chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment drugs and concomitant drugs are not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  First shipment was received it on 15-Mar-2021, and since they did not know it was refrozen, they used it beyond 14-Apr-2021. They had a sheet from the first shipment, that showed the transport conditions up to the time they had it. The earliest time on this sheet was 15-Mar-2021 at 6.45 AM, and the graph started at 0.4 degree C at 6.45AM, it had a 10-15 minutes time stamp, and stated that between 6:45 and 7AM it had -2 degree C. Once they received the shipment, they placed it at freezer temperature, at around -20 degree C. After that, they removed a vial from the freezer to use it that same day, whenever they needed a vial to administer the vaccine. The doses were viable up to 14-Apr-2021, the 30 days since it was thawed. The highest temperature could confirmed for the one shipment was 0.4 degrees Celsius, and the lowest was about -20 degrees Celsius.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  First shipment was received it on 15-Mar-2021, and since they did not know it was refrozen, they used it beyond 14-Apr-2021. They had a sheet from the first shipment, that showed the transport conditions up to the time they had it. The earliest time on this sheet was 15-Mar-2021 at 6.45 AM, and the graph started at 0.4 degree C at 6.45AM, it had a 10-15 minutes time stamp, and stated that between 6:45 and 7AM it had -2 degree C. Once they received the shipment, they placed it at freezer temperature, at around -20 degree C. After that, they removed a vial from the freezer to use it that same day, whenever they needed a vial to administer the vaccine. The doses were viable up to 14-Apr-2021, the 30 days since it was thawed. The highest temperature could confirmed for the one shipment was 0.4 degrees Celsius, and the lowest was about -20 degrees Celsius.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 15-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose of the vaccine past expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose of the vaccine past expiration date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose of the vaccine past expiration date). On 18-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose of the vaccine past expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported. Vaccine was stored in refrigerator on 16Sep2021 and administered to patient on 18Sep2021  Reporter did not knowtotal amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77° F) because she was not there that day, but supposes about 4 hs.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got one vaccination over 42 days ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got one vaccination over 42 days ago) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got one vaccination over 42 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got one vaccination over 42 days ago) had resolved.            No concomitant medications were reported.  No treatment medications were reported
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Greater than 35 days between Covid-19 vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Covid-19 vaccination) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 001A21A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Covid-19 vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between Covid-19 vaccination) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 048A21A and 024M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LORAZEPAM for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced BURNING SENSATION (Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Immediately after receiving 3rd dose, she experienced burning in throat,torso,upper arm,chest,lower back) outcome was unknown.            Concomitant product included unspecified BP medications. Patient received her 1st dose on 12Feb2021, 2nd dose on 09Mar2021 and 3rd dose on 01Sep2021 on her right arm intramuscularly in deltoid muscle. Immediately after receiving 3rd dose, she experienced burning in Torso. Her throat was also burning. Her upper arm was burning. She was kept at site. After she went to home, since that time, she has been having burning sensation in chest, torso, upper arm, lower back and throat.
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: Erythema polymorphus; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA MULTIFORME (Erythema polymorphus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (Erythema polymorphus) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema polymorphus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided.  Treatment information was not  provided.  Company Comment : This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of Erythema Multiforme. The event occurred on an unknown date and it is not clear if it was before or after the Moderna Covid-19 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a male patient of unknown age with no known medical history who experienced the unexpected event of Erythema Multiforme. The event occurred on an unknown date and it is not clear if it was before or after the Moderna Covid-19 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   The patient had take IV Fluids as a treatment medication.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Dose given past the 12 hour post puncture time; Patient aged 16 years took vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-327879 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021; A 16 year old patient got her both doses; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 066D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses). On 18-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-325327 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021). On 11-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22Jul2021 and 10Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  It was unable to clarify whether vial that underwent temperature excursions on 22Jul2021 and 10Aug2021 was administered to patient(s).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Significant Follow up - Patient identifier added, patients date of birth added.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Lethargy, Pyrexia
