chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose given 27APRIL2021 and asking for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose given 27APRIL2021 and asking for second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose given 27APRIL2021 and asking for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose given 27APRIL2021 and asking for second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Condition aggravated, Diarrhoea, Headache
Clinical narrative: not getting better, instead getting worse on a daily basis; "can't function at work"; chills; headaches; nausea; something in his stomach; feeling "super sick"; diarrhea 3 times a day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills) and HEADACHE (headaches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills), HEADACHE (headaches) and NAUSEA (nausea). On an unknown date, the patient experienced IMPAIRED WORK ABILITY ("can't function at work") and CONDITION AGGRAVATED (not getting better, instead getting worse on a daily basis). At the time of the report, MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea), IMPAIRED WORK ABILITY ("can't function at work") and CONDITION AGGRAVATED (not getting better, instead getting worse on a daily basis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Malaise, Nausea
Clinical narrative: not getting better, instead getting worse on a daily basis; "can't function at work"; chills; headaches; nausea; something in his stomach; feeling "super sick"; diarrhea 3 times a day; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills) and HEADACHE (headaches) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills), HEADACHE (headaches) and NAUSEA (nausea). On an unknown date, the patient experienced IMPAIRED WORK ABILITY ("can't function at work") and CONDITION AGGRAVATED (not getting better, instead getting worse on a daily basis). At the time of the report, MALAISE (feeling "super sick"), DIARRHOEA (diarrhea 3 times a day), ABDOMINAL DISCOMFORT (something in his stomach), CHILLS (chills), HEADACHE (headaches), NAUSEA (nausea), IMPAIRED WORK ABILITY ("can't function at work") and CONDITION AGGRAVATED (not getting better, instead getting worse on a daily basis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There were 9 patients instead of 10 as initially reported of which this case is for the 7th patient. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-314567, MOD-2021-314573, MOD-2021-314468, MOD-2021-314517, MOD-2021-314545, MOD-2021-314555, MOD-2021-314793, MOD-2021-314805, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information included no new information
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; 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 HEADACHE (Headache) 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 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered; 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 EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a vaccine that had Expiration date Mar 06, 2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were not reported. No treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site swelling
Clinical narrative: Swelling about 1 inch high at injection site / diameter of a baseball at injection site; 1st dose maybe 1Aug20212nd dose yesterday 8Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021) 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 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site). On 08-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-314674 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Hypoaesthesia, Illness
Clinical narrative: She passed out after she got home from church; so sick; could not feel my left arm, it felt like somebody else's arm; dizzy; incoherent; wheezing; trouble breathing; thought I was dying; nauseous; 103 fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She passed out after she got home from church) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She passed out after she got home from church) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (She passed out after she got home from church), ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Incoherent, Loss of consciousness, Nausea, Pyrexia, Wheezing
Clinical narrative: She passed out after she got home from church; so sick; could not feel my left arm, it felt like somebody else's arm; dizzy; incoherent; wheezing; trouble breathing; thought I was dying; nauseous; 103 fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She passed out after she got home from church) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She passed out after she got home from church) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (She passed out after she got home from church), ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden
Clinical narrative: She was in bed/ not doing so hot/ knocked down in bed for two days; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (She was in bed/ not doing so hot/ knocked down in bed for two days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced BEDRIDDEN (She was in bed/ not doing so hot/ knocked down in bed for two days). At the time of the report, BEDRIDDEN (She was in bed/ not doing so hot/ knocked down in bed for two days) outcome was unknown.            No concomitant was reported. No treatment was reported.   This case was linked to MOD-2021-314558 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feeling a little sick after her second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling a little sick after her second vaccination) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 (feeling a little sick after her second vaccination). At the time of the report, VACCINATION COMPLICATION (feeling a little sick after her second vaccination) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity
Clinical narrative: arm hurts; felt poorly more than the first time; chill, bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu shot (Seemed to have trouble breathing and didn't reported anything like that. Like congested.). Past adverse reactions to the above products included Unwell with Flu shot.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills). At the time of the report, PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) had resolved.            No concomitant medications reported No treatment medications reported.   This case was linked to MOD-2021-314548 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Nausea, Oropharyngeal pain
Clinical narrative: I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest; I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat; Diarrhea; Nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) and OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Has body aches from that) and Chest pain - cardiac (Cardiac history: Has chest pains sometimes (1-2x/month, or every 3 months).).    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) and OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) had not resolved and DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Company comment: This case refers to a 29-year-old female patient with a medical history of rheumatoid arthritis and cardiac chest pain who experienced the unexpected events of Chest Discomfort and Oropharyngeal Pain approximately 1 day after the first dose of Spikevax. No causality assessment was provided by the reporter. The past medical history of chest pain remains a confounder.The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case refers to a 29-year-old female patient with a medical history of rheumatoid arthritis and cardiac chest pain who experienced the unexpected events of Chest Discomfort and Oropharyngeal Pain approximately 1 day after the first dose of Spikevax. No causality assessment was provided by the reporter. The past medical history of chest pain remains a confounder.The benefit-risk relationship of Spikevax is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red circle in the injection site (second dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)). At the time of the report, VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included steroids. Treatment information was not provided.   This case was linked to MOD-2021-314562, MOD-2021-314599 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) 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 drug details were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now). In 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment medications were reported.  This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Maternal exposure before pregnancy. The event occurred at the time of the first dose of Moderna COVID-19 vaccine. The patient received the first dose of vaccine before the gestation period, at the time of the report patient was 2 weeks pregnant and vaccination occurred one month prior, no exact date provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Maternal exposure before pregnancy. The event occurred at the time of the first dose of Moderna COVID-19 vaccine. The patient received the first dose of vaccine before the gestation period, at the time of the report patient was 2 weeks pregnant and vaccination occurred one month prior, no exact date provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Ocular discomfort, Rash
