chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Headache, Magnetic resonance imaging brain
Clinical narrative: Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came.  Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Throat irritation
Clinical narrative: Blood pressure 170/84; lost ability to speak intelligibly; foggy; headache; scratchy throat; fatigue; Body aches; This is a spontaneous report from a non-contactable consumer. A 72-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 28Jan2021, 11:00 AM (lot number:EL3249), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in Doctor's office/urgent care. The patient medical condition included right Bundle Branch Block, cardiac from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medication included paracetamol (TYLENOL) and Upgraid. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 06Jan2021, 02:00PM (lot number: EL3249) at the age of 72 years for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for covid-19. Twenty-four hours after vaccine received, on 29Jan2021 at 03:00 PM, the patient suddenly lost ability to speak intelligibly. The patient stated "I was completely aware though a little "foggy". Blood pressure 170/84. Friend present thought I was having a TIA and called 911. Ambulance came.  Within 25 minutes, my ability to speak returned slowly. By the time I got to the ER, (45 minutes after onset), my ability to speak had mostly returned." Many blood labs were drawn, CT of head done, MRI of head done. EKG done. No cause of incident or evidence of TIA seen. After 5 hours, the patient was discharged with orders to come back if symptoms reoccurred. The patient had a headache, scratchy throat, fatigue and body aches in 2021. Since then the patient had a variety of tests, labs and Dr. visits. Blood pressure has been higher than her normal of 120/80, at intervals during the day in 2021. Since no evidence of TIA has been found, the patient was wondering if there have been any other reports of this loss of speaking ability (aphasia) occurring with any other vaccine recipients. The patient received treatment for the events. The consumer considered the events as non-serious. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site hypoaesthesia
Clinical narrative: numbness and heaviness in her whole arm/given in her right upper arm and that was the arm that was numb and heavy feeling; heaviness in her whole arm / discomfort at the site of injection; This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration in the right upper arm on 21Jan2021 at 1:30 or 2pm at a single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Concomitant medication included medication for high blood pressure. The patient received the first dose on 21Jan2021 and has experienced numbness and heaviness in her whole arm on 25Jan2021. She was calling because she wanted to know what to should she do about it. She was leery about getting the second dose. The patient was asking if this is normal, it doesn't feel normal. She has called her doctor and was waiting to hear back from them. On 21Jan2021, on the day she got the injection, she noticed discomfort at the site of injection but that only lasted that day and that has resolved. Now she only has the heaviness and numbness, this started on 25Jan2021, 4 days later and was still ongoing. The vaccine was given in her right upper arm and that was the arm that was numb and heavy feeling. Outcome of the events was not recovered. The event numbness and heaviness in her whole arm was reported as serious (medically significant).; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events vaccination site hypoaesthesia and vaccination site discomfort cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Breast pain, Computerised tomogram, Fatigue, Mouth haemorrhage
Clinical narrative: she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth injury, Pain
Clinical narrative: she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain
Clinical narrative: she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; she had a cut to the top of the roof of her mouth that had uncontrollable bleeding; right breast hurts; it radiates around to her back; Fatigue; and can't lift or pull anything and it really, really hurts; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunisation. Medical history included sinus disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received a flu shot on an unspecified date. Consumer is calling about the Pfizer COVID-19 vaccine, and says she just spoke to a nurse who told her to call and find out if her experience for what she had after her first shot on Friday of the past week had been reported before. She says that on Saturday (23Jan2021), she woke up and her right breast hurt, there is something in there, it radiates around to her back, along with having fatigue. She says she was told to see if anyone else reported this, she expected normal stuff like, flu stuff, this is not that. She says she is on her way to urgent care to have that looked at. She asks if condition persists, she is supposed to get her second dose on 12Feb, does she get it? She got her first dose last Friday (22Jan2021) then woke up Saturday and can't lift or pull anything and it really, really hurts. She says to add to this, which she talked to two doctors (docs) who said it was unrelated, that night she had a cut to the top of the roof of her mouth that had uncontrollable bleeding, she went to the emergency room for that and got a shot to help her coagulate blood, and will be seeing an ENT so hopefully that will be under control. No further details provided about shot to help her coagulate blood. She got the flu shot but that was Thanksgiving, way back, not recent. She is going to get her sinuses checked out, they did a CAT scan yesterday, and is going to the doctor for that 1Feb. She is concerned that the breast pain started last Saturday and is still really painful, she doesn't know why all of a sudden that happened, so she is going to the urgent care to see if they can do something for it, and will be getting an appointment with her OBGYN. For her right breast hurting, she took Tylenol and Ibuprofen, that is all she has done. Tylenol, LOT: PPAO33, EXP: Sep2022. Ibuprofen, LOT: 113132. