chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash vesicular, Skin exfoliation, Skin swelling
Clinical narrative: My skin peeled off like having a sunburn; Got a severe rash that blistered and got swollen; Got a severe rash that blistered and got swollen; Got a severe rash that blistered and got swollen; Turned my entire body red; My skin peeled off like having a sunburn; Dose: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; TORSEMIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 05Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "Dose: 3"; SKIN EXFOLIATION (non-serious), SUNBURN (non-serious) all with onset 13Nov2021, outcome "recovering" and all described as "My skin peeled off like having a sunburn"; RASH (non-serious), BLISTER (non-serious), SWELLING (non-serious) all with onset 13Nov2021, outcome "recovering" and all described as "Got a severe rash that blistered and got swollen"; ERYTHEMA (non-serious) with onset 13Nov2021, outcome "recovering", described as "Turned my entire body red". The events "my skin peeled off like having a sunburn", "got a severe rash that blistered and got swollen", "got a severe rash that blistered and got swollen", "got a severe rash that blistered and got swollen", "turned my entire body red" and "my skin peeled off like having a sunburn" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin exfoliation, rash, blister, swelling, erythema, sunburn.  Additional Information: The most recent COVID-19 vaccine was administered was withheld. Hospitalization was not Prolonged. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was One a Day Women Vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The treatment received for the adverse event was Steroid cream and returned to dr second time received.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Immunisation, Rash, Skin exfoliation
Clinical narrative: My skin peeled off like having a sunburn; Got a severe rash that blistered and got swollen; Got a severe rash that blistered and got swollen; Got a severe rash that blistered and got swollen; Turned my entire body red; My skin peeled off like having a sunburn; Dose: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; TORSEMIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 05Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "Dose: 3"; SKIN EXFOLIATION (non-serious), SUNBURN (non-serious) all with onset 13Nov2021, outcome "recovering" and all described as "My skin peeled off like having a sunburn"; RASH (non-serious), BLISTER (non-serious), SWELLING (non-serious) all with onset 13Nov2021, outcome "recovering" and all described as "Got a severe rash that blistered and got swollen"; ERYTHEMA (non-serious) with onset 13Nov2021, outcome "recovering", described as "Turned my entire body red". The events "my skin peeled off like having a sunburn", "got a severe rash that blistered and got swollen", "got a severe rash that blistered and got swollen", "got a severe rash that blistered and got swollen", "turned my entire body red" and "my skin peeled off like having a sunburn" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin exfoliation, rash, blister, swelling, erythema, sunburn.  Additional Information: The most recent COVID-19 vaccine was administered was withheld. Hospitalization was not Prolonged. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was One a Day Women Vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The treatment received for the adverse event was Steroid cream and returned to dr second time received.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sunburn, Swelling
Clinical narrative: My skin peeled off like having a sunburn; Got a severe rash that blistered and got swollen; Got a severe rash that blistered and got swollen; Got a severe rash that blistered and got swollen; Turned my entire body red; My skin peeled off like having a sunburn; Dose: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; TORSEMIDE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 05Apr2021, when the patient was 64 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 08Mar2021, when the patient was 63 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "Dose: 3"; SKIN EXFOLIATION (non-serious), SUNBURN (non-serious) all with onset 13Nov2021, outcome "recovering" and all described as "My skin peeled off like having a sunburn"; RASH (non-serious), BLISTER (non-serious), SWELLING (non-serious) all with onset 13Nov2021, outcome "recovering" and all described as "Got a severe rash that blistered and got swollen"; ERYTHEMA (non-serious) with onset 13Nov2021, outcome "recovering", described as "Turned my entire body red". The events "my skin peeled off like having a sunburn", "got a severe rash that blistered and got swollen", "got a severe rash that blistered and got swollen", "got a severe rash that blistered and got swollen", "turned my entire body red" and "my skin peeled off like having a sunburn" were evaluated at the physician office visit. Therapeutic measures were taken as a result of skin exfoliation, rash, blister, swelling, erythema, sunburn.  Additional Information: The most recent COVID-19 vaccine was administered was withheld. Hospitalization was not Prolonged. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was One a Day Women Vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The treatment received for the adverse event was Steroid cream and returned to dr second time received.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FH8028) at the age of 55 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: J&J vaccine (Dose 1, lot: 1805031, Route of administration: Left arm), administration date: 31Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "got their booster dose"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "Received First dose J&J Vaccine and booster dose Pfizer Covid 19 Vaccine"; PRODUCT PREPARATION ERROR (non-serious) with onset 19Nov2021, outcome "unknown", described as "received a notice that wrong diluent, sterile water specifically, was used in their booster shots"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "sore arm"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "Exhausted". Additional information: The patient taking Pfizer Covid Vaccine because it had been 8 months. Event sore arm began three hours after receiving the booster dose Pfizer Covid 19 Vaccine on 19Nov2021 and progressively got more sore. The soreness went away after a couple of days. Exhaustion began the night of 19Nov2021 and went away.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101648051 same drug/event different patient
