chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: veins in the back of my knees are hurting; On 4/8 I woke up very sick; By 1 pm I was sleepy and woke up at 3; By 4-5 pm I had chills; By 4-5 pm I had  body ache; nausea; heart palpitations; mild sore arm; By 6-8 pm I was vomiting a lotOn 4/8 I woke up very sick. Kept throwing up water and liquids; All night I felt sick9 pm and still feeling sick; sensitivity to noises as well; had raising thoughts in my mind. The raising thoughts and things in my mind bother me.; I have the feeling that I can feel my kidneys, liver, intestines; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 07Apr2021 at 10:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN,0.5mg) 3 in the night from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 07Apr2021 the patient experienced sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She had sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines 21:00 and still feeling sick. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She have sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her  mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines. 21:00 and still feeling sick were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Palpitations, Somnolence
Clinical narrative: veins in the back of my knees are hurting; On 4/8 I woke up very sick; By 1 pm I was sleepy and woke up at 3; By 4-5 pm I had chills; By 4-5 pm I had  body ache; nausea; heart palpitations; mild sore arm; By 6-8 pm I was vomiting a lotOn 4/8 I woke up very sick. Kept throwing up water and liquids; All night I felt sick9 pm and still feeling sick; sensitivity to noises as well; had raising thoughts in my mind. The raising thoughts and things in my mind bother me.; I have the feeling that I can feel my kidneys, liver, intestines; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 07Apr2021 at 10:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN,0.5mg) 3 in the night from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 07Apr2021 the patient experienced sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She had sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines 21:00 and still feeling sick. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She have sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her  mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines. 21:00 and still feeling sick were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachyphrenia, Vascular pain, Vomiting
Clinical narrative: veins in the back of my knees are hurting; On 4/8 I woke up very sick; By 1 pm I was sleepy and woke up at 3; By 4-5 pm I had chills; By 4-5 pm I had  body ache; nausea; heart palpitations; mild sore arm; By 6-8 pm I was vomiting a lotOn 4/8 I woke up very sick. Kept throwing up water and liquids; All night I felt sick9 pm and still feeling sick; sensitivity to noises as well; had raising thoughts in my mind. The raising thoughts and things in my mind bother me.; I have the feeling that I can feel my kidneys, liver, intestines; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on 07Apr2021 at 10:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included alprazolam (MANUFACTURER UNKNOWN,0.5mg) 3 in the night from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 07Apr2021 the patient experienced sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She had sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines 21:00 and still feeling sick. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sleepy by 13:00 and woke up at 15:00. By 16:00-17:00 she had chills, body ache, no fever, nausea, heart palpitations, feeling that her blood was on fire, mild sore arm. By 18:00-20:00 she was vomiting a lot and also going to the bathroom loose no diarrhea. All night she felt sick and had raising thoughts in her mind. She have sensitivity to noises as well. On 08Apr2021 she woke up very sick. Kept throwing up water and liquids. Couldn't eat. By 13:00 she have thrown up some more. The raising thoughts and things in her  mind bother her. By 15:00 her veins in the back of her knees are hurting. She have the feeling that she can feel her kidneys, liver, intestines. 21:00 and still feeling sick were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: neuropathy; sinusitis; I had tingling in my both my legs and right hand having; tittinitus; vertigo; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8733; Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in 2021, after receiving first dose of vaccination, the patient experienced neuropathy, sinusitis, tinnitus [worse, date started: 2 weeks after vaccine], constant nausea [worse-daily, date started: 3 weeks], vertigo [worse, incapacitating, date started: 4 weeks], tingling in both legs and right hand having shifting over or Paresthesia [worse, since: two months, continuing]. Patient reported she cannot take second dose, and all this happened starting 2 weeks from first vaccine. As per all doctors she cannot receive second dose. Outcome of the for events tingling, tinnitus, vertigo and nausea was not resolved (reported as patient still experiencing the events) and outcome of rest of events was unknown.  Follow-up (27Jul2021): The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer. This 60-year-old female consumer (Patient) reported in response to Non-HCP letter sent that included: Suspect product details added and new events added (neuropathy, vertigo, tinnitus, nausea), Patient details and Primary reporter's information updated.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Tinnitus, Vertigo
