chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Fall, Gait disturbance, Musculoskeletal stiffness
Clinical narrative: Severe muscle stiffness; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; affecting my walking; fallen several times; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included penicillin, sulfa, aspirin, anything related to horse serum, cats and insect bites allergy, fibromyalgia, irritable bowel syndrome and arthritis from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EL3247) dose 1 on 26Jan2021 10:45 AM at 84 years old in the left arm for COVID-19 Immunization. The facility where the most recent COVID-19 vaccine was administered was in the urgent care center. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Feb2021, severe muscle stiffness and pain in neck, shoulders, upper back, arms and shoulders the day after the vaccine. This has not abated after two months. The patient stated, "it is significantly affecting my walking, and I am unstable now and have nearly fallen several times. I cannot even move my head to read the paper without pain, and rarely drive anymore as well. I have had fibromyalgia for many years and know that pain well; this is different". The outcome of events was not recovered. The patient resulted in disability or permanent damage. No treatment was given to the patient for the events.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Severe muscle stiffness; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; affecting my walking; fallen several times; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included penicillin, sulfa, aspirin, anything related to horse serum, cats and insect bites allergy, fibromyalgia, irritable bowel syndrome and arthritis from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EL3247) dose 1 on 26Jan2021 10:45 AM at 84 years old in the left arm for COVID-19 Immunization. The facility where the most recent COVID-19 vaccine was administered was in the urgent care center. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Feb2021, severe muscle stiffness and pain in neck, shoulders, upper back, arms and shoulders the day after the vaccine. This has not abated after two months. The patient stated, "it is significantly affecting my walking, and I am unstable now and have nearly fallen several times. I cannot even move my head to read the paper without pain, and rarely drive anymore as well. I have had fibromyalgia for many years and know that pain well; this is different". The outcome of events was not recovered. The patient resulted in disability or permanent damage. No treatment was given to the patient for the events.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Pulmonary thrombosis, Scan with contrast
Clinical narrative: bilateral pulmonary blood clots; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201, expiration date not reported) via an unspecified route of administration, administered in the right arm on 12Feb2021 as single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus diagnosed 1.5-2 years ago, ongoing neuropathy peripheral diagnosed about two years ago, and ongoing glaucoma diagnosed about 9 months ago. Concomitant medications included metformin for diabetes mellitus; rosuvastatin calcium (CRESTOR) for neuropathy peripheral; dorzolamide for glaucoma; latanoprost for glaucoma; all ongoing. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EL9261) administered on 21Jan2021 (at the age of 56 years old) for Covid-19 Immunization. No other vaccine was given within four weeks prior to the first administration date of the suspect vaccine. The patient experienced bilateral pulmonary blood clots on 29Mar2021 and will have to be on apixaban (ELIQUIS) for the rest of her life. She stated that she was fine before the shot and stated that it was not that long between the second dose and diagnosis. The patient was hospitalized for bilateral pulmonary blood clots from 29Mar2021 to 31Mar2021. The event required a visit to the emergency room. The outcome of the event was recovered with sequelae on an unspecified date.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: bilateral pulmonary blood clots; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201, expiration date not reported) via an unspecified route of administration, administered in the right arm on 12Feb2021 as single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus diagnosed 1.5-2 years ago, ongoing neuropathy peripheral diagnosed about two years ago, and ongoing glaucoma diagnosed about 9 months ago. Concomitant medications included metformin for diabetes mellitus; rosuvastatin calcium (CRESTOR) for neuropathy peripheral; dorzolamide for glaucoma; latanoprost for glaucoma; all ongoing. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot Number: EL9261) administered on 21Jan2021 (at the age of 56 years old) for Covid-19 Immunization. No other vaccine was given within four weeks prior to the first administration date of the suspect vaccine. The patient experienced bilateral pulmonary blood clots on 29Mar2021 and will have to be on apixaban (ELIQUIS) for the rest of her life. She stated that she was fine before the shot and stated that it was not that long between the second dose and diagnosis. The patient was hospitalized for bilateral pulmonary blood clots from 29Mar2021 to 31Mar2021. The event required a visit to the emergency room. The outcome of the event was recovered with sequelae on an unspecified date.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Respiratory tract congestion, Tinnitus, Vertigo
