chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hot flush, Influenza like illness
Clinical narrative: not feeling great (1st dose); hot flashes (1st dose); dizziness (1st dose); covid-19 symptoms (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling great (1st dose)), HOT FLUSH (hot flashes (1st dose)), DIZZINESS (dizziness (1st dose)) and INFLUENZA LIKE ILLNESS (covid-19 symptoms (1st dose)) in a  patient of an unknown age and gender 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 FEELING ABNORMAL (not feeling great (1st dose)), HOT FLUSH (hot flashes (1st dose)), DIZZINESS (dizziness (1st dose)) and INFLUENZA LIKE ILLNESS (covid-19 symptoms (1st dose)). At the time of the report, FEELING ABNORMAL (not feeling great (1st dose)), HOT FLUSH (hot flashes (1st dose)), DIZZINESS (dizziness (1st dose)) and INFLUENZA LIKE ILLNESS (covid-19 symptoms (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       DIAGNOSTIC RESULTS: On an unknown date, SARS-CoV-2 test: Tested negative.  No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-046185 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination complication
Clinical narrative: Head pain; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head pain) and VACCINATION COMPLICATION (Feeling bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 HEADACHE (Head pain) and VACCINATION COMPLICATION (Feeling bad). At the time of the report, HEADACHE (Head pain) and VACCINATION COMPLICATION (Feeling bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Testicular pain, Testicular swelling
Clinical narrative: Discomfort in groin area; Testicles were swelling / Testicles were enlarged; Testicles were painful; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Discomfort in groin area), TESTICULAR SWELLING (Testicles were swelling / Testicles were enlarged) and TESTICULAR PAIN (Testicles were painful) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Vasectomy (few years ago). Concomitant products included FISH OIL (FISH OIL OMEGA 3), ROSUVASTATIN, NIACIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Discomfort in groin area), TESTICULAR SWELLING (Testicles were swelling / Testicles were enlarged) and TESTICULAR PAIN (Testicles were painful). The patient was treated with IBUPROFEN for Groin discomfort, Testicular swelling and Testicular pain, at a dose of 800 milligram. On 15-Feb-2021, MUSCULOSKELETAL DISCOMFORT (Discomfort in groin area), TESTICULAR SWELLING (Testicles were swelling / Testicles were enlarged) and TESTICULAR PAIN (Testicles were painful) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Cold compress and Ibuprofen 800mg used as treatment   This case was linked to MOD-2021-323864 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Migraine, Myalgia, Rash erythematous
Clinical narrative: hot flash; migraine; red rash; aches around body; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flash), MIGRAINE (migraine), RASH ERYTHEMATOUS (red rash) and MYALGIA (aches around body) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 011M20A and 002B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX), ALBUTEROL [SALBUTAMOL], DULOXETINE HYDROCHLORIDE (DULOXETINE HCL) and TRAZODONE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced HOT FLUSH (hot flash), MIGRAINE (migraine), RASH ERYTHEMATOUS (red rash) and MYALGIA (aches around body). At the time of the report, HOT FLUSH (hot flash), MIGRAINE (migraine), RASH ERYTHEMATOUS (red rash) and MYALGIA (aches around body) outcome was unknown.            No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Nine patients was administered the vaccine beyond the manufacturer date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nine patients was administered the vaccine beyond the manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nine patients was administered the vaccine beyond the manufacturer date of expiry). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Nine patients was administered the vaccine beyond the manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. No Treatment medication reported. Reported that the date moved to refrigeration was on 14 September 2021 Use by date was on 31 August 2021
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pyrexia
Clinical narrative: dizziness; fever; horrible fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (dizziness), PYREXIA (fever) and FATIGUE (horrible fatigue) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059721A) for COVID-19 vaccination. No Medical History information was reported.  On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced DIZZINESS (dizziness), PYREXIA (fever) and FATIGUE (horrible fatigue). In August 2021, DIZZINESS (dizziness), PYREXIA (fever) and FATIGUE (horrible fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant treatment was reported. No treatment medications was reported   This case was linked to MOD-2021-324103
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: since getting this unapproved vaccine I just don't feel the same anymore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (since getting this unapproved vaccine I just don't feel the same anymore) in a  patient of an unknown age and gender 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 VACCINATION COMPLICATION (since getting this unapproved vaccine I just don't feel the same anymore). At the time of the report, VACCINATION COMPLICATION (since getting this unapproved vaccine I just don't feel the same anymore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Nasopharyngitis, Pain in extremity
Clinical narrative: Soreness in her back, legs and feet; Cold symptoms; Bones were hurting; Soreness in her back, legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Soreness in her back, legs and feet), NASOPHARYNGITIS (Cold symptoms), BONE PAIN (Bones were hurting) and PAIN IN EXTREMITY (Soreness in her back, legs and feet) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced BACK PAIN (Soreness in her back, legs and feet), NASOPHARYNGITIS (Cold symptoms), BONE PAIN (Bones were hurting) and PAIN IN EXTREMITY (Soreness in her back, legs and feet). At the time of the report, BACK PAIN (Soreness in her back, legs and feet), NASOPHARYNGITIS (Cold symptoms), BONE PAIN (Bones were hurting) and PAIN IN EXTREMITY (Soreness in her back, legs and feet) outcome was unknown.            No concomitants medication were provided.  No treatment medication were provided.  No lab data has been provided by the reporter.   Reporter did not allow further contact
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Myalgia
