chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Musculoskeletal stiffness, Myalgia, Neck pain
Clinical narrative: she had neck pain; stiffness in that area; she was dizzy; shoulder pain; muscle pain radiated up to her neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (she had neck pain), MUSCULOSKELETAL STIFFNESS (stiffness in that area), DIZZINESS (she was dizzy), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain radiated up to her neck) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced NECK PAIN (she had neck pain), MUSCULOSKELETAL STIFFNESS (stiffness in that area), DIZZINESS (she was dizzy), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain radiated up to her neck). At the time of the report, NECK PAIN (she had neck pain), MUSCULOSKELETAL STIFFNESS (stiffness in that area), DIZZINESS (she was dizzy), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain radiated up to her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided. Weight of the patient is reported to be as 126 (unknown unit)   This case was linked to MOD-2022-442077 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Balance disorder, Vertigo
Clinical narrative: Vertigo after 2nd dose; Balance issues after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo after 2nd dose) and BALANCE DISORDER (Balance issues after 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VERTIGO (Vertigo after 2nd dose) and BALANCE DISORDER (Balance issues after 2nd dose). On 09-Mar-2021, VERTIGO (Vertigo after 2nd dose) and BALANCE DISORDER (Balance issues after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Antibody test: greater than 20 (Inconclusive) Greater than 20. On 10-Dec-2021, Antibody test: 13.5 (High) 13.5.         No Concomitant product use was reported.  The patient stated that within a month after 2nd dose, the patient had vertigo and balance issues for 1 week. The patient stated that they had a medical history of vertigo and was not sure if the vaccine caused it. On 27-May-2021 an antibody test result came back greater than 20 and on 10-Dec-2021 the antibody test result was 13.5 which was still pretty high but very good for almost a year after vaccination.  No treatment information was provided.   This case was linked to MOD-2022-441875 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Muscle aches in patients back/Muscle aches resolved in March 2021; Muscle aches in patients legs/Muscle aches resolved in March 2021; tired for 24 hours; Muscle aches in patients back/Muscle aches resolved in March 2021; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Muscle aches in patients back/Muscle aches resolved in March 2021), PAIN IN EXTREMITY (Muscle aches in patients legs/Muscle aches resolved in March 2021), FATIGUE (tired for 24 hours) and MYALGIA (Muscle aches in patients back/Muscle aches resolved in March 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced BACK PAIN (Muscle aches in patients back/Muscle aches resolved in March 2021), PAIN IN EXTREMITY (Muscle aches in patients legs/Muscle aches resolved in March 2021), FATIGUE (tired for 24 hours) and MYALGIA (Muscle aches in patients back/Muscle aches resolved in March 2021). On 25-Feb-2021, FATIGUE (tired for 24 hours) had resolved. In March 2021, BACK PAIN (Muscle aches in patients back/Muscle aches resolved in March 2021), PAIN IN EXTREMITY (Muscle aches in patients legs/Muscle aches resolved in March 2021) and MYALGIA (Muscle aches in patients back/Muscle aches resolved in March 2021) had resolved.            No concomitant medication were reported   No treatment information was reported   This case was linked to MOD-2022-441953 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Non Significant Follow Up received on 06Jan2022
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Feel weak/was worse; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak/was worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-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 ASTHENIA (Feel weak/was worse). At the time of the report, ASTHENIA (Feel weak/was worse) had resolved. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2022-441836, MOD-2022-441961 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain, Pyrexia
Clinical narrative: Received an expired booster dose; Similar to the first but less severe (body pain); Similar to the first but less severe (Fever); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Similar to the first but less severe (body pain)), PYREXIA (Similar to the first but less severe (Fever)) and EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 029A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose). In December 2021, the patient experienced PAIN (Similar to the first but less severe (body pain)) and PYREXIA (Similar to the first but less severe (Fever)). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) had resolved. At the time of the report, PAIN (Similar to the first but less severe (body pain)) and PYREXIA (Similar to the first but less severe (Fever)) outcome was unknown.            Patient experienced events less severe than the first dose. No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-441836, MOD-2022-441951 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Pregnant woman received first shot; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant woman received first shot) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding.    