chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial flutter, Heart rate increased
Clinical narrative: On 05May2021 I went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized.; On 05May2021 I went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized.; This is a spontaneous report from a contactable Nurse (patient). A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EW0150), dose 2 intramuscular, administered in Arm Left on 06Apr2021 14:45 (Age at vaccination 56 years) as dose 2, single for covid-19 immunization. Medical history included hypertension. The patient's concomitant medications were not reported. The patient previously took minocin and sudafed (Known allergies). Historical vaccine included first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6202), dose 1 via an intramuscular administration on 09Mar2021 at 02:30 PM (Age at vaccination 56 years) in Arm Left as dose 1, single for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been not tested for COVID-19. On 05May2021 at 19:45 the patient went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized. The patient was hospitalized on 05may2021. Patient went into an irregular heart rhythm called atrial flutter with elevated heart rate and was hospitalized for 2 days. Patient received Cardizem as treatment for event. Patient visited emergency care room. Facility where the most recent COVID-19 vaccine was administered at hospital. Seriousness criteria-Caused/prolonged hospitalization: Yes. The clinical outcome of events was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Limited information of reported events preclude a comprehensive causality assessment however causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to event.  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: F
Vaccine: COVID19
Symptoms: Condition aggravated, Contusion, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a patient (reporter's wife). A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was admitted in the hospital for 3 days after she got her first dose shot, 5 days later. Her left arm first got swelled up and got puffy, 4 days after that her elbow to wrist turned black and blue in side of her wrist. Later her whole left arm is swollen and bruised. Reporter stated that her left forearm is painful and the site she got the vaccine is her left arm. Outcome for event condition aggravated was reported as not recovered however for other all events it was reported as unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for a patient (reporter's wife). A female patient of an unspecified age received bnt162b2 (BNT162B2, Batch/Lot Number: EW0185), dose 1 via an unspecified route of administration, administered in Arm Left on Jun2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was admitted in the hospital for 3 days after she got her first dose shot, 5 days later. Her left arm first got swelled up and got puffy, 4 days after that her elbow to wrist turned black and blue in side of her wrist. Later her whole left arm is swollen and bruised. Reporter stated that her left forearm is painful and the site she got the vaccine is her left arm. Outcome for event condition aggravated was reported as not recovered however for other all events it was reported as unknown. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident, Haemorrhagic stroke
Clinical narrative: Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; This is a spontaneous report from a contactable consumer. This 61-year-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 16Mar2021 at 15:00 hours on left arm (at 61-year-old) as dose 1, single for COVID-19 immunization. Medical history included cardiac failure. The allergies were reported as none. Concomitant medications included sacubitril valsartan sodium hydrate (Entresto) taken for an unspecified indication, carvedilol taken for an unspecified indication and spironolactone taken for an unspecified indication. On 18Mar2021 at 10:00 PM the patient experienced loss of vision, cerebrovascular accident and hemorrhagic stroke. The patient required emergency room visit and was hospitalized for 3 days. Therapeutic measures were taken with nir angiogram cerebral. The event outcome was unknown. It was mentioned that no other vaccine was received in four weeks, patient had no covid prior vaccination and was not tested for covid post vaccination. The device date was 03Jul2021.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort
