chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body; It went from dots to blotches.; This spontaneous case was reported by a patient and describes the occurrence of RASH (The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body) and RASH MACULAR (It went from dots to blotches.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     Patient had no allergies. Patient has never had Covid positive test or diagnosis. Patient did not receive other vaccines one month prior to Moderna Covid-19 vaccine.  Concurrent medical conditions included Thyroid function decreased (for the past 2 yrs) and Cardiac arrhythmia.   On 26-Jun-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced RASH (The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body) and RASH MACULAR (It went from dots to blotches.). The patient was treated with PRAMOCAINE HYDROCHLORIDE (CERAVE ITCH RELIEF) at an unspecified dose and frequency; MAGNESIUM SULFATE (EPSOM SALT) at a dose of baths; OATMEAL at a dose of baths; BAKING SODA at a dose of baths; ALOE VERA at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, RASH (The rash on chest, it was like the dots were connecting & starting to fill in on my chest/ rash all over his body) and RASH MACULAR (It went from dots to blotches.) had not resolved.            No concomitant medications were reported. Patient received first booster and second booster dose. On 02-Jun-2022, patient saw a cardiologist and patent wore a cardiac monitor for 3 days. Patient sought medical care for the adverse event. The patient symptoms worsened.   This case was linked to MOD-2022-606692 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2022: Follow up contains updated narrative. On 11-Jul-2022: Follow up contains information on second booster dose (lot number) and updated event verbatim.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 012F21A, 001A21A and 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FALL (Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor). At the time of the report, FALL (Lying on the floor as he fell/Suddenly fell/Was sitting on the chair and fell/Had hot water all over his clothes/Found himself on the floor) outcome was unknown. No concomitant medication were provided. No treatment medication were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-606177, US-MODERNATX, INC.-MOD-2022-606162 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606177:(Mother-in-law case) US-MODERNATX, INC.-MOD-2022-606162:(Wife case)
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (soreness) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Patient have none allergies (medications, food and other products). Previously administered products included for Product used for unknown indication: Flu shot (Flu vaccine given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high (No change in status such as improvement or worsening), Blood cholesterol abnormal (No change in status such as improvement or worsening) and Thyroid disorder (No change in status such as improvement or worsening). 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) had resolved. Patient height is reported as 5'6. Concomitant medicine includes regular medications for high blood pressure, cholesterol, and thyroid issues. It was reported as patient did not experienced any similar event in the past and AE cause patient to patient called a doctor. No treatment information were reported by the reporter. This case was linked to MOD-2022-606972 (Patient Link). Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: just before I was due to get the 1st booster, I tested positive for Covid-19.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (just before I was due to get the 1st booster, I tested positive for Covid-19.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (just before I was due to get the 1st booster, I tested positive for Covid-19.). At the time of the report, COVID-19 (just before I was due to get the 1st booster, I tested positive for Covid-19.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: (Positive) Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Did AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized): Yes. No concomitant medications was reported. No treatment medications was reported.  Patient had medical history related to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.  Company comment: This spontaneous case concerns a patient of unknown age and gender, with underlying medical history of COVID-19, who experienced the unexpected, non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the second dose of mRNA1273. Patient tested positive for COVID-19 on an unspecified date. Further details regarding the clinical course and treatment were not provided. The patient's underlying medical history of COVID-19 remain as a confounder in this case.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with underlying medical history of COVID-19, who experienced the unexpected, non-serious adverse event of special interest COVID-19, which occurred at an unknown interval after receiving the second dose of mRNA1273. Patient tested positive for COVID-19 on an unspecified date. Further details regarding the clinical course and treatment were not provided. The patient's underlying medical history of COVID-19 remain as a confounder in this case.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Vaccination site discomfort
Clinical narrative: I'm legally blind./I started to lose my vision,; I felt the needle hit my bone; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (I'm legally blind./I started to lose my vision,) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 BLINDNESS (I'm legally blind./I started to lose my vision,) (seriousness criterion medically significant) and VACCINATION SITE DISCOMFORT (I felt the needle hit my bone). At the time of the report, BLINDNESS (I'm legally blind./I started to lose my vision,) and VACCINATION SITE DISCOMFORT (I felt the needle hit my bone) outcome was unknown.            No concomitant medication information was provided. Patient had her third booster back in July/ August. In December 2021, her doctor said it was probably from the booster since she didn't  have any health problems. No treatment medication was provided.  Company comment:  This is a spontaneous case concerning  a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Blindness and expected non-serious event of Vaccination site discomfort. The events occurred on an unknown date, after the third dose of mRNA-1273 Vaccine.  No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Blindness and expected non-serious event of Vaccination site discomfort. The events occurred on an unknown date, after the third dose of mRNA-1273 Vaccine.  No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (patient received fourth booster 1 day after expiration date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 058A222A) for COVID-19 immunization. No preexisting condition or allergy reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (patient received fourth booster 1 day after expiration date). At the time of the report, administered expired product (patient received fourth booster 1 day after expiration date) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. No other side effect reported.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose of Moderna Covid-19 vaccine was given after the 30-day beyond use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given after the 30-day beyond use by date.) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given after the 30-day beyond use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was given after the 30-day beyond use by date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient was administered first dose, second dose and first booster dose of unknown manufacturer on an unknown date. On 09-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 2nd dose of Moderna Covid-19 vaccine, on the 14th day) in a 29-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On 17-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 2nd dose of Moderna Covid-19 vaccine, on the 14th day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He received his 2nd dose of Moderna Covid-19 vaccine, on the 14th day) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Unknown if AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). Unknown if the patient experienced a similar event in the past. Unknown if symptoms improved or worsened. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have had ringing in my ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I have had ringing in my ear) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced TINNITUS (I have had ringing in my ear). At the time of the report, TINNITUS (I have had ringing in my ear) outcome was unknown.            No concomitant medications were provided by the reporter.  Patient had received second booster dose.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day; the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose) and PRODUCT STORAGE ERROR (had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (the pharmacy had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day and they inadvertently gave a dose) and PRODUCT STORAGE ERROR (had a vial of Moderna in their refrigerator and it eclipsed the 30 days by one day) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 10-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. There was no adverse event and product complain associated with this case.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2022: Live follow up received and Batch Number was added.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site rash
Clinical narrative: it turned into a solid red circle/couple of little raised, red bumps around the injection site/red/by Sunday it was just a pink outline; started to develop a rash at the injection site; couple of little raised, red bumps around the injection site/raised/flat/an inch around the injection site/faded quite a bit; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE RASH (started to develop a rash at the injection site), VACCINATION SITE MASS (couple of little raised, red bumps around the injection site/raised/flat/an inch around the injection site/faded quite a bit) and VACCINATION SITE ERYTHEMA (it turned into a solid red circle/couple of little raised, red bumps around the injection site/red/by Sunday it was just a pink outline) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2022, the patient experienced VACCINATION SITE RASH (started to develop a rash at the injection site) and VACCINATION SITE MASS (couple of little raised, red bumps around the injection site/raised/flat/an inch around the injection site/faded quite a bit). On 09-Jul-2022, the patient experienced VACCINATION SITE ERYTHEMA (it turned into a solid red circle/couple of little raised, red bumps around the injection site/red/by Sunday it was just a pink outline). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 11-Jul-2022, VACCINATION SITE RASH (started to develop a rash at the injection site), VACCINATION SITE MASS (couple of little raised, red bumps around the injection site/raised/flat/an inch around the injection site/faded quite a bit) and VACCINATION SITE ERYTHEMA (it turned into a solid red circle/couple of little raised, red bumps around the injection site/red/by Sunday it was just a pink outline) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided by the reporter. It was reported  that it lasted for 2-3 days and he did not experience any systemic symptoms after receiving his 1st dose.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: adult patient received dose from pediatric vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial). At the time of the report, INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received second booster dose. HCP confirmed that patient received her dose from a vial labeled for 6 months to 5 years.  Treatment information was not provided by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: adult patient received dose from pediatric vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milligram. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial). At the time of the report, INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: adult patient almost received a dose from a pediatric vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (adult patient almost received a dose from a pediatric vial) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (adult patient almost received a dose from a pediatric vial). At the time of the report, INCORRECT DOSE ADMINISTERED (adult patient almost received a dose from a pediatric vial) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment medications were reported.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2-year-old patient might have received 0.25ml of the adult Moderna COVID-19 vaccine (Red Cap Vial).; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2-year-old patient might have received 0.25ml of the adult Moderna COVID-19 vaccine (Red Cap Vial).) in a 2-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.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2-year-old patient might have received 0.25ml of the adult Moderna COVID-19 vaccine (Red Cap Vial).). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2-year-old patient might have received 0.25ml of the adult Moderna COVID-19 vaccine (Red Cap Vial).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-607282, MOD-2022-607283 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Received vaccine from a vial that had been punctured over 23 hours ago; Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been punctured over 23 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 31H21A and 040C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Jul-2021 at 10:25 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022 at 10:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been punctured over 23 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been punctured over 23 hours ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received this dose on 24MAR2022,second Moderna Covid-19 vaccine booster today on 12Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. The vial initially stored in refrigerator 28-Jun-2022, vial first punctured on 11-Jul-2022 at 14:10. Vial was stored under Room temperature post puncture and Vial did not undergo any temperature excursion issue. No treatment medication reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2022-607275 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Immunisation reaction
