chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Magnetic resonance imaging, Memory impairment, Peripheral swelling
Clinical narrative: Felt funny; Fever; Chills; Diarrhea; Problem with speech; Problem with short term memory; Couldn't remember anything; Problem with leg and feet swelling; Blood pressure was sky high; Did not receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt funny), PYREXIA (Fever), CHILLS (Chills), DIARRHOEA (Diarrhea) and SPEECH DISORDER (Problem with speech) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shellfish allergy. Concomitant products included FISH OIL for Memory impaired, CALCIUM, B-Complex and DIURETICS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt funny), PYREXIA (Fever), CHILLS (Chills), DIARRHOEA (Diarrhea), SPEECH DISORDER (Problem with speech), AMNESIA (Problem with short term memory), MEMORY IMPAIRMENT (Couldn't remember anything), PERIPHERAL SWELLING (Problem with leg and feet swelling), BLOOD PRESSURE INCREASED (Blood pressure was sky high) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). At the time of the report, FEELING ABNORMAL (Felt funny), PYREXIA (Fever), CHILLS (Chills), DIARRHOEA (Diarrhea), SPEECH DISORDER (Problem with speech), AMNESIA (Problem with short term memory), MEMORY IMPAIRMENT (Couldn't remember anything), PERIPHERAL SWELLING (Problem with leg and feet swelling), BLOOD PRESSURE INCREASED (Blood pressure was sky high) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (High) Blood pressure was sky high.. On an unknown date, Computerised tomogram: (Negative) For stroke. On an unknown date, Magnetic resonance imaging: (Negative) For stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitants are Blood pressure medication; cholesterol medication; gout medication; thyroid medications were reported. No concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, Speech disorder
Clinical narrative: Felt funny; Fever; Chills; Diarrhea; Problem with speech; Problem with short term memory; Couldn't remember anything; Problem with leg and feet swelling; Blood pressure was sky high; Did not receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt funny), PYREXIA (Fever), CHILLS (Chills), DIARRHOEA (Diarrhea) and SPEECH DISORDER (Problem with speech) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shellfish allergy. Concomitant products included FISH OIL for Memory impaired, CALCIUM, B-Complex and DIURETICS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt funny), PYREXIA (Fever), CHILLS (Chills), DIARRHOEA (Diarrhea), SPEECH DISORDER (Problem with speech), AMNESIA (Problem with short term memory), MEMORY IMPAIRMENT (Couldn't remember anything), PERIPHERAL SWELLING (Problem with leg and feet swelling), BLOOD PRESSURE INCREASED (Blood pressure was sky high) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). At the time of the report, FEELING ABNORMAL (Felt funny), PYREXIA (Fever), CHILLS (Chills), DIARRHOEA (Diarrhea), SPEECH DISORDER (Problem with speech), AMNESIA (Problem with short term memory), MEMORY IMPAIRMENT (Couldn't remember anything), PERIPHERAL SWELLING (Problem with leg and feet swelling), BLOOD PRESSURE INCREASED (Blood pressure was sky high) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (High) Blood pressure was sky high.. On an unknown date, Computerised tomogram: (Negative) For stroke. On an unknown date, Magnetic resonance imaging: (Negative) For stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitants are Blood pressure medication; cholesterol medication; gout medication; thyroid medications were reported. No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash around vaccinated area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around vaccinated area) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash around vaccinated area). At the time of the report, VACCINATION SITE RASH (Rash around vaccinated area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 doses given today after vial was punctured 30May2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) 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.   Technician states that 8 doses of vaccine were administered on 30-may-2021 with Lot  049C21A 5Nov2021.   No concomitant medication was reported.   The treatment information was not given.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Skin mass
Clinical narrative: 2 Bumps by my Collarbone after getting the 2nd Injection in my left arm; swollen lymph nodes after the 2nd Moderna Injecction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (2 Bumps by my Collarbone after getting the 2nd Injection in my left arm) and LYMPHADENOPATHY (swollen lymph nodes after the 2nd Moderna Injecction) in a patient of an unknown age and gender 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 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 SKIN MASS (2 Bumps by my Collarbone after getting the 2nd Injection in my left arm) and LYMPHADENOPATHY (swollen lymph nodes after the 2nd Moderna Injecction). At the time of the report, SKIN MASS (2 Bumps by my Collarbone after getting the 2nd Injection in my left arm) and LYMPHADENOPATHY (swollen lymph nodes after the 2nd Moderna Injecction) outcome was unknown.            Concomitant medications were not provided by the reporter.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Soreness in that arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in that arm) and FATIGUE (Fatigue) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0032C (L or I) A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced MYALGIA (Soreness in that arm) and FATIGUE (Fatigue). On 11-May-2021, MYALGIA (Soreness in that arm) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO CONCOMITANT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE  PROVIDED.