Clinical narrative: I got a node on my arm; Arm is red near the blue mark on my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186, Expiry date: unknown), via an unspecified route of administration on 02Jul2021 as dose 1, single for covid-19 immunization. The medical history and concomitant medications were not reported. The patient stated, got the shot yesterday (02Jul2021) and now was trying to find out help because of a node on arm, today when woke up the arm was red near the blue mark on arm. The outcome of events was unknown.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: in a lot of pain; Fever; Vomiting; Severe headache, very bad headache; This is a spontaneous report from a contactable consumer (parent). A 12-years-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number and expiration date were unknown), dose 2 via an unspecified route of administration on 02Jul2021 02:30 (age at vaccination: 12-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Jul2021 at 02:30, the reporter's daughter just got her second dose of vaccine for the Covid-19 and at 03:00 in the morning, she started with the side effects which included fever since then, vomiting and severe headache, very bad headache. At 04:00 in the morning, the reporter further stated that She was in a lot of pain, her headache was killer her. The reporter thought that going to take her to the (unspecified, which was not clear) because she can't take the pain anymore. The outcome of the events was unknown.   Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Headache, Loss of consciousness, Neck injury, Vertigo
Clinical narrative: it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my certain position of my neck and I had neck issues; It caused some massive confusion; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date not reported, age at the time of vaccination: 63-year-old), via an unspecified route of administration, in Arm Right (shoulder) on 06May2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported), in Arm right (shoulder) on 15Apr2021(got about noon time, got it about may be earlier at about 10 am) for covid-19 immunization. The patient did have any vaccination since he was a child. On 06May2021, the patient had the shot in noon right above 1 pm and went home laid down and felt kind of like he did the first time only little better. Actually he felt pretty good and came and laid down for 24 hour period, and on 07May2021, he went to do some laundry at 3 pm, just one 'load of sheets' and then came home, and upon coming home in his apartment complex it's kind of, snakes as come in those left and right kind of and let permit from going fast, so, he come home and pulled in and when he pull in he got this nasty feeling like, but he was looking at the rare view and got 4 cars behind him, and they were really tight behind, but he can't move any faster and he was not going to speed up just because, and when he was looking at them, at the rare view and forward, and was doing those 3 things, he probably turned around to see and while doing his head just Spun and got the sick feeling and passed out and his head ended up in the passenger seat and bounced up and he think he might have messed up his certain position of neck and had neck issues, and blow the car and wreck his car and it's in shop right now. And also it caused some massive confusion and he wrecked his car and may have the surgery on neck again because of banging of neck on the seat, it was the bad accident but thank god he didn't hit anybody. That the only good thing about the whole thing, that nobody else got hurt but I got hurt. He also have to go to 2 emergency rooms. When patient was asked about the lot number and other questions, he asked to slow down as his head was hurting as he just can't keep up with the caller and it starting to bother him and started to give bad headache but because his brain was working over time. As a corrective therapy, the patient's doctor has not offered any kind of medication for that occurrence. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Hiatus hernia, Loss of consciousness, Malaise
Clinical narrative: it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my certain position of my neck and I had neck issues; It caused some massive confusion; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date not reported, age at the time of vaccination: 63-year-old), via an unspecified route of administration, in Arm Right (shoulder) on 06May2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported), in Arm right (shoulder) on 15Apr2021(got about noon time, got it about may be earlier at about 10 am) for covid-19 immunization. The patient did have any vaccination since he was a child. On 06May2021, the patient had the shot in noon right above 1 pm and went home laid down and felt kind of like he did the first time only little better. Actually he felt pretty good and came and laid down for 24 hour period, and on 07May2021, he went to do some laundry at 3 pm, just one 'load of sheets' and then came home, and upon coming home in his apartment complex it's kind of, snakes as come in those left and right kind of and let permit from going fast, so, he come home and pulled in and when he pull in he got this nasty feeling like, but he was looking at the rare view and got 4 cars behind him, and they were really tight behind, but he can't move any faster and he was not going to speed up just because, and when he was looking at them, at the rare view and forward, and was doing those 3 things, he probably turned around to see and while doing his head just Spun and got the sick feeling and passed out and his head ended up in the passenger seat and bounced up and he think he might have messed up his certain position of neck and had neck issues, and blow the car and wreck his car and it's in shop right now. And also it caused some massive confusion and he wrecked his car and may have the surgery on neck again because of banging of neck on the seat, it was the bad accident but thank god he didn't hit anybody. That the only good thing about the whole thing, that nobody else got hurt but I got hurt. He also have to go to 2 emergency rooms. When patient was asked about the lot number and other questions, he asked to slow down as his head was hurting as he just can't keep up with the caller and it starting to bother him and started to give bad headache but because his brain was working over time. As a corrective therapy, the patient's doctor has not offered any kind of medication for that occurrence. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck injury, Neck pain, Post-traumatic neck syndrome, Restlessness
