chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to 17 year old; A spontaneous report was received from a health care professional concerning a 17-year-old, female patient who received Moderna (mRNA-1273).   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not provided.  On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the event vaccine administered to 17 year old was considered as recovered.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd vaccine 20 days after the first shot; A spontaneous report was received from a healthcare professional concerning a 45-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) twenty days after the first dose, which was outside of the guidelines.  The patient's medical history was not provided. No relevant concomitant medication was reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 026L20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 038K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 05 Feb 2021, after the vaccination, the reporter analyzed the Agency document and found that the patient had already received the first dose twenty days ago, which was outside of the guidelines.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event, vaccination taken twenty days after the first dose, which was outside of the guidelines, was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 026L20A for first dose and lot # 038K20A for second dose) with no associated AEs reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: muscle soreness at the injection site; This is a spontaneous report from a contactable pharmacist (patient). A 52-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) at the age of 52-years-old, via an unspecified route of administration on left arm on 04Feb2021 at 09:30 AM at single dose for COVID-19 immunization. The patient's medical history was not reported. She was not pregnant at the time of vaccination. Concomitant medications included levothyroxine and multivitamin. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic (also reported as other). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced muscle soreness at the injection site on 05Feb2021. The patient did not receive any treatment in response to the event. The outcome of the event was recovering. The event was assessed as non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Swelling
Clinical narrative: Swelling; redness; soreness down to the elbow; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 25Jan2021 11:00, at single dose, for covid-19 immunization. The patient has no medical history. Concomitant medications included estradiol (VAGIFEM) and, vitamins. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The vaccine was administered in the hospital. The patient experienced swelling; redness; and soreness down to the elbow - all on 01Feb2021. The patient had not recovered from these adverse events and; no treatment was received for them. The patient has not been tested for COVID-19 since the vaccination.  Information about the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: Exhaustion/fatigue; This is a spontaneous report from a contactable patient. A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 04Feb2021 at 10:30, at a single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EL3247) on 14Jan2021 at 10:45 AM, in the right arm, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. The patient showed a negative nasal swab on 21Jan2021. On 04Feb2021, at 19:00, the patient experienced exhaustion/fatigue. The event was considered non-serious. The patient did not receive treatment for the event. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema marginatum, Rash
Clinical narrative: Rash in the back that looks like erythema marginatum, no itch.; Rash in the back that looks like erythema marginatum, no itch.; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL9262; expiration date: unknown) at vaccination age of 40-year-old via an unspecified route of administration in the left arm on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included mouse allergy, asthma, OSA (obstructive sleep apnea syndrome) and allergy. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone propionate (FLOVENT) and menthol, methyl salicylate (SALONPAS). The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EL3247) at vaccination age of 40-year-old via an unspecified route of administration in the left arm on 14Jan2021 14:00 at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient had rash in the back that looks like erythema marginatum with no itch on 04Feb2021. The events were considered as non-serious. The patient did not receive treatment for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Pain
Clinical narrative: Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a contactable consumer (patient). A 75 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265), via an unspecified route of administration (on right arm) on 30Jan2021 12:30 (at the age of 75 -years-old), single dose for COVID-19 immunization. Concomitant medication included levothyroxine sodium (L THYROXINE), rosuvastatin, magnesium. Back pain, extremely painful back muscle spasms. Started minor pain 3 days after vaccine didn't associate it with vaccination, very painful and spasms on day 6. Have not had any back injury or strain that patient was aware of. It was reported that adverse events started 04Feb2021 19:00. Patient just wanted to be sure if ok to take 2nd vaccination. The outcome of the events was not recovered. No treatment given for any of the adverse events. The events were assessed as non-serious by the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hunger