On 15-Jan-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. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant woman received first shot). The delivery occurred on an unknown date, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. On 15-Jan-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant woman received first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 22-Jan-2021,the patient found out that she was pregnant and she delivered the baby on Sep-2021, was currently breastfeeding and never received the second shot.  No concomitant medication were reported.  No treatment information was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna booster, after 30 day use by date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day use by date). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna booster, after 30 day use by date) had resolved.      No concomitant Products were reported. No treatment information was reported. Patient received Booster and patient questioned the Pharmacy, they said it may be a typo or someone put the manufacturing date instead. Patient had concerns about the efficacy of the vaccine and what they should do.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (If a 12 year old was given the moderna vaccine by mistake can it cause them harm ?) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter asked if a 12 year old was given the Moderna vaccine by mistake can it cause them harm.  No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Rhinorrhoea
Clinical narrative: Feeling bad; Feels a little bit with a cough; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Feels a little bit with a cough), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling bad) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced COUGH (Feels a little bit with a cough) and RHINORRHOEA (Runny nose). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling bad). The patient was treated with CAMPHOR, EUCALYPTUS GLOBULUS OIL, MENTHOL (VICK VAPORUB [CAMPHOR;EUCALYPTUS GLOBULUS OIL;MENTHOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Feels a little bit with a cough), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Feeling bad) had not resolved.    No concomitant medications were provided.  The patient got the first two shots of Moderna and now wanted to get the third one. The patient was feeling a little bit with a cough. The patient mentioned that it had been three days since the patient started to experience cough and a runny nose. The patient was feeling bad.  Other treatment information provided included Tea and water.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 mcg. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient receive a 100 mcg dose of the Moderna Vaccine as Booster or 2nd dose) had resolved.        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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pyrexia
Clinical narrative: Recurrent Pain in the base of skull for 4 days  post second vaccine; Pain in the base of skull (Back of neck) for 4 days; Chills for 2 days after 2nd vaccine; Fever for 2 days after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Recurrent Pain in the base of skull for 4 days  post second vaccine), NECK PAIN (Pain in the base of skull (Back of neck) for 4 days), CHILLS (Chills for 2 days after 2nd vaccine) and PYREXIA (Fever for 2 days after 2nd vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced NECK PAIN (Pain in the base of skull (Back of neck) for 4 days), CHILLS (Chills for 2 days after 2nd vaccine) and PYREXIA (Fever for 2 days after 2nd vaccine). In June 2021, the patient experienced NECK PAIN (Recurrent Pain in the base of skull for 4 days  post second vaccine). In April 2021, NECK PAIN (Pain in the base of skull (Back of neck) for 4 days), CHILLS (Chills for 2 days after 2nd vaccine) and PYREXIA (Fever for 2 days after 2nd vaccine) had resolved. In June 2021, NECK PAIN (Recurrent Pain in the base of skull for 4 days  post second vaccine) had resolved.            No Concomitant product use was reported.  The patient stated that after the second shot, the patient had chills, and high fever which was not measured for 2 days. After 2 days, the patient started having pain in the base of skull (back of neck) which lasted for 4 days. The Pain in the base of skull came back a couple of months later and this time it lasted for 4 days. For the past 6 months, the pain in the base of skull had not come back.  About the medical history, the patient reported that they think they had high intraocular pressure but undiagnosed. The patient had a history of Migraine, but the pain patient experienced after vaccination was nothing like Migraine.  No treatment information was provided.   Reporter did not allow further contact
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to a 12 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12 year old patient) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12 year old patient). On 05-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 12 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided Patient had not experienced any symptoms