Clinical narrative: low energy; low temperature on third day; I had very bad back pain the next day; then felt lethargic for four days after; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Right, on 21Jul2021 at 15:30 PM (age at vaccination: 53 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included ongoing vertigo only (I have ongoing protentional vertigo and reduced occasionally) and known allergies: dairy products. Family history included gallbladder surgery (I had gallbladder surgery 1991), hernial surgery in 1997, and tonsils comrodin past 1972. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Right, on 22Jun2021 at 03:30 PM (age at vaccination: 53 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that she felt fine with first shot but her second day of second shot on 22Jul2021 at 01:00 PM, felt intense back pain and bit low energy, then on 22Jul2021 at 12:30 PM, she felt lethargic for four days after and low temperature of 96 degree on third day on 24Jul2021 at 02:30 AM which was low and low energy at least five day. She was not told of when booster was and if protect against variants and shot needs to best improved if they people to got booster noone. beats to safest throughout the first shot is not one symptoms but others did. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included temperature with 96 degree (I had a temperature of 96 degree which was low) on an unspecified date. Outcome of the event I had very bad back pain the next day was recovering, then felt lethargic for four days after was recovered on an unspecified date, low temperature on third day was recovered on 26Jul2021, and low energy was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: severe lower back pain; This is a spontaneous report from a contactable other HCP. This 34-year-old female other HCP (patient) reported for herself that: A 34-years-old non- pregnant female patient received bnt162b2 (BNT162B2; solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Jul2021 13:15 (at a age of 34-year-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypertension, and back pain was ongoing. same pain 7 years ago after epidural for pregnancy. No covid prior vaccination, no covid tested post vaccination, no Known allergies and no other vaccine in four weeks. The patient's concomitant medications were not reported. The patient experienced severe lower back pain on 27Jul2021 13:15. No treatment received with AE. Outcome of event was recovered with lasting effects on unspecified date.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Second shot 05/30 I have had severe joint pains. Hands wrists ankles knees; This is a spontaneous report from a contactable other hcp (patient). A 45-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration on 27Apr2021 as, dose 1, single for covid-19 immunisation. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection (Batch/Lot Number: Not reported), via an unspecified route of administration on 30May2021 as dose 2, single for covid-19 immunisation. Medical history included overweight, depression, migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had allergy of morphine, melon and experienced hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31May2021, the patient experienced severe joint pains. hands wrists ankles knees. The patient did not receive any treatment for the events. The outcome of the event was not recovered.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Thyroid function test abnormal
Clinical narrative: elevated thyroid levels/thyroid numbers are out of range; This is a spontaneous report from a contactable consumer or other non hcp.   A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  on an unspecified date the patient experienced elevated thyroid levels/thyroid numbers are out of range. The patient underwent lab tests and procedures which included thyroid function test: elevated thyroid levels. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the first case out of 2 cases. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm on 13Aug2021 (Age at vaccination was 69 years) as DOSE 2, SINGLE for covid-19 immunization. Medical history included glaucoma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 23Jul2021 (Age at vaccination was 69 years) as dose 1, single for COVID-19 immunization. On 13Aug2021 the patient reported that, patient and his wife both got pains in their arms that they got them in, they went back to get the 2nd shot, now patient just got pain in the arm that he got it from. The treatment was not received. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Nausea, Pain in extremity, Parosmia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11Aug2021 (age at vaccination 21-years-old) as dose 2, single for covid-19 immunization. The historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in arm left on 01Jul201 (age at vaccination 21-years-old) as dose 1, single for covid-19 immunization. Medical history included anxiety, depression and patient previously took Prednisone and experienced allergies. Concomitant medications included citalopram, omeprazole (PRILOSEC), bupropion (BUPROPION) taken within two weeks. Patient did not any other vaccine in four weeks. On 14Aug2021, patient stated that she has begun losing taste and her ability to smell, everything smelled like a chemical now. She is also extremely nauseous all day but especially after eating anything, sore arm, raised skin at injection site and low-grade fever. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Patient received no treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site reaction
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11Aug2021 (age at vaccination 21-years-old) as dose 2, single for covid-19 immunization. The historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in arm left on 01Jul201 (age at vaccination 21-years-old) as dose 1, single for covid-19 immunization. Medical history included anxiety, depression and patient previously took Prednisone and experienced allergies. Concomitant medications included citalopram, omeprazole (PRILOSEC), bupropion (BUPROPION) taken within two weeks. Patient did not any other vaccine in four weeks. On 14Aug2021, patient stated that she has begun losing taste and her ability to smell, everything smelled like a chemical now. She is also extremely nauseous all day but especially after eating anything, sore arm, raised skin at injection site and low-grade fever. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and not been tested since the vaccination. Patient received no treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: an allergic reaction/ get one on her first dose with the Pfizer-BioNTech COVID-19 Vaccine; the injection site was really itchy and red like a mosquito bit it; the injection site was really itchy and red like a mosquito bit it; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced an allergic reaction get one on her first dose with the pfizer-biontech covid-19 vaccine on 2021 with outcome of unknown, the injection site was really itchy and red like a mosquito bit it causing injection site pruritus and injection site erythema on 2021 with outcome of unknown.    Follow-up (16Aug2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself that: she is scheduled for the second dose of the Pfizer Covid-19 vaccine on 13Aug2021,.said that she was not able to get the second dose on 13Aug2021. She mentioned that she took the first dose on 23Jul2021. is asking if there is a grace period or timeframe for her to reschedule her second dose.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
Clinical narrative: 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far...; 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far...; 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far...; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in Arm Left on 07Aug2021 at 15:30 (at the age of 35 years old) as single for covid-19 immunisation. Medical history included Hashimotos. The patient had known allergies to Amoxi-clavaunate. Concomitant medications included levothyroxine, liothyronine (NP THYROID), vitamins nos. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Aug2021 at 12:00 AM patient experienced 2 weeks early menstruation, not always pink or red. Often orangish drainage, enough to fill at least 3 pads daily. Began within 48hrs post 1st vaccine and has continued for a week so far. The patient did not receive any treatments for the events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Nasal congestion, Pain
