chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported.  27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.  No treatment information was provided by the reporter.  This case contains information for the 10 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications was reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 12 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) 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 ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)).    No concomitant medication was reported. No treatment medication was reported. This case contains information for the 13th of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  It was reported that, the 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 7 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported. 27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5ml.                                 No treatment information was provided by the reporter. This case contains information for the 23 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 14 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 24 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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)) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                 No treatment information was reported. This case is for the 15th patient out of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.  No treatment information was provided by the reporter.  This case contains information for the 16 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  It was reported that, the 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 25 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). No concomitant medications were reported.  27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml. No treatment information was provided by the reporter.  This case contains information for the 22 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) 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 ACCIDENTAL UNDERDOSE (Patient received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)).    No concomitant medications were provided. No treatment medications were reported.  This case was reported for 18th patient of 27 adult patients.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Patient received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medication was reported.     27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 19 of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant medications were not reported.  It was reported that, the 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the 27th patient of 27 adult patients described by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose) 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 PRODUCT DOSE OMISSION ISSUE (patient that got a Moderna vaccination early this year on 30Mar2022, but she never came back for the second dose).    Concomitant medications were not reported.                        Patient now wanting a booster dose.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications was reported. 27 adult patients received pediatric dose of Bivalent  COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                  No treatment information was provided by the reporter.  This case contains information for the second of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) 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 vaccination.     No Medical History information was reported.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)) 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 ACCIDENTAL UNDERDOSE (patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)).    No concomitant drug was reported. No treatment drug was reported. This case contains information for the 3rd of 27 adult patients described by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                 No treatment information was reported. This case is for the 5th patient out of 27 adult patients described by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Body ache; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    Previously administered products included for Drug use for unknown indication: Iron and Erythromycin. Past adverse reactions to the above products included Drug hypersensitivity with Erythromycin and Iron. Concurrent medical conditions included Psoriatic arthritis.   On 28-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for Injection, Single Dose Pen. On 28-Sep-2022, the patient experienced MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (fatigue). On 29-Sep-2022, MYALGIA (Body ache), CHILLS (Chills) and FATIGUE (fatigue) had resolved.            No concomitant medication information was provided.  The reporter's causality for body aches, chills and fatigue with Adalimumab Solution for Injection, single dose pen was not provided.  Agency's opinion was that the causality for the event(s) of body aches, chills and fatigue with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.  Agency's opinion was that the causality for the event(s) of body aches, chills and fatigue with Adalimumab Solution for Injection was Not Provided.  number was reported as 4782590.  It was unknown if patient was enrolled in COVID-19 vaccine trial or not.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medication was reported.   No treatment medication was reported.  The case contains a patient out of 27 adult patients who received pediatric dose of bivalent vaccine of 0.25 ml instead of 0.5ml.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medication were reported.  Practice manager reported that 27 adult patients received pediatric dose of Bivalent Moderna COVID-19 vaccine (0.25 ml instead of 0.5 ml)           No treatment information was provided by the reporter.  This case contains information for the 9th of 27 adult patients described by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Psoriasis, Sinusitis, Vaccination site pain