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain for 2-3days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arm pain for 2-3days) in an 89-year-old female patient 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 PAIN IN EXTREMITY (arm pain for 2-3days). At the time of the report, PAIN IN EXTREMITY (arm pain for 2-3days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2022-442844 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: positive side effect that I have had from the booster; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (positive side effect that I have had from the booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (positive side effect that I have had from the booster). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (positive side effect that I have had from the booster) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medications were reported.  Patient was just curious if other people with my condition have had the same.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient was given an expired dose.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Intermenstrual bleeding, Menstruation irregular, Myalgia
Clinical narrative: started having menstrual spotting; the night as I slept my period started unexpectedly; chills; muscle aches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (started having menstrual spotting), MENSTRUATION IRREGULAR (the night as I slept my period started unexpectedly), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (Tiredness) 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 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (started having menstrual spotting), MENSTRUATION IRREGULAR (the night as I slept my period started unexpectedly), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (Tiredness). At the time of the report, INTERMENSTRUAL BLEEDING (started having menstrual spotting), MENSTRUATION IRREGULAR (the night as I slept my period started unexpectedly), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2022-443324, MOD-2022-445119 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (second dose of the Moderna COVID-19 vaccine also set off menstruations at a time where I should not have gotten them. (2 weeks after my previous cycle's bleeding had stopped)) in a 21-year-old female patient 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 MENSTRUATION IRREGULAR (second dose of the Moderna COVID-19 vaccine also set off menstruations at a time where I should not have gotten them. (2 weeks after my previous cycle's bleeding had stopped)). At the time of the report, MENSTRUATION IRREGULAR (second dose of the Moderna COVID-19 vaccine also set off menstruations at a time where I should not have gotten them. (2 weeks after my previous cycle's bleeding had stopped)) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-443290, MOD-2022-441878, MOD-2022-445119 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.). At the time of the report, VACCINATION COMPLICATION (Several patients had reactions to the second dose of the Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant no treatment medication were reported.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (first 2 doses of Pfizer). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster). On 06-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old patient received first 2 doses of Pfizer and a 3rd dose being a Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Herpes virus infection, Illness, Malaise, Pyrexia
Clinical narrative: Had some sores on her vagina; She got sick; Doctors thought she had herpes from 1st dose; Her stomach was on fire; Did not feel well.; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PAIN (Had some sores on her vagina), ILLNESS (She got sick), HERPES VIRUS INFECTION (Doctors thought she had herpes from 1st dose), DYSPEPSIA (Her stomach was on fire) and MALAISE (Did not feel well.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VULVOVAGINAL PAIN (Had some sores on her vagina), ILLNESS (She got sick), HERPES VIRUS INFECTION (Doctors thought she had herpes from 1st dose), DYSPEPSIA (Her stomach was on fire), MALAISE (Did not feel well.), PYREXIA (Fever) and VOMITING (Throwing up). At the time of the report, VULVOVAGINAL PAIN (Had some sores on her vagina), ILLNESS (She got sick), HERPES VIRUS INFECTION (Doctors thought she had herpes from 1st dose), DYSPEPSIA (Her stomach was on fire), MALAISE (Did not feel well.), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2022-444326 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Vulvovaginal pain