Clinical narrative: neuropathy; sinusitis; I had tingling in my both my legs and right hand having; tittinitus; vertigo; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8733; Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in 2021, after receiving first dose of vaccination, the patient experienced neuropathy, sinusitis, tinnitus [worse, date started: 2 weeks after vaccine], constant nausea [worse-daily, date started: 3 weeks], vertigo [worse, incapacitating, date started: 4 weeks], tingling in both legs and right hand having shifting over or Paresthesia [worse, since: two months, continuing]. Patient reported she cannot take second dose, and all this happened starting 2 weeks from first vaccine. As per all doctors she cannot receive second dose. Outcome of the for events tingling, tinnitus, vertigo and nausea was not resolved (reported as patient still experiencing the events) and outcome of rest of events was unknown.  Follow-up (27Jul2021): The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer. This 60-year-old female consumer (Patient) reported in response to Non-HCP letter sent that included: Suspect product details added and new events added (neuropathy, vertigo, tinnitus, nausea), Patient details and Primary reporter's information updated.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neuropathy peripheral, Paraesthesia, Sinusitis, Tinnitus
Clinical narrative: neuropathy; sinusitis; I had tingling in my both my legs and right hand having; tittinitus; vertigo; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8733; Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in 2021, after receiving first dose of vaccination, the patient experienced neuropathy, sinusitis, tinnitus [worse, date started: 2 weeks after vaccine], constant nausea [worse-daily, date started: 3 weeks], vertigo [worse, incapacitating, date started: 4 weeks], tingling in both legs and right hand having shifting over or Paresthesia [worse, since: two months, continuing]. Patient reported she cannot take second dose, and all this happened starting 2 weeks from first vaccine. As per all doctors she cannot receive second dose. Outcome of the for events tingling, tinnitus, vertigo and nausea was not resolved (reported as patient still experiencing the events) and outcome of rest of events was unknown.  Follow-up (27Jul2021): The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer. This 60-year-old female consumer (Patient) reported in response to Non-HCP letter sent that included: Suspect product details added and new events added (neuropathy, vertigo, tinnitus, nausea), Patient details and Primary reporter's information updated.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: neuropathy; sinusitis; I had tingling in my both my legs and right hand having; tittinitus; vertigo; nausea; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8733; Expiration date: 31Jul2021), via an unspecified route of administration on 30Mar2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in 2021, after receiving first dose of vaccination, the patient experienced neuropathy, sinusitis, tinnitus [worse, date started: 2 weeks after vaccine], constant nausea [worse-daily, date started: 3 weeks], vertigo [worse, incapacitating, date started: 4 weeks], tingling in both legs and right hand having shifting over or Paresthesia [worse, since: two months, continuing]. Patient reported she cannot take second dose, and all this happened starting 2 weeks from first vaccine. As per all doctors she cannot receive second dose. Outcome of the for events tingling, tinnitus, vertigo and nausea was not resolved (reported as patient still experiencing the events) and outcome of rest of events was unknown.  Follow-up (27Jul2021): The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 27Jul2021, this case now contains all required information to be considered valid. This is a follow-up spontaneous report received from a contactable consumer. This 60-year-old female consumer (Patient) reported in response to Non-HCP letter sent that included: Suspect product details added and new events added (neuropathy, vertigo, tinnitus, nausea), Patient details and Primary reporter's information updated.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Epistaxis, Hemiplegic migraine
Clinical narrative: After vaccine #2, my fever got up to 105; a hemiplegic migraine was triggered; subsequent "falling asleep" of my face, arm, spine; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 16:30 (Batch/Lot number was not reported) (at the age of 33-years-old) as dose 2, single for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing hemiplegic migraine. Concomitant medications included sumatriptan succinate (IMITREX) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient previously took REGLAN [metoclopramide hydrochloride] and experienced drug hypersensitivity. Historical vaccine included BNT162B2 (unknown lot number) in the left arm as dose 1, single on 11Mar2021 18:30 (at the age of 33-years old) for COVID-19 immunisation and experienced fatigue. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 since the vaccination with negative result. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was a life-long hemiplegic migraine patient. Prior to taking vaccine number two, she was fine. The patient had no reaction other than fatigue. After vaccine number two, on 02Apr2021 at 01:00 her fever got up to 105 (unspecified units) and a hemiplegic migraine was triggered. The patient had to go to the emergency room three days after the vaccine was given to have them help her break the hemiplegic migraine and subsequent "falling asleep" of her face, arm, spine on an unknown date in Apr2021. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events which also included treatment with medications to relieve the hemiplegic migraine. On 04Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event fever got up to 105 and a hemiplegic migraine was triggered, and subsequent "falling asleep" of face, arm, spine was resolving at the time of this report.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Hemiplegic migraine, Hypoaesthesia, Pyrexia, SARS-CoV-2 test