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Missing menstrual cycle) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (Missing menstrual cycle). At the time of the report, MENSTRUATION IRREGULAR (Missing menstrual cycle) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. NO CONCOMITANT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE PROVIDED. NO CLEAR DOSE TEXT WAS GIVEN.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: body have a reaction to the second vaccination shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (body have a reaction to the second vaccination shot) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (body have a reaction to the second vaccination shot). At the time of the report, VACCINATION COMPLICATION (body have a reaction to the second vaccination shot) outcome was unknown.            NO CONCOMITANT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE PROVIDED.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: arms now magnetic where I received the vaccine/shot;; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (arms now magnetic where I received the vaccine/shot;) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (arms now magnetic where I received the vaccine/shot;). At the time of the report, VACCINATION COMPLICATION (arms now magnetic where I received the vaccine/shot;) outcome was unknown.            NO CONCOMITENT DRUGS WERE PROVIDED. NO TREATMENT DRUGS WERE PROVIDED. Patient wants to know why are  arms magnetic where received the shot and had both shots .
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: have rash on back and stomach started after first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (have rash on back and stomach started after first shot) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (have rash on back and stomach started after first shot). At the time of the report, RASH (have rash on back and stomach started after first shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided  Treatment medication was not provided   This case was linked to MOD-2021-193871 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Erythema, Headache, Myalgia, Pain in extremity
Clinical narrative: Lower back hurts; Arm sore; Arm itch; Redness; Headache; Body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back hurts), PAIN IN EXTREMITY (Arm sore), PRURITUS (Arm itch), ERYTHEMA (Redness) and HEADACHE (Headache) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Lower back hurts), PAIN IN EXTREMITY (Arm sore), PRURITUS (Arm itch), ERYTHEMA (Redness), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, BACK PAIN (Lower back hurts), PAIN IN EXTREMITY (Arm sore), PRURITUS (Arm itch), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown and ERYTHEMA (Redness) had resolved.            Concomitant product information was not provided.  The reported events began on unknown date after receiving the second dose of the vaccine.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Lower back hurts; Arm sore; Arm itch; Redness; Headache; Body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back hurts), PAIN IN EXTREMITY (Arm sore), PRURITUS (Arm itch), ERYTHEMA (Redness) and HEADACHE (Headache) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Lower back hurts), PAIN IN EXTREMITY (Arm sore), PRURITUS (Arm itch), ERYTHEMA (Redness), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, BACK PAIN (Lower back hurts), PAIN IN EXTREMITY (Arm sore), PRURITUS (Arm itch), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown and ERYTHEMA (Redness) had resolved.            Concomitant product information was not provided.  The reported events began on unknown date after receiving the second dose of the vaccine.   Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Fear, Pain in extremity
Clinical narrative: I felt chest pression that went to my ears; I got scared and thought it was a heart attack; I felt tired like when I had COVID before the first dose of the Moderna vaccine; strong pain in left lower leg / the pain came back a week after and then pain got better; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (strong pain in left lower leg / the pain came back a week after and then pain got better), CHEST DISCOMFORT (I felt chest pression that went to my ears), FEAR (I got scared and thought it was a heart attack) and FATIGUE (I felt tired like when I had COVID before the first dose of the Moderna vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (strong pain in left lower leg / the pain came back a week after and then pain got better). On an unknown date, the patient experienced CHEST DISCOMFORT (I felt chest pression that went to my ears), FEAR (I got scared and thought it was a heart attack) and FATIGUE (I felt tired like when I had COVID before the first dose of the Moderna vaccine). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 85 mg; IBUPROFEN at a dose of 200 mg once a day and AMLODIPINE at a dose of 5 mg. At the time of the report, CHEST DISCOMFORT (I felt chest pression that went to my ears), FEAR (I got scared and thought it was a heart attack) and FATIGUE (I felt tired like when I had COVID before the first dose of the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient took first shot of vaccine 4 months ago and is yet to take the 2nd dose) had resolved.            Patient is unable to go for the second dose due to an unrelated tooth infection and swollen gum. No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I had my second shot and now im sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I had my second shot and now im sick) 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 ILLNESS (I had my second shot and now im sick). At the time of the report, ILLNESS (I had my second shot and now im sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication reported by reporter. No Treatment Medication reported by reporter.   Reporter did not allow further contact