Clinical narrative: Tinnitus in right ear; Vertigo; Congestion and partial hearing loss in left ear/Congestion and partial hearing loss in right ear; Congestion and partial hearing loss in left ear/Congestion and partial hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, 34 years old. Medical history reported as none. No other vaccines in four weeks. No COVID prior vaccination. No known allergies. Concomitant medication included isotretinoin (ACCUTANE) taken for an unspecified indication, start and stop date were not reported (in two weeks). It was further reported that congestion and partial hearing loss in left ear occurred on 28Mar2021 09:00 through 31Mar2021 and was resolving over time. There was vertigo in the morning of 31Mar2021, congestion and partial hearing loss in right ear starting 03Apr2021 and resolving over time. Tinnitus in right ear starting 03Apr2021. Tinnitus has still not gone away. The patient underwent lab tests and procedures which included Nasal Swab: negative on 16Mar2021, 23Mar2021, 30Mar2021, 06Apr2021, 13Apr2021, and 20Apr2021. Therapeutic measures were taken as a result of congestion and partial hearing loss in left ear/congestion and partial hearing loss in right ear, vertigo, and tinnitus in right ear (methylprednisolone). The events required physician office visit. Outcome of the events deafness bilateral and ear congestion was recovering, while vertigo and tinnitus was not recovered. The events were reported as serious (disability).  Information about lot and batch number was requested.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness bilateral, Ear congestion, SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Tinnitus in right ear; Vertigo; Congestion and partial hearing loss in left ear/Congestion and partial hearing loss in right ear; Congestion and partial hearing loss in left ear/Congestion and partial hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, 34 years old. Medical history reported as none. No other vaccines in four weeks. No COVID prior vaccination. No known allergies. Concomitant medication included isotretinoin (ACCUTANE) taken for an unspecified indication, start and stop date were not reported (in two weeks). It was further reported that congestion and partial hearing loss in left ear occurred on 28Mar2021 09:00 through 31Mar2021 and was resolving over time. There was vertigo in the morning of 31Mar2021, congestion and partial hearing loss in right ear starting 03Apr2021 and resolving over time. Tinnitus in right ear starting 03Apr2021. Tinnitus has still not gone away. The patient underwent lab tests and procedures which included Nasal Swab: negative on 16Mar2021, 23Mar2021, 30Mar2021, 06Apr2021, 13Apr2021, and 20Apr2021. Therapeutic measures were taken as a result of congestion and partial hearing loss in left ear/congestion and partial hearing loss in right ear, vertigo, and tinnitus in right ear (methylprednisolone). The events required physician office visit. Outcome of the events deafness bilateral and ear congestion was recovering, while vertigo and tinnitus was not recovered. The events were reported as serious (disability).  Information about lot and batch number was requested.
Age: 17.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Chills, Heart rate increased, Pyrexia, Syncope
Clinical narrative: Fainting twice the next morning; Tachycardia (up to 145 bpm); somewhat disoriented for about 24 hours; Chills and fever starting that evening; Chills and fever starting that evening; Very lightheaded; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 22Apr2021 15:00 (Batch/Lot number was not reported) at the age of 17 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included colecalciferol, fish oil (VITAMIN D WITH OMEGA 3); saccharomyces boulardii (FLORASTOR); and multivitamins; all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included bnt162b2 on 01Apr2021 (product=COVID 19, brand=Pfizer, Lot number=ER8737, Administration time=03:00 PM, Vaccine location=Right arm, Dose number=1, age at vaccination=17 years) for COVID-19 immunization. On 22Apr2021 20:00, the patient experienced fainting twice the next morning, tachycardia (up to 145 bpm), somewhat disoriented for about 24 hours, chills and fever starting that evening, and very lightheaded. No treatment was given for the events. The patient was recovering from the events. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since the vaccination.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Chills, Disorientation, Dizziness, Heart rate, Pyrexia
Clinical narrative: Fainting twice the next morning; Tachycardia (up to 145 bpm); somewhat disoriented for about 24 hours; Chills and fever starting that evening; Chills and fever starting that evening; Very lightheaded; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 22Apr2021 15:00 (Batch/Lot number was not reported) at the age of 17 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included colecalciferol, fish oil (VITAMIN D WITH OMEGA 3); saccharomyces boulardii (FLORASTOR); and multivitamins; all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included bnt162b2 on 01Apr2021 (product=COVID 19, brand=Pfizer, Lot number=ER8737, Administration time=03:00 PM, Vaccine location=Right arm, Dose number=1, age at vaccination=17 years) for COVID-19 immunization. On 22Apr2021 20:00, the patient experienced fainting twice the next morning, tachycardia (up to 145 bpm), somewhat disoriented for about 24 hours, chills and fever starting that evening, and very lightheaded. No treatment was given for the events. The patient was recovering from the events. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since the vaccination.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Syncope, Tachycardia