Clinical narrative: had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am) and MYALGIA (sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), CARVEDILOL (COREG), APIXABAN (ELIQUIS), ASPIRIN [ACETYLSALICYLIC ACID], MELATONIN, IRON POLYSACCHARIDE COMPLEX (FERREX) and UBIDECARENONE (Q-10 CO-ENZYME) for an unknown indication.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced MYALGIA (sore arm). On 17-Sep-2021, the patient experienced DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am). At the time of the report, DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am) and MYALGIA (sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIARRHOEA (had diarrhea early this morning, 2 episodes of diarrhea at about 3am and then at 7:30am) to be unlikely related. No further causality assessment was provided for MYALGIA (sore arm).    Other medications also include Men's Vitamin. No treatments were reported. Patient reported they ate tacos ,diarrhea may be due to this or shot.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine administered after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion). In June 2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered after temperature excursion) 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.   Concomitant medication was not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included LEFLUNOMIDE for Rheumatoid arthritis.    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 PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Lip pain, Swelling face
Clinical narrative: facial swelling; soreness in the eyes; soreness in the lips; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), EYE PAIN (soreness in the eyes) and LIP PAIN (soreness in the lips) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (facial swelling), EYE PAIN (soreness in the eyes) and LIP PAIN (soreness in the lips). At the time of the report, SWELLING FACE (facial swelling), EYE PAIN (soreness in the eyes) and LIP PAIN (soreness in the lips) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia
Clinical narrative: Patient is showing symptoms of Bell's palsy; Face numbness, and it is pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Patient is showing symptoms of Bell's palsy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Patient is showing symptoms of Bell's palsy) (seriousness criterion medically significant) and HYPOAESTHESIA (Face numbness, and it is pretty bad). At the time of the report, BELL'S PALSY (Patient is showing symptoms of Bell's palsy) and HYPOAESTHESIA (Face numbness, and it is pretty bad) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns a patient of unknown age and gender who experienced serious expected event of Bell's palsy on unknown date after receiving both doses of the Moderna Covid-19 vaccine. No medical history provided. Dechallenge is unknown and rechallenge is unknown. The benefit-risk relationship is not affected by this report for the Moderna 19 vaccine.; Sender's Comments: This case concerns a patient of unknown age and gender who experienced serious expected event of Bell's palsy on unknown date after receiving both doses of the Moderna Covid-19 vaccine. No medical history provided. Dechallenge is unknown and rechallenge is unknown. The benefit-risk relationship is not affected by this report for the Moderna 19 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever of 99.8 F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 99.8 F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PYREXIA (low grade fever of 99.8 F). At the time of the report, PYREXIA (low grade fever of 99.8 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) 99.8 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient was fine.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Therapeutic response unexpected, Vaccination complication
Clinical narrative: "Covid Feet"; after completion of the series she stated that the shots cured her symptoms / receiving both doses of the vaccine helped a condition; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("Covid Feet") and THERAPEUTIC RESPONSE UNEXPECTED (after completion of the series she stated that the shots cured her symptoms / receiving both doses of the vaccine helped a condition) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("Covid Feet") and THERAPEUTIC RESPONSE UNEXPECTED (after completion of the series she stated that the shots cured her symptoms / receiving both doses of the vaccine helped a condition). At the time of the report, VACCINATION COMPLICATION ("Covid Feet") and THERAPEUTIC RESPONSE UNEXPECTED (after completion of the series she stated that the shots cured her symptoms / receiving both doses of the vaccine helped a condition) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) never tested positive for the virus.         Treatment information was not provided. List of concomitant medication were not given. Patient reported that receiving both doses of the vaccine helped a condition. Patient had "Covid Feet" but never tested positive for the virus, after completion of the series she stated that the shots cured her symptoms
Age: 63.0
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 63-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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). At the time of the report, 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.        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 provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Her husband was unable to receive his second dose because he had a brain surgery; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Her husband was unable to receive his second dose because he had a brain surgery) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Brain operation (brain surgery).    On 16-Mar-2021, 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 (Her husband was unable to receive his second dose because he had a brain surgery). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Her husband was unable to receive his second dose because he had a brain surgery) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: Vaccine went into the eye of one of the vaccine providers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into the eye of one of the vaccine providers) in a  patient of an unknown age and gender 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 ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into the eye of one of the vaccine providers). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine went into the eye of one of the vaccine providers) had resolved.        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.