Clinical narrative: Rash behind my ear, now its spreading; Eyes start to close and shut a little bit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The medical history was not reported by reporter.  Concomitant products included PROBIOTICS NOS, LAMOTRIGINE (LAMICTAL), CLOPIDOGREL, CARVEDILOL, DULOXETINE, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ATORVASTATIN CALCIUM (LIPITOR), DIAZEPAM (VALIUM), CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include emgality shot.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Injection site swelling, Myalgia, Paraesthesia
Clinical narrative: numbness in face, neck and cheeks; tingling in face,neck and cheeks; Sick; Injection site swollen; achiness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in face, neck and cheeks), PARAESTHESIA (tingling in face,neck and cheeks), ILLNESS (Sick), MYALGIA (achiness) and INJECTION SITE SWELLING (Injection site swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in face, neck and cheeks), PARAESTHESIA (tingling in face,neck and cheeks), ILLNESS (Sick), MYALGIA (achiness) and INJECTION SITE SWELLING (Injection site swollen). At the time of the report, HYPOAESTHESIA (numbness in face, neck and cheeks), PARAESTHESIA (tingling in face,neck and cheeks), ILLNESS (Sick), MYALGIA (achiness) and INJECTION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2021-314649 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Rash, Vaccination site swelling
Clinical narrative: Numbness in face; Sickness; injection site got swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash). At the time of the report, HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-314553, MOD-2021-314553 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pruritus, Rash, Rash macular
Clinical narrative: 2 red blotches in my right armpit; swollen lymph nodes; Itchy; rash; This last week it has been really bad; everything irritates it; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash) and MALAISE (This last week it has been really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it). At the time of the report, RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it) 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.   Concomitant and treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: 2 red blotches in my right armpit; swollen lymph nodes; Itchy; rash; This last week it has been really bad; everything irritates it; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash) and MALAISE (This last week it has been really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it). At the time of the report, RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it) 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.   Concomitant and treatment medications were not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness
Clinical narrative: Sick after second vaccine/ Out of it, after second vaccine; Chills after second vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick after second vaccine/ Out of it, after second vaccine) and CHILLS (Chills after second vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ILLNESS (Sick after second vaccine/ Out of it, after second vaccine) and CHILLS (Chills after second vaccine). On 19-Feb-2021, ILLNESS (Sick after second vaccine/ Out of it, after second vaccine) and CHILLS (Chills after second vaccine) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tender sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender sore arm). At the time of the report, TENDERNESS (tender sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided.  No Treatment medication was provided.   This case was linked to MOD-2021-314581 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site reaction
Clinical narrative: Covid arm small area; Sore ankle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle) 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 VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle). At the time of the report, VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle) 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. With side effects (slight)
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Muscle twitching, Paraesthesia
Clinical narrative: Tingling in feet and legs; twitching legs and abdomen; brain fog; pretty bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Rocephin).    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: very high temperatures/101.6; shakes; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high temperatures/101.6) and TREMOR (shakes) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 042220A and 031220A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (very high temperatures/101.6) and TREMOR (shakes). At the time of the report, PYREXIA (very high temperatures/101.6) and TREMOR (shakes) outcome was unknown.            Concomitant product usage were not provided. Treatment details were not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Pyrexia
Clinical narrative: Administered past the 30 day refrigeration time; Fever; Achiness; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time), PYREXIA (Fever) and MYALGIA (Achiness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025L20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppressant drug therapy (immunosuppressant medication).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Achiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PYREXIA (Fever) and MYALGIA (Achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. She received the 3rd dose because she is on immunosuppressant medication   This case was linked to MOD-2021-314740, MOD-2021-314678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up information received and added Reporter and Information added for dose 1 and dose 2.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Ear discomfort, Ear pain, Lymphadenopathy, Otorrhoea
Clinical narrative: very concerned and anxious about her future prognosis with symptoms lasting now 5 months; left ear pain, fluid, and fullness; left ear pain, fluid, and fullness; left ear pain, fluid, and fullness; very enlarged, firm, and painful lymph nodes; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes), EAR PAIN (left ear pain, fluid, and fullness), ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes). On 15-Jun-2021, the patient experienced EAR PAIN (left ear pain, fluid, and fullness), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness). On an unknown date, the patient experienced ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months). At the time of the report, LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes), EAR PAIN (left ear pain, fluid, and fullness), ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Ultrasound Doppler: abnormal (abnormal) 1 cm node with non-pathological results..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Symptoms: It was reported that on 10-Apr-2021, the patient started experienced a cluster of swollen lymph nodes in supraclavicular fossa on the left side, became enlarged, firm & painful, she had an appointment with ENT for the symptoms as the adenopathy was not completely resolved, pain was resolved but she had non painful nodes in that region. She was prescribed a TMJ regimen. After she was undergone an ultrasound which showed that left ear pain was resolved with minimal fullness, her follow up was schedule for Feb 2022.  No concomitant medications were reported No treatment medications were reported.