Clinical narrative: After vaccine #2, my fever got up to 105; a hemiplegic migraine was triggered; subsequent "falling asleep" of my face, arm, spine; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 16:30 (Batch/Lot number was not reported) (at the age of 33-years-old) as dose 2, single for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing hemiplegic migraine. Concomitant medications included sumatriptan succinate (IMITREX) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]). The patient previously took REGLAN [metoclopramide hydrochloride] and experienced drug hypersensitivity. Historical vaccine included BNT162B2 (unknown lot number) in the left arm as dose 1, single on 11Mar2021 18:30 (at the age of 33-years old) for COVID-19 immunisation and experienced fatigue. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had been tested for COVID-19 since the vaccination with negative result. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was a life-long hemiplegic migraine patient. Prior to taking vaccine number two, she was fine. The patient had no reaction other than fatigue. After vaccine number two, on 02Apr2021 at 01:00 her fever got up to 105 (unspecified units) and a hemiplegic migraine was triggered. The patient had to go to the emergency room three days after the vaccine was given to have them help her break the hemiplegic migraine and subsequent "falling asleep" of her face, arm, spine on an unknown date in Apr2021. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events which also included treatment with medications to relieve the hemiplegic migraine. On 04Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event fever got up to 105 and a hemiplegic migraine was triggered, and subsequent "falling asleep" of face, arm, spine was resolving at the time of this report.  Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Eyelid function disorder, Fatigue, Headache, Heart rate increased
Clinical narrative: Tachycardia (resting heart rate overnight and day after was 20bpm higher than normal); headache; body ache; sore arm; night sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expiration date not reported) via an unspecified route of administration, administered in arm left on 20Apr2021 10:15 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included small fibre neuropathy, Hypermobility, POTS (postural orthostatic tachycardia), chronic urticaria, Raynaud's and known allergies: Sulfa (drug hypersensitivity) from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK8732 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 30Mar2021 15:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. On 20Apr2021 22:00, the patient experienced tachycardia (resting heart rate overnight and day after was 20bpm higher than normal), headache, body ache, sore arm, night sweat and chills. She did not receive other vaccine in four weeks. If Covid prior vaccination reported as unknown. She did not test for COVID post vaccination. On 20Apr2021, the patient underwent lab tests and procedures which included heart rate as 20 bpm higher than normal overnight and day after. No treatment reported for the adverse events. The seriousness of the events was reported as non-serious. The outcome of the events was not resolved.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Tachycardia (resting heart rate overnight and day after was 20bpm higher than normal); headache; body ache; sore arm; night sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expiration date not reported) via an unspecified route of administration, administered in arm left on 20Apr2021 10:15 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included small fibre neuropathy, Hypermobility, POTS (postural orthostatic tachycardia), chronic urticaria, Raynaud's and known allergies: Sulfa (drug hypersensitivity) from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK8732 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 30Mar2021 15:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. On 20Apr2021 22:00, the patient experienced tachycardia (resting heart rate overnight and day after was 20bpm higher than normal), headache, body ache, sore arm, night sweat and chills. She did not receive other vaccine in four weeks. If Covid prior vaccination reported as unknown. She did not test for COVID post vaccination. On 20Apr2021, the patient underwent lab tests and procedures which included heart rate as 20 bpm higher than normal overnight and day after. No treatment reported for the adverse events. The seriousness of the events was reported as non-serious. The outcome of the events was not resolved.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Heart rate, Night sweats, Pain
Clinical narrative: Tachycardia (resting heart rate overnight and day after was 20bpm higher than normal); headache; body ache; sore arm; night sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expiration date not reported) via an unspecified route of administration, administered in arm left on 20Apr2021 10:15 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included small fibre neuropathy, Hypermobility, POTS (postural orthostatic tachycardia), chronic urticaria, Raynaud's and known allergies: Sulfa (drug hypersensitivity) from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK8732 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 30Mar2021 15:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. On 20Apr2021 22:00, the patient experienced tachycardia (resting heart rate overnight and day after was 20bpm higher than normal), headache, body ache, sore arm, night sweat and chills. She did not receive other vaccine in four weeks. If Covid prior vaccination reported as unknown. She did not test for COVID post vaccination. On 20Apr2021, the patient underwent lab tests and procedures which included heart rate as 20 bpm higher than normal overnight and day after. No treatment reported for the adverse events. The seriousness of the events was reported as non-serious. The outcome of the events was not resolved.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Tachycardia
