chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Muscle tightness
Clinical narrative: major back pain/back pain; hip tightness; Hip pain; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (major back pain/back pain), MUSCLE TIGHTNESS (hip tightness) and ARTHRALGIA (Hip pain) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first 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. On 12-Nov-2021, the patient experienced BACK PAIN (major back pain/back pain) (seriousness criterion hospitalization), MUSCLE TIGHTNESS (hip tightness) (seriousness criterion hospitalization) and ARTHRALGIA (Hip pain) (seriousness criterion hospitalization). At the time of the report, BACK PAIN (major back pain/back pain), MUSCLE TIGHTNESS (hip tightness) and ARTHRALGIA (Hip pain) had not resolved.            No concomitant drug was reported. On 12-Nov-2021, patient received first booster dose. It was reported that patient received first and second dose as a full dose. The patient was concerned that they might have a side effect of the vaccine. The adverse events caused patient to seek medical care. No treatment drug was reported. Company Comment This spontaneous case concerns a 57-years-old, with no medical history reported who experienced the unexpected seriousness criteria hospitalization events of back pain, muscle tightness and arthralgia unknown days after  3rd. dose of  mRNA-1273 vaccine.  At the time of the report, the event had not resolved.   The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 57-years-old, with no medical history reported who experienced the unexpected seriousness criteria hospitalization events of back pain, muscle tightness and arthralgia unknown days after  3rd. dose of  mRNA-1273 vaccine.  At the time of the report, the event had not resolved.   The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: patient didn't feel good after his vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (patient didn't feel good after his vaccination) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (patient didn't feel good after his vaccination). At the time of the report, MALAISE (patient didn't feel good after his vaccination) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (Unknown) was unknown.   No concomitant medication was reported.  Reporter stated that the patient did not feel good after his vaccinations either.  No treatment information was provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse event; Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Bivalent vaccine was administered to a patient a little lower than the deltoid muscle.).    No concomitant medications was reported. No treatment medications was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: my sister felt horrible after getting her 4th booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (my sister felt horrible after getting her 4th booster) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced FEELING ABNORMAL (my sister felt horrible after getting her 4th booster). At the time of the report, FEELING ABNORMAL (my sister felt horrible after getting her 4th booster) outcome was unknown.            No Concomitant medication were reported. No treatment drug were reported.   Reporter did not allow further contact
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Administered Moderna vaccine for 6 months to 5 year to a patient  greater than 5 year old / dosage given was 0.5 mL).    No concomitant medications were provided by the reporter.  It was reported that nurse administered the Moderna COVID-19 vaccine for 6 months to 5 year to a patient greater than 5 year old. The wrong product was administered but the correct dosage was given to patient (0.5 mL).  Patient had not reported any adverse reactions to the dose.  No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product monitoring error
Clinical narrative: doses involved in possible excursion/missed 97 hours worth of temperature data logging; There was an issue with where they found out that they missed 97 hours worth of data logging; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging), PRODUCT MONITORING ERROR (There was an issue with the where they found out that they missed 97 hours worth of data logging) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging), PRODUCT MONITORING ERROR (There was an issue  where they found out that they missed 97 hours worth of data logging) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging), PRODUCT MONITORING ERROR (There was an issue with where they found out that they missed 97 hours worth of data logging) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (doses involved in possible excursion/missed 97 hours worth of temperature data logging) and PRODUCT MONITORING ERROR (There was an issue where they found out that they missed 97 hours worth of data logging).    No concomitant medications were reported.  The reporter stated there might a possible excursion with the Moderna COVID-19 vaccines and was unable to confirm it as there were 97 hours missed for data logging.  On 08-Sep-2022, the vial was moved from freezer to refrigerator and was now stored in the fridge.  There was no change in the vaccine state upon visual inspection.  The vial did not undergo an excursion previously and was not punctured.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646284:same reporter
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event, SARS-CoV-2 test
Clinical narrative: No Adverse event; Received a full dose as the third dose instead on a half dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full dose as the third dose instead on a half dose) and NO ADVERSE EVENT (No Adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 007M20A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Low blood pressure.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full dose as the third dose instead on a half dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received a full dose as the third dose instead on a half dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive, in summer.         No concomitant medication was reported.    While in the call caller stated that for her third dose she received a full dose instead of a half dose. No treatment information was reported.   This case was linked to MOD-2022-646309 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue, Underdose