Clinical narrative: it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my certain position of my neck and I had neck issues; It caused some massive confusion; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date not reported, age at the time of vaccination: 63-year-old), via an unspecified route of administration, in Arm Right (shoulder) on 06May2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported), in Arm right (shoulder) on 15Apr2021(got about noon time, got it about may be earlier at about 10 am) for covid-19 immunization. The patient did have any vaccination since he was a child. On 06May2021, the patient had the shot in noon right above 1 pm and went home laid down and felt kind of like he did the first time only little better. Actually he felt pretty good and came and laid down for 24 hour period, and on 07May2021, he went to do some laundry at 3 pm, just one 'load of sheets' and then came home, and upon coming home in his apartment complex it's kind of, snakes as come in those left and right kind of and let permit from going fast, so, he come home and pulled in and when he pull in he got this nasty feeling like, but he was looking at the rare view and got 4 cars behind him, and they were really tight behind, but he can't move any faster and he was not going to speed up just because, and when he was looking at them, at the rare view and forward, and was doing those 3 things, he probably turned around to see and while doing his head just Spun and got the sick feeling and passed out and his head ended up in the passenger seat and bounced up and he think he might have messed up his certain position of neck and had neck issues, and blow the car and wreck his car and it's in shop right now. And also it caused some massive confusion and he wrecked his car and may have the surgery on neck again because of banging of neck on the seat, it was the bad accident but thank god he didn't hit anybody. That the only good thing about the whole thing, that nobody else got hurt but I got hurt. He also have to go to 2 emergency rooms. When patient was asked about the lot number and other questions, he asked to slow down as his head was hurting as he just can't keep up with the caller and it starting to bother him and started to give bad headache but because his brain was working over time. As a corrective therapy, the patient's doctor has not offered any kind of medication for that occurrence. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: it started to give me bad headache; Passed out; My head just Spun; I think I might have messed up my certain position of my neck and I had neck issues; It caused some massive confusion; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiry date not reported, age at the time of vaccination: 63-year-old), via an unspecified route of administration, in Arm Right (shoulder) on 06May2021 13:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number not reported), in Arm right (shoulder) on 15Apr2021(got about noon time, got it about may be earlier at about 10 am) for covid-19 immunization. The patient did have any vaccination since he was a child. On 06May2021, the patient had the shot in noon right above 1 pm and went home laid down and felt kind of like he did the first time only little better. Actually he felt pretty good and came and laid down for 24 hour period, and on 07May2021, he went to do some laundry at 3 pm, just one 'load of sheets' and then came home, and upon coming home in his apartment complex it's kind of, snakes as come in those left and right kind of and let permit from going fast, so, he come home and pulled in and when he pull in he got this nasty feeling like, but he was looking at the rare view and got 4 cars behind him, and they were really tight behind, but he can't move any faster and he was not going to speed up just because, and when he was looking at them, at the rare view and forward, and was doing those 3 things, he probably turned around to see and while doing his head just Spun and got the sick feeling and passed out and his head ended up in the passenger seat and bounced up and he think he might have messed up his certain position of neck and had neck issues, and blow the car and wreck his car and it's in shop right now. And also it caused some massive confusion and he wrecked his car and may have the surgery on neck again because of banging of neck on the seat, it was the bad accident but thank god he didn't hit anybody. That the only good thing about the whole thing, that nobody else got hurt but I got hurt. He also have to go to 2 emergency rooms. When patient was asked about the lot number and other questions, he asked to slow down as his head was hurting as he just can't keep up with the caller and it starting to bother him and started to give bad headache but because his brain was working over time. As a corrective therapy, the patient's doctor has not offered any kind of medication for that occurrence. The outcome of events was unknown.  