Clinical narrative: she was not feeling good; no appetite; fatigue; headache; muscle pain; joint pain; fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (maybe more than once, but for sure on Mar2021) in March 2021 and Pericarditis (more than a decade ago, cause was not determined and not hospitalized.). Family history included Penicillin allergy (Patient maybe allergic to Penicillin because of family history, but unknown) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). On 11-Jul-2021, IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       it was reported that Right after 1st and 2nd dose patient experienced a series of symptoms for about 3 to 5 days. it was reported that Doctors told patient that all this symptoms might be due to an inflammatory response, that looked like her body is fighting against something, but they did not know the cause yet. Patient had not experienced a similar event in the past. Patient had not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. Antibiotics and steroids were reported as treatment medication but patient did not remember names.   This case was linked to MOD-2022-607281 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: she was not feeling good; no appetite; fatigue; headache; muscle pain; joint pain; fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (maybe more than once, but for sure on Mar2021) in March 2021 and Pericarditis (more than a decade ago, cause was not determined and not hospitalized.). Family history included Penicillin allergy (Patient maybe allergic to Penicillin because of family history, but unknown) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). On 11-Jul-2021, IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       it was reported that Right after 1st and 2nd dose patient experienced a series of symptoms for about 3 to 5 days. it was reported that Doctors told patient that all this symptoms might be due to an inflammatory response, that looked like her body is fighting against something, but they did not know the cause yet. Patient had not experienced a similar event in the past. Patient had not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. Antibiotics and steroids were reported as treatment medication but patient did not remember names.   This case was linked to MOD-2022-607281 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest discomfort, Decreased appetite, Dizziness
Clinical narrative: she was not feeling good; no appetite; fatigue; headache; muscle pain; joint pain; fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (maybe more than once, but for sure on Mar2021) in March 2021 and Pericarditis (more than a decade ago, cause was not determined and not hospitalized.). Family history included Penicillin allergy (Patient maybe allergic to Penicillin because of family history, but unknown) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). On 11-Jul-2021, IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       it was reported that Right after 1st and 2nd dose patient experienced a series of symptoms for about 3 to 5 days. it was reported that Doctors told patient that all this symptoms might be due to an inflammatory response, that looked like her body is fighting against something, but they did not know the cause yet. Patient had not experienced a similar event in the past. Patient had not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. Antibiotics and steroids were reported as treatment medication but patient did not remember names.   This case was linked to MOD-2022-607281 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hypersensitivity, Inflammation
Clinical narrative: she was not feeling good; no appetite; fatigue; headache; muscle pain; joint pain; fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (maybe more than once, but for sure on Mar2021) in March 2021 and Pericarditis (more than a decade ago, cause was not determined and not hospitalized.). Family history included Penicillin allergy (Patient maybe allergic to Penicillin because of family history, but unknown) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). On 11-Jul-2021, IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       it was reported that Right after 1st and 2nd dose patient experienced a series of symptoms for about 3 to 5 days. it was reported that Doctors told patient that all this symptoms might be due to an inflammatory response, that looked like her body is fighting against something, but they did not know the cause yet. Patient had not experienced a similar event in the past. Patient had not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. Antibiotics and steroids were reported as treatment medication but patient did not remember names.   This case was linked to MOD-2022-607281 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: she was not feeling good; no appetite; fatigue; headache; muscle pain; joint pain; fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (maybe more than once, but for sure on Mar2021) in March 2021 and Pericarditis (more than a decade ago, cause was not determined and not hospitalized.). Family history included Penicillin allergy (Patient maybe allergic to Penicillin because of family history, but unknown) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). On 11-Jul-2021, IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       it was reported that Right after 1st and 2nd dose patient experienced a series of symptoms for about 3 to 5 days. it was reported that Doctors told patient that all this symptoms might be due to an inflammatory response, that looked like her body is fighting against something, but they did not know the cause yet. Patient had not experienced a similar event in the past. Patient had not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. Antibiotics and steroids were reported as treatment medication but patient did not remember names.   This case was linked to MOD-2022-607281 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Swelling, Vaginal haemorrhage
Clinical narrative: she was not feeling good; no appetite; fatigue; headache; muscle pain; joint pain; fever; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (maybe more than once, but for sure on Mar2021) in March 2021 and Pericarditis (more than a decade ago, cause was not determined and not hospitalized.). Family history included Penicillin allergy (Patient maybe allergic to Penicillin because of family history, but unknown) since an unknown date. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). On 11-Jul-2021, IMMUNISATION REACTION (she was not feeling good), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       it was reported that Right after 1st and 2nd dose patient experienced a series of symptoms for about 3 to 5 days. it was reported that Doctors told patient that all this symptoms might be due to an inflammatory response, that looked like her body is fighting against something, but they did not know the cause yet. Patient had not experienced a similar event in the past. Patient had not experienced symptoms like this before receiving the Moderna COVID-19 vaccine. Antibiotics and steroids were reported as treatment medication but patient did not remember names.   This case was linked to MOD-2022-607281 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Immunisation reaction, Influenza like illness, Pain in extremity
Clinical narrative: Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions; Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day; Sore arm; Felt slightly tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions), INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired). On an unknown date, the patient experienced IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms after recieving each Moderna vaccine/flu like symptoms for just about a day), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt slightly tired) had resolved. At the time of the report, IMMUNISATION REACTION (Reacted pretty strongly to all Moderna doses/felt she had some immunity because she experienced these reaactions) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported by reporter.  It was reported after taking Ibuprofen or Tylenol (pain reducer) patient slept through night and felt fine after waking up next morning.   This case was linked to MOD-2022-607286, MOD-2022-607284 (Patient Link).