chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Genital infection fungal, Nausea, Oral candidiasis, Pyrexia
Clinical narrative: normal symptoms of thrush/yeast thrush infection in mouth; irritation down in crotch area/thrush down in crotch area; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (normal symptoms of thrush/yeast thrush infection in mouth), GENITAL INFECTION FUNGAL (irritation down in crotch area/thrush down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Fungal infection.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced ORAL CANDIDIASIS (normal symptoms of thrush/yeast thrush infection in mouth), GENITAL INFECTION FUNGAL (irritation down in crotch area/thrush down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with FLUCONAZOLE for Adverse event, at a dose of tablet once a day for 10 days qd and FAMOTIDINE for Throat irritation and Thrush oral, at a dose of 1 tablet once a day for 10 days. At the time of the report, ORAL CANDIDIASIS (normal symptoms of thrush/yeast thrush infection in mouth), GENITAL INFECTION FUNGAL (irritation down in crotch area/thrush down in crotch area), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included antifungal medication for months, on and off for fungal infection.   This case was linked to MOD-2021-369207 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Insomnia, Myalgia
Clinical narrative: Did not sleep very well; Feel so crappie; Fever/ temperatures is  101.8°F/ low grade temperature; Chills; Lot of body aches and pains; Right arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep very well), FEELING ABNORMAL (Feel so crappie), PYREXIA (Fever/ temperatures is  101.8°F/ low grade temperature), CHILLS (Chills) and MYALGIA (Lot of body aches and pains) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Colostomy (Emergency surgery due to colon been perforated.) on 28-May-2021. Concomitant products included ALENDRONATE SODIUM (FOSAMAX), CALCIUM, COLECALCIFEROL (VITAMIN D3) and PROBIOTICS NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (Right arm is really sore). On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Did not sleep very well), FEELING ABNORMAL (Feel so crappie), PYREXIA (Fever/ temperatures is  101.8°F/ low grade temperature), CHILLS (Chills) and MYALGIA (Lot of body aches and pains). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, INSOMNIA (Did not sleep very well), FEELING ABNORMAL (Feel so crappie), PYREXIA (Fever/ temperatures is  101.8°F/ low grade temperature), CHILLS (Chills), MYALGIA (Lot of body aches and pains) and VACCINATION SITE PAIN (Right arm is really sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8° F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient mentioned he got into surgery in 3 weeks to have a reversal procedure for their colostomy bag.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Did not sleep very well; Feel so crappie; Fever/ temperatures is  101.8°F/ low grade temperature; Chills; Lot of body aches and pains; Right arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep very well), FEELING ABNORMAL (Feel so crappie), PYREXIA (Fever/ temperatures is  101.8°F/ low grade temperature), CHILLS (Chills) and MYALGIA (Lot of body aches and pains) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 001A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Colostomy (Emergency surgery due to colon been perforated.) on 28-May-2021. Concomitant products included ALENDRONATE SODIUM (FOSAMAX), CALCIUM, COLECALCIFEROL (VITAMIN D3) and PROBIOTICS NOS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (Right arm is really sore). On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Did not sleep very well), FEELING ABNORMAL (Feel so crappie), PYREXIA (Fever/ temperatures is  101.8°F/ low grade temperature), CHILLS (Chills) and MYALGIA (Lot of body aches and pains). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, INSOMNIA (Did not sleep very well), FEELING ABNORMAL (Feel so crappie), PYREXIA (Fever/ temperatures is  101.8°F/ low grade temperature), CHILLS (Chills), MYALGIA (Lot of body aches and pains) and VACCINATION SITE PAIN (Right arm is really sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8° F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient mentioned he got into surgery in 3 weeks to have a reversal procedure for their colostomy bag.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Arm is tight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Arm is tight) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A20, 029K20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Arm is tight). At the time of the report, VACCINATION SITE INDURATION (Arm is tight) outcome was unknown.            No Concomitants and Treatment medication were reported.   This case was linked to MOD-2021-369389, MOD-2021-369392 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 040B21A and 031M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.            No treatment medications were reported.  Patient stated that he is taking other unspecified medication.   This case was linked to MOD-2021-369453, MOD-2021-369437 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up received and contains no new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nasopharyngitis, Nausea, Vaccination site induration