Clinical narrative: Tachycardia (resting heart rate overnight and day after was 20bpm higher than normal); headache; body ache; sore arm; night sweats; chills; This is a spontaneous report from a contactable consumer (patient). A 38-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0153, Expiration date not reported) via an unspecified route of administration, administered in arm left on 20Apr2021 10:15 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included small fibre neuropathy, Hypermobility, POTS (postural orthostatic tachycardia), chronic urticaria, Raynaud's and known allergies: Sulfa (drug hypersensitivity) from an unknown date and unknown if ongoing. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK8732 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 30Mar2021 15:45 (at the age of 38-year-old) as single dose for COVID-19 immunization. On 20Apr2021 22:00, the patient experienced tachycardia (resting heart rate overnight and day after was 20bpm higher than normal), headache, body ache, sore arm, night sweat and chills. She did not receive other vaccine in four weeks. If Covid prior vaccination reported as unknown. She did not test for COVID post vaccination. On 20Apr2021, the patient underwent lab tests and procedures which included heart rate as 20 bpm higher than normal overnight and day after. No treatment reported for the adverse events. The seriousness of the events was reported as non-serious. The outcome of the events was not resolved.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Atrial fibrillation, Chills, Headache, Heart rate
Clinical narrative: Chills; High fever; Body ache; Nausea; Diarrhea; Abnormal heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 41-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 07Apr2021 at 08:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPRIN), both from unknown dates for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 02:00, the patient experienced chills, high fever, headache, body ache, nausea, diarrhea and abnormal heartbeat. The clinical outcome of the events chills, high fever, body ache, nausea, diarrhea and abnormal heartbeat was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Pain, Pyrexia
Clinical narrative: Chills; High fever; Body ache; Nausea; Diarrhea; Abnormal heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 41-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 07Apr2021 at 08:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPRIN), both from unknown dates for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 02:00, the patient experienced chills, high fever, headache, body ache, nausea, diarrhea and abnormal heartbeat. The clinical outcome of the events chills, high fever, body ache, nausea, diarrhea and abnormal heartbeat was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Heart rate abnormal, Nausea, Pain
Clinical narrative: Chills; High fever; Body ache; Nausea; Diarrhea; Abnormal heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 41-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 07Apr2021 at 08:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPRIN), both from unknown dates for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 02:00, the patient experienced chills, high fever, headache, body ache, nausea, diarrhea and abnormal heartbeat. The clinical outcome of the events chills, high fever, body ache, nausea, diarrhea and abnormal heartbeat was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; High fever; Body ache; Nausea; Diarrhea; Abnormal heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 41-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 07Apr2021 at 08:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPRIN), both from unknown dates for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 02:00, the patient experienced chills, high fever, headache, body ache, nausea, diarrhea and abnormal heartbeat. The clinical outcome of the events chills, high fever, body ache, nausea, diarrhea and abnormal heartbeat was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/ batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Fatigue, Hypotension, Musculoskeletal stiffness, Neck pain
Clinical narrative: Blood pressure dropped; Could not move her left arm higher than shoulder height; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration in left arm, on 25Apr2021 at 12:30 PM (at the age of 47 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included ongoing fibromyalgia. The patient's concomitant medication included levonorgestrel (MIRENA). The patient previously took tetracycline and morphine and experienced allergies to both medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The COVID-19 vaccine was administered in a public health clinic or facility. In 2021, the patient had a severe reaction to the first dosage where her blood pressure dropped dramatically, and she could not move her left arm higher than shoulder height for 3 to 4 days afterwards. No treatment was administered for the events. The events were considered non-serious. The patient was administered with the second dose of COVID-19 vaccine (Lot Number: EW0185) on 16May2021 at 12:00 PM in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Vaccination site movement impairment