Clinical narrative: Fatigue; dizziness; increased hunger; This is a spontaneous report received from a contactable consumer (patient). A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration, on 19Jan2021 10:00, at single dose, for COVID-19 immunization. There was no medical history. Concomitant medication included cetirizine hydrochloride (ZYRTEC). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 19Jan2021 at 23:00, the patient experienced fatigue, dizziness and increased hunger. No treatment was given for the events. The patient recovered from the events in Jan2021. The reporter assessed the events as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her Left arm shoulder pain.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer(patient) reported that a female patient of an unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 30Jan2021 on left arm at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the dose, patient was injected with cortisone for her left arm shoulder pain. She is asking if it will lessen the effects of the vaccine.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Pain, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 24-year-old (age at vaccination was 24-year-old) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 04Feb2021 02:00 PM at single dose in left arm for COVID-19 immunization at Workplace clinic. Medical history was not reported. No Known allergies. The patient was not pregnant at time of vaccination. No covid prior vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), ibuprofen, melatonin. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Jan2021, 02:00 PM in left arm for COVID-19 immunization. On 04Feb2021 08:00 PM patient experienced soreness in arm where injection occurred, general body aches, migraine headache, slight nausea and fatigue. No treatment for adverse events. No covid tested post vaccination. No other vaccine in four weeks. The outcome of events was recovering.   Information about batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318), via an unspecified route of administration (Injected into left arm up high below the shoulder) on 04Feb2021 (at age of 68 years old) at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced shingles on 05Feb2021. The outcome of event was unknown. She did not know if it was related and didn't care. Her concern was the ER doctor did not seem to be too concerned. The pharmacist thought she should call and let Pfizer know and tell her what to do next. She would like to know if she should continue to get next shot. She had not heard it was one of the side effects. She stated she was hoping she nipped it in the bud, but said it would get worse. If got shingles like any herpes virus, if take the medication at the onset, it help with the breakout. It still took two weeks to get out of system. She had a lot of fat and was not sure if it went into the muscle.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date  at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on 05Feb2021. The outcome of event was unknown. It was reported that the ER doctor didn't think getting the second vaccine would be a problem and her pharmacist said there may be an issue and instructed her to call Pfizer for more information.  Information about lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Hypertensive crisis, Hypoaesthesia, Insomnia
Clinical narrative: hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine.   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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Nausea, Palpitations, Paraesthesia, Polyuria
Clinical narrative: hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine.   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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin discolouration, Temperature intolerance, Thirst
Clinical narrative: hypertensive crisis; mental fog; I had systemic reaction with numbness; tingling; extreme nausea; headache; thirst; palpitations; changes to color of extremities; cold/heat intolerance; diuresis; inability to eat; inability to eat or sleep; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old female (not pregnant) patient received BNT162B2 (lot number: ek9231) second dose on 06Jan2021 on left arm at single dose for covid-19 immunization. Medical history included hypothyroidism and allergies to penicillin. Concomitant medications in two weeks included levothyroxine sodium (SYNTHROID), liothyronine, magnesium carbonate (MAG 2), trimebutine maleate (MOTRI), zinc, curcuma longa (CURCUMA). The patient previously took BNT162B2 (lot number: ek5730) first dose on 17Dec2020 10:00 AM (age of vaccination was 49-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. On 10Feb2021 07:00 (also reported as 08Feb2021), approximately one month after 2nd vaccine, patient received a steroid epidural with contrast and a day after she had systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep. Not sure if related to vaccine. No COVID prior vaccination. COVID tested post vaccination (Nasal Swab, PCR) on 17Feb2021 and result was Negative. The outcome of the event was recovering. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. Hospitalization for 2 days. Patient received symptomatic management as treatment.; Sender's Comments: It is unclear what was the indication for the mentioned 'steroid epidural with contrast ' performed one month after the second dose of BNT162B2. The reported systemic reaction with numbness, tingling, extreme nausea, headache, thirst, palpitations, hypertensive crisis, changes to color of extremities, cold/heat intolerance, extreme thirst, mental fog, diuresis, inability to eat or sleep seems attributable to the reported procedure, or the unspecified indication for the procedure, rather than BNT162B2 vaccine.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Disease recurrence
Clinical narrative: left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; left side of his face is paralyzed and his left eye will not blink/ he thought he had a stroke/diagnosed with Bell's Palsy/had Bell's Palsy in the past several years ago; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included that he had Bell's Palsy in the past several years ago. The patient's concomitant medications were not reported. The patient experienced Bell's Palsy after receiving the first dose of the Pfizer Covid 19 vaccine. He stated that the left side of his face is paralyzed and his left eye will not blink. He received the first dose of the vaccine on a Thursday and the following Wednesday he went to the ER because he thought he had a stroke. He was diagnosed with Bell's Palsy, was given medication, and its been a week and his eye still is not blinking. His doctor is uncertain if he should receive the second dose of the vaccine or not. He was asking if he should he get the second dose and how many people were in the study. He also asked if he gets the second dose, if it will make the Bell's palsy worse. Therapeutic measures were taken as a result of event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, and on a positive drug-event temporal association,  the Company  assessed that a reasonable possibility could not be excluded that the suspect product BNT162B2 contributed to the occurrence of the reported events Bell's palsy and Disease recurrence. 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: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Osteoarthritis, Rheumatoid arthritis