Clinical narrative: Very cold; Very dizzy; Nauseous; Chills/Shivering; Arm is tight; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Very cold), DIZZINESS (Very dizzy), VACCINATION SITE INDURATION (Arm is tight), NAUSEA (Nauseous) and CHILLS (Chills/Shivering) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 011A21A and 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE INDURATION (Arm is tight). On 31-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASOPHARYNGITIS (Very cold), DIZZINESS (Very dizzy), NAUSEA (Nauseous) and CHILLS (Chills/Shivering). At the time of the report, NASOPHARYNGITIS (Very cold), DIZZINESS (Very dizzy), VACCINATION SITE INDURATION (Arm is tight), NAUSEA (Nauseous) and CHILLS (Chills/Shivering) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2021-369498, MOD-2021-369499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Oct-2021: Follow up received contains start date of the Events.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-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 FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications are provided by the reporter.   This case was linked to MOD-2021-371351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow up received on 01Nov2021 contains Batch number, start date for the suspect product, patient age and event were added.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 5 days after my friends brother took the vaccine he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (5 days after my friends brother took the vaccine he died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Company Comment: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of Death. The event occurred approximately 5 days after a dose of mRNA-1273 (Moderna Covid-19 vaccine); It's unknow if it was the first or second dose. The rechallenge was not applicable. Limited information provided precludes a complete medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-369784 (E2B Linked Report).; Sender's Comments: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of Death. The event occurred approximately 5 days after a dose of mRNA-1273 (Moderna Covid-19 vaccine); It's unknow if it was the first or second dose. The rechallenge was not applicable. Limited information provided precludes a complete medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report. US-MODERNATX, INC.-MOD-2021-369784:MOD21-158695/Same reporter; Reported Cause(s) of Death: brother took the vaccine he died
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.; I had fatigue; Felt soreness at the arm, swelling at injection site; Felt soreness at the arm, swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.), FATIGUE (I had fatigue), VACCINATION SITE SWELLING (Felt soreness at the arm, swelling at injection site) and VACCINATION SITE PAIN (Felt soreness at the arm, swelling at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 COVID-19 (The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.), FATIGUE (I had fatigue), VACCINATION SITE SWELLING (Felt soreness at the arm, swelling at injection site) and VACCINATION SITE PAIN (Felt soreness at the arm, swelling at injection site). At the time of the report, COVID-19 (The patient also reports developing a breakthrough COVID-19 infection after having been vaccinated.), FATIGUE (I had fatigue), VACCINATION SITE SWELLING (Felt soreness at the arm, swelling at injection site) and VACCINATION SITE PAIN (Felt soreness at the arm, swelling at injection site) had resolved.            No treatment information was provided.  Company Comment - This case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site mass (I got a bump and redness on my arm after getting the booster dose) and vaccination site erythema (I got a bump and redness on my arm after getting the booster dose) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date,  patient experienced  vaccination site mass (I got a bump and redness on my arm after getting the booster dose) and vaccination site erythema (I got a bump and redness on my arm after getting the booster dose). At the time of the report, vaccination site mass (I got a bump and redness on my arm after getting the booster dose) and vaccination site erythema (I got a bump and redness on my arm after getting the booster dose) outcome: unknown. No concomitant medications or treatment information provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: I'm having a delayed reaction; rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'm having a delayed reaction) and RASH (rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07EC21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (I'm having a delayed reaction) and RASH (rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.). The patient was treated with PREDNISONE for Rash, at a dose of 1 dosage form twice a day. At the time of the report, VACCINATION COMPLICATION (I'm having a delayed reaction) and RASH (rash all over my body/Rash is pronounced on both arms, both feet, and face/ rash all over her body from head to toe/Rash is pronounced on both arms/Rash is pronounced on both feet/Rash is on the face.) outcome was unknown.            Concomitant medications were not provided.   