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on 27Jan2021. Therapeutic measures were taken as a result of she had a cut to the top of the roof of her mouth that had uncontrollable bleeding she had a cut to the top of the roof of her mouth that had uncontrollable bleeding and right breast hurts. The outcome of the events was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: cannot get flu shot, allergic to them; Initial information was received on 26-Jan-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient) via social media. This case involves a patient (unknown demographics) who could not get INFLUENZA VACCINE as he/she was allergic to it (allergy to vaccine).  It was unknown if the patient had any concomitant disease or risk factor.  The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed allergy (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.   The details medication and reason for taking the medicine were not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event, and no further information provided; Nurse called to report a dose of VAQTA that was inadvertently administered after its labeled expiry date. Involved VAQTA expired on 11-JAN-2021 and was administered on 18-JAN-2021; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 18-JAN-2021, the patient was inadvertent vaccinated with  an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 dose of 0.5 milliliter (route of administration, anatomical location and vaccine scheme were not provided), lot number S032359 has been verified to be a valid lot number, expiration date was on 11-JAN-2021, as prophylaxis (expired product administered).There was no prior temperature excursions reported. The nurse inquired about need for revaccination. No additional adverse event, and no further information provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Confusional state, Dysarthria, Dyspnoea, Heart rate increased, Hypoaesthesia
Clinical narrative: INCREASED HEART RATE; NUMBNESS; TINGLING; SLURRED SPEECH; CONFUSION; OUT OF BREATH; A spontaneous report has been received from a consumer. The report concerns a female patient (age 31 years, height 60 in, weight 160 lb).    No medical history was reported.     Concomitant medication included Cosentyx for psoriatic arthritis, autoimmune condition.     The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for prevention on 03-JAN-2021.     On 04-JAN-2021, the patient experienced increased heart rate (preferred term: Heart rate increased), numbness (preferred term: Hypoaesthesia), tingling (preferred term: Paraesthesia), slurred speech (preferred term: Dysarthria) and confusion (preferred term: Confusional state). On an unknown date, the patient experienced out of breath (preferred term: Dyspnoea).     At the time of reporting, the event of out of breath was ongoing. At the time of reporting, the event of increased heart rate was improving. The outcome of the event(s) of numbness, tingling, slurred speech and confusion was unknown.     The events were considered non-serious.     Laboratory values are available.
Age: 34.0
Sex: F
Vaccine: FLUN4
Symptoms: Paraesthesia
Clinical narrative: INCREASED HEART RATE; NUMBNESS; TINGLING; SLURRED SPEECH; CONFUSION; OUT OF BREATH; A spontaneous report has been received from a consumer. The report concerns a female patient (age 31 years, height 60 in, weight 160 lb).    No medical history was reported.     Concomitant medication included Cosentyx for psoriatic arthritis, autoimmune condition.     The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) once/single administration, via nasal route, for prevention on 03-JAN-2021.     On 04-JAN-2021, the patient experienced increased heart rate (preferred term: Heart rate increased), numbness (preferred term: Hypoaesthesia), tingling (preferred term: Paraesthesia), slurred speech (preferred term: Dysarthria) and confusion (preferred term: Confusional state). On an unknown date, the patient experienced out of breath (preferred term: Dyspnoea).     At the time of reporting, the event of out of breath was ongoing. At the time of reporting, the event of increased heart rate was improving. The outcome of the event(s) of numbness, tingling, slurred speech and confusion was unknown.     The events were considered non-serious.     Laboratory values are available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; fever; chills; muscle pain; Fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in an unspecified number of an adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever, chills, muscle pain and fatigue. On an unknown date, the outcome of the pain in arm, fever, chills, muscle pain and fatigue were unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, muscle pain and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. It was reported that two dose Shingrix vaccine, for instance which protects older adults against the virus that causes painful shingles, results in sore arms in 78 percent of patients and muscle pain and fatigue in more than 40 percent of patients. The vaccine also caused fever and chills. This case has been linked with the case US2020AMR248304, reported by reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Decreased appetite, Diarrhoea, Headache, Hypersomnia