Clinical narrative: Had some sores on her vagina; She got sick; Doctors thought she had herpes from 1st dose; Her stomach was on fire; Did not feel well.; Fever; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PAIN (Had some sores on her vagina), ILLNESS (She got sick), HERPES VIRUS INFECTION (Doctors thought she had herpes from 1st dose), DYSPEPSIA (Her stomach was on fire) and MALAISE (Did not feel well.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VULVOVAGINAL PAIN (Had some sores on her vagina), ILLNESS (She got sick), HERPES VIRUS INFECTION (Doctors thought she had herpes from 1st dose), DYSPEPSIA (Her stomach was on fire), MALAISE (Did not feel well.), PYREXIA (Fever) and VOMITING (Throwing up). At the time of the report, VULVOVAGINAL PAIN (Had some sores on her vagina), ILLNESS (She got sick), HERPES VIRUS INFECTION (Doctors thought she had herpes from 1st dose), DYSPEPSIA (Her stomach was on fire), MALAISE (Did not feel well.), PYREXIA (Fever) and VOMITING (Throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2022-444326 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took a dose from J&J, then took a Moderna full dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took a dose from J&J, then took a Moderna full dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE for an unknown indication.    On 10-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took a dose from J&J, then took a Moderna full dose). On 10-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took a dose from J&J, then took a Moderna full dose) had resolved.            Concomitant medication was not reported. Treatment information was not reported.  Patient reports they took a J&J vaccine back on 07Apr2021,Batch number 203A21A
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Temp of 100.7; Very bad headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Very bad headache) and PYREXIA (Temp of 100.7) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022 at 12:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022 at 4:00 PM, the patient experienced HEADACHE (Very bad headache). On an unknown date, the patient experienced PYREXIA (Temp of 100.7). At the time of the report, HEADACHE (Very bad headache) and PYREXIA (Temp of 100.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: 100.7 (High) 100.7.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  No treatment medication was provided.  It was reported that temperature started during the night on an unknown date in January 2022.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Erythema, Feeling abnormal, Feeling hot, Hypoaesthesia
Clinical narrative: It is a nerve problem/ The vaccine affected the nerves of my face; Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd; Numbness in the lips, just a little; Left side of his face felt numb; Worried; Left side of his face felt warm; Face was oddly red, not sever, but red enough to notice; Left side of his face started tingling; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (It is a nerve problem/ The vaccine affected the nerves of my face), FEELING ABNORMAL (Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd), ANXIETY (Worried), FEELING HOT (Left side of his face felt warm) and ERYTHEMA (Face was oddly red, not sever, but red enough to notice) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, the patient experienced ANXIETY (Worried), FEELING HOT (Left side of his face felt warm), ERYTHEMA (Face was oddly red, not sever, but red enough to notice), PARAESTHESIA (Left side of his face started tingling) and HYPOAESTHESIA (Left side of his face felt numb). On 04-Jan-2022, the patient experienced HYPOAESTHESIA ORAL (Numbness in the lips, just a little). On 06-Jan-2022, the patient experienced FEELING ABNORMAL (Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd). On an unknown date, the patient experienced NEURALGIA (It is a nerve problem/ The vaccine affected the nerves of my face). On 02-Jan-2022, ERYTHEMA (Face was oddly red, not sever, but red enough to notice) had resolved. At the time of the report, NEURALGIA (It is a nerve problem/ The vaccine affected the nerves of my face), FEELING ABNORMAL (Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd) and ANXIETY (Worried) outcome was unknown and FEELING HOT (Left side of his face felt warm), PARAESTHESIA (Left side of his face started tingling), HYPOAESTHESIA ORAL (Numbness in the lips, just a little) and HYPOAESTHESIA (Left side of his face felt numb) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Patient stated that the time of vaccination was 3 'O' clock.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Neuralgia, Paraesthesia
Clinical narrative: It is a nerve problem/ The vaccine affected the nerves of my face; Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd; Numbness in the lips, just a little; Left side of his face felt numb; Worried; Left side of his face felt warm; Face was oddly red, not sever, but red enough to notice; Left side of his face started tingling; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (It is a nerve problem/ The vaccine affected the nerves of my face), FEELING ABNORMAL (Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd), ANXIETY (Worried), FEELING HOT (Left side of his face felt warm) and ERYTHEMA (Face was oddly red, not sever, but red enough to notice) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2022, the patient experienced ANXIETY (Worried), FEELING HOT (Left side of his face felt warm), ERYTHEMA (Face was oddly red, not sever, but red enough to notice), PARAESTHESIA (Left side of his face started tingling) and HYPOAESTHESIA (Left side of his face felt numb). On 04-Jan-2022, the patient experienced HYPOAESTHESIA ORAL (Numbness in the lips, just a little). On 06-Jan-2022, the patient experienced FEELING ABNORMAL (Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd). On an unknown date, the patient experienced NEURALGIA (It is a nerve problem/ The vaccine affected the nerves of my face). On 02-Jan-2022, ERYTHEMA (Face was oddly red, not sever, but red enough to notice) had resolved. At the time of the report, NEURALGIA (It is a nerve problem/ The vaccine affected the nerves of my face), FEELING ABNORMAL (Feels like it got worse/may be 60% feeling  Ok /leg on that same side felt maybe odd) and ANXIETY (Worried) outcome was unknown and FEELING HOT (Left side of his face felt warm), PARAESTHESIA (Left side of his face started tingling), HYPOAESTHESIA ORAL (Numbness in the lips, just a little) and HYPOAESTHESIA (Left side of his face felt numb) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.  