This case was linked to MOD-2021-372576 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant follow-up, patient information, suspect drug information and treatment drug updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness in the injection site; Tenderness in the injection site; Sore in the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Oct-2021 and was forwarded to Moderna on 01-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in the injection site), VACCINATION SITE PAIN (Tenderness in the injection site) and VACCINATION SITE PAIN (Sore in the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastric disorder. Concomitant products included CIMETIDINE (TAGAMET [CIMETIDINE]) for Gastric disorder.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE PAIN (Tenderness in the injection site) and VACCINATION SITE PAIN (Sore in the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness in the injection site) had not resolved and VACCINATION SITE PAIN (Tenderness in the injection site) and VACCINATION SITE PAIN (Sore in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Pain, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: diagnose with a granuloma annular; pain on my foot; swollen on my foot; I have had an issue with a gross rash in my foot and leg; soreness; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (diagnose with a granuloma annular), PAIN (soreness), PAIN IN EXTREMITY (pain on my foot), PERIPHERAL SWELLING (swollen on my foot) and RASH (I have had an issue with a gross rash in my foot and leg) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (soreness). On an unknown date, the patient experienced GRANULOMA ANNULARE (diagnose with a granuloma annular), PAIN IN EXTREMITY (pain on my foot), PERIPHERAL SWELLING (swollen on my foot) and RASH (I have had an issue with a gross rash in my foot and leg). At the time of the report, GRANULOMA ANNULARE (diagnose with a granuloma annular) had not resolved and PAIN (soreness), PAIN IN EXTREMITY (pain on my foot), PERIPHERAL SWELLING (swollen on my foot) and RASH (I have had an issue with a gross rash in my foot and leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included unspecified Thyroid medication. Treatment included 2 different unspecified ointment creams.   This case was linked to MOD-2021-370444 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: body aches; fever of 100F; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (fever of 100F) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced MYALGIA (body aches), PYREXIA (fever of 100F) and CHILLS (chills). At the time of the report, MYALGIA (body aches), PYREXIA (fever of 100F) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 100 (High) fever of 100F.         no concomitant and treatment medications are provided by the reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired booster dose (more than a month ago, 13SEP2021).; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster dose (more than a month ago, 13SEP2021).) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster dose (more than a month ago, 13SEP2021).). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster dose (more than a month ago, 13SEP2021).) had resolved.            No concomitant or treatment medication provided.  The patient experienced no adverse events after vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Both my father and my mother took your Moderna Covid vaccine and both died a few weeks later; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Both my father and my mother took your Moderna Covid vaccine and both died a few weeks later) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          No concomitant products were reported. No treatment drugs were reported.  Company Comment: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of Death (Nos). The event occurred approximately few weeks (unspecified) after a dose of mRNA-1273 (Moderna Covid-19 vaccine), It's unknwon if it was the first or second dose. The rechallenge was not applicable. Limited information provided precludes a completed medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-370921 (Patient Link).; Sender's Comments: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected event of Death (Nos). The event occurred approximately few weeks (unspecified) after a dose of mRNA-1273 (Moderna Covid-19 vaccine), It's unknwon if it was the first or second dose. The rechallenge was not applicable. Limited information provided precludes a completed medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Both my father and my mother took your Moderna Covid vaccine and both died a few weeks later; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Both my father and my mother took your Moderna Covid vaccine and both died a few weeks later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          No Concomitant medication was provided.  No treatment medication was provided.  Company Comment: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of Death (Nos). The event occurred approximately few weeks (unspecified) after a dose of mRNA-1273 (Moderna Covid-19 vaccine); It's unknown if it was first or second dose. The rechallenge was not applicable. Limited information provided precludes a complete medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-370905 (Patient Link).; Sender's Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of Death (Nos). The event occurred approximately few weeks (unspecified) after a dose of mRNA-1273 (Moderna Covid-19 vaccine); It's unknown if it was first or second dose. The rechallenge was not applicable. Limited information provided precludes a complete medical or causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose I had arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (First dose I had arm soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE for an unknown indication.    