chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Achy arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 036B21A, 051F21A and 066K21) for COVID-19 prophylaxis.     The patient's past medical history included Anemia, Vaccination adverse reaction and COVID-19. Previously administered products included for Product used for unknown indication: VACCINE, HERPES SIMPLEX 1, IRON, AZITHROMYCIN, ZINC and PREDNISONE. Past adverse reactions to the above products included No adverse event with AZITHROMYCIN, IRON, PREDNISONE, VACCINE, HERPES SIMPLEX 1 and ZINC.      No concomitant medication information provided. It was reported that patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I got COVID 1.5 weeks ago) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 004F21A, 013620A and 039K20-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2022, the patient experienced COVID-19 (I got COVID 1.5 weeks ago). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I got COVID 1.5 weeks ago) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2023, SARS-CoV-2 test: (Positive) on Saturday.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that, Patient started with nasal congestion about 1.5 weeks ago and COVID-19 home test was positive on Saturday. Patient called the doctor and doctor kept patient on Paxlovid.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19Dec2022 and second Moderna dose received on 06Jan2023) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     No Known drug allergy.    On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-Jan-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19Dec2022 and second Moderna dose received on 06Jan2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19Dec2022 and second Moderna dose received on 06Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         They administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark. No adverse events reported.  Treatment medications were not reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19 Dec 2022 and second Moderna dose received on 06 Jan 2023) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     No known drug allergy.  The patient's past medical history included COVID-19 on 31-Aug-2022.   On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Jan-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19 Dec 2022 and second Moderna dose received on 06 Jan 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Covid vaccine administered 10 days too early/first Moderna dose received on 19 Dec 2022 and second Moderna dose received on 06 Jan 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2022, SARS-CoV-2 test: Positive.       Patient received second dose of Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, nurse gave it at the 19th day mark.  Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark.) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     The patient had no known drug allergies. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic conditions or long-standing health conditions at the time of vaccination. The patient did not receive any prescription, over the counter medications, dietary supplements, or herbal remedies at the time of vaccination or at the time of adverse event.  The patient's past medical history included COVID-19 (PCR) on 12-Aug-2020.    For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second Moderna initial series too early. Instead of doing it at the 1 month or 28 days mark, they gave it at the 19th day mark.).    No concomitant medications were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE BRUISING (slight bruise) and VACCINATION SITE PAIN (slight injection site pain) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055Z22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2022, the patient received fifth 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 VACCINATION SITE BRUISING (slight bruise) and VACCINATION SITE PAIN (slight injection site pain). At the time of the report, VACCINATION SITE BRUISING (slight bruise) outcome was unknown and VACCINATION SITE PAIN (slight injection site pain) was resolving.            No concomitant medications were reported.   The patient received his first vaccine on 29-Jan-2021 (lot number: 004M20A) on left arm. The patient received his second vaccine of the primary series on 04-Mar-2021 (lot number 032M20A) on left arm. The patient received his third Moderna vaccine as a full dose on 18-Aug-2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days early) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     Patient had no known drug allergies. Patient had no acute illness at the time of vaccination and up to one month before.  Patient had not received other vaccines within one month prior to any dose of Moderna COVID-19 vaccine.  Concurrent medical conditions included Asthma (No recent changes in conditions status.). Concomitant products included LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL SULFATE for an unknown indication.   On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-Jan-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days early) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days early).    No other vaccine given on the same day as Moderna COVID-19 vaccine.  It was reported that, the patient had received 2nd COVID vaccine 10 days too early.  No adverse event reported.  No treatment medications were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days too early) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     Patient had no acute illness at the time of vaccination and up to one month before and no chronic or long-standing health conditions.  Concurrent medical conditions included Drug allergy (Lansoprazole allergy). Concomitant products included NAPROXEN from 29-Nov-2022 to an unknown date for an unknown indication.   On 19-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 dosage form. On 06-Jan-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days too early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Covid vaccine administered 10 days too early) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           The patient received second COVID vaccine 10 days too early.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The contact's friend received 2 doses of the Moderna covid 19 vaccines and then had COVID in September 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (The contact's friend received 2 doses of the Moderna covid 19 vaccines and then had COVID in September 2022) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (The contact's friend received 2 doses of the Moderna covid 19 vaccines and then had COVID in September 2022). At the time of the report, COVID-19 (The contact's friend received 2 doses of the Moderna covid 19 vaccines and then had COVID in September 2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was unknown the patient receive any other vaccines in the 4 weeks prior to COVID-19.  Patient had covid-19 infection and was diagnosed after taking a home covid-19 test. Patient did not have any symptoms at this time.  No treatment medication were provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Illness, Pain
