chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE PUNCTURED AT 9:40 AM ON PREVIOUS DAY AND WAS ADMINISTERED TO A PATIENT AT 12:20 PM ON THE DAY OF REPORT; This spontaneous report received from a pharmacist concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 11-NOV-2021 12:20 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced vaccine punctured at 9:40 am on previous day and was administered to a patient at 12:20 pm on the day of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine punctured at 9:40 am on previous day and was administered to a patient at 12:20 pm on the day of report was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Pyrexia
Clinical narrative: RIGHT SIDE STOMACH PAIN WITH DEEP INSPIRATION; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient did not have any history of drug abuse or illicit drug use. No concomitant medication was used. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-NOV-2021, the patient experienced right side stomach pain with deep inspiration. On 11-NOV-2021, the patient experienced fever. On 11-NOV-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, and right side stomach pain with deep inspiration. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Head discomfort, Pain in extremity
Clinical narrative: arm was a little sore; head felt a little funny for a couple of hours; lost her balance; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore), HEAD DISCOMFORT (head felt a little funny for a couple of hours) and BALANCE DISORDER (lost her balance) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Loss of energy (before the first dose). Concomitant products included VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (head felt a little funny for a couple of hours) and BALANCE DISORDER (lost her balance). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 10-Mar-2021, HEAD DISCOMFORT (head felt a little funny for a couple of hours) had resolved. On 11-Mar-2021, BALANCE DISORDER (lost her balance) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was a little sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication of the patient also included unknown Herbs.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-255333, MOD-2021-370450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Additional information received and dose 1 details and Concomitant product details were added. On 29-Jul-2021: Telephone contact report was received and contains no new information. Previous FU was amended. Added med history and deleted the reporter's sister information. Action taken updated. On 01-Nov-2021: Events her head felt a little funny for a couple of hours and she lost her balance added. Previously added events were deleted from this case as those were pertaining to dose 2 case.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; JANSSEN 3/13/2021, MODERNA BOOSER 1/2 DOSE 10/25/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (JANSSEN 3/13/2021, MODERNA BOOSER 1/2 DOSE 10/25/2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN on 13-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (JANSSEN 3/13/2021, MODERNA BOOSER 1/2 DOSE 10/25/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (JANSSEN 3/13/2021, MODERNA BOOSER 1/2 DOSE 10/25/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided. It was reported that Moderna vaccine (Lot# 026C21A) was pulled from the freezer on 10/13/2021 with a "use by date" of 11/12/2021 (30 days storage viability in the fridge). The Moderna Vial does not have an expiration date on it. However the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 10/24/2021.    Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up contained non significant information. Added historical vaccine from initial version to narrative. Added vaccine expiry date.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 837 patients received expired dose; variable"; typically 20 day cycle outside; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (837 patients received expired dose) and PRODUCT STORAGE ERROR (variable"; typically 20 day cycle outside) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (837 patients received expired dose) and PRODUCT STORAGE ERROR (variable"; typically 20 day cycle outside). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (837 patients received expired dose) and PRODUCT STORAGE ERROR (variable"; typically 20 day cycle outside) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Event verbatim : include Per Moderna Lot analysis, regarding doses administered on 25Oct2021, 26Oct2021, 27Oct2021: Moderna cannot guarantee patients received full protection against the COVID-19 Virus started on 04-Nov-2021. No concomitant medications are provided. No treatment medications are provided.  Company comment include This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced Expired product administered and Product storage error with no associate adverse events after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax) booster dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received on 04-NOV-21 contains non significant information. On 10-Nov-2021: Follow up received on 10-NOV-21 contains no new information; Sender's Comments: This case concerns a patient of unknown gender and age with no details on relevant medical history, who experienced Expired product administered and Product storage error with no associate adverse events after mRNA- 1273 Moderna vaccine (Moderna COVID-19 Vaccine / Spikevax) booster dose. The benefit-risk relationship of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine is not affected by this report