Clinical narrative: Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Excruciating joint pain in my body; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 11Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included Sjogren's autoimmune syndrome. The patient's concomitant medications were not reported. In Feb2021, the patient had excruciating joint pain in the body. The patient was unsure if the reaction could be osteoarthritis because it was "symmetrical, definitely a trend of RA". The outcome of the events, 'excruciating joint pain in the body', 'osteoarthritis' and 'RA', was unknown. The patient was due to receive the second dose of vaccination on 04Mar2021.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body height
Clinical narrative: Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Unsure if this reaction could be Osteoarthritis because it is "symmetrical, definitely a trend of RA"; Excruciating joint pain in my body; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 11Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included Sjogren's autoimmune syndrome. The patient's concomitant medications were not reported. In Feb2021, the patient had excruciating joint pain in the body. The patient was unsure if the reaction could be osteoarthritis because it was "symmetrical, definitely a trend of RA". The outcome of the events, 'excruciating joint pain in the body', 'osteoarthritis' and 'RA', was unknown. The patient was due to receive the second dose of vaccination on 04Mar2021.  Information about lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Moderately severe dizziness and nausea; Moderately severe dizziness and nausea; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at left leg on 19Feb2021 14:00 at single dose for COVID-19 immunization. The patient had allergies to fermented, mold producing foods: cheese, mushrooms and yeast. The patient had other medical history including osteoporosis, hypothyroidism and asthma. The patient is not pregnant.  No other vaccine in four weeks. Concomitant medications (medications in two weeks) included levothyroxine and liothirinine. The patient previously received the first dose of BNT162B2 on 20Jan2021 15:00 for COVID-19 immunization. On day four following the second vaccine, on 23Feb2021 10:00, the patient experienced moderately severe dizziness and nausea. She could not move or walk without feeling extremely nauseous and dizzy. There was no treatment for the events. The events were assessed as serious medically significant by reporter. The patient had no COVID prior vaccination and not COVID tested post vaccination. The patient was recovering from the events.   Information on lot /batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging
Clinical narrative: Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable physician. A 39-year-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 20Jan2021, first dose on 30Dec2020, both at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none. Known allergies was no. If COVID prior vaccination was no. If COVID tested post vaccination was no. If other vaccine in four weeks was no. Other medications in two weeks was no. Concomitant medications were not reported. Patient developed right Bells Palsy on 18Feb2021. AE resulted in emergency room/department or urgent care. AE treatment included prednisone, magnetic resonance imaging (MRI) in Feb2021. The outcome of the event was not recovered.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, drug causality cannot be completely excluded. Serious Facial paralysis may be considered as late sequel to BNT162B2 injection, due to appropriate chronological relation. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, SARS-CoV-2 test, Transaminases increased
Clinical narrative: Pericarditis; Transaminitis; This is a spontaneous report from a contactable Other- Health Professional (patient). A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) via an unspecified route of administration on 13Jan2021 15:15 at single dose on left arm, for covid-19 immunisation. Medical history included chronic immune Idiopathic thrombocytopenic purpura (ITP), allergies to Mushroom. The patient did not have covid prior vaccination. The patient's concomitant medications were not reported. The patient experienced pericarditis and transaminitis on 03Feb2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 6 days. The patient received treatment medications for the events. The lab test included Nasal Swab, covid test: negative on 05Feb2021. The outcome of events was not recovered.; Sender's Comments: Based on the limited information provided, causality relationship cannot be clearly established and cannot be excluded.The case will be reassessed should additional information become available.~ The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Burning sensation, Erythema, Hypertension, Systemic lupus erythematosus