Clinical narrative: doses administered after excursion on 22-Aug-2022 to 04-Sep-2022; No adverse event; Administered dose that experienced the excursion; Patient received 0.25 ml as a first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022 at 11:45 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 24-Aug-2022 at 11:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion) and UNDERDOSE (Patient received 0.25 ml as a first dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022), UNDERDOSE (Patient received 0.25 ml as a first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Administered dose that experienced the excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion on 22-Aug-2022 to 04-Sep-2022) and UNDERDOSE (Patient received 0.25 ml as a first dose).    No concomitant medications were reported.  Vaccine was stored in fridge at the time of excursion. The maximum temperature reached was 52.8 Fahrenheit and the excursion duration was 8 days, 16 hours, and 30 minutes. on 22-Aug-2022 the vial was moved from freezer to refrigerator and vaccine was stored in fridge as of now. Total 3 doses were impacted from the vial. A total of 3 doses were administered with no previous excursions. On 05-Sep-2022 fridge died, ever since the fridge went out of range that past weekend and no doses was administered. The temperature went up to 70 degree and the vaccine in that fridge were moved to another fridge.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2022: Follow up received no new information.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001L21-2A, 009021A and 026B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot and Flu shot. Past adverse reactions to the above products included Chills with Flu shot; and Fever with Flu shot. Concurrent medical conditions included Sjogren's syndrome (15 years), Drug allergy and Allergy to antibiotic. Concomitant products included LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), LORAZEPAM, ESTRADIOL, AMLODIPINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) had resolved.            It was reported that the previous Moderna COVID-19 vaccines has made patient really sick. The patient experienced a similar event in the past with flu shot.  Patient had never been diagnosed with/ tested positive for COVID-19.  No treatment details were provided   This case was linked to MOD-2022-646758, MOD-2021-272492 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: chills; fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001L21-2A, 009021A and 026B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot and Flu shot. Past adverse reactions to the above products included Chills with Flu shot; and Fever with Flu shot. Concurrent medical conditions included Sjogren's syndrome (15 years), Drug allergy and Allergy to antibiotic. Concomitant products included LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), LORAZEPAM, ESTRADIOL, AMLODIPINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) had resolved.            It was reported that the previous Moderna COVID-19 vaccines has made patient really sick. The patient experienced a similar event in the past with flu shot.  Patient had never been diagnosed with/ tested positive for COVID-19.  No treatment details were provided   This case was linked to MOD-2022-646758, MOD-2021-272492 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received a Monovalent Booster dose instead of a bivalent booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first 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. On 13-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a Monovalent Booster dose instead of a bivalent booster shot).    No concomitant drug was reported. No treatment drug was reported.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose administered on 22Mar2021 and 2nd dose administered on 10Apr2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 22Mar2021 and 2nd dose administered on 10Apr2021) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 048B21A) for COVID-19 vaccination.     The patient had not ever diagnosed with COVID positve test.  The patient's past medical history included Ex-smoker (Former smoker) in 2012. Concurrent medical conditions included Seasonal allergy, Drug allergy (does not feel well when given Sudafed), Drug allergy (does not feel well when given Codeine), COPD (slight COPD), Emphysema (slight emphysema), Osteoporosis and Depression. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Depression.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 22Mar2021 and 2nd dose administered on 10Apr2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 22Mar2021 and 2nd dose administered on 10Apr2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: patient had a regular CatScan to monitor her lungs.         No treatment medications were provided by the reporter.   This case was linked to MOD-2022-568686 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Aortic aneurysm
Clinical narrative: small aortic aneurysm; This spontaneous case was reported by a patient and describes the occurrence of AORTIC ANEURYSM (small aortic aneurysm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient had a weak immune system.).   In May 2022, the patient 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 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 AORTIC ANEURYSM (small aortic aneurysm). At the time of the report, AORTIC ANEURYSM (small aortic aneurysm) outcome was unknown.            No concomitant medication was provided.  It was reported that patient received 2 shots of Moderna COVID-19 Vaccine primary series and 2 updated shots because he had a weak immune system.   Patient mentioned he had a small aortic aneurysm that doctors found after receiving Moderna COVID-19 Vaccines, they mentioned it might be there even before the vaccines, and patient did not know if it was related to the vaccine.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 02L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose admninistered on 26-Jan-2021 and second dose admnistered on 10-Mar 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2022-646995 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: My sister took a flu shot, then took a Moderna shot after and she got sick.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (My sister took a flu shot, then took a Moderna shot after and she got sick.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (My sister took a flu shot, then took a Moderna shot after and she got sick.). At the time of the report, ILLNESS (My sister took a flu shot, then took a Moderna shot after and she got sick.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014520A and 029L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (26Jan2021: 1st dose of Moderna Covid-19 vaccine, 10Mar2021: 2nd dose of Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were not reported.  Patient received full dose for first and second dose.  No treatment medications were reported.   This case was linked to MOD-2022-647010 (Patient Link).