Clinical narrative: Got Sick; Sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Got Sick) and PAIN (Sore) in a male patient of an unknown age 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 ILLNESS (Got Sick) and PAIN (Sore). At the time of the report, ILLNESS (Got Sick) and PAIN (Sore) had resolved.            No concomitant medication was reported.  It was reported that patient got sick and sore for about 2 days.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (tated her son and his girlfriend received a single dose of the vaccine last year, but never received a second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (tated her son and his girlfriend received a single dose of the vaccine last year, but never received a second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (tated her son and his girlfriend received a single dose of the vaccine last year, but never received a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided          No Concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age 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.    In October 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 an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.  It was reported two weeks ago patient got the latest strain of Covid. Patient boosted in October, but that booster did not save patient and two weeks later patient was still battling symptoms, which was gradually diminishing with time and neither of patient was well yet.  No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient received monovalent Moderna Covid-19 vaccine instead of Moderna Bivalent Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received monovalent Moderna Covid-19 vaccine instead of Moderna Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.         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 (The patient received monovalent Moderna Covid-19 vaccine instead of Moderna Bivalent Vaccine).    Patient received monovalent Moderna COVID-19 vaccine instead of Moderna Bivalent vaccine. Bivalent vaccine Lot 057A22A expiration date February 6, 2023.  No concomitant medication reported. No treatment medication reported.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Patient received Moderna bivalent booster dose that had undergone a temperature excursion.; product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE ( Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE ( Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE ( Patient received Moderna bivalent booster dose that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: patient was administered with half of a dose instead of the full dose of Moderna COVID-19 Vaccine Bivalent; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (patient was administered with half of a dose instead of the full dose of Moderna COVID-19 Vaccine Bivalent) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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 UNDERDOSE (patient was administered with half of a dose instead of the full dose of Moderna COVID-19 Vaccine Bivalent) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, UNDERDOSE (patient was administered with half of a dose instead of the full dose of Moderna COVID-19 Vaccine Bivalent) 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 UNDERDOSE (patient was administered with half of a dose instead of the full dose of Moderna COVID-19 Vaccine Bivalent).    No concomitant information was reported. Reporter stated that, patient was administered with half of a dose instead of the full dose of Moderna COVID-19 Vaccine Bivalent. It was unknown if patient reported any AEs. No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    The case was reported for 2nd patient out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant medication was provided.  It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: Patient received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion.).    The case was reported for 4th out of 77 adult patients who had received the vaccine as reported by the reporter.  No concomitant drug information was provided.  It was reported that the vaccine was administered to 77 patients before it was known if the vaccine was ok to use after the excursion.  Treatment drug information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: patient received Moderna bivalent booster doses that had undergone a temperature excursion; patient received Moderna bivalent booster doses that had undergone a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage 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)) (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 (patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    This case is about 7th patient out of 77 patient. Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    This case contains information for the 9th of 77 patients described by the reporter.  No concomitant product was reported. It was reported that the dose was administered to patient before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna bivalent booster doses that had undergone a temperature excursion; Patient received Moderna bivalent booster doses that had undergone a temperature excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion).    This case included information of 6th patient out of 77 reported patients.  No concomitant product reported by reporter.  77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    This case contains information for the 11 out of 77 adult patients described by the reporter. No concomitant information was reported. It was reported that, Approximately 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; The doses were administered before it was known if the vaccine was ok to use after the excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (The doses were administered before it was known if the vaccine was ok to use after the excursion).    No concomitant medication was reported.  No treatment medication was reported.  This case was related to patient number 8 out of 77.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Sex: U
Vaccine: COVID19
Symptoms: Milia
Clinical narrative: Left and right breast center of nipple has developed melia cysts; This spontaneous case was reported by a patient and describes the occurrence of MILIA (Left and right breast center of nipple has developed melia cysts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MILIA (Left and right breast center of nipple has developed melia cysts). At the time of the report, MILIA (Left and right breast center of nipple has developed melia cysts) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MILIA (Left and right breast center of nipple has developed melia cysts) to be related.    No concomitant medication was reported.  Patient experienced a side effect from the vaccine. It was typically around a month after receiving the injection that it had happened. It had been after the boosters that the issue had occurred. Left and right breast center of nipple developed Melia cysts. Patient did not considered it as a coincidence as it had happened three times and each time after the boosters.  Patient's dermatologist had extracted them but had no knowledge about the connection and thought it could be a possibility.  Patient asked if anyone else reported this happening to their body.   This case was linked to MOD-2023-696512 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant medications details were not reported by the reporter.  Reportedly, the doses were administered before it was known if the vaccine was ok to use after the excursion.  Treatment details were not reported by the reporter.  This case was related to patient number 13 out of 77 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Patient received Moderna bivalent booster doses that had undergone a temperature excursion; Patient received Moderna bivalent booster doses that had undergone a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage 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)) (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 (Patient received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    Concomitant medication was not reported.  Patient received Moderna bivalent booster doses that had undergone a temperature excursion. The dose were administered before it was known if the vaccine was ok to use after the excursion. Treatment medication was not reported.  This case contains information for the 15th of 77 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case