Clinical narrative: lupus flare-ups; bright red face; face is on fire; blood pressure went up high; trembling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included lupus. Concomitant medications were not reported. The patient's doctor told the patient to get the shot. And at 10:15 am after, the patient got a very bright red face. Her face is on fire. The patient thought it was really strange so she went to the paramedics, for which she might have stayed for half an hour. Her blood pressure went soon very high too. She don't have high blood pressure. The patient was also having lupus flare-ups. It happened to her twice last night. Also, last night, her face scrubbed bright red again. Her blood pressure went up high and she started trembling. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: lupus flare-ups; bright red face; face is on fire; blood pressure went up high; trembling; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included lupus. Concomitant medications were not reported. The patient's doctor told the patient to get the shot. And at 10:15 am after, the patient got a very bright red face. Her face is on fire. The patient thought it was really strange so she went to the paramedics, for which she might have stayed for half an hour. Her blood pressure went soon very high too. She don't have high blood pressure. The patient was also having lupus flare-ups. It happened to her twice last night. Also, last night, her face scrubbed bright red again. Her blood pressure went up high and she started trembling. Outcome of the events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Hallucination, Nervousness, Paranoia
Clinical narrative: Hallucinations; Anxiety; Paranoia; She was nervous; she wasn't feeling right; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, first dose on 25Jan2021, then second dose on 13Feb2021 both at single dose on the left arm, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension, both from an unknown date. Concomitant medication includes taking an unspecified medication for years, pain pills or whatever and the doctor said that it can take up to 7 days to leave the system. On 27Jan2021 at 10:00 am, 2 days after the first dose, it was reported that patient began to have hallucinations, anxiety, and paranoia. On an unspecified date in Jan2021 after the first dose, the patient reported that she was nervous, she is not feeling the same. The events continued after the second dose. She went to the Emergency room on Valentine's day 14Feb2021, she was not admitted and went home the same day. They just told her don't drive and talk to her primary Care Doctor. She then made an appoint for the primary care doctor on 17Feb2021. She has no other vaccines on the same day or in the 4 weeks prior. She has no other family medical history to provide. The outcome of the events hallucinations, anxiety, and paranoia is slowly going down and recovering while for the rest of the events was unknown.  Information on lot number/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gait disturbance, Loss of consciousness, Vertigo
Clinical narrative: passed out; This will drive me nuts all day; I don't feel comfortable walking in my own house; I got up this morning with the feeling of vertigo; getting little worse, worse than they were; This is a spontaneous report from a contactable Consumer. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number of Covid-19 Vaccine: 592671000-1, Expiry Date of Covid-19 Vaccine: 31May2021, Lot: EL9267), via an unspecified route of administration on 21Feb2021 13:24 at single dose for covid-19 immunisation. The patient medical history were none. Concomitant drug received. Patient stated, "Yes, I am on Inhalation Pump so, I take it went for one when I need it, I just had that was just little while ago, it wasn't (Incomplete sentence). The patient stated, "I got my second shot (Covid-19 Vaccine by Pfizer) Sunday about 1:30(13:24 PM) it says on the piece of paper, and I was fine all day Sunday, Monday(22Feb2021), I got up this morning with the feeling of vertigo, which I have had in the years of the past okay, all day, got out of shower from the bathroom out here and get some coffee, and I sat down I went to get up and the vertigo hit and I almost fall over, now I went into the shower and I dropped the wash cloth on the floor, so I went down to pick it up and again  almost passed out, almost immediately, and I sat and I get in the kitchen for some toast and I said well let me see what happens here and sat down eating some toast and when I got up to put dirty dishes in the sink, I almost again passed out, now I just got up to get the check I have to write to the gentleman right here who is working for me and just before that I got the same thing now I don't like it, how are these supposed to last, is what I want to know because I can't, this will drive me nuts all day, I can't go anywhere, I can't drive anywhere, yeah I don't feel comfortable walking in my own house. Right now, I have to say I am feeling them getting little worse, worse than they were." No treatment. Outcome was not recovered.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Chills, Dyspnoea, Fatigue
Clinical narrative: was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; Vomiting; Nausea; Chills; Tiredness; Jaw pain; stress on my heart; shortness of breath; no energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number AN5318) , via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation .  The patient previously took the first dose bnt162b2 on 05Jan2021for covid-19 immunization at 79-years-old, then experienced headache, chills, jaw pain, tiredness, nausea, vomiting. The patient medical history was not reported.  The patient's concomitant medications were not reported.  In 2021, the patient have had both the shots of the vaccine (COVID Vaccine) and was still having a lot of symptoms that should not be having like headache, chills, jaw pain, tiredness, nausea, vomiting and patient have had both of them (Both shots) and patient also have been in the hospital with this. The patient had bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then and then got the second shot on 26Jan2021 and it got worse. The patient had chills and shortness of breath and after the second shot, the patient landed in the hospital. The physician did several tests. The patient was bleeding, stool was black from blood, and patient was vomiting blood. The patient had stress on heart and did not have a heart attack but had stress on heart. The patient had no energy and cannot breath and it is just that have not energy. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214946 same patient/drug/event, different dose