Information about lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: Pain in arm; Malaise; Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer or other non-health care professional (patient Mother) reported for her 14-years-old daughter (Patient). This is Report 2 of 2.  A 14-years-old female patient received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jun2021 as dose 1, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Mother reported that her older daughter got the first dose of the Covid-19 vaccine on Friday (18Jun2021) and she had experienced pain in her arm, malaise, nausea, headache, and fatigue beginning the evening of the shot. The next day, 19Jun2021, the patient kind of felt that way as well, but towards the end of that day started to feel better. The outcome for the events was reported as recovered on 19Jun2021.   Information about batch/ lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Experiencing kind of like vaginal bleeding and I had, my period ended two weeks ago; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), 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 was calling to ask like or to actually state like, patient had her Pfizer shot done yesterday and today, patient experiencing kind of like vaginal bleeding and patient had, her period ended two weeks ago. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: Injection site reaction 2 days post vaccination after second dose. 3.5 cm x 5.5 cm injection site erythema; Injection site reaction 2 days post vaccination after second dose. 3.5 cm x 5.5 cm injection site erythema; This is a spontaneous report from a contactable other hcp. A 13-years-old female patient received second dose of BNT162B2 (Formulation; Solution for injection; Batch/Lot number: unknown), dose 2 via an unspecified route of administration on 02Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 03Jul2021 the patient experienced Injection site reaction 2 days post vaccination after second does. 3.5 cm x 5.5 cm injection site erythema. AE resulted in emergency room/department or urgent care. The patient received treatment with Diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information related to batch/Lot no. was requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity
Clinical narrative: Muscle pain; Joint pain; she was having pain in her left side and that went to her leg, when she was walking it hurt; she was having pain in her left side and that went to her leg, when she was walking it hurt; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 18Jun2021 (Lot Number: EW0185) as dose 2, single at the age of 55-year-old for covid-19 immunisation. Concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in right arm on 28May2021 as dose 1, single at the age of 55-year-old for covid-19 immunization. The patient got her BioNTech Covid-19 Vaccine first shot on "2852021" (not clarified) and got her last (dose) on 18Jun2021. Since she had Covid vaccine she had muscle pain and joint pain like that. She did not know what was wrong about with her left she was having pain in her left side and that went to her leg, she did not know what was causing. She was applying cream (treatment) just while ago, she had muscle pain and joint pain and she was not sure. She was trying to figure out what was causing. When probed for event start date, the patient stated, she saw this pain about 3-4 weeks ago. (Further not clarified. Hence, not captured in the tab). The patient added, That was all she was not worried and she was just confirming that she said just kind of when she was walking it hurt, she wanted make sure if not vaccine was causing it. No any prior vaccination. Therapeutic measures were taken as a result of events which included cream. The outcome of events was not recovered.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: the bend same arm she got the injection, it is a little bit a colored that's almost like a bruise but it's not a bruise.; This is a spontaneous report from a contactable consumer (Patient's parent). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0181), via an unspecified route of administration in deltoid left (left upper arm) on 20Jun2021 (at the age of 15 years old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated trying to figure out, her daughter got her first dose Pfizer vaccine on 20Jun2021 and she scheduled to get by next sunday to get her second dose but last night or now this morning on 03Jul2021 she has like a knot or spot on her arm right towards the bend same arm she got the injection, it is a little bit a colored that's almost like a bruise but it's not a bruise. Not at the injection site it's further down and today marks the second week she got it on two weeks ago and again it just popped up this morning and again don't know if we need to be concerned or not. Reporter was worried about that color on her arm. Reporter had no idea about treatment received for the problem. The outcome of event was not resolved.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Haemorrhage, Ischaemia, Swelling