Clinical narrative: Fainting twice the next morning; Tachycardia (up to 145 bpm); somewhat disoriented for about 24 hours; Chills and fever starting that evening; Chills and fever starting that evening; Very lightheaded; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 22Apr2021 15:00 (Batch/Lot number was not reported) at the age of 17 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included colecalciferol, fish oil (VITAMIN D WITH OMEGA 3); saccharomyces boulardii (FLORASTOR); and multivitamins; all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included bnt162b2 on 01Apr2021 (product=COVID 19, brand=Pfizer, Lot number=ER8737, Administration time=03:00 PM, Vaccine location=Right arm, Dose number=1, age at vaccination=17 years) for COVID-19 immunization. On 22Apr2021 20:00, the patient experienced fainting twice the next morning, tachycardia (up to 145 bpm), somewhat disoriented for about 24 hours, chills and fever starting that evening, and very lightheaded. No treatment was given for the events. The patient was recovering from the events. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since the vaccination.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Chest pain, Differential white blood cell count, Electrocardiogram, Full blood count
Clinical narrative: swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirst; trembling; arm soreness; I felt instantly dehydrated; had difficulty swallowing and breathing; had difficulty swallowing and breathing; throat tightness; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EW170 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 19:45 (at the age of 38-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 75mg. The patient was not pregnant at the time of vaccination. It was unknown whether patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, 20:00, after inoculation of the 1st dose of the Pfizer COVID 19 vaccine, 'I felt instantly dehydrated, had difficulty swallowing and breathing'. After 30 mins, she felt a little better and went home. At about 21:30 she was able to breathe adequately but had throat tightness and arm soreness. The following day, at around 19:00, her symptoms re-occurred, only more seriously. She felt again swelling of her tongue, throat tightening, difficulty breathing, thirst, joint pain/trembling and inability to feel my right hand. Her hands were very cold and clammy. She sought emergency help at the Emergency room. The patient received treatment- decadron, benadryl, Pepcid. The seriousness of the event was considered as serious hospitalization by reporter consumer. Outcome of the events was unknown.   Follow up needed, further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Paraesthesia, Pharyngeal swelling, Troponin I
Clinical narrative: swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirst; trembling; arm soreness; I felt instantly dehydrated; had difficulty swallowing and breathing; had difficulty swallowing and breathing; throat tightness; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EW170 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 19:45 (at the age of 38-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 75mg. The patient was not pregnant at the time of vaccination. It was unknown whether patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, 20:00, after inoculation of the 1st dose of the Pfizer COVID 19 vaccine, 'I felt instantly dehydrated, had difficulty swallowing and breathing'. After 30 mins, she felt a little better and went home. At about 21:30 she was able to breathe adequately but had throat tightness and arm soreness. The following day, at around 19:00, her symptoms re-occurred, only more seriously. She felt again swelling of her tongue, throat tightening, difficulty breathing, thirst, joint pain/trembling and inability to feel my right hand. Her hands were very cold and clammy. She sought emergency help at the Emergency room. The patient received treatment- decadron, benadryl, Pepcid. The seriousness of the event was considered as serious hospitalization by reporter consumer. Outcome of the events was unknown.   Follow up needed, further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dehydration, Dysphagia, Dyspnoea, Hypoaesthesia
Clinical narrative: swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirst; trembling; arm soreness; I felt instantly dehydrated; had difficulty swallowing and breathing; had difficulty swallowing and breathing; throat tightness; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EW170 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 19:45 (at the age of 38-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 75mg. The patient was not pregnant at the time of vaccination. It was unknown whether patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, 20:00, after inoculation of the 1st dose of the Pfizer COVID 19 vaccine, 'I felt instantly dehydrated, had difficulty swallowing and breathing'. After 30 mins, she felt a little better and went home. At about 21:30 she was able to breathe adequately but had throat tightness and arm soreness. The following day, at around 19:00, her symptoms re-occurred, only more seriously. She felt again swelling of her tongue, throat tightening, difficulty breathing, thirst, joint pain/trembling and inability to feel my right hand. Her hands were very cold and clammy. She sought emergency help at the Emergency room. The patient received treatment- decadron, benadryl, Pepcid. The seriousness of the event was considered as serious hospitalization by reporter consumer. Outcome of the events was unknown.   Follow up needed, further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral coldness, Swollen tongue, Thirst, Throat tightness