Clinical narrative: feeling under the weather; pain that took her down for a day; felt like a cold with a stuffy nose; felt like a cold with a stuffy nose; felt run down for a day; This is a spontaneous report from a contactable consumer (patient's boyfriend) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on 09Feb2021 (45-year-old at vaccination) as Dose number unknown, Single for Covid-19 immunization. This report is related to study or program. The patient's medical history and concomitant medications were not reported. The reporter stated that, his girlfriend took the shot at the exact same time and same place. She did not experience any of those symptoms regarding heart palpitations. She had some issues with feeling under the weather and the pain took her down for a day. He believed this was a more normal reaction associated with the vaccine. The reporter stated that she received the vaccine at the same location at the same time, but he has no way to confirm at this time if it was the same lot number. He does not knew that. He knew that she took it in the same room together. Her experience was quite different. The reporter stated that the patient had significant but not profound reaction. It was like anything other people had when taking it, felt like a cold with stuffy nose. She felt run down for a day. Kind of frankly what he expected he would have had that as well. She considered the reaction she had as "normal". It was an expected reaction to the vaccine as described in the media. Any health care provider who gave it to them would consider her reaction completely normal. No other lasting effects or issues, what so ever. She had nothing with heart rhythm or sweating, or shortness of breath. The outcome of the events was recovered on an unknown date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Immune system disorder, Nasopharyngitis
Clinical narrative: her immune system is jeopardized; When she has a cough she doesn't breathe right; When she has a cough she doesn't breathe right; as she was having a cold.; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored program. A female patient of an unspecified age received of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient medical history and concomitant medication were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: was not provided), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. It was stated that she always gets the same cold around Christmas and in summer on an unknown date. She has this now and hasn't had it in a few years. stated it could be good for her immune system. States it was not any different than it always was. States it's no better or no worse; it was the same garbage. States it goes away when she takes Zithromycin, states she needs 500mg not the 250mg because the 250mg did not help. On an unknown date, the patient stated it was the same cough, something that she gets. Said of course when she has a cough she doesn't breathe right. The patient said she cannot take generic because that was not good. The patient wants to know how she can get the 3rd dose of covid-19 vaccine. She had both doses before. She said her immune system was jeopardized as she was having a cold on an unknown date. She took a cough medicine Zithromycin. Therapeutic measures were taken as a result of all events and treatment included Zithromycin. The outcome of the event was unknown.   The follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: feeling tired; no energy; low grade fever that came on gradually (100.1, 100.6 and never got past 100); little soreness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration on 06Aug2021 (at the age of 69-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced little soreness on unspecified date in Aug2021, feeling tired, no energy, low grade fever that came on gradually (100.1, 100.6 and never got past 100) on 13Aug2021. The patient underwent lab tests and procedures which included body temperature: 100.1, 100.6 and never got past 100 on 13Aug2021. The events were not serious. Caller decided to get first Pfizer shot last Friday, 06Aug2021. Everything was fine, he just experienced a little soreness. However, he was feeling tired and has no energy at the time of this report. This started the day before this report, and he was not having any headaches. He wanted to know how long after the shot will the side effects show up and how long they last. Seven days after the first shot, started feeling all the effects, a low-grade fever that came on gradually (100.1, 100.6 and never got past 100), tired beyond belief and felt like he ran a marathon, and had no energy whatsoever on Friday, Saturday and Sunday (13Aug2021, 14Aug2021 and 15Aug2021). Friday and Saturday were tough days and Sunday it started to subside. He stated he called his afterhours doctor/nurse and they said if it gets worse come down. He stated it wasn't that bad, he let it ride out and the day before this report (yesterday; 16Aug2021) was fine. After providing the verbal response he stated he already got his answer because his symptoms came on after 7 days and subsided and everything was great. He was going to get his second dose on the 27th. Clinical outcome of events was recovered on an unspecified date in Aug2021.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpatations. I've never had this feeling ever.; This is a spontaneous report from a contactable Consumer. This 55-year-old male consumer (patient) reported that.  A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 15Aug2021 14:30 as (At the age of 55-years) dose 1, single for covid-19 immunisation. Medical history included Slight Asthma, Outdoor Allergies, Slight chronic obstructive pulmonary disease (COPD), Swelling of the legs and ankles from an unknown date and unknown if ongoing. Other medications in two weeks: Metformin, levothyroxine sodium (SYNTHROID), fexofenadine hydrochloride (ALLEGRA), Mens Multi-Vitamin taken for an unspecified indication, start and stop date were not reported.The patient previously  Laundry detergent and experienced dermatitis contact Known allergies of  Laundry detergent. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced heart palpatations. i've never had this feeling ever on 17Aug2021 04:00. Patient did not receive any treatment for event. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: made her very sick; This is a spontaneous report from a contactable consumer(patient) or other non hcp report based on information received by Pfizer from Regulatory Agency (Docket No. 85D-0249).   A 60-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/ lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient stated that the 1st dose made her very sick. The event outcome was reported as unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.