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: deviation from dosing schedule; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (deviation from dosing schedule) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (deviation from dosing schedule). At the time of the report, PRODUCT DOSE OMISSION ISSUE (deviation from dosing schedule) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was reported by reporter. No Treatment Medication was reported by reporter.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 doses given today after vial was punctured 30May2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tenderness, Vaccination site erythema, Vaccination site reaction
Clinical narrative: COVID arm; big round red spot at the injection site; can barely touch it and it is tender; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), VACCINATION SITE ERYTHEMA (big round red spot at the injection site), TENDERNESS (can barely touch it and it is tender) and VACCINATION SITE REACTION (COVID arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced MYALGIA (Sore arm). On 31-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (big round red spot at the injection site) and TENDERNESS (can barely touch it and it is tender). On 20-Jun-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-May-2021, MYALGIA (Sore arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (big round red spot at the injection site), TENDERNESS (can barely touch it and it is tender) and VACCINATION SITE REACTION (COVID arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Treatment medication include ice compress.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-231343 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: added new treatment medication
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Paraesthesia
Clinical narrative: rash is slightly tingly; red rash from the injection site; headache; chills and sweats; tired; sweaty; thirsty; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), THIRST (thirsty), PARAESTHESIA (rash is slightly tingly), VACCINATION SITE RASH (red rash from the injection site) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 069C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-May-2021, the patient experienced HYPERHIDROSIS (sweaty), THIRST (thirsty), HEADACHE (headache), CHILLS (chills and sweats) and FATIGUE (tired). On 31-May-2021, the patient experienced PARAESTHESIA (rash is slightly tingly) and VACCINATION SITE RASH (red rash from the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and TRIAMCINOLONE ACETONIDE ACETATE ongoing since an unknown date for Rash, at a dose of UNK dosage form. At the time of the report, HYPERHIDROSIS (sweaty), THIRST (thirsty), PARAESTHESIA (rash is slightly tingly), VACCINATION SITE RASH (red rash from the injection site), HEADACHE (headache), CHILLS (chills and sweats) and FATIGUE (tired) outcome was unknown.            Treatment medication was not provided  Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Vaccination site rash
Clinical narrative: rash is slightly tingly; red rash from the injection site; headache; chills and sweats; tired; sweaty; thirsty; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), THIRST (thirsty), PARAESTHESIA (rash is slightly tingly), VACCINATION SITE RASH (red rash from the injection site) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 069C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 29-May-2021, the patient experienced HYPERHIDROSIS (sweaty), THIRST (thirsty), HEADACHE (headache), CHILLS (chills and sweats) and FATIGUE (tired). On 31-May-2021, the patient experienced PARAESTHESIA (rash is slightly tingly) and VACCINATION SITE RASH (red rash from the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form and TRIAMCINOLONE ACETONIDE ACETATE ongoing since an unknown date for Rash, at a dose of UNK dosage form. At the time of the report, HYPERHIDROSIS (sweaty), THIRST (thirsty), PARAESTHESIA (rash is slightly tingly), VACCINATION SITE RASH (red rash from the injection site), HEADACHE (headache), CHILLS (chills and sweats) and FATIGUE (tired) outcome was unknown.            Treatment medication was not provided  Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Vaccination complication
Clinical narrative: Experiencing a side effect; When can he take ibuprofe and it not affect his immune response; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experiencing a side effect) and IMMUNE SYSTEM DISORDER (When can he take ibuprofe and it not affect his immune response) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second 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 (Experiencing a side effect) and IMMUNE SYSTEM DISORDER (When can he take ibuprofe and it not affect his immune response). At the time of the report, VACCINATION COMPLICATION (Experiencing a side effect) and IMMUNE SYSTEM DISORDER (When can he take ibuprofe and it not affect his immune response) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       How long does someone have flulike symptoms after 2 injection?  how long do these symptoms last? Concomitant medication use was unknown       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash very itcy) 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 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash very itcy). At the time of the report, RASH PRURITIC (Rash very itcy) had not resolved. Concomitant medication use was unknown. Treatment information was unknown. This case was linked to MOD-2021-193828.