On 27-Jan-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 PAIN IN EXTREMITY (First dose I had arm soreness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (First dose I had arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-371023, MOD-2021-371024 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: herpes voster also known as shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (herpes voster also known as shingles) 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 HERPES ZOSTER (herpes voster also known as shingles) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to HERPES ZOSTER. At the time of the report, HERPES ZOSTER (herpes voster also known as shingles) was resolving.            No concomitant medications were reported.  No treatment information was provided.  Reported that after 2nd jab of Moderna -about 2 days after got a serious rash on back and upper leg- herpes voster also known as shingles. Just spent 5 days in hospital for treatment  Company Comment : This case concerns a patient with no reported relevant medical history, who experienced the unexpected serious event of herpes zoster. The date of onset was not reported, neither vaccination date. As per source document, the patient states the event occurred 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as no additional dose is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient with no reported relevant medical history, who experienced the unexpected serious event of herpes zoster. The date of onset was not reported, neither vaccination date. As per source document, the patient states the event occurred 2 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as no additional dose is expected. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest discomfort, Chills, Myalgia, Pain in extremity
Clinical narrative: Arm pain which went down to the wrist/Sore arm; pressure on her chest; bump on the injection site; I had cramps in abdomen it felt like a pulled muscle; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain which went down to the wrist/Sore arm), CHEST DISCOMFORT (pressure on her chest), VACCINATION SITE MASS (bump on the injection site), ABDOMINAL PAIN (I had cramps in abdomen it felt like a pulled muscle) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 032121A and 0321A2GA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL DIHYDRATE (PRINIVIL), ACETYLSALICYLIC ACID (ASPIRIN) and TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain which went down to the wrist/Sore arm), CHEST DISCOMFORT (pressure on her chest), VACCINATION SITE MASS (bump on the injection site), ABDOMINAL PAIN (I had cramps in abdomen it felt like a pulled muscle), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain which went down to the wrist/Sore arm), CHEST DISCOMFORT (pressure on her chest), VACCINATION SITE MASS (bump on the injection site), ABDOMINAL PAIN (I had cramps in abdomen it felt like a pulled muscle), CHILLS (chills) and MYALGIA (muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-371560 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Arm pain which went down to the wrist/Sore arm; pressure on her chest; bump on the injection site; I had cramps in abdomen it felt like a pulled muscle; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain which went down to the wrist/Sore arm), CHEST DISCOMFORT (pressure on her chest), VACCINATION SITE MASS (bump on the injection site), ABDOMINAL PAIN (I had cramps in abdomen it felt like a pulled muscle) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 032121A and 0321A2GA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL DIHYDRATE (PRINIVIL), ACETYLSALICYLIC ACID (ASPIRIN) and TOLTERODINE L-TARTRATE (DETROL) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain which went down to the wrist/Sore arm), CHEST DISCOMFORT (pressure on her chest), VACCINATION SITE MASS (bump on the injection site), ABDOMINAL PAIN (I had cramps in abdomen it felt like a pulled muscle), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain which went down to the wrist/Sore arm), CHEST DISCOMFORT (pressure on her chest), VACCINATION SITE MASS (bump on the injection site), ABDOMINAL PAIN (I had cramps in abdomen it felt like a pulled muscle), CHILLS (chills) and MYALGIA (muscle aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-371560 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis in the setting of recent COVID-19 vaccination. Case Rep. 2021     The patient's past medical history included Gastroesophageal reflux disease.   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 MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging heart: abnormal (abnormal) Cardiac MRI supported Myocarditis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    This literature reported three patients who presented with chest pain after receiving either the BNT162b2 Pfizer/BioNTech or mRNA-1273 Moderna/NIH vaccine.   