Patient stated that the time of vaccination was 3 'O' clock.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: she had "moderna arm". after her second Moderna Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (she had "moderna arm". after her second Moderna Covid-19) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 VACCINATION SITE REACTION (she had "moderna arm". after her second Moderna Covid-19). At the time of the report, VACCINATION SITE REACTION (she had "moderna arm". after her second Moderna Covid-19) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2022-443243 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Herpes simplex test, Illness, Malaise, Pyrexia
Clinical narrative: Did not feel well/but worse; She went to ER because her vagina was black; Her stomach was on fire,but worse; Had some sores on her vagina/but worse; She got sick/but worse; Fever/but worse; Throwing up/but worse; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse) and ILLNESS (She got sick/but worse) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse), ILLNESS (She got sick/but worse), PYREXIA (Fever/but worse) and VOMITING (Throwing up/but worse). At the time of the report, MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse), ILLNESS (She got sick/but worse), PYREXIA (Fever/but worse) and VOMITING (Throwing up/but worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Herpes simplex test: came back false (Negative) came back false.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The patient had same symptoms from  1st dose but worse. The patient went to ER, because the vagina was black and took Herpes Tests and all came back false.   This case was linked to MOD-2022-443828 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal disorder, Vomiting, Vulvovaginal pain
Clinical narrative: Did not feel well/but worse; She went to ER because her vagina was black; Her stomach was on fire,but worse; Had some sores on her vagina/but worse; She got sick/but worse; Fever/but worse; Throwing up/but worse; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse) and ILLNESS (She got sick/but worse) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse), ILLNESS (She got sick/but worse), PYREXIA (Fever/but worse) and VOMITING (Throwing up/but worse). At the time of the report, MALAISE (Did not feel well/but worse), VAGINAL DISORDER (She went to ER because her vagina was black), DYSPEPSIA (Her stomach was on fire,but worse), VULVOVAGINAL PAIN (Had some sores on her vagina/but worse), ILLNESS (She got sick/but worse), PYREXIA (Fever/but worse) and VOMITING (Throwing up/but worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Herpes simplex test: came back false (Negative) came back false.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The patient had same symptoms from  1st dose but worse. The patient went to ER, because the vagina was black and took Herpes Tests and all came back false.   This case was linked to MOD-2022-443828 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID vaccine booster dose of 0.25mL but the dose was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine booster dose of 0.25mL but the dose was expired) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine booster dose of 0.25mL but the dose was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine booster dose of 0.25mL but the dose was expired) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin mass
Clinical narrative: arm is very swollen; big bump on it; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is very swollen) and SKIN MASS (big bump on it) 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 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PERIPHERAL SWELLING (arm is very swollen) and SKIN MASS (big bump on it). At the time of the report, PERIPHERAL SWELLING (arm is very swollen) and SKIN MASS (big bump on it) had not resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses were given beyond the 12-hour mark; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark). On 04-Jan-2022 at 11:00 AM, EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. 2 doses from 1 vial were administered 12 hours post-puncture. On 08-Dec-2021 the vial was initially stored in the refrigerator. vial was first punctured on 03-Jan-2022 at 2:45 PM. The vaccine was administrated on 04-Jan-2022 at 11AM.. vial was exposed to room temperature range 8° to 25°C= 46° to 77°F. No treatment medication were provided.   This case was linked to MOD-2022-444869 (Patient Link).