Clinical narrative: Doesn't recognize Husband or family; Not eating much; Nausea; Headache; Diarrhea; Sleeping 24hs a day; A spontaneous report was received from a health care professional concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family.    The patient's medical history included Alzheimer's disease. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium.   On 08 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the reporter states the patient went into a sharp decline, diarrhea, nausea, headache and sleeping 24 hours a day.   A few days later, the patient was not eating much and did not recognize her husband or family.   Treatment for the event included paracetamol, emergency room visits, and nursing care center placement.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family, were considered unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient with a medical history of Alzheimer's disease, who experienced unexpected events of diarrhea, hypersomnia, decreased appetite, confusional state and expected events of nausea and headache. The events of diarrhea, nausea, headache and hypersomnia occurred 5 days after the first dose of mRNA-1273 (Lot 025J20-2A) and, the events of decreased appetite and confusional state occurred unspecified number of days later. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Very limited information regarding this event has been provided at this time.  Alzheimer's disease is a confounding factor too. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Doesn't recognize Husband or family; Not eating much; Nausea; Headache; Diarrhea; Sleeping 24hs a day; A spontaneous report was received from a health care professional concerning a 78-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family.    The patient's medical history included Alzheimer's disease. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium.   On 08 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the reporter states the patient went into a sharp decline, diarrhea, nausea, headache and sleeping 24 hours a day.   A few days later, the patient was not eating much and did not recognize her husband or family.   Treatment for the event included paracetamol, emergency room visits, and nursing care center placement.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, developed diarrhea, nausea, headache, sleeping 24 hours a day, not eating, and didn't recognize husband or family, were considered unknown.; Reporter's Comments: This case concerns a 78-year-old, female patient with a medical history of Alzheimer's disease, who experienced unexpected events of diarrhea, hypersomnia, decreased appetite, confusional state and expected events of nausea and headache. The events of diarrhea, nausea, headache and hypersomnia occurred 5 days after the first dose of mRNA-1273 (Lot 025J20-2A) and, the events of decreased appetite and confusional state occurred unspecified number of days later. Treatment for the event included paracetamol, emergency room visits, and nursing care center placement. Very limited information regarding this event has been provided at this time.  Alzheimer's disease is a confounding factor too. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: Became unresponsive; Looked like having a seizure; Felt light headed; BP extremely low; Profusely sweating; Heart rate extremely low; A spontaneous report was received from a pharmacist, concerning a 35-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt light headed, became unresponsive, looked like having a seizure, BP extremely low, heart rate extremely low, and profusely sweating.  The patient's medical history, as provided by the reporter, included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included hydrochlorothiazide/lisinopril.  On 29 Jan 2021, five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient felt light-headed five minutes after receiving the vaccine. He then became unresponsive but was breathing and had a pulse. The reporter stated it looked like the patient was having a seizure; his eyes rolled upward, his left arm shook, and he did not respond to touch or voice. It was reported that 911 was immediately called and responded within a couple of minutes. The patient's blood pressure and heart rate were extremely low, and he was profusely sweating. The reporter stated that the patient came to and still felt very light-headed. The patient was then taken to the emergency department. Medical tests and laboratory results were unknown, but the reporter stated that a magnetic resonance imaging (MRI) was possibly performed. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, became unresponsive and looked like having a seizure, were resolved on 29 Jan 2021. The outcome for the events, felt light headed, BP extremely low, heart rate extremely low, and profusely sweating, was unknown.; Reporter's Comments: This case concerns a 35-year-old, female, with medical history of high blood pressure, who experienced a serious unexpected event of syncope, seizure, and non-serious unexpected events of dizziness, hypotension, hyperhidrosis, and heart rate decreased. The events occurred 1 day (5 min) after mRNA-1273 (Lot# 025L20A). Treatment information was not provided. Concomitant medications included: hydrochlorothiazide/lisinopril. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Seizure, Syncope