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arm; Tightness around arm; Fingers hurting (not getting better); Arm is hurting (waking up in the morning),but she still has pain in her arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), MUSCLE TIGHTNESS (Tightness around arm), PAIN IN EXTREMITY (Fingers hurting (not getting better)) and MYALGIA (Arm is hurting (waking up in the morning),but she still has pain in her arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), MUSCLE TIGHTNESS (Tightness around arm), PAIN IN EXTREMITY (Fingers hurting (not getting better)) and MYALGIA (Arm is hurting (waking up in the morning),but she still has pain in her arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm), MUSCLE TIGHTNESS (Tightness around arm), PAIN IN EXTREMITY (Fingers hurting (not getting better)) and MYALGIA (Arm is hurting (waking up in the morning),but she still has pain in her arm) outcome was unknown.            Concomitant medication use was unknown  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Pain, Pyrexia
Clinical narrative: Got the flu; Aches/ Pains; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Got the flu), PAIN (Aches/ Pains) and PYREXIA (Fever) 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 INFLUENZA (Got the flu), PAIN (Aches/ Pains) and PYREXIA (Fever). At the time of the report, INFLUENZA (Got the flu), PAIN (Aches/ Pains) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced a side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect) in a  patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect). At the time of the report, VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations). At the time of the report, PALPITATIONS (Palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  The reporter did not know if it was Moderna or Pfizer vaccine. Company Comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Anger, Irritability
Clinical narrative: feel angry/grouchy/mean after the 2nd shot; feel angry/grouchy/mean after the 2nd shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (feel angry/grouchy/mean after the 2nd shot) and ANGER (feel angry/grouchy/mean after the 2nd shot) 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 IRRITABILITY (feel angry/grouchy/mean after the 2nd shot) and ANGER (feel angry/grouchy/mean after the 2nd shot). At the time of the report, IRRITABILITY (feel angry/grouchy/mean after the 2nd shot) and ANGER (feel angry/grouchy/mean after the 2nd shot) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pain in extremity
Clinical narrative: Pain; Hotness of left arm; Redness of left arm; Soreness in left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pain), FEELING HOT (Hotness of left arm), ERYTHEMA (Redness of left arm) and PAIN IN EXTREMITY (Soreness in left arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced PAIN (Pain), FEELING HOT (Hotness of left arm), ERYTHEMA (Redness of left arm) and PAIN IN EXTREMITY (Soreness in left arm). At the time of the report, PAIN (Pain), FEELING HOT (Hotness of left arm), ERYTHEMA (Redness of left arm) and PAIN IN EXTREMITY (Soreness in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Time between her two Moderna vaccines was 11 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time between her two Moderna vaccines was 11 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time between her two Moderna vaccines was 11 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time between her two Moderna vaccines was 11 weeks) had resolved.            concomitant medication was not provided. Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: able to see the spot after the night in the next morning; itchy thumb area on right hand; slight rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (able to see the spot after the night in the next morning), PRURITUS (itchy thumb area on right hand) and RASH (slight rash) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-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 RASH MACULAR (able to see the spot after the night in the next morning), PRURITUS (itchy thumb area on right hand) and RASH (slight rash). At the time of the report, RASH MACULAR (able to see the spot after the night in the next morning), PRURITUS (itchy thumb area on right hand) and RASH (slight rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Consistent tinnitus / Constant ringing in left ear- tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Consistent tinnitus / Constant ringing in left ear- tinnitus) 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 TINNITUS (Consistent tinnitus / Constant ringing in left ear- tinnitus). At the time of the report, TINNITUS (Consistent tinnitus / Constant ringing in left ear- tinnitus) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received on 09-jun-2021 contains patient ethnicity and race information was updated.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 doses given today after vial was punctured 30May2021. Technician did not know vial was from 30May2021".) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD21-104754, MOD21-104756, MOD21-104758, MOD21-104759, MOD21-104760, MOD21-104761, MOD21-104762 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Contact information updated
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Sleeping the entire week after; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping the entire week after) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-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 HYPERSOMNIA (Sleeping the entire week after). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, HYPERSOMNIA (Sleeping the entire week after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications  daily medicine  Patient when went for emergency care were given steroids to open up her lungs   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow Up information was received on 26-Jul-2021 Event Outcome updated.