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FH8028) at the age of 55 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: J&J vaccine (Dose 1, lot: 1805031, Route of administration: Left arm), administration date: 31Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "got their booster dose"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "Received First dose J&J Vaccine and booster dose Pfizer Covid 19 Vaccine"; PRODUCT PREPARATION ERROR (non-serious) with onset 19Nov2021, outcome "unknown", described as "received a notice that wrong diluent, sterile water specifically, was used in their booster shots"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "sore arm"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "Exhausted". Additional information: The patient taking Pfizer Covid Vaccine because it had been 8 months. Event sore arm began three hours after receiving the booster dose Pfizer Covid 19 Vaccine on 19Nov2021 and progressively got more sore. The soreness went away after a couple of days. Exhaustion began the night of 19Nov2021 and went away.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101648051 same drug/event different patient
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Lot number: FH8028) at the age of 55 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: J&J vaccine (Dose 1, lot: 1805031, Route of administration: Left arm), administration date: 31Mar2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "got their booster dose"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "Received First dose J&J Vaccine and booster dose Pfizer Covid 19 Vaccine"; PRODUCT PREPARATION ERROR (non-serious) with onset 19Nov2021, outcome "unknown", described as "received a notice that wrong diluent, sterile water specifically, was used in their booster shots"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "sore arm"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovered" (Nov2021), described as "Exhausted". Additional information: The patient taking Pfizer Covid Vaccine because it had been 8 months. Event sore arm began three hours after receiving the booster dose Pfizer Covid 19 Vaccine on 19Nov2021 and progressively got more sore. The soreness went away after a couple of days. Exhaustion began the night of 19Nov2021 and went away.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101648051 same drug/event different patient
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: administration of improperly stored vaccines
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis, Treatment at Hospital.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: administration of improperly stored vaccines
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: administration of improperly stored vaccines
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Extra dose administered, Fatigue, Headache, Injection site pain
Clinical narrative: Muscle aches/pain; Chills; Fatigue; Headache; Fever; Nausea; Injection site pain; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 26Nov2021 at 12:00 (Lot number: UNKNOWN) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa-based medication. Concomitant medications included: DULOXETINE; PANTOPRAZOLE; SPIRONOLACTONE and MILI.  Past drug history included: Demerol, reaction: "Drug allergy", notes: Known allergy: Demerol; Topiramate, reaction: "Drug allergy", notes: Known allergy: Topiramate. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 29Apr2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 12:00, outcome "unknown", described as "Dose received: 3"; MYALGIA (non-serious), CHILLS (non-serious), FATIGUE (non-serious), HEADACHE (non-serious), PYREXIA (non-serious), NAUSEA (non-serious), VACCINATION SITE PAIN (non-serious); all with onset 27Nov2021, outcome "recovered" (an unknown date in 2021) and all described as "Muscle aches/pain, chills, fatigue, headache, fever, nausea and injection site pain". Therapeutic measures were not taken as a result of myalgia, fatigue, headache, pyrexia, nausea and vaccination site pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches/pain; Chills; Fatigue; Headache; Fever; Nausea; Injection site pain; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 26Nov2021 at 12:00 (Lot number: UNKNOWN) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa-based medication. Concomitant medications included: DULOXETINE; PANTOPRAZOLE; SPIRONOLACTONE and MILI.  Past drug history included: Demerol, reaction: "Drug allergy", notes: Known allergy: Demerol; Topiramate, reaction: "Drug allergy", notes: Known allergy: Topiramate. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 29Apr2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 12:00, outcome "unknown", described as "Dose received: 3"; MYALGIA (non-serious), CHILLS (non-serious), FATIGUE (non-serious), HEADACHE (non-serious), PYREXIA (non-serious), NAUSEA (non-serious), VACCINATION SITE PAIN (non-serious); all with onset 27Nov2021, outcome "recovered" (an unknown date in 2021) and all described as "Muscle aches/pain, chills, fatigue, headache, fever, nausea and injection site pain". Therapeutic measures were not taken as a result of myalgia, fatigue, headache, pyrexia, nausea and vaccination site pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Immunisation, Myalgia
