chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Parosmia, Pyrexia, SARS-CoV-2 test, Sinusitis
Clinical narrative: Pretty aggressive inflammation in my sinuses; I lost my taste/smell; I lost my taste/smell; swollen lymph nodes; chills; fever; body aches; headaches; smelling smoke(campfire, not cigarette); This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smelling smoke(campfire, not cigarette)), SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell), ANOSMIA (I lost my taste/smell) and LYMPHADENOPATHY (swollen lymph nodes) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 011M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine and Levaquin).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAROSMIA (smelling smoke(campfire, not cigarette)), CHILLS (chills), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches). On an unknown date, the patient experienced SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell), ANOSMIA (I lost my taste/smell) and LYMPHADENOPATHY (swollen lymph nodes). On 14-Mar-2021, PAROSMIA (smelling smoke(campfire, not cigarette)), CHILLS (chills), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headaches) had resolved. At the time of the report, SINUSITIS (Pretty aggressive inflammation in my sinuses), AGEUSIA (I lost my taste/smell) and ANOSMIA (I lost my taste/smell) had not resolved and LYMPHADENOPATHY (swollen lymph nodes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: (Positive) tested positive for COVID-19. In January 2021, SARS-CoV-2 test: (Positive) tested positive for COVID-19.         No treatment information was provided.   This case was linked to MOD-2021-046849 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: added patient medical history , updated product tab , added events
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site is warm to the touch; Injection site itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to the touch) and VACCINATION SITE PRURITUS (Injection site itches) 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 VACCINATION SITE WARMTH (Injection site is warm to the touch) and VACCINATION SITE PRURITUS (Injection site itches). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to the touch) and VACCINATION SITE PRURITUS (Injection site itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Had cancer for 8 years after vaccine there is no sign of cancer; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Had cancer for 8 years after vaccine there is no sign of cancer) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer (for 8 years).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 THERAPEUTIC RESPONSE UNEXPECTED (Had cancer for 8 years after vaccine there is no sign of cancer). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Had cancer for 8 years after vaccine there is no sign of cancer) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second vaccination received outside of the recommended time frame; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination received outside of the recommended time frame) 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 07-Apr-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination received outside of the recommended time frame). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second vaccination received outside of the recommended time frame) outcome was unknown.            No concomitant medications included.  Treatment medications were not provided.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects to come on after a week; 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 (side effects to come on after a week) 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 VACCINATION COMPLICATION (side effects to come on after a week). At the time of the report, VACCINATION COMPLICATION (side effects to come on after a week) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: greater than 35 days from first Covid-19 vaccine to second; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days from first Covid-19 vaccine to second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days from first Covid-19 vaccine to second). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days from first Covid-19 vaccine to second) 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 were reported.  Treatment medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Are bloody noses a side effect?; 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 EPISTAXIS (Are bloody noses a side effect?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reporter by the reporter.     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 EPISTAXIS (Are bloody noses a side effect?). At the time of the report, EPISTAXIS (Are bloody noses a side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.     Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            .No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (Nausea) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 038B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concurrent medical conditions included Depression. Concomitant products included BUPROPION for Depression, EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) and VITAMIN D NOS for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (Nausea) outcome was unknown.            Concomitant Medication Generic Truvada was Indicated to use for Prevention of HIV
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: really sick fr the 2 nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (really sick fr the 2 nd vaccine) 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 MALAISE (really sick fr the 2 nd vaccine). At the time of the report, MALAISE (really sick fr the 2 nd vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: patch was very hot; Patch  was  very hard; Upper arm (below the injection site)  developed a patch; Patch  was very red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (patch was very hot), INJECTION SITE INDURATION (Patch  was  very hard), INJECTION SITE RASH (Upper arm (below the injection site)  developed a patch) and INJECTION SITE ERYTHEMA (Patch  was very red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Apr-2021, the patient experienced INJECTION SITE WARMTH (patch was very hot), INJECTION SITE INDURATION (Patch  was  very hard), INJECTION SITE RASH (Upper arm (below the injection site)  developed a patch) and INJECTION SITE ERYTHEMA (Patch  was very red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (patch was very hot), INJECTION SITE INDURATION (Patch  was  very hard), INJECTION SITE RASH (Upper arm (below the injection site)  developed a patch) and INJECTION SITE ERYTHEMA (Patch  was very red) outcome was unknown.            Concomitant medication was not provided.   This case was linked to MOD-2021-176564 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; 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 HYPERSENSITIVITY (Allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Product dose omission issue