Clinical narrative: Blood pressure dropped; Could not move her left arm higher than shoulder height; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration in left arm, on 25Apr2021 at 12:30 PM (at the age of 47 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included ongoing fibromyalgia. The patient's concomitant medication included levonorgestrel (MIRENA). The patient previously took tetracycline and morphine and experienced allergies to both medications. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The COVID-19 vaccine was administered in a public health clinic or facility. In 2021, the patient had a severe reaction to the first dosage where her blood pressure dropped dramatically, and she could not move her left arm higher than shoulder height for 3 to 4 days afterwards. No treatment was administered for the events. The events were considered non-serious. The patient was administered with the second dose of COVID-19 vaccine (Lot Number: EW0185) on 16May2021 at 12:00 PM in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Pain, Pruritus, Urticaria
Clinical narrative: Neuropathy in legs from prior condition increased substantially; Neuropathy in legs from prior condition increased substantially; Full body hives that subsided after 2.5 days; This is a spontaneous report received from a contactable consumer (patient). This 45-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) on 20Apr2021 at 12:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Guillain-Barre Syndrome in 2019 and residual neuropathy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, duloxetine hydrochloride (CYMBALTA), cranberry, and plantago ovata seed husk (PSYLLIUM HUSK) from unknown dates for unknown indications. The patient did not have any relevant past drug history. The patient previously received dose 1 of BNT162B2 (lot number EP7533) on 30Mar2021 at 12:00 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. On 23Apr2021 at 18:00 the patient experienced full body hives that subsided after 2.5 days and then neuropathy in legs from prior condition increased substantially. The patient visited a doctor or other health professional/clinic as a result of the events. The patient underwent lab tests and procedures which included nasal swab on 28Apr2021 with a result of negative. The patient did not receive any treatment for the events. The outcome of hives and neuropathy increased was recovering.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Neuropathy peripheral, SARS-CoV-2 test, Urticaria
Clinical narrative: Neuropathy in legs from prior condition increased substantially; Neuropathy in legs from prior condition increased substantially; Full body hives that subsided after 2.5 days; This is a spontaneous report received from a contactable consumer (patient). This 45-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0164) on 20Apr2021 at 12:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Guillain-Barre Syndrome in 2019 and residual neuropathy. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole, duloxetine hydrochloride (CYMBALTA), cranberry, and plantago ovata seed husk (PSYLLIUM HUSK) from unknown dates for unknown indications. The patient did not have any relevant past drug history. The patient previously received dose 1 of BNT162B2 (lot number EP7533) on 30Mar2021 at 12:00 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. On 23Apr2021 at 18:00 the patient experienced full body hives that subsided after 2.5 days and then neuropathy in legs from prior condition increased substantially. The patient visited a doctor or other health professional/clinic as a result of the events. The patient underwent lab tests and procedures which included nasal swab on 28Apr2021 with a result of negative. The patient did not receive any treatment for the events. The outcome of hives and neuropathy increased was recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Erythema, Headache, Impaired work ability, Malaise
Clinical narrative: low grade fever/ fever spiked again to 101.2F (just one time on the evening) and then it has always been from 99F-100F and has been going up and down which scared her; Developed rash on her arm and torso/she had rash on her legs and nothing on the arms anymore and still lightly on her torso; RBC, kidney, liver enzymes counts were elevated; RBC, kidney, liver enzymes counts were elevated; RBC, kidney, liver enzymes counts were elevated; Platelet count dropped; Muscle ache; Immature RBC; Sore left arm; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 31Mar2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Lab data included Bone marrow biopsy result was reported as Immature RBC; Liver enzymes counts with results elevated; Platelet count with result decreased; RBC with results elevated and Kidney with elevated results. Fever was 101.2F on 01May2021. On an unspecified date in Apr2021 patient mentioned that everything was fine except for the sore left arm and muscle ache, on 13Apr2021 (Tuesday) she thought that her antibody has been on surge, 0n 15Apr2021 (Thursday) she had developed rash on her arm and torso and she had rash on her legs and nothing on the arms anymore and still lightly on her torso, on April 17 & 19, 2021- physician ordered some laboratory and her labs came back as "messed up". RBC, kidney, liver enzymes counts were elevated, platelet count dropped. Ended up with a hematologist/oncologist that ordered bone marrow biopsy which she was cleared of but had described an immature RBC. On 22Apr2021 rash on the torso started to get better. On 01May2021 she had low grade fever and it spiked again to 101.2F (just one time on the evening) and then it has always been from 99F-100F and has been going up and down which scared her. On 05May2021 (Wednesday) her low grade fever started to stabilize, and her situation was improving and had zero fever, also feeling more energy. She mentioned that the rash scares her and the whole reaction and according to her she is not someone who gets sick immediately. Outcome of event Pain in arm was not recovered, Fever was recovered on 05May2021, Rash was recovered on 22Apr2021 and unknown for other events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.