Clinical narrative: Sore arm from Moderna vaccines; covid-19; Plaque psoriasis flare up located under bra line and thighs; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), PSORIASIS (Plaque psoriasis flare up located under bra line and thighs), SINUSITIS (Sinus infection) and VACCINATION SITE PAIN (Sore arm from Moderna vaccines) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 12-Jan-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (covid-19), PSORIASIS (Plaque psoriasis flare up located under bra line and thighs) and SINUSITIS (Sinus infection). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm from Moderna vaccines). In 2022, COVID-19 (covid-19) and SINUSITIS (Sinus infection) had resolved. At the time of the report, PSORIASIS (Plaque psoriasis flare up located under bra line and thighs) had not resolved and VACCINATION SITE PAIN (Sore arm from Moderna vaccines) outcome was unknown.            No relevant concomitant medications were reported.   There was no reported medical history.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the events of covid-19, sinus infection and sore arm from moderna vaccines with adalimumab solution for injection was no reasonable possibility.  The reporter's causality for the events of plaque psoriasis flare up located under bra line and thighs with adalimumab solution for injection was reasonable possibility.  Company's opinion was that the causality for the events of covid-19, plaque psoriasis flare up located under bra line and thighs, sinus infection and sore arm from moderna vaccines with adalimumab solution for injection was not provided.  No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Gait inability
Clinical narrative: Could not walk; Eyes inflammed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could not walk) and EYE INFLAMMATION (Eyes inflammed) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced GAIT INABILITY (Could not walk) and EYE INFLAMMATION (Eyes inflamed). At the time of the report, GAIT INABILITY (Could not walk) and EYE INFLAMMATION (Eyes inflamed) outcome was unknown.     No concomitant medications were reported.  No treatment medications were reported.  It was unknown if patient was enrolled in COVID-19-vaccine trial.  The reporter's causality for the events of Could not walk and Eyes inflamed with adalimumab solution for injection was not provided. The reporter's causality for the events of Could not walk and Eyes inflamed with Moderna COVID-19 vaccine was assessed as reasonable possibility.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthritis, COVID-19, Illness
Clinical narrative: COVID; sick; arthritis flared; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID), ILLNESS (sick) and ARTHRITIS (arthritis flared) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782588) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   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 and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID), ILLNESS (sick) and ARTHRITIS (arthritis flared). At the time of the report, COVID-19 (COVID) was resolving and ILLNESS (sick) and ARTHRITIS (arthritis flared) outcome was unknown.      No relevant concomitant medications were reported.   It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The patient had covid and was very sick got the vaccine and was very sick from it and it flared up her arthritis to being very bad colic acid along with rinvoq plans on getting flu shot but wants to find out if she should stop taking medication.  The reporter's causality for the events of arthritis flared, covid and sick with Upadacitinib was Not Provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Immunisation reaction, Lung disorder
Clinical narrative: Heart issues; Lung issue; Patient experienced all symptoms that come with it; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart issues), LUNG DISORDER (Lung issue) and IMMUNISATION REACTION (Patient experienced all symptoms that come with it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart issues), LUNG DISORDER (Lung issue) and IMMUNISATION REACTION (Patient experienced all symptoms that come with it). At the time of the report, CARDIAC DISORDER (Heart issues), LUNG DISORDER (Lung issue) and IMMUNISATION REACTION (Patient experienced all symptoms that come with it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient started treatment on an unspecified date with Moderna COVID-19 Vaccine at an unspecified dose.  It was reported the patient experienced all symptoms that come with it, including heart issues and lung issues.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Systemic lupus erythematosus
Clinical narrative: she received the 2nd shot, her lupus was reactivated; This spontaneous case was reported by a nurse and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (she received the 2nd shot, her lupus was reactivated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Systemic lupus erythematosus.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (she received the 2nd shot, her lupus was reactivated) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (she received the 2nd shot, her lupus was reactivated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was reported that 30 days later, after the patient had received the second dose of the vaccine, the lupus had re-activated.  No treatment drug information was provided.  Company Comment: This spontaneous case concerns an unknown-years-old female patient, with  medical history of Systemic lupus erythematosus who experienced the unexpected seriousness criterion medically significant event of Systemic lupus erythematosus unknown days after  2nd.  dose of  mRNA-1273 vaccine.  It was reported that 30 days after the mentioned dose of the vaccine, the lupus had reactivated; on an unknown date the antibody test was positive. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.   Reporter did not allow further contact; Sender's Comments: Company Comment This spontaneous case concerns an unknown-years-old female patient, with  medical history of Systemic lupus erythematosus who experienced the unexpected seriousness criterion medically significant event of Systemic lupus erythematosus unknown days after  2nd.  dose of  mRNA-1273 vaccine.  It was reported that 30 days after the mentioned dose of the vaccine, the lupus had reactivated; on an unknown date the antibody test was positive. The benefit-risk relationship of mrna-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.