Clinical narrative: Muscle aches/pain; Chills; Fatigue; Headache; Fever; Nausea; Injection site pain; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 26Nov2021 at 12:00 (Lot number: UNKNOWN) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa-based medication. Concomitant medications included: DULOXETINE; PANTOPRAZOLE; SPIRONOLACTONE and MILI.  Past drug history included: Demerol, reaction: "Drug allergy", notes: Known allergy: Demerol; Topiramate, reaction: "Drug allergy", notes: Known allergy: Topiramate. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 29Apr2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 12:00, outcome "unknown", described as "Dose received: 3"; MYALGIA (non-serious), CHILLS (non-serious), FATIGUE (non-serious), HEADACHE (non-serious), PYREXIA (non-serious), NAUSEA (non-serious), VACCINATION SITE PAIN (non-serious); all with onset 27Nov2021, outcome "recovered" (an unknown date in 2021) and all described as "Muscle aches/pain, chills, fatigue, headache, fever, nausea and injection site pain". Therapeutic measures were not taken as a result of myalgia, fatigue, headache, pyrexia, nausea and vaccination site pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Muscle aches/pain; Chills; Fatigue; Headache; Fever; Nausea; Injection site pain; Dose received: 3; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.   A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 26Nov2021 at 12:00 (Lot number: UNKNOWN) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing) and "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: sulfa-based medication. Concomitant medications included: DULOXETINE; PANTOPRAZOLE; SPIRONOLACTONE and MILI.  Past drug history included: Demerol, reaction: "Drug allergy", notes: Known allergy: Demerol; Topiramate, reaction: "Drug allergy", notes: Known allergy: Topiramate. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 08Apr2021, when the patient was 42 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 18:00), administration date: 29Apr2021, when the patient was 42 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 12:00, outcome "unknown", described as "Dose received: 3"; MYALGIA (non-serious), CHILLS (non-serious), FATIGUE (non-serious), HEADACHE (non-serious), PYREXIA (non-serious), NAUSEA (non-serious), VACCINATION SITE PAIN (non-serious); all with onset 27Nov2021, outcome "recovered" (an unknown date in 2021) and all described as "Muscle aches/pain, chills, fatigue, headache, fever, nausea and injection site pain". Therapeutic measures were not taken as a result of myalgia, fatigue, headache, pyrexia, nausea and vaccination site pain.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Fatigue, Gaze palsy, Lethargy, Muscle rigidity
Clinical narrative: Generalized tonic-clonic seizure during sleep approximately 10 hours after vaccine administration.  Episode lasted less than 5 minutes. Returned to sleep at end of the episode and returned to baseline in the morning, except for sleeping longer than usually expected.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Seizure, Unresponsive to stimuli
Clinical narrative: Generalized tonic-clonic seizure during sleep approximately 10 hours after vaccine administration.  Episode lasted less than 5 minutes. Returned to sleep at end of the episode and returned to baseline in the morning, except for sleeping longer than usually expected.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Generalised tonic-clonic seizure, Hypersomnia
Clinical narrative: Generalized tonic-clonic seizure during sleep approximately 10 hours after vaccine administration.  Episode lasted less than 5 minutes. Returned to sleep at end of the episode and returned to baseline in the morning, except for sleeping longer than usually expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Headache, Wheezing
Clinical narrative: Started wheezing and having chest pains and headaches. Went to ER and was dx with pericarditis.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: Started wheezing and having chest pains and headaches. Went to ER and was dx with pericarditis.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Wheezing
Clinical narrative: Started wheezing and having chest pains and headaches. Went to ER and was dx with pericarditis.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: GAVE PEDIATRIC DOSE TO 12 YEAR OLD
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Interchange of vaccine products
Clinical narrative: Pharmacist has give 0.6ml Pfizer vaccine.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacist has give 0.6ml Pfizer vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: i had a miscarriage 5 days after getting the second dose of the phizer vaccine
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Light rash(3? diameter), swelling at injection site
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis, Magnetic resonance imaging
Clinical narrative: Bell?s palsy. Facial paralysis on the right side of my face. Still ongoing.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Fatigue, Nausea, Vomiting
Clinical narrative: Tiredness and nauseousness the day of the vaccine after receiving it, the next day I began vomiting, vomited everything and couldn?t even drink water, body temperature was flaring up then going back down. Went to the emergency room where I received IV fluids after vomiting for days after vaccine
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Maternal exposure during pregnancy, Umbilical cord around neck
Clinical narrative: Pregnancy was healthy normal pregnancy.  Due date 8/31/21.  Birth weight 6lbs 6oz.  Cord was knotted and around babies neck.  Baby delivered safely.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Myalgias, rigors, fever, sore throat which lasted approximately 24 hours before decreasing.. Acetaminophen helped slightly.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Chest pain, Dyspnoea, Extra dose administered, Myocardial infarction
Clinical narrative: Severe chest pains and shortness of breath (Myocarditis and Pericarditis detailed as potential side-effects by the CDC).  I had experienced similar side-effects earlier this year around the time of my previous two vaccinations, but didn't connect those symptoms with the vaccine until this most recent episode.  The onset was so specific, and sudden (less than 24 hours) after my third dose- I was positive it was a reaction to my third booster.  It felt like I was having a heart attack, so I went to an urgent care facility where a dr. confirmed my suspicions that I was having an adverse reaction to the vaccine.