Clinical narrative: CVA; ischemic; suffered hemorrhagic bleed; Swelling; This is a spontaneous report from a contactable other health care professional. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single (at the age of 73-years-old) for COVID-19 immunization at public health clinic/veterans administration facility. The patient medical history included coronary artery disease (CAD), hypersensitivity lung disease (HLD). Concomitant medications within 2 weeks of vaccination included bisoprolol, ASA, clopidogrel bisulfate (PLAVIX); all taken for an unspecified indication, start and stop date were not reported. The patient does not have any known allergies. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and had not been diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19 was unknown. On 22Jun2021, the patient experienced with cerebrovascular accident (CVA), ischemic, clot removed, then suffered hemorrhagic bleed; now swelling, on mannitol in ICU. Patient was hospitalized for 14days. Adverse events (AE) resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment received for AEs was unknown. device timestamp 04Jul2021. The outcome of the events was reported as not recovered.  Information on Lot/Batch information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Cerebrovascular accident, Ischaemia, Haemorrhage, and Swelling and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Discomfort, Myalgia, Oropharyngeal pain
Clinical narrative: I received on top of my right arm and having burning sensation going from my back of my knees and up into my neck/Burning sensation all over my body; Low grade temperature 99.0 a little bit fever; a little bit of sore throat; a little bit of pressure in my hand; muscle are really sore; This is a spontaneous report from a contactable consumer (patient). A 27-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0179, Expiry date: 30Aug2021) via an unspecified route of administration in right arm on 01Jul2021 (at the age of 27-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0169; Expiry date: 31Aug2021) via an unspecified route of administration in right arm on 10Jun2021 (at the age of 27-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included depression from an unknown date to unknown if ongoing. Concomitant medication included Prozac (Fluoxetine Hydrochloride) 20mg for depression from an unknown date to unknown date. The patient didn't receive other prior vaccination before four weeks. On an unspecified date, the patient reported that I received on top of my right arm and having burning sensation going from back of my knees and up into my neck/ Burning sensation all over my body; a little bit of pressure in my hand, Low grade temperature 99.0 a little bit fever, muscle are really sore and a little bit of sore throat and a little bit of pressure in my hand. The patient did not receive treatment for adverse events. The outcome of the adverse events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I received on top of my right arm and having burning sensation going from my back of my knees and up into my neck/Burning sensation all over my body; Low grade temperature 99.0 a little bit fever; a little bit of sore throat; a little bit of pressure in my hand; muscle are really sore; This is a spontaneous report from a contactable consumer (patient). A 27-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0179, Expiry date: 30Aug2021) via an unspecified route of administration in right arm on 01Jul2021 (at the age of 27-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EW0169; Expiry date: 31Aug2021) via an unspecified route of administration in right arm on 10Jun2021 (at the age of 27-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included depression from an unknown date to unknown if ongoing. Concomitant medication included Prozac (Fluoxetine Hydrochloride) 20mg for depression from an unknown date to unknown date. The patient didn't receive other prior vaccination before four weeks. On an unspecified date, the patient reported that I received on top of my right arm and having burning sensation going from back of my knees and up into my neck/ Burning sensation all over my body; a little bit of pressure in my hand, Low grade temperature 99.0 a little bit fever, muscle are really sore and a little bit of sore throat and a little bit of pressure in my hand. The patient did not receive treatment for adverse events. The outcome of the adverse events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, COVID-19, Condition aggravated, Hypoaesthesia, Lethargy