Clinical narrative: swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirst; trembling; arm soreness; I felt instantly dehydrated; had difficulty swallowing and breathing; had difficulty swallowing and breathing; throat tightness; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EW170 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 19:45 (at the age of 38-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 75mg. The patient was not pregnant at the time of vaccination. It was unknown whether patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, 20:00, after inoculation of the 1st dose of the Pfizer COVID 19 vaccine, 'I felt instantly dehydrated, had difficulty swallowing and breathing'. After 30 mins, she felt a little better and went home. At about 21:30 she was able to breathe adequately but had throat tightness and arm soreness. The following day, at around 19:00, her symptoms re-occurred, only more seriously. She felt again swelling of her tongue, throat tightening, difficulty breathing, thirst, joint pain/trembling and inability to feel my right hand. Her hands were very cold and clammy. She sought emergency help at the Emergency room. The patient received treatment- decadron, benadryl, Pepcid. The seriousness of the event was considered as serious hospitalization by reporter consumer. Outcome of the events was unknown.   Follow up needed, further information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirst; trembling; arm soreness; I felt instantly dehydrated; had difficulty swallowing and breathing; had difficulty swallowing and breathing; throat tightness; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EW170 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 19:45 (at the age of 38-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 75mg. The patient was not pregnant at the time of vaccination. It was unknown whether patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, 20:00, after inoculation of the 1st dose of the Pfizer COVID 19 vaccine, 'I felt instantly dehydrated, had difficulty swallowing and breathing'. After 30 mins, she felt a little better and went home. At about 21:30 she was able to breathe adequately but had throat tightness and arm soreness. The following day, at around 19:00, her symptoms re-occurred, only more seriously. She felt again swelling of her tongue, throat tightening, difficulty breathing, thirst, joint pain/trembling and inability to feel my right hand. Her hands were very cold and clammy. She sought emergency help at the Emergency room. The patient received treatment- decadron, benadryl, Pepcid. The seriousness of the event was considered as serious hospitalization by reporter consumer. Outcome of the events was unknown.   Follow up needed, further information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypotension, Vomiting
Clinical narrative: 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Insomnia, Nausea
Clinical narrative: 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; Not sleeping at night; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak.  Had to call 911.; This is a spontaneous report from contactable consumer. A 41year old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8735), via an unspecified route of administration administered on Left arm at 24Apr2021 12:30 PM (at the age of 41 years) as a single dose for covid-19 immunisation. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8734), via an unspecified route of administration administered on Left arm at 03Apr2021 04:30 PM as a single dose for covid-19 immunisation. The patient's medical history included asthma and premature ventricular contractions. Patient's past drug included aspirin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Zyrtec, Lexapro 5mg, sprintec (birth c) and Vit C. On 25-APR-2021 02:30 Patient stated that not sleeping at night, 14 hrs after vaccination onset of nausea then an hour later onset of aggressive vomiting, diarrhea, shudders, difficulty breathing, feeling faint and weak. Treatment was received for the adverse event Ems came checked pulse and blood pressure gave plan. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, UNK, UNK, VARZOS, VARZOS, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I was vaccinated for Shingles/Zostavax on 1 /09/15/I have had no Shingles side effects until 8 hours after my first Covid/ Mild Shingles symptomson left side of abdomen and left side of back.; This spontaneous report was received from a 64-year-old female consumer referring to herself through Pfizer.  The patient had allergies to sulfamethoxazole (+) trimethoprim (SMZ-TMP DS) ,  rofecoxib (VIOXX) captured in MARRS (case # 2104USA007684), fresh pineapple, and raw shrimp. Her historical conditions included one severe and one mild case of shingles, and acid reflux (GERD). Concomitant therapies included estradiol and estradiol (+) norethindrone acetate (COMBIPATCH).    