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash macular, Rash pruritic, Vaccination site pain
Clinical narrative: has little red dots. Which spread in her back and all over her body but more under her arm/She is itching, she has a rash; She is itching, she has a rash; Headaches; She received the vaccine in her left thigh. She been complaining her leg hurt; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH MACULAR (has little red dots. Which spread in her back and all over her body but more under her arm/She is itching, she has a rash), RASH PRURITIC (She is itching, she has a rash), HEADACHE (Headaches) and VACCINATION SITE PAIN (She received the vaccine in her left thigh. She been complaining her leg hurt) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     The patient never tested positive or diagnosed with COVID-19. The patient did not have any allergies related to medications, food and other products.     On 26-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (has little red dots. Which spread in her back and all over her body but more under her arm/She is itching, she has a rash), RASH PRURITIC (She is itching, she has a rash), HEADACHE (Headaches) and VACCINATION SITE PAIN (She received the vaccine in her left thigh. She been complaining her leg hurt). At the time of the report, RASH MACULAR (has little red dots. Which spread in her back and all over her body but more under her arm/She is itching, she has a rash), RASH PRURITIC (She is itching, she has a rash), HEADACHE (Headaches) and VACCINATION SITE PAIN (She received the vaccine in her left thigh. She been complaining her leg hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: After her first booster dose the patient  had severe diarrhea.; After her first booster dose the patient was tired the next day; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (After her first booster dose the patient  had severe diarrhea.) and FATIGUE (After her first booster dose the patient was tired the next day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 007M20A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced DIARRHOEA (After her first booster dose the patient  had severe diarrhea.) and FATIGUE (After her first booster dose the patient was tired the next day). At the time of the report, DIARRHOEA (After her first booster dose the patient  had severe diarrhea.) and FATIGUE (After her first booster dose the patient was tired the next day) outcome was unknown.       No concomitant medication was reported. No treatment medications were reported.    This case was linked to MOD-2022-647022, MOD-2022-647021 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Follow-up received included-vaccine lot numbers and vaccination dates updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired the next day; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tired the next day) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 939903, 007M20A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (tired the next day). At the time of the report, FATIGUE (tired the next day) outcome was unknown.     No concomitant medications were reported.   No treatment details were reported.   This case was linked to MOD-2022-647022, MOD-2022-647019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2022: Follow up information included vaccine lot numbers and vaccination dates updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Vaccine Administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022 at 9:30 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Sep-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered).    No concomitant medication was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product label confusion
Clinical narrative: label she noticed it said 0.5 or 0.25 mL based on age and it was confusing for her; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT LABEL CONFUSION (label she noticed it said 0.5 or 0.25 mL based on age and it was confusing for her), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (label she noticed it said 0.5 or 0.25 mL based on age and it was confusing for her), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (label she noticed it said 0.5 or 0.25 mL based on age and it was confusing for her), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT LABEL CONFUSION (label she noticed it said 0.5 or 0.25 mL based on age and it was confusing for her) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medication was reported.  Reporter stated that the dosage of Moderna COVID-19 Vaccine, Bivalent was 0.5 mL, but in the label they noticed it said 0.5 or 0.25 mL based on age and it was confusing.  No treatment information was provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Cough