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial was initially stored in the refrigerator on 20-Apr-2021.    Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up information received contains no new information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a dose from a vial more than 30 days on the fridge; The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of the first episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) and the second episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced the first episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 14-Jul-2021, last episode of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial was initially stored in the refrigerator on 20-Apr-2021. The patient did not experienced any adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up information received contains no new information. On 02-Nov-2021: Follow-up information received contains additional details related to the Events. On 05-Nov-2021: Follow-up information received contains no new information.; Sender's Comments: This case concerns a 36-year-old, female patient, with no reported medical history, who experienced Expired product administered. This event occurred on both first and second dose administration of the Moderna COVID 19 vaccine. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Herpes zoster, Rash
Clinical narrative: patient was worried; Rash began developing that night, FOUR DAYS AFTER the booster shot.; Came down with shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Came down with shingles), ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 004M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Chest pain, Shoulder pain and Back pain. Concurrent medical conditions included Hypertension (within past 2 years.) and High cholesterol (within past 2 years.). Concomitant products included ATORVASTATIN for Coronary artery disease, VALACICLOVIR and HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN + HIDROCLOROTIAZIDA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced HERPES ZOSTER (Came down with shingles). On an unknown date, the patient experienced ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.). The patient was treated with METHYLPREDNISOLONE from 30-Oct-2021 to 01-Nov-2021 for Shingles, at a dose of 4 mg. At the time of the report, HERPES ZOSTER (Came down with shingles) had not resolved and ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HERPES ZOSTER (Came down with shingles) to be not related. No further causality assessments were provided for ANXIETY (patient was worried) and RASH (Rash began developing that night, FOUR DAYS AFTER the booster shot.).    Patient says the episode was unrelated to the vaccine because he started having pain under the shoulder, the back and under the chest area, prior to the vaccine. Patient went to the doctor and doctor said it was common to feel pain preceding the shingles rash. As patient was worried it might affect somehow the effectiveness of the vaccine and the immune response.   This case was linked to MOD-2021-372016 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received on 02-Nov-2021 is significant it has information related to Patient's demographics and event details updated. On 04-Nov-2021: non signi follow-up On 05-Nov-2021: Significant Follow up-Secondary Reporter added,Date of event and outcome of event updated, Medical History added.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Left arm sore at injection site/pain on left arm/pain in left arm were vaccine was injected; 14 year old son was given the Moderna covid19 vaccine an that it was the wrong vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included Hand pain with INFLUENZA VACCINE. Concurrent medical conditions included Allergy to nuts, Crab, Pollen, Cat, Dog, and Improvement after treatment since April 2018. Concomitant products included VITAMIN D from 2019 to an unknown date, VITAMIN C from 2019 to an unknown date and MULTIVITAMIN for an unknown indication.    On 29-Oct-2021 at 3:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE. On 29-Oct-2021 at 8:00 PM, the patient experienced VACCINATION SITE PAIN. On 29-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE had resolved. On 01-Nov-2021, VACCINATION SITE PAIN had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter stated that patient was inadvertently given his first dose of the Moderna vaccine on 29 OCT 2021 instead of Pfizer's. Patient had treated his left arm pain with pack of ice. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes on 01-Nov-2021 the Follow up received contain significant information. Added reporter details, patient Date Of Birth, suspect product details, and events. On 04-Nov-2021 the Follow up received was non significant. On 04-Nov-2021 the Follow up received contain significant information, updated patient demographics, medical history, vaccination time, concomitant drugs, and event details.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: had very bad side effect with second injection; became really ill; had an attack had to run out and get air; dizziness; weakness; chills; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness) and ASTHENIA (weakness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness), ASTHENIA (weakness), CHILLS (chills) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness), ASTHENIA (weakness), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness, Vaccination complication
Clinical narrative: had very bad side effect with second injection; became really ill; had an attack had to run out and get air; dizziness; weakness; chills; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness) and ASTHENIA (weakness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness), ASTHENIA (weakness), CHILLS (chills) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (had very bad side effect with second injection), ILLNESS (became really ill), DYSPNOEA (had an attack had to run out and get air), DIZZINESS (dizziness), ASTHENIA (weakness), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: felt lousy; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt lousy) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt lousy) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (felt lousy) and PYREXIA (fever) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-370051 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Vaccination complication