Clinical narrative: Became unresponsive; Looked like having a seizure; Felt light headed; BP extremely low; Profusely sweating; Heart rate extremely low; A spontaneous report was received from a pharmacist, concerning a 35-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt light headed, became unresponsive, looked like having a seizure, BP extremely low, heart rate extremely low, and profusely sweating.  The patient's medical history, as provided by the reporter, included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included hydrochlorothiazide/lisinopril.  On 29 Jan 2021, five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 29 Jan 2021, the patient felt light-headed five minutes after receiving the vaccine. He then became unresponsive but was breathing and had a pulse. The reporter stated it looked like the patient was having a seizure; his eyes rolled upward, his left arm shook, and he did not respond to touch or voice. It was reported that 911 was immediately called and responded within a couple of minutes. The patient's blood pressure and heart rate were extremely low, and he was profusely sweating. The reporter stated that the patient came to and still felt very light-headed. The patient was then taken to the emergency department. Medical tests and laboratory results were unknown, but the reporter stated that a magnetic resonance imaging (MRI) was possibly performed. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, became unresponsive and looked like having a seizure, were resolved on 29 Jan 2021. The outcome for the events, felt light headed, BP extremely low, heart rate extremely low, and profusely sweating, was unknown.; Reporter's Comments: This case concerns a 35-year-old, female, with medical history of high blood pressure, who experienced a serious unexpected event of syncope, seizure, and non-serious unexpected events of dizziness, hypotension, hyperhidrosis, and heart rate decreased. The events occurred 1 day (5 min) after mRNA-1273 (Lot# 025L20A). Treatment information was not provided. Concomitant medications included: hydrochlorothiazide/lisinopril. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: fever; aches; chills; headache; This is a spontaneous report from a contactable other healthcare professional, the patient. This 51 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EJ1686, dose 2, single dose via unknown route of administration in the left arm on 19Jan2021 at 09:15 AM (at the age of 51 years-old) for COVID-19 vaccination. Medical history included gastroesophageal reflux disease (GERD). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EH9899, dose 1 via unknown route of administration in the left arm on an unknown date at 09: 45 AM. The patient was not pregnant at the time of vaccination. The patient had no known medication allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MOTRIN), dextromethorphan, doxylamine, ephedrine, ethanol, paracetamol (NYQUIL) and omeprazole. On 19Jan2021 at 20:00, about twelve hours following the second injection, the patient developed a fever, aches, chills and headache that  lasted for approximately 24 hours. The clinical outcome of fever, aches, chills and headache was recovered on an unknown date in Jan2021. Treatment received for fever, aches, chills and headache included an unknown over the counter medication without relief. Since the vaccination, the patient has not been tested for COVID-19.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain the next day at site of injection; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, via an unknown route of administration in the right arm on 23Jan2021 at 15:30 (at the age of 75-years-old) as a single dose for Covid-19 immunization. Medical history included aneurysm and pacemaker from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It is unknown if patient received any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced pain at the site of injection. Treatment was not given for the event. The clinical outcome of the event vaccination site pain was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tension headache
Clinical narrative: severe tension/pain on left side of head; severe tension/pain on left side of head; This is a spontaneous report from a contactable healthcare professional.  A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration right arm on 21Jan2021 as single dose for covid-19 immunization. No medical history was noted.  No allergies to medications, food, or other products.  Concomitant medication included celecoxib (CELEXA). On 24Jan2021, at  08:00, the patient experienced severe tension/pain on left side of head. This was elaborated as behind the eye and above brow bone, radiates to back of neck. The events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. The outcome of severe tension/pain on left side of head  was not recovered.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red mark on his shot mark; This is a spontaneous report from a contactable consumer.  An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EL9262, via an unspecified route of administration in the right arm on 22Jan2021 at SINGLE DOSE for covid-19 immunization. The patient has no other relevant medical history. The patient's concomitant medications were not reported. The patient experienced red mark on his shot mark on 24Jan2021. The mark was not raised, and it is about the size of a pencil eraser. Patient does not have any feeling or pain (in this mark). The outcome of event was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain assessment, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ELO140, intramuscular in the left arm the age of 55-years on 30Dec2020 14:00 at SINGLE DOSE for COVID-19 immunization.  Medical history included penicillin allergy, GERD (gastrooesophageal reflux disease), osteoarthritis and spinal stenosis. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included dorzolamide hydrochloride, ketorolac tromethamine and timolol maleate. On 31Dec2020 08:00, patient woke up with muscle soreness in both quads it was a 4/10 pain. It lasted for 24 hours in the left. Since 31Dec2020, she still has soreness in the right quad, initially it was the entire muscle and then it settles to proximal & lateral to hip. The pain level was 2/10. Outcome of events was not recovered. The patient did not received treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia
Clinical narrative: back pain upper mid back, spread to left & right side; lower back muscles on the left & right side; This is a spontaneous report from a contactable healthcare professional. A 55-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on her right arm, via an unspecified route of administration on 23Dec2020 10:00 at a single dose for covid-19 immunization. Medical history included hypertension (HTN), asthma, obesity, postmenopause, hay fever, pre diabetic and allergy to sulfa. Concomitant medication included chlorthalidone, carvedilol (COREG), fexofenadine hydrochloride (ALLEGRA) and phytomenadione (VITAMIN K). The patient experienced back pain upper mid back, spread to left & right side and lower back muscles on the left & right side.; both on 03Jan2021 11:00 AM. The patient received lidocaine, methacarbamol, T3, prednisolone dosepak as treatment for the events. The outcome of the events was recovering.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary
Clinical narrative: severe contraction of chest muscles and neck lasting about 20 minutes; This is a spontaneous report from a contactable consumer (patient).  A 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL1283, expiry date unknown), via an unspecified route of administration on 25Jan2021 at 10:30 on the left arm at a single dose for COVID-19 immunization.  Medical history included allergies to bee stings from an unknown date and unknown if ongoing.  Concomitant medication included salbutamol sulfate (ALBUTEROL).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25Jan2021 at 11:30, one hour after injection the had severe contraction of chest muscles and neck lasting about 20 minutes. The patient did not receive treatment for the event. The outcome of the event was recovered.  The event was reported as non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Muscle aches; joints ache; slight head ache; This is a spontaneous report from a contactable consumer.  A 21-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 25Jan2021 at 13:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), montelukast (MANUFACTURER UNKNOWN), and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing.  The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously took sulfamethoxazole/trimethoprim (BACTRIM) from unknown dates for an unknown indication and experienced drug allergy.   On 25Jan2021 at 19:00, the patient experienced muscle aches, joints ache, and slight headache (reported as in the morning).  The patient did not receive any treatment for the events. The clinical outcomes of muscle aches, joints ache, and slight headache were recovering.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling cold, Nausea, Tremor
Clinical narrative: severe chills; vomiting; Diarrhea; lots of nausea; her whole body was trembling violently; she was very cold; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient started experiencing severe chills and her whole body was trembling violently, she was very cold. Followed with vomiting, diarrhea and lots of nausea. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe chills; vomiting; Diarrhea; lots of nausea; her whole body was trembling violently; she was very cold; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient started experiencing severe chills and her whole body was trembling violently, she was very cold. Followed with vomiting, diarrhea and lots of nausea. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Vaccination site pain
Clinical narrative: first dose was administred on 28Dec2020 and second dose on 21Jan2021; Sore arm at injection site; body aches during the second shot for a full 24 hours; This is a spontaneous report from a contactable pharmacist (the patient).  A non-pregnant 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the left arm on 21Jan2021 as a single dose for COVID-19 immunization. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included spironolactone, ethinylestradiol, levonorgestrel (AVIANE), cholecalciferol. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Historical vaccine include the first dose of BNT162B2, lot #EK9231, intramuscular in the left arm on 28Dec2020 at the age of 26-year-old for COVID-19 immunization. On 22Jan2021, the patient experienced sore arm at injection site, (but not as severe in comparison to the flu shot), and body aches during the second shot for a full 24 hours. The events were reported as non-serious. Treatment for the events included acetaminophen 500 mg - 2 tablets by mouth twice daily. The clinical outcome of the events sore arm at injection site, and body aches during the second shot for a full 24 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Headache; Chills; Body aches; Nausea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 19Jan2021 08:28 at 0.3 mL, single for COVID-19 immunization. Medical history included Open heart surgery in Jan2003 and in Jan2018 (he had two open heart surgeries, the first one in Jan2003, and the last one in Jan2018);Stent placement (he has had 14 stents placed over a period of time, the last stents were done when open heart surgery was done, they put in 3 that time, in Jan2018); and Gallbladder removal on 16Jun2020. The patient's concomitant medications were not reported. The patient previously took influenza vaccine (flu vaccine) in Sep2020. The patient had a reaction to the COVID-19 vaccine two days (on 21Jan2021) after getting it. He had a really bad headache, chills, body aches and nausea, a whole series of things went wrong. He woke up at 04:00 21Jan2021 with an intense headache. The reaction happened all together, his headache, body aches, chills, and very bad nausea started about the same time, he contacted his doctor that day. At time of report was the first day he was starting to feel better. It was the first day he didn't have a headache, he was feeling better now, he was basically in bed from Thursday on. He got up a little bit yesterday, and at the time of report he was feeling much better, it lasted 4 to 5 days (as reported). He took Tylenol 500mg, two of them, and kept taking it 6 hours apart, it was all he had to take, and it barely touched it (UPC: 30043739 LOT SMA115, EXP Sep2022). The outcome of the event headache recovered on 26Jan2021; and recovering outcome for the other events.