Clinical narrative: Excessive/prolonged Cough; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Sep2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team,. A 53-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 03Aug2022 as dose number unknown, 0.5 ml single (one time administration) (Lot number: FJ2607, Expiration Date: 31Aug2023) at the age of 53 years intramuscular (IM) for immunization (also reported as "patient reported cough"), Device Lot Number: FJ2607, Device Expiration Date: 31Aug2023. The patient's relevant medical history was not reported. The patient took concomitant medications (per patient take OTC drugs). The following information was reported: COUGH (non-serious) with onset 04Aug2022, outcome "not recovered", described as "Excessive/prolonged Cough". Therapeutic measures were not taken as a result of cough. Additional information:  A nurse reporting a temperature excursion with Prevnar 20 and wanted to get information about stability. Temperature excursion: The highest temperature was 8.7 Celsius for 15 minutes and the lowest temperature was 2 Celsius for one hour. The nurse wanted to know if the vaccine was still good to administer to patients. The lot numbers involved in the excursion were FJ2605, FJ2606, FJ2607. Prevnar 20 was administered to patients. Male and Female 40-70 years old. Administered to 21 patients in total. No complaints from any patients at this time. No side effects have been reported from the patients. Most of the patients received the Prevnar 20 after 13Jul2022. On 13Sep2022, the nurse reported that this patient experienced excessive cough. The patient only started prolonged cough after receiving vaccine. No rechallenge. There was no admission to hospital due to the event. No emergency room visit, no treatment received, no specific tests and no surgery required. The patient was not deceased. It was unknown if there was a reasonable possibility that the event was related to suspect product as assessed by the nurse; then later on the same follow-up, the same nurse reported that there is no reasonable possibility that the event is related to the suspect pro duct.  No follow-up attempts are needed. No further information is expected.  Follow-Up (19Sep2022): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: sudden onset of hands and feet itching; throat tightening mild for 2-3 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2022 at 16:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "Hypermobility spectrum disorder" (unspecified if ongoing), notes: Hypermobility Spectrum Disorder (subset of, Ehlers-Danlos).; "known allergies: legumes" (unspecified if ongoing), notes: known allergies: legumes. Concomitant medication(s) included: ARMOUR THYROID; GINGER ROOT EXTRACT. Past drug history included: Corticosteroids, reaction(s): "known allergies: corticosteroids". Vaccination history included: Covid-19 vaccine (DOSE: 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: THROAT TIGHTNESS (medically significant) with onset 09Sep2022 at 17:30, outcome "recovered" (2022), described as "throat tightening mild for 2-3 hours"; PRURITUS (non-serious) with onset 12Sep2022, outcome "recovered" (2022), described as "sudden onset of hands and feet itching". Therapeutic measures were taken as a result of throat tightness, pruritus.  Clinical Course: No other vaccine in four weeks. Other medications in two weeks included Armour Thyroid 90, Ginger root supplements 1100 mg. No covid prior vaccination and not tested for covid post vaccination. known allergies included legumes, corticosteroids. 1 hour after administration, throat tightening mild for 2-3 hours (history of this will legumes or corticosteroids/carry epipen). 55 hours after administration, sudden onset of hands and feet itching. Administered Benedryl and Pepcid. Within 60 minutes, SX subsided. Ae treatment included when 2nd SX started, Benedryl 25mg  and Pepcid.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive home COVID-19 test on; positive home COVID-19 test; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  A 61-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 19May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 13Jun2022, outcome "unknown", described as "positive home COVID-19 test"; VACCINATION FAILURE (medically significant) with onset 13Jun2022, outcome "unknown", described as "positive home COVID-19 test on". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) positive, notes: positive home COVID-19 test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure and Covid -19  cannot be ruled out.
Age: 37.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm at injection site; light fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 17:00 as dose 4 (booster), single (Lot number: 11185) at the age of 37 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Sep2022 as unk, single (Batch/Lot number: unknown), in left arm for influenza. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; OMEPRAZOLE; ATORVASTATIN. Vaccination history included: BNT162b2 (DOSE:3), administration date: 24Nov2021, for Covid-19 immunization, reaction(s): "myalgia", "Vaccination site pain", "general fatigue", "Immunization"; BNT162b2 (DOSE;2), administration date: 05May2021, for COVID-19 immunization; BNT162b2 (DOSE;1), administration date: 09Apr2021, for Covid-19 immunization, reaction(s): "vaccination site pain". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Sep2022 at 07:00, outcome "recovering", described as "Sore arm at injection site"; FATIGUE (non-serious) with onset 14Sep2022 at 07:00, outcome "recovering", described as "light fatigue". Therapeutic measures were not taken as a result of vaccination site pain, fatigue.  Additional information: Patient not had covid prior vaccination, covid not tested post vaccination.   No follow-up attempts are possible. No further information is expected.