Clinical narrative: has not received his second vaccination within the Moderna stated time frame; feel fatigued; chills; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received his second vaccination within the Moderna stated time frame), FATIGUE (feel fatigued) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (feel fatigued) and CHILLS (chills). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received his second vaccination within the Moderna stated time frame). On 13-Feb-2021, FATIGUE (feel fatigued) and CHILLS (chills) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received his second vaccination within the Moderna stated time frame) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.        No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: my knee pain after 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 ARTHRALGIA (my knee pain after vaccine shot) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included Losartan 50mg and blood thinner for an unknown indication.    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 ARTHRALGIA (my knee pain after vaccine shot). At the time of the report, ARTHRALGIA (my knee pain after vaccine shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by the reporter.    Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 76-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 25-May-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) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination complication
Clinical narrative: minimal reaction after second dose; tiredness after the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (minimal reaction after second dose) and FATIGUE (tiredness after the second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-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 VACCINATION COMPLICATION (minimal reaction after second dose) and FATIGUE (tiredness after the second dose). At the time of the report, VACCINATION COMPLICATION (minimal reaction after second dose) and FATIGUE (tiredness after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 (Rash) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) 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.    In January 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 (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter Patient did not received second dose and it has been months after the first dose.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: NNI only asking for FU On 26-Jul-2021: NNI only asking for FU
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: chest pain; shortness of breath; 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 CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) 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 25-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 CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath). At the time of the report, CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Blood in the urine; 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 BLOOD URINE PRESENT (Blood in the urine) 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 BLOOD URINE PRESENT (Blood in the urine). At the time of the report, BLOOD URINE PRESENT (Blood in the urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Same arm where he received vaccine got magnetic; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCOMFORT (Same arm where he received vaccine got magnetic) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     no medical history was reported.     On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE DISCOMFORT (Same arm where he received vaccine got magnetic). At the time of the report, VACCINATION SITE DISCOMFORT (Same arm where he received vaccine got magnetic) 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 were reported.  Treatment medications were not provided by the reporter   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 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 PYREXIA in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA. At the time of the report, PYREXIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: past dosing schedule window; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past dosing schedule window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past dosing schedule window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past dosing schedule window) 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.   Patient came to receive the second dose on 26May2021 outside of the normal scheduled window.  Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: irregular heart beat; 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 HEART RATE IRREGULAR (irregular heart beat) 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 HEART RATE IRREGULAR (irregular heart beat). At the time of the report, HEART RATE IRREGULAR (irregular heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea
Clinical narrative: Still having generalized malaise; Diarrhea; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Still having generalized malaise), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) 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, the patient experienced MALAISE (Still having generalized malaise), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, MALAISE (Still having generalized malaise), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Ultrasound scan, Vaccination site pain
Clinical narrative: Keeps me waking in night; Soreness of upper arm/Pain in 6 different places in upper arm/Getting worse and serious; Pain next to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Keeps me waking in night), VACCINATION SITE PAIN (Soreness of upper arm/Pain in 6 different places in upper arm/Getting worse and serious) and INJECTION SITE PAIN (Pain next to the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Steatohepatitis and Kidney disorder. Concurrent medical conditions included Rheumatoid arthritis and Heart disease, unspecified.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Keeps me waking in night), VACCINATION SITE PAIN (Soreness of upper arm/Pain in 6 different places in upper arm/Getting worse and serious) and INJECTION SITE PAIN (Pain next to the injection site). At the time of the report, INSOMNIA (Keeps me waking in night), VACCINATION SITE PAIN (Soreness of upper arm/Pain in 6 different places in upper arm/Getting worse and serious) and INJECTION SITE PAIN (Pain next to the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (Negative) ultrasound to ruled out any possibility of blood clots..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness on her upper arm; bigger swelling on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (bigger swelling on upper arm) and ERYTHEMA (redness on her upper arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (bigger swelling on upper arm). On 26-May-2021, the patient experienced ERYTHEMA (redness on her upper arm). At the time of the report, PERIPHERAL SWELLING (bigger swelling on upper arm) and ERYTHEMA (redness on her upper arm) outcome was unknown.            Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    This case was linked to MOD-2021-176435 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-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) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  The vials were placed in the refrigerator on 21-Apr-2021 and stayed in the same location until their administration date on 25-May-2021.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cold sweat, Communication disorder, Fall, Fatigue