Clinical narrative: Nerve irritation throughout body; Numbness in feet; Vaginal flare up; Vaginal flare up; Viral shedding on lower back; Viral shedding on lower back; Lethargy; Also mild Covid reaction; This is a spontaneous report from a contactable consumer who is reported for herself that. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration in arm Left on 28Apr2021 (age at vaccination was 33-year-old) as dose1, single for COVID-19 immunization. Medical history included herpes simplex from an unknown date and unknown if ongoing Hsv2. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination include vitamin b complex (B COMPLEX (B50), l-lysine acetate (L-LYSINE ACETATE), cholecalciferol (VITAMINS D3), calcium (CALCIUM), magnesium (MAGNESIUM), zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30May2021 patient experienced nerve irritation throughout body, numbness in feet, vaginal flare up, vaginal flare up, viral shedding on lower back, lethargy, on 30Apr2021 12:00 mild covid reaction (60 hours after the first shot). Due to the events patient visited Doctor or other healthcare professional office/clinic visit. Treatment received for the events was Home remedies and Zyrtec d. The outcome of the events was recovered with lasting effects on an unspecified date in 2021.  Information related to batch/Lot no. was requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Viral infection, Vulvovaginal burning sensation
Clinical narrative: Nerve irritation throughout body; Numbness in feet; Vaginal flare up; Vaginal flare up; Viral shedding on lower back; Viral shedding on lower back; Lethargy; Also mild Covid reaction; This is a spontaneous report from a contactable consumer who is reported for herself that. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration in arm Left on 28Apr2021 (age at vaccination was 33-year-old) as dose1, single for COVID-19 immunization. Medical history included herpes simplex from an unknown date and unknown if ongoing Hsv2. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within 2 weeks of vaccination include vitamin b complex (B COMPLEX (B50), l-lysine acetate (L-LYSINE ACETATE), cholecalciferol (VITAMINS D3), calcium (CALCIUM), magnesium (MAGNESIUM), zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30May2021 patient experienced nerve irritation throughout body, numbness in feet, vaginal flare up, vaginal flare up, viral shedding on lower back, lethargy, on 30Apr2021 12:00 mild covid reaction (60 hours after the first shot). Due to the events patient visited Doctor or other healthcare professional office/clinic visit. Treatment received for the events was Home remedies and Zyrtec d. The outcome of the events was recovered with lasting effects on an unspecified date in 2021.  Information related to batch/Lot no. was requested.
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Gout
Clinical narrative: Had an acute gout attack and I have experienced this twice; First acute gout attack on my right great toe; Experienced my second one on my left great toe; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 Immunization. Patient had an acute gout attack and patient has experienced this twice on an unspecified date in 2021. Patient have never had a history of gout, patient do not overconsume alcohol or any typical gout diet foods however the only change in my lifestyle is receiving both Pfizer vaccine injections, the last one was February 2nd (later clarified). Approximately, one month ago, patient experienced my first acute gout attack on my right great toe and yesterday, patient has now experienced my second one on my left great toe. So, patient wondering if there are any other reported cases of this happening. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Flushing, Pain in extremity, SARS-CoV-2 test, Urticaria
Clinical narrative: cheeks felt hot; dry mouth; Both arm pain; hives where got vaccine; This is a spontaneous report from a non-contactable consumer nurse (patient). A 50-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID 19 VACCINE, Formulation: solution for injection, Lot Number Ep7534, Expiration date: not reported) via an unspecified route of administration in Leg Left on 21Mar2021 (age at vaccination 50-years-old) at 09:45 AM as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 on an unknown date (prior vaccination), migraine and had allergies for penicillin from an unknown date and unknown if ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included magnesium, ibuprofen (ADVIL [IBUPROFEN]) and atorvastatin 1 pill taken for an unspecified indication, from an unknown start date. On an unspecified date in Mar2021, the patient experienced both arm pain, hives where the patient got vaccine and Cheeks felt hot, dry mouth on 22Mar2021. On 11May2021, the patient underwent lab test and procedures which included Nasal Swab (Sars-CoV-2 test) was negative. The events was reported as non serious. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: Arm is sore, now it's through my chest; I do not go anywhere and I lay on my bed because my chest is sore; Arm is sore, now it's through my chest; I do not go anywhere and I lay on my bed because my chest is sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received 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 it was reported as consumer stated, "It's been 3 days ago I had shot (unspecified medication) in my arm and next day two days later my arm is sore, now it's through my chest." And it was reported as "I do sit, I do not go I lay on my bed, I watch TV and I am not going anywhere because my chest is sore." The outcome of the events was unknown.  Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 as a Dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that, came to know a man who walked outside of the center and died right after the Covid vaccine from a heart attack. The reporter was unsure if it was Pfizer. People were there to help the patient right away and he still died. The reporter can't find much information about this event on the internet because of censorship. On 08Feb2021, the patient collapsed and later died after leaving the vaccination site. The patient died 25 mins after receiving the vaccine. First responders got to the man in seconds, and he passed away in the hospital. It was not reported if an autopsy was performed or not.  Information on the lot/batch number had been requested.; Reported Cause(s) of Death: Heart attack
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Partial seizures
Clinical narrative: focal seizures; my pulse spikes to 158; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number and Expiration date were not reported), 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. The patient had experienced focal seizures, my pulse spikes to 158 on an unspecified date. The patient underwent lab tests and procedures which included heart rate increased to 158 on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cheilitis, Fatigue, Loss of consciousness, Syncope, Tooth injury
Clinical narrative: unconscious for 15 minutes.; two teeth knocked out; lips busted; laid up for 3 days; fainted; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number EW0179, expiration date not reported), via an unspecified route of administration on 30Jun2021 as dose 2, single for covid-19 immunization (71 years when vaccinated). Historical vaccine included bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number EWO170, expiration date not reported), via an unspecified route of administration on 30Jun2021 as dose 1, single for covid-19 immunization (71 year when vaccinated) and had no adverse effect. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Medical history included multiple sclerosis from an unknown date in Jan2002 to an unknown date (he has been okay for the past 7 years, as reported). The patient's concomitant medications were not reported. The patient previously took Avonex for central nervous system lesion and experienced adverse drug reaction (very bad). On 30Jun2021, the patient received his second dose and after 10mins the patient headed for home and the patient drove for about 400 yards from the country health department, walked in the kitchen and as soon as he got inside the patient fainted. The patient was unconscious for 15min. The fainting resulted in lips busted, two teeth knocked out and was laid up for 3days. The patient was not hospitalized for the events. The patient did not visit any emergency room or physician due to the events. The outcome of the events was reported as unknown at the time of report. Information about lot/batch number has been requested.  Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Second dose: muscle soreness and muscle pain; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: flu-like symptoms, hot and cold, chills and fever; Second dose: arm soreness; This is a spontaneous report from a contactable nurse (patient). A 72-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0187; NDC number and expiry date was reported as unknown) via an unspecified route of administration on 01Jul2021 at 15:00 (at the age of 72-years-old) in right arm as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included multiple sclerosis from 1980 and ongoing. Family medical history relevant to adverse event was reported as heart disease from an unknown date and unknown if ongoing. No investigation assessment was reported. It was unknown if the patient had SARS-CoV2 antibodies at diagnosis. No information was provided on multiorgan failure or any new/ worsened symptoms/signs during the covid-19 illness experienced (including date of onset/worsening). The patient was not a smoker/former smoker. She was not taking any medications routinely prior to the event being reported. Additional vaccines administered on same date of the Pfizer suspect were reported as none. Prior Vaccinations (within 4 weeks) and list of any other vaccinations within four weeks prior to the first administration date of the suspect vaccine included nothing except for the first shot. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EW0176; NDC number and expiry date was reported as unknown) on 11Jun2021 in right arm for COVID-19 immunization and experienced sore arm. The patient did not have a positive test for SARS-CoV2. The patient experienced flu like symptoms, chills, fever and she was hot and cold on 01Jul2021 at 20:30. She also had muscle soreness and muscle pain on 01Jul2021 at 23:00. She noticed arm soreness before she went to bed, somewhere around 23:00. The events were bothering her. She did not require emergency room and physician office visit. The patient was not hospitalized or admitted to an intensive care unit and she did not require supplemental oxygen. Treatment medication included Tylenol. Relevant tests were reported as none. The outcome of all the events was not resolved.