febrile convulsion
Clinical narrative: 2 febrile seizures; This is a spontaneous report from a contactable physician. A 2-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced 2 febrile seizures about 2 days after the dose and went to hospital on an unspecified date. At the reporting time, she was ok now. Outcome of event was recovered on an unspecified date.  The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: A possibly contributory role of PREVENAR 13 in triggering the onset of febrile seizures cannot be fully excluded, considering the temporal relationship and known adverse event profile  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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Depressed mood, Drug ineffective
Clinical narrative: Today I was diagnosed with Covid 19.; Today I was diagnosed with Covid 19.; I am devastated; This is a spontaneous report received from a contactable consumer or other non hcp.   A 56-years-old male patient received bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date,at the age of 56 years old,as Dose number unknown,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced he was diagnosed with covid 19 on an unspecified date and devastated on an unspecified date.The outcome of the events was unknown.Patient wanted to know what are the Short Term & Long Term effects after Covid 19 disappears.  Follow-up (01Sep2021): This is a follow-up spontaneous report received from a contactable consumer.Forwarded as an Adverse Event and Medical Inquiry on 01Sep2021 Reporter provided verification of contact address on 31Aug2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Echocardiogram, Electrocardiogram ambulatory, Heart rate irregular
Clinical narrative: Diagnosis was Supraventricular Tachycardia; I got fast and irregular heartbeat.; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; This is a spontaneous report from a contactable consumer. A 64-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 29Jul2021 14:00 (Lot Number: FA7485) (Age at vaccination: 64-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included anxiety, GERD and fibromyalgia; all since from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besilate (Strength: 2.5 mg) at 2.5 mg unknown frequency; alprazolam at an unknown dose and frequency (0, 25) and calcium. The patient previously took Penicillin, Cipro and experienced drug hypersensitivity, Contrast dye and experienced allergy to chemicals. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 07:30, the patient experienced starting next day after vaccine, I got fast and irregular heartbeat. It did not go away, and since then I went to a cardiologist who did echocardiogram and a Holter monitor. Diagnosis was Supraventricular Tachycardia. I never had any heart problems before this event. Doctor prescribed metoprolol, 25 mg and irregular heartbeat is generally under control but not completely gone. I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw. I went to emergency room to be sure it was not a hear attack and they said it was not. The patient underwent lab tests and procedures which included echocardiogram: unknown on 30Jul2021 (I went to a cardiologist who did echocardiogram and a Holter monitor), Holter Monitor: unknown on 30Jul2021 (I went to a cardiologist who did echocardiogram and a Holter monitor), Rapid Test: negative on 31Aug2021 (Nasal Swab). Patient received treatment of Metoprolol 25 mg. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Supraventricular tachycardia
Clinical narrative: Diagnosis was Supraventricular Tachycardia; I got fast and irregular heartbeat.; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw; This is a spontaneous report from a contactable consumer. A 64-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 29Jul2021 14:00 (Lot Number: FA7485) (Age at vaccination: 64-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included anxiety, GERD and fibromyalgia; all since from an unknown date and unknown if ongoing. Concomitant medications included amlodipine besilate (Strength: 2.5 mg) at 2.5 mg unknown frequency; alprazolam at an unknown dose and frequency (0, 25) and calcium. The patient previously took Penicillin, Cipro and experienced drug hypersensitivity, Contrast dye and experienced allergy to chemicals. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 07:30, the patient experienced starting next day after vaccine, I got fast and irregular heartbeat. It did not go away, and since then I went to a cardiologist who did echocardiogram and a Holter monitor. Diagnosis was Supraventricular Tachycardia. I never had any heart problems before this event. Doctor prescribed metoprolol, 25 mg and irregular heartbeat is generally under control but not completely gone. I also have pain/discomfort around my heart area on my left side, radiating to side, back and up to neck and jaw. I went to emergency room to be sure it was not a hear attack and they said it was not. The patient underwent lab tests and procedures which included echocardiogram: unknown on 30Jul2021 (I went to a cardiologist who did echocardiogram and a Holter monitor), Holter Monitor: unknown on 30Jul2021 (I went to a cardiologist who did echocardiogram and a Holter monitor), Rapid Test: negative on 31Aug2021 (Nasal Swab). Patient received treatment of Metoprolol 25 mg. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted / I fainted with both doses; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 20Jul2021 10:00 (Batch/Lot Number: EW0187) (at the age of 14 years old) as single dose, and dose 2 via an unspecified route of administration, administered in left arm on 10Aug2021 10:15 (Batch/Lot Number: EW0187) (at the age of 15 years old) as single dose, for Covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. There were no concomitant medications. The patient fainted on 11Aug2021 at 12:00. The patient reported that she fainted with both doses. She did not receive any treatment. Outcome of the events was recovered with sequelae.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: ED; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm in Aug2021 (Lot Number: FC3181) at the age of 40-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. COVID prior vaccination was none. COVID tested post vaccination was none. The patient didn't receive other vaccine in four weeks. In Aug2021, the patient experienced ED. No treatment was received. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.