Age: 7.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Woke up in the morning with several hives under armpits and shoulder/neck area about 8 total with injection site red and swollen about 2.5" long. Patient complained of itchiness. Gave patient 5 mg of ODT cetirizine BID as well as hydrocortisone 2.5% ointment BID for 2 days. Sunday, patient used ice pack for itchiness throughout the day.  Monday night: injection site has almost return to normal. hives are still present with complaint of itchiness.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, Pyrexia, Sleep disorder
Clinical narrative: She woke up out of sleep with myalgias, rigors, fever and sore throat which lasted approximately 20 hours before decreasing.   She had acetaminophen every 4 hours which only partially helped.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Feeling cold, Pain, Pyrexia
Clinical narrative: Patient started having severe body aches about 6 to 8 hours after administered the Moderna booster vaccine, then had fever (exact temperature didn't get recorded) for at least 8 hours. Patient took aspirin to help, and felt better with fever and body aches after 2 days. Patient reported cold/chill feeling after couple of days.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio decreased, Anion gap normal, Aspartate aminotransferase normal, Basophil count decreased
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Basophil percentage decreased, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin decreased, Blood calcium decreased
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride increased, Blood creatinine normal, Blood glucose normal, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio increased, Blood urea normal, Carbon dioxide normal
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count decreased, Eosinophil percentage, Globulin, Granulocyte count, Granulocyte percentage
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit, Haemoglobin normal, Lymphocyte count, Lymphocyte percentage, Mean cell haemoglobin concentration decreased
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal, Monocyte count, Monocyte percentage
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count, Neutrophil percentage, Peripheral swelling, Platelet count normal, Prealbumin
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Protein total decreased, Pruritus, Red blood cell count normal, Red cell distribution width normal, Urticaria
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: Exactly 10 days after I received my Moderna booster shoot, I started to experience hives on multiple parts of my body, starting with mostly my hands and neck.  My fingers got swollen to the point where my wedding ring would not come off, so I went to the Emergency Department and they gave me IV solu-medrol, Pepcid, and Benadryl.  The ED doctor also tried to use lubricating jelly to get the ring off, but none of these were able to get it off.  It did prevent my fingers from swelling too much, so I was sent home and prescribed a 4 day treatment of 40mg prednisone daily and 50mg Benadryl every 6 hours.  My ring came off the 3rd night but the hives have persisted, traveling to different parts of my body. They have been on my hands, palms, shins, feet, scalp, back, neck, shoulders, and buttocks. I am still using benadryl nightly and cetirizine during the day, as well as hydrocortisone cream topically when the itching becomes too much.  I have an appointment with the doctor on 12/14 to discuss all of the above.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest pain, Myocarditis, Troponin
Clinical narrative: Myocarditis Troponin = 12 Required hospital admission Sxs = severe, worsening chest pain beginning approximately 24hrs following booster dose
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vestibular neuronitis
Clinical narrative: dizziness (vestibular neuritis)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: pulled 19 dose out of the Moderna vial and administered to different patients; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (pulled 19 dose out of the Moderna vial and administered to different patients) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Nov-2021, the patient received third 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced UNDERDOSE (pulled 19 dose out of the Moderna vial and administered to different patients). On 24-Nov-2021, UNDERDOSE (pulled 19 dose out of the Moderna vial and administered to different patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Event verbatim was updated On 30-Nov-2021: The recent follow up contains significant information due to adverse event(s) did not occurred after the vaccine was administered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Mechanical urticaria, Pruritus, Rash, Rash papular
Clinical narrative: Urticaria and intense pruritus appears spontaneously in randomly patches across the body, often affecting large areas to a moderate degree, but exhibiting sever dermatographic characteristics, responding quickly to scratching with raised, blister-like reactions. The condition is chronic but shifts in and out in intensity and location, and significantly impairs sleep. Treatment with topical steroid cream is moderately successful, as is treatment with oral antihistamine. In the 6 days since appearing, this condition has neither improved nor deteriorated further.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular, Urticaria
Clinical narrative: Urticaria and intense pruritus appears spontaneously in randomly patches across the body, often affecting large areas to a moderate degree, but exhibiting sever dermatographic characteristics, responding quickly to scratching with raised, blister-like reactions. The condition is chronic but shifts in and out in intensity and location, and significantly impairs sleep. Treatment with topical steroid cream is moderately successful, as is treatment with oral antihistamine. In the 6 days since appearing, this condition has neither improved nor deteriorated further.