Clinical presentation, biomarker supported Myocarditis  Concomitant medications were not reported  Treatment medications were not reported  Company Comment: This is a literature review case concerning a 36-year-old, male patient with medical history of Gastroesophageal reflux disease, who experienced the unexpected serious (hospitalization and AESI) event of Myocarditis. The event occurred after the second dose of Moderna COVID 19 vaccine, unknown time to onset. Clinical presentation, biomarker, and cardiac MRI supported myocarditis. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.; Sender's Comments: This is a literature review case concerning a 36-year-old, male patient with medical history of Gastroesophageal reflux disease, who experienced the unexpected serious (hospitalization and AESI) event of Myocarditis. The event occurred after the second dose of Moderna COVID 19 vaccine, unknown time to onset. Clinical presentation, biomarker, and cardiac MRI supported myocarditis. The rechallenge is not applicable. The benefit-risk relationship of Moderna COVID 19 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: 2 vials were punctured 28 times each, 8 time more than the 20 puncture advised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 vials were punctured 28 times each, 8 time more than the 20 puncture advised) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 vials were punctured 28 times each, 8 time more than the 20 puncture advised). In October 2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (2 vials were punctured 28 times each, 8 time more than the 20 puncture advised) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment drugs were reported.  Reporter stated that vials were punctured 28 times each, 8 time more than the 20 puncture advised, on 10/22/2021 and 10/25/2021.  No adverse events  were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Vaccination site pain
Clinical narrative: I feel cold, it wakes me up at night; I feel shoulder aches; pain at the injection site that won't go away; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Oct-2021 and was forwarded to Moderna on 01-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (I feel cold, it wakes me up at night), ARTHRALGIA (I feel shoulder aches) and VACCINATION SITE PAIN (pain at the injection site that won't go away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D32M20A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, LATANOPROST and TIMOLOL for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 FEELING COLD (I feel cold, it wakes me up at night), ARTHRALGIA (I feel shoulder aches) and VACCINATION SITE PAIN (pain at the injection site that won't go away). At the time of the report, FEELING COLD (I feel cold, it wakes me up at night) outcome was unknown and ARTHRALGIA (I feel shoulder aches) and VACCINATION SITE PAIN (pain at the injection site that won't go away) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included Metformin-Glyburide for an unknown indication. No treatment medications were reported.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Has muscle problems in all areas of his body; joint pain/pain moved to the right side, then to the elbow; Headache/severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/severe headaches), MYALGIA (Has muscle problems in all areas of his body) and ARTHRALGIA (joint pain/pain moved to the right side, then to the elbow) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache/severe headaches). On an unknown date, the patient experienced MYALGIA (Has muscle problems in all areas of his body) and ARTHRALGIA (joint pain/pain moved to the right side, then to the elbow). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache/severe headaches), MYALGIA (Has muscle problems in all areas of his body) and ARTHRALGIA (joint pain/pain moved to the right side, then to the elbow) had not resolved.            Before getting the shot he probably only had 5 headaches in his life, now he has them all the time. Moderna shipped vials with about 50% more content that it should No concomitant medication was provided Treatment included Tylenol for headaches, it subsidded for a while, and when it comes back and he takes some more. Does not know how much he's taking.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received on 04 nov 2021 contains no new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Myalgia, Pain in extremity
Clinical narrative: Couldn't get up of bed; sore arm; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Couldn't get up of bed), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Hypertension, Multiple allergies (Patient is allergic to everything.) and Acne. Concomitant products included AZELAIC ACID for Acne.    On 09-Feb-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 BEDRIDDEN (Couldn't get up of bed), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache). The patient was treated with DIAZEPAM for Anxiety, at a dose of 1 dosage form. At the time of the report, BEDRIDDEN (Couldn't get up of bed), PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had an appointment in November to get some cardiac test such as ECG, cardiac test, cardiac enzymes.  Other concomitants include Tersac.  Patient takes Treatment medicines she is on blood pressure pills.   This case was linked to MOD-2021-370454, MOD-2021-371161, MOD-2021-370575 (Patient Link).