Clinical narrative: not feeling too good at the moment; had a very unpleasant reaction/all basically what's listed as side effects; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling too good at the moment), VACCINATION COMPLICATION (had a very unpleasant reaction/all basically what's listed as side effects), HEADACHE (headache) and NAUSEA (nausea) in an elderly male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (not feeling too good at the moment), VACCINATION COMPLICATION (had a very unpleasant reaction/all basically what's listed as side effects), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (not feeling too good at the moment), VACCINATION COMPLICATION (had a very unpleasant reaction/all basically what's listed as side effects), HEADACHE (headache) and NAUSEA (nausea) was resolving.            No concomitant medication was mentioned. No treatment medication was mentioned. The reporter stated that the patient, was in his 70, and was slowly improving & had no side effects with the 1st two doses.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea
Clinical narrative: Got really sick; Bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick), HEADACHE (Bad headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got really sick), HEADACHE (Bad headache) and NAUSEA (Nausea). At the time of the report, ILLNESS (Got really sick), HEADACHE (Bad headache) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not provided. Treatment medications were not provided.   This case was linked to MOD-2021-370042, MOD-2021-370043 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headaches for a week; Tired for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE and FATIGUE in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 031L20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Bladder cancer and COPD.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE and FATIGUE. At the time of the report, HEADACHE and FATIGUE had resolved.            Concomitant medication was not provided by the reporter. Treatment medication was not reported. This case concerns a 70-year-old, female patient with relevant medical history of Bladder cancer and COPD, who experienced the expected non-serious events of Headache and Fatigue. The events occurred on an unknown date after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The patient's medical history of Bladder cancer and COPD, remain as confounders for the occurrence of the events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. This case concerns a 70-year-old, female patient with relevant medical history of Bladder cancer and COPD, who experienced the expected non-serious events of Headache and Fatigue. The events occurred on an unknown date after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The patient's medical history of Bladder cancer and COPD, remain as confounders for the occurrence of the events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, Nasal discomfort, SARS-CoV-2 test
Clinical narrative: An employee gave the daughter in law covid; Stuffed up sinus; Nasal burns; Lack of drug effect; Broke with COVID/Tired for a couple of days/coughing; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2, SINUS CONGESTION, NASAL DISCOMFORT, DRUG INEFFECTIVE, and COVID-19 in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced DRUG INEFFECTIVE. 13-Sep-2021, the patient experienced COVID-19. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2, SINUS CONGESTION, and NASAL DISCOMFORT. At the time of the report, EXPOSURE TO SARS-COV-2, SINUS CONGESTION, NASAL DISCOMFORT, DRUG INEFFECTIVE, and COVID-19 outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 13-Sep-2021, SARS-CoV-2 test) Positive.         No relevant concomitant medications were reported. Patient wears mask and was asymptomatic and as per reporter,  was vaccinated with both doses (manufacturer unknown) gave the patient COVID. From the patient, her own six year old daughter and husband got COVID. No treatment information was provided.  This case concerns a 35-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. Drug ineffective was considered an additional event. The events occurred approximately 7 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: An employee gave the daughter in law covid; Stuffed up sinus; Nasal burns; Lack of drug effect; Broke with COVID/Tired for a couple of days/coughing; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2, SINUS CONGESTION, NASAL DISCOMFORT, DRUG INEFFECTIVE, and COVID-19 in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced DRUG INEFFECTIVE. 13-Sep-2021, the patient experienced COVID-19. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2, SINUS CONGESTION, and NASAL DISCOMFORT. At the time of the report, EXPOSURE TO SARS-COV-2, SINUS CONGESTION, NASAL DISCOMFORT, DRUG INEFFECTIVE, and COVID-19 outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 13-Sep-2021, SARS-CoV-2 test) Positive.         No relevant concomitant medications were reported. Patient wears mask and was asymptomatic and as per reporter,  was vaccinated with both doses (manufacturer unknown) gave the patient COVID. From the patient, her own six year old daughter and husband got COVID. No treatment information was provided.  This case concerns a 35-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. Drug ineffective was considered an additional event. The events occurred approximately 7 months after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Headache, Illness, Nausea