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Haematemesis, Haematochezia, Haemorrhage, Investigation, Nausea
Clinical narrative: was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; Vomiting; Nausea; Chills; Tiredness; Jaw pain; stress on my heart; shortness of breath; no energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number AN5318) , via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation .  The patient previously took the first dose bnt162b2 on 05Jan2021for covid-19 immunization at 79-years-old, then experienced headache, chills, jaw pain, tiredness, nausea, vomiting. The patient medical history was not reported.  The patient's concomitant medications were not reported.  In 2021, the patient have had both the shots of the vaccine (COVID Vaccine) and was still having a lot of symptoms that should not be having like headache, chills, jaw pain, tiredness, nausea, vomiting and patient have had both of them (Both shots) and patient also have been in the hospital with this. The patient had bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then and then got the second shot on 26Jan2021 and it got worse. The patient had chills and shortness of breath and after the second shot, the patient landed in the hospital. The physician did several tests. The patient was bleeding, stool was black from blood, and patient was vomiting blood. The patient had stress on heart and did not have a heart attack but had stress on heart. The patient had no energy and cannot breath and it is just that have not energy. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214946 same patient/drug/event, different dose
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in jaw, Vomiting
Clinical narrative: was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; was bleeding, my stool was black from blood, and I was vomiting blood; Vomiting; Nausea; Chills; Tiredness; Jaw pain; stress on my heart; shortness of breath; no energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old patient of an unspecified gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number AN5318) , via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation .  The patient previously took the first dose bnt162b2 on 05Jan2021for covid-19 immunization at 79-years-old, then experienced headache, chills, jaw pain, tiredness, nausea, vomiting. The patient medical history was not reported.  The patient's concomitant medications were not reported.  In 2021, the patient have had both the shots of the vaccine (COVID Vaccine) and was still having a lot of symptoms that should not be having like headache, chills, jaw pain, tiredness, nausea, vomiting and patient have had both of them (Both shots) and patient also have been in the hospital with this. The patient had bad jaw pain. The patient had the first shot on 05Jan2021 and had the problems since then and then got the second shot on 26Jan2021 and it got worse. The patient had chills and shortness of breath and after the second shot, the patient landed in the hospital. The physician did several tests. The patient was bleeding, stool was black from blood, and patient was vomiting blood. The patient had stress on heart and did not have a heart attack but had stress on heart. The patient had no energy and cannot breath and it is just that have not energy. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021214946 same patient/drug/event, different dose
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Headache, Malaise
Clinical narrative: still wasn't feeling too well; Slightly elevated temperature of 98.9; Breathing really fast; Headache; Shivering; This is a spontaneous report from a contactable nurse. A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on 21Feb2021 (about 9:20AM-9:30AM) at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was vaccinated with the first dose of BNT162B2 on an unspecified date at 73-year-old for COVID-19 immunization. The patient had his second COVID-19 Vaccine yesterday, 21Feb2021 and had a significant reaction. Last night (21Feb2021), about 12 hours later, he started getting a headache, he was breathing really fast, and shivering. He tried to calm himself down and went to bed. This morning (22Feb2021) he got up around 7AM and still wasn't feeling too well. His temperature was slightly elevated at 98.9 on 22Feb2021. His normal temperature is 97.1. He knows his own body and was pretty convinced his reaction was from a slightly elevated temperature and everything that comes with that. He went back to bed this morning and slept until 11:30AM. He got up and felt good. He took his temperature a few minutes ago and it was back to 97.1. The outcome of the events was recovered.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), to reported events cannot totally be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: still wasn't feeling too well; Slightly elevated temperature of 98.9; Breathing really fast; Headache; Shivering; This is a spontaneous report from a contactable nurse. A 73-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on 21Feb2021 (about 9:20AM-9:30AM) at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient was vaccinated with the first dose of BNT162B2 on an unspecified date at 73-year-old for COVID-19 immunization. The patient had his second COVID-19 Vaccine yesterday, 21Feb2021 and had a significant reaction. Last night (21Feb2021), about 12 hours later, he started getting a headache, he was breathing really fast, and shivering. He tried to calm himself down and went to bed. This morning (22Feb2021) he got up around 7AM and still wasn't feeling too well. His temperature was slightly elevated at 98.9 on 22Feb2021. His normal temperature is 97.1. He knows his own body and was pretty convinced his reaction was from a slightly elevated temperature and everything that comes with that. He went back to bed this morning and slept until 11:30AM. He got up and felt good. He took his temperature a few minutes ago and it was back to 97.1. The outcome of the events was recovered.; Sender's Comments: Based on temporal association and safety profile of the product, the contributory role of the suspect product  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), to reported events cannot totally be excluded.