Clinical narrative: slumped over bathroom sink; could not communicate or move; could not communicate or move; felt cold and clammy; whole upper body (including head) was spasming/contracting; felt drugged; fatigue; sore arm/extreme soreness; This spontaneous case was reported by a nurse and describes the occurrence of FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy) and MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in 2009. Concomitant products included CENTRUM FORTE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (sore arm/extreme soreness). On 20-May-2021, the patient experienced FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy), MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) and FEELING ABNORMAL (felt drugged). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 20-May-2021, FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy), MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) and FEELING ABNORMAL (felt drugged) had resolved. On 22-May-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (sore arm/extreme soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 116/70 (normal) 116/70. On an unknown date, Heart rate: 72 (normal) 72. On an unknown date, Oxygen saturation: 99 % (normal) 99.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-176770 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21 JUL 2021: No new information. On 21-Jul-2021: NNI
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Hypokinesia, Muscle spasms, Oxygen saturation
Clinical narrative: slumped over bathroom sink; could not communicate or move; could not communicate or move; felt cold and clammy; whole upper body (including head) was spasming/contracting; felt drugged; fatigue; sore arm/extreme soreness; This spontaneous case was reported by a nurse and describes the occurrence of FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy) and MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in 2009. Concomitant products included CENTRUM FORTE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (sore arm/extreme soreness). On 20-May-2021, the patient experienced FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy), MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) and FEELING ABNORMAL (felt drugged). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 20-May-2021, FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy), MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) and FEELING ABNORMAL (felt drugged) had resolved. On 22-May-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (sore arm/extreme soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 116/70 (normal) 116/70. On an unknown date, Heart rate: 72 (normal) 72. On an unknown date, Oxygen saturation: 99 % (normal) 99.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-176770 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21 JUL 2021: No new information. On 21-Jul-2021: NNI
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slumped over bathroom sink; could not communicate or move; could not communicate or move; felt cold and clammy; whole upper body (including head) was spasming/contracting; felt drugged; fatigue; sore arm/extreme soreness; This spontaneous case was reported by a nurse and describes the occurrence of FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy) and MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in 2009. Concomitant products included CENTRUM FORTE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced FATIGUE (fatigue) and VACCINATION SITE PAIN (sore arm/extreme soreness). On 20-May-2021, the patient experienced FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy), MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) and FEELING ABNORMAL (felt drugged). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 20-May-2021, FALL (slumped over bathroom sink), HYPOKINESIA (could not communicate or move), COMMUNICATION DISORDER (could not communicate or move), COLD SWEAT (felt cold and clammy), MUSCLE SPASMS (whole upper body (including head) was spasming/contracting) and FEELING ABNORMAL (felt drugged) had resolved. On 22-May-2021, FATIGUE (fatigue) and VACCINATION SITE PAIN (sore arm/extreme soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 116/70 (normal) 116/70. On an unknown date, Heart rate: 72 (normal) 72. On an unknown date, Oxygen saturation: 99 % (normal) 99.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-176770 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21 JUL 2021: No new information. On 21-Jul-2021: NNI
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: my arm is in so much pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my arm is in so much pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C211A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE PAIN (my arm is in so much pain). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (my arm is in so much pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not reported.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: first dose was Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 18-Apr-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer). On 18-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: 1 ml dose of Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of OVERDOSE (1 ml dose of Moderna vaccine) 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 ml. On 26-May-2021, the patient experienced OVERDOSE (1 ml dose of Moderna vaccine). On 26-May-2021, OVERDOSE (1 ml dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever 100.9; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever 100.9) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-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 26-May-2021, the patient experienced PYREXIA (fever 100.9). At the time of the report, PYREXIA (fever 100.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Pyrexia: 100.9 (High) 100.9.         Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Really dizzy; Nauseous; 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 DIZZINESS (Really dizzy) and NAUSEA (Nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Really dizzy) and NAUSEA (Nauseous). At the time of the report, DIZZINESS (Really dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter No treatment medications provided by the reporter.