Clinical narrative: Had a reaction each time; Got really sick; Bad headache; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ADVERSE REACTION, ILLNESS, HEADACHE, and NAUSEA 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 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION, ILLNESS, HEADACHE, and NAUSEA. At the time of the report, ADVERSE REACTION, ILLNESS, HEADACHE, and NAUSEA outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-370042, MOD-2021-370027 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ATORVASTATIN, VITAMIN D, VITAMIN E, VITAMIN C, and ASPIRIN for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN. The patient was treated with TYLENOL ongoing since an unknown date for Adverse event, at a dose of UNKNOWN. At the time of the report, VACCINATION SITE PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Tylenol which did nothing.   This case was linked to MOD-2021-370096 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, and VACCINATION SITE INFLAMMATION in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 023M20A, and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, VACCINATION SITE INFLAMMATION, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, HEADACHE, PYREXIA, NAUSEA, VOMITING, and FATIGUE. At the time of the report, ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, HEADACHE, PYREXIA, NAUSEA, VOMITING, and FATIGUE outcome was unknown and VACCINATION SITE INFLAMMATION, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Body temperature 101F (High).         No concomitant medication was provided. No treatment medication was provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-370018 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Suspected COVID-19, Taste disorder, Vaccination site inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, and VACCINATION SITE INFLAMMATION in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 023M20A, and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, VACCINATION SITE INFLAMMATION, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, HEADACHE, PYREXIA, NAUSEA, VOMITING, and FATIGUE. At the time of the report, ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, HEADACHE, PYREXIA, NAUSEA, VOMITING, and FATIGUE outcome was unknown and VACCINATION SITE INFLAMMATION, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Body temperature 101F (High).         No concomitant medication was provided. No treatment medication was provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-370018 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, and VACCINATION SITE INFLAMMATION in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 023M20A, and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, VACCINATION SITE INFLAMMATION, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, HEADACHE, PYREXIA, NAUSEA, VOMITING, and FATIGUE. At the time of the report, ILLNESS, DECREASED APPETITE, TASTE DISORDER, SUSPECTED COVID-19, HEADACHE, PYREXIA, NAUSEA, VOMITING, and FATIGUE outcome was unknown and VACCINATION SITE INFLAMMATION, VACCINATION SITE SWELLING, and VACCINATION SITE PAIN had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Body temperature 101F (High).         No concomitant medication was provided. No treatment medication was provided.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-370018 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Diarrhoea, Dyspnoea, Fatigue, Nausea
Clinical narrative: Had a difficult time breathing; Cold sweat; Diarrhea; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA, COLD SWEAT, DIARRHOEA, NAUSEA, and FATIGUE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, the patient experienced DYSPNOEA. 31-Oct-2021, the patient experienced COLD SWEAT, DIARRHOEA, NAUSEA, and FATIGUE. On 01-Nov-2021, DYSPNOEA, COLD SWEAT, DIARRHOEA, NAUSEA, and FATIGUE had resolved.            No concomitant medication was provided.             No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA and NAUSEA in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 013M20A, and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced DIARRHOEA and NAUSEA. The patient was treated with LOPERAMIDE HYDROCHLORIDE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, DIARRHOEA and NAUSEA had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. She has used Imodium for 2 days with some improvement.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence
Clinical narrative: gases; loose stool/diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (gases) and DIARRHOEA (loose stool/diarrhea) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced FLATULENCE (gases) and DIARRHOEA (loose stool/diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency. At the time of the report, FLATULENCE (gases) and DIARRHOEA (loose stool/diarrhea) outcome was unknown.            Concomitant medications were not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: left side of face went numb; Tingling like it was asleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA and PARAESTHESIA in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heartburn. Concomitant products included NEXIUM for Heartburn.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA and PARAESTHESIA. At the time of the report, HYPOAESTHESIA was resolving and PARAESTHESIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. The patient experienced the left side of her face went numb and tingling like it was asleep. The patient said the numbing never really went away but decreased Patient reached out to her doctor about getting the second shot. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) (batch number was 21C21A). Patient got the second dose of the Moderna vaccine did not have any additional side effects. Patient reported being on Nexium for heartburn before receiving the Moderna vaccine. This case concerns a 40-year-old female patient with no relevant medical history, who experienced the unexpected event of Hypoesthesia and Paraesthesia. The events occurred the same day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Temperature excursion that occurred on the 25 Oct 2021. Fridge went out of range for 7 minutes/Patients given doses out of temperature range; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE. On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Lightheaded; Head is not clear; Shortness of Breath; Headache; Fatigue; Erroneously received full dose booster; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, and FATIGUE in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 019B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-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 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, FATIGUE, and ACCIDENTAL OVERDOSE. On 25-Oct-2021, ACCIDENTAL OVERDOSE had resolved. At the time of the report, DIZZINESS, FEELING ABNORMAL, DYSPNOEA, HEADACHE, and FATIGUE outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.