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: unsure if there was any vaccine in the syringe; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (unsure if there was any vaccine in the syringe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 UNDERDOSE (unsure if there was any vaccine in the syringe). At the time of the report, UNDERDOSE (unsure if there was any vaccine in the syringe) 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 provided by reporter. No treatment medications were provided by reporter.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Ocular discomfort, Pain
Clinical narrative: Everything outside and in hurts/ It all hurts; My eyes want to pop out and I want to die the pain is so bad; My fingers and toes are completely numb; It hurts to breathe. It all hurts; This is a spontaneous report from a contactable consumer (Patient). A 41-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 20Jul2021 at 12:30 (at the age of 41-years-old) as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received PFIZER (Batch/Lot Number: Not reported), via an unspecified route of administration on 29Jun2021 as a DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient said, I'm trying to tell you how we sock I am. Patient reported that, on 20Jul2021 at 14:45, everything outside and in hurts/ it all hurts, my eyes want to pop out and I want to die the pain is so bad, my fingers and toes are completely numb it hurts to breathe and, it all hurts. Patient did not receive any treatment for the events. Outcome of all events were not resolved.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Menstrual spotting began and has not stopped since.; This is a spontaneous report from a contactable consumer. A 36-year-old (Non-pregnant) female consumer (patient) reported that he received First Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Jun2021 11:00 (at the age of 36-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. On 03Jul2021 patient experienced menstrual spotting began and has not stopped since. Patient did not receive any treatment. Patient was not tested for COVID post vaccination. Outcome of event was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Severe hair loss after second vaccination dose 12Apr2021; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (Patient) reported for herself.  A 54-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) on 12Apr2021 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, GERD, eczema and seasonal allergies. Concomitant medication included symbicort inhaler. Patient previously took received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), in left arm on 22Mar2021 at 11:15 am (at the age of 54-year-old) as a single dose for COVID-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. Tested covid post vaccination. No known allergies. On Apr2021, the patient experienced Severe hair loss after second vaccination dose. Event resulted in Physician Office Visit. No treatment was given. Patient underwent laboratory test which included Nasal Swab/PCR resulted negative on 21May2021. Outcome of the event was recovering.  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: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Balance disorder, C-reactive protein normal, Chest X-ray normal, Computerised tomogram head
Clinical narrative: complaining of dizziness unsteadiness on her feet and episode of syncope .  Patient states felt body aches, and the morning of presentation to the ER went to the bathroom to get ready for work and passed out does not remember the event but does remember afterwards feeling unsteady on her feet confused and having dizziness.  pt with symmetric strength and normal sensation on exam but with loss of balance and unsteady gait with ambulation.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Full blood count normal, Gait disturbance, Loss of consciousness
Clinical narrative: complaining of dizziness unsteadiness on her feet and episode of syncope .  Patient states felt body aches, and the morning of presentation to the ER went to the bathroom to get ready for work and passed out does not remember the event but does remember afterwards feeling unsteady on her feet confused and having dizziness.  pt with symmetric strength and normal sensation on exam but with loss of balance and unsteady gait with ambulation.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Pain, SARS-CoV-2 test negative, Syncope, Troponin normal
Clinical narrative: complaining of dizziness unsteadiness on her feet and episode of syncope .  Patient states felt body aches, and the morning of presentation to the ER went to the bathroom to get ready for work and passed out does not remember the event but does remember afterwards feeling unsteady on her feet confused and having dizziness.  pt with symmetric strength and normal sensation on exam but with loss of balance and unsteady gait with ambulation.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: painful tender lymphadenopathy of R axilla, R biceps, R inguinal beginning day of 2nd vaccine and worsening over the week prior to ED visit.  pt received steroids for outpt treatment.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Exposure during pregnancy, Full blood count, Human chorionic gonadotropin positive, Metabolic function test
Clinical narrative: 1 week after vaccination pt began with lower ab pain and vaginal spotting.  estimated gestational age 10w1d by u/s.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vaginal haemorrhage