On 09-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for shingles (prophylaxis). On 02-JUL-2018 and 01-DEC-2018, the patient was vaccinated with doses of zoster rgE vaccine (mammalian) (SHINGRIX), respectively (formulation, concentration, administered dose, vaccination scheme frequency, route and anatomical location of vaccination, lot number, and expiration date were not provided for any of these vaccines).  On 16-APR-2021 at 11:45, the patient was vaccinated with the first dose of COVID-19 vaccine mRNA (mRNA 1273) on the left arm (batch number ER2613) (formulation, concentration, vaccination scheme frequency, route of administration, and expiration date were not provided). On the same date at 19:45, 8 hours post administration, the patient experienced mild shingles symptoms on the left side of her abdomen and left side of her back (Herpes zoster). No treatment was given for the event.  The outcome of herpes zoster was reported as not resolved. The causality between the event and the suspect therapies was unknown.; Sender's Comments:  US-009507513-2104USA007684:
Age: 59.0
Sex: F
Vaccine: COVID19, UNK, UNK, VARZOS, VARZOS, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster
Clinical narrative: I was vaccinated for Shingles/Zostavax on 1 /09/15/I have had no Shingles side effects until 8 hours after my first Covid/ Mild Shingles symptomson left side of abdomen and left side of back.; This spontaneous report was received from a 64-year-old female consumer referring to herself through Pfizer.  The patient had allergies to sulfamethoxazole (+) trimethoprim (SMZ-TMP DS) ,  rofecoxib (VIOXX) captured in MARRS (case # 2104USA007684), fresh pineapple, and raw shrimp. Her historical conditions included one severe and one mild case of shingles, and acid reflux (GERD). Concomitant therapies included estradiol and estradiol (+) norethindrone acetate (COMBIPATCH).    On 09-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for shingles (prophylaxis). On 02-JUL-2018 and 01-DEC-2018, the patient was vaccinated with doses of zoster rgE vaccine (mammalian) (SHINGRIX), respectively (formulation, concentration, administered dose, vaccination scheme frequency, route and anatomical location of vaccination, lot number, and expiration date were not provided for any of these vaccines).  On 16-APR-2021 at 11:45, the patient was vaccinated with the first dose of COVID-19 vaccine mRNA (mRNA 1273) on the left arm (batch number ER2613) (formulation, concentration, vaccination scheme frequency, route of administration, and expiration date were not provided). On the same date at 19:45, 8 hours post administration, the patient experienced mild shingles symptoms on the left side of her abdomen and left side of her back (Herpes zoster). No treatment was given for the event.  The outcome of herpes zoster was reported as not resolved. The causality between the event and the suspect therapies was unknown.; Sender's Comments:  US-009507513-2104USA007684:
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adenovirus test, Alanine aminotransferase normal, Antinuclear antibody negative, Aspartate aminotransferase increased, Biopsy heart
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. Case will be reassessed if additional information is received. 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid, Borrelia test negative, Catheterisation cardiac, Chest pain, Chills
Clinical narrative: positive cardiac enzymes; myocarditis; hypotension 3 days post 2nd vaccination who was admitted; left-sided chest pain; sob; diaphoresis; dizziness; paresthesia's to his hands; transient fever; chills; headache; body aches; This is a spontaneous report from a contactable physician. A 22-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, in the left arm on 17Apr2021 (Batch/Lot Number: ER8731) (at the age of 22-years-old) as a single dose for COVID-19 immunisation as a single dose for COVID-19 immunisation. Medical history included scoliosis from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient previously received the first dose of BNT162b2 on 22Mar2021ont at 08:45 in intramuscularly in the left arm (Lot Number: ER8727) for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Apr2021, the patient developed transient fever, chills, headache, and body aches which resolved 24 hours after his 2nd Pfizer vaccine, followed by left-sided chest pain, shortness of breath (SOB), diaphoresis, dizziness, paresthesias to his hands; hypotension 3 days post 2nd vaccination, on 20Apr2021, patient was admitted to hospital with positive cardiac enzymes, initially troponin T baseline at 663, 1 hour follow-up troponin T at 943 with troponin T delta at 42%. A 3-hour troponin T at 1913 with a troponin T3HR delta at 189% and CPK >1000 with the diagnosis of myocarditis. Covid screen was negative, Covid antibody was negative, HIV was negative, drug screen negative and rest of work up for other causes so far negative. On 20Apr2021, he was transferred to another hospital for further cardiac care. Treatments for the events included pressor, cardiac medications, cath, etc. Patient remains hospitalized. In Apr2021, the patient recovered from the events, body aches, headache, chills, transient fever. The patient had not recovered from the events, positive cardiac enzymes, myocarditis, hypotension, left-sided chest pain, SOB, diaphoresis, dizziness, and paresthesias to his hands.; Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be fully excluded based on temporal relationship and lack of alternate explanation at this time. Case will be reassessed if additional information is received. 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.