Clinical narrative: 1 week after vaccination pt began with lower ab pain and vaginal spotting.  estimated gestational age 10w1d by u/s.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Condition aggravated, Infarction, Magnetic resonance imaging abnormal
Clinical narrative: Patient presented with stroke on 9/5 patient presented with multiple acute infarcts again on 9/21
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Pulmonary embolism, Thrombosis
Clinical narrative: multiple sub segmental Pulmonary Embolism, overall large thrombus burden
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Pain
Clinical narrative: Fever; severe chills; severe body pain; deep cough; headaches; extreme fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172), dose 1 via an unspecified route of administration, administered in Left Arm on 29Apr2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included fibromyalgia, breast cancer female, breast inflammation, arthritis, drug hypersensitivity and covid-19 from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. The patient had allergies : Penicillin, sulpha. She was not pregnant at time of vaccination. The patient had received other vaccine in four weeks prior to the COVID-19. The patient received other medications in two weeks. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received in response to the adverse events. On 02May2021, the patient experienced fever, severe chills, severe body pain, deep cough, headaches, extreme fatigue. The outcome of the event Cough was not recovered. The outcome of other events Fever, severe chills, severe body pain, headaches, extreme fatigue was recovered/resolved with Sequel.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; severe chills; severe body pain; deep cough; headaches; extreme fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself that: A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0172), dose 1 via an unspecified route of administration, administered in Left Arm on 29Apr2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included fibromyalgia, breast cancer female, breast inflammation, arthritis, drug hypersensitivity and covid-19 from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. The patient had allergies : Penicillin, sulpha. She was not pregnant at time of vaccination. The patient had received other vaccine in four weeks prior to the COVID-19. The patient received other medications in two weeks. Prior to vaccination, the patient had been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received in response to the adverse events. On 02May2021, the patient experienced fever, severe chills, severe body pain, deep cough, headaches, extreme fatigue. The outcome of the event Cough was not recovered. The outcome of other events Fever, severe chills, severe body pain, headaches, extreme fatigue was recovered/resolved with Sequel.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lip swelling, Mouth swelling, Nasal congestion, Pain
Clinical narrative: swollen upper lip/ Top lip is swollen; swollen mouth/ Mouth is Swollen; body ache; stuffy nose/Nose is stopped up like he has a cold; fever; head ache; This is a spontaneous report from a contactable consumer or other non hcp.  A 15-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3180), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 15:15 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. It was Reported that, the patient experienced swollen upper lip/ top lip is swollen serious, swollen mouth/ mouth is swollen, body ache, stuffy nose/nose is stopped up like he has a cold on 17Aug2021 with outcome of not recovered, headache on 16Aug2021 with outcome of not recovered, fever on 16Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of swollen upper lip/ top lip is swollen (lip swelling), swollen mouth/ mouth is swollen (mouth swelling), headache (headache), body ache (pain), stuffy nose/nose is stopped up like he has a cold (nasal congestion), fever (pyrexia).   Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: swollen upper lip/ Top lip is swollen; swollen mouth/ Mouth is Swollen; body ache; stuffy nose/Nose is stopped up like he has a cold; fever; head ache; This is a spontaneous report from a contactable consumer or other non hcp.  A 15-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3180), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 15:15 as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. It was Reported that, the patient experienced swollen upper lip/ top lip is swollen serious, swollen mouth/ mouth is swollen, body ache, stuffy nose/nose is stopped up like he has a cold on 17Aug2021 with outcome of not recovered, headache on 16Aug2021 with outcome of not recovered, fever on 16Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of swollen upper lip/ top lip is swollen (lip swelling), swollen mouth/ mouth is swollen (mouth swelling), headache (headache), body ache (pain), stuffy nose/nose is stopped up like he has a cold (nasal congestion), fever (pyrexia).   Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Fatigue; Fever; Muscle & body aches; Muscle & body aches; Headache; Overall sick feeling; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot Number: FA7485 expiry date was unknown) via an unspecified route of administration at arm left on 18Aug2021 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine, lisdexamfetamine mesilate taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have Known allergies. Historical vaccine dose 1, brand: Pfizer COVID 19, (lot number: FA7485 expiry date was unknown) via unspecified route of administration at Left arm on date: 24Jul2021 05:30 PM as a single dose for COVID0-19 immunisation. On 18Aug2021 23:00 Fatigue, Fever, Muscle & body aches, Headache, overall sick feeling, Nausea. No treatment was given for adverse events. Outcome of the events was not recovered.   Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue; Fever; Muscle & body aches; Muscle & body aches; Headache; Overall sick feeling; Nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot Number: FA7485 expiry date was unknown) via an unspecified route of administration at arm left on 18Aug2021 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine, lisdexamfetamine mesilate taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have Known allergies. Historical vaccine dose 1, brand: Pfizer COVID 19, (lot number: FA7485 expiry date was unknown) via unspecified route of administration at Left arm on date: 24Jul2021 05:30 PM as a single dose for COVID0-19 immunisation. On 18Aug2021 23:00 Fatigue, Fever, Muscle & body aches, Headache, overall sick feeling, Nausea. No treatment was given for adverse events. Outcome of the events was not recovered.   Follow-Up (31Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gait disturbance, Hypoaesthesia
Clinical narrative: lost feeling in my legs; my inside was on fire; I couldn't walk; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0171, Expiration Date: not reported), via an unspecified route of administration on 16Aug2021 as dose 2, single for COVID-19 immunization (at the age of 51-year-old). Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ER8737, Expiration Date: not reported), via an unspecified route of administration on 23Jul2021 for COVID-19 immunization (at the age of 51-year-old). No medical history was reported. There were no concomitant medications. The patient experienced lost feeling in my legs, my inside was on fire and i couldn't walk on 16Aug2021. It was reported that, she went and had the vaccine done. The first shot was not a problem but the second shot was not as fortunate. The second shot, she lost feeling in her legs 30 minutes after she had it, she could not 'simp'  her leg, her inside was on fire and she lost feeling in her legs, she couldn't walk. No laboratory test was done. The patient did not receive treatment for events. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pruritus, Vomiting
Clinical narrative: Vaccinated on sunday and today (tuesday) woke up feeling itchy all over; Severe diarrhea after vaccination; Also vomited about twice; This is a spontaneous report from a contactable consumer (Patient). This 30-year-old male consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: Fc3181) dose 1, Via an unspecified route of administration, administered in left arm on 22Aug2021 at 16:00 (at the age of 30-year-old) COVID-19 as dose 1, single for Covid-19 immunisation at Pharmacy or Drug Store. Patient medical history was none. Known allergies to past drug Amoxicillin. The patient concomitant medications were not reported. Patient has not received any other vaccine in four weeks and not received any other medication in the last two weeks. The patient was not diagnosed covid-19 prior to vaccination and not tested for covid-19, post vaccination. The patient experienced severe diarrhoea. Had to run to use restroom every 30 minutes to an hour for about 9 hours day after vaccination. Also vomited about twice on 23Aug2021 at 01:15. Vaccinated on sunday and today (tuesday) woke up feeling itchy all over. The patient did not received treatment for the events. Outcome of other events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Right hip really hurt; This is a spontaneous report from a contactable consumer.   This 77-year-old female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EWO178) via an unspecified route of administration into the left arm on 06Aug2021 at 13:20 (at the age of 77-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Aug2021, the patient experienced right hip really hurt. She had her shot and she was okay for a couple of days, but on the third day her right hip really hurt and she was wondering if that was a side effect. It was still hurting, that is why she was calling. No history of previous immunization with the Pfizer vaccine considered as suspect, no prior vaccinations (within 4 weeks). Treatment was reported as none. Report not related to a study or programme. No investigation assessment. Outcome of the event was not resolved.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling in underarm area on right arm; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old non-Pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0168), via an unspecified route of administration on 23Aug2021 at 13:00(at the age of 57-years-old) administered in Arm Right as a single dose for COVID-19 immunisation at Public Health Clinic/Military Facility. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0168), via an unspecified route of administration on 28Jul2021 at 09:00 am administered in Arm Right as a single dose for COVID-19 immunisation at Public Health Clinic/Military Facility. The patient medical history was not reported. Concomitant medication(s) included estradiol taken for an unspecified indication, start and stop date 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 has not been tested for COVID-19. The patient had no allergies. On 25Aug2021 at 05:00 AM, the patient experienced swelling in underarm area on right arm. No treatment was given for the event. The outcome of the event was not recovered.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.