chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Suicidal ideation
Clinical narrative: suicidal during most of 2020 and 2021 because of the isolation; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (suicidal during most of 2020 and 2021 because of the isolation) in an adult female patient 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, the patient experienced SUICIDAL IDEATION (suicidal during most of 2020 and 2021 because of the isolation) (seriousness criterion medically significant). At the time of the report, SUICIDAL IDEATION (suicidal during most of 2020 and 2021 because of the isolation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was concerned about increase in price for the COVID vaccine, because not enough people were vaccinated already. No concomitant product was reported. Patient received Moderna COVID-19 vaccine before 2021 in a study. She thought that she got the actual vaccine sometime in October and she was in the placebo group before that. She was suicidal during most of 2020 and 2021 because of the isolation. No treatment information was reported.; Reporter's Comments: Company comment: This spontaneous case concerns an adult female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Suicidal ideation which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Latency cannot be determined as the date of vaccination and onset of event are not reported. Other details are not available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patients was given the Moderna pediatric dose instead of the bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients was given the Moderna pediatric dose instead of the bivalent booster dose).    Concomitant medication was not reported.  It was reported by HCP that patient received Moderna pediatric dose instead of the bivalent booster dose. Treatment medication was not reported. No adverse event observed for patient.  This case contains information for the 1st of 16 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-697907, MODERNATX, INC.-MOD-2023-697934, MODERNATX, INC.-MOD-2023-697960, MODERNATX, INC.-MOD-2023-697981, MODERNATX, INC.-MOD-2023-698005, MODERNATX, INC.-MOD-2023-698021, MODERNATX, INC.-MOD-2023-698029, MODERNATX, INC.-MOD-2023-698031, MODERNATX, INC.-MOD-2023-698045, MODERNATX, INC.-MOD-2023-698059, MODERNATX, INC.-MOD-2023-698062, MODERNATX, INC.-MOD-2023-698064, MODERNATX, INC.-MOD-2023-698073, MODERNATX, INC.-MOD-2023-698078, MODERNATX, INC.-MOD-2023-698039 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-697907:2 of 16 case MODERNATX, INC.-MOD-2023-697934:3 of 16 case MODERNATX, INC.-MOD-2023-698021:7 of 16 case MODERNATX, INC.-MOD-2023-697960:4 of 16 case MODERNATX, INC.-MOD-2023-698005:6 of 16 case MODERNATX, INC.-MOD-2023-697981:5 of 16 case MODERNATX, INC.-MOD-2023-698031:9 of 16 case MODERNATX, INC.-MOD-2023-698078:16 of 16 case MODERNATX, INC.-MOD-2023-698073:15 of 16 case MODERNATX, INC.-MOD-2023-698062:13 of 16 case MODERNATX, INC.-MOD-2023-698059:12 of 16 case MODERNATX, INC.-MOD-2023-698029:8 of 16 case MODERNATX, INC.-MOD-2023-698045:11 of 16 case MODERNATX, INC.-MOD-2023-698064:14 of 16 case MODERNATX, INC.-MOD-2023-698039:10 of 16 case
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenopia, COVID-19, Ocular discomfort
Clinical narrative: COVID-19; she felt her muscle into the eyes were very heavy to close, she had droopy eyes, having eye issues; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), ASTHENOPIA (she felt her muscle into the eyes were very heavy to close, she had droopy eyes,) and OCULAR DISCOMFORT (having eye issues) in a 58-year-old female patient 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.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine in October 2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    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. In October 2022, the patient experienced ASTHENOPIA (she felt her muscle into the eyes were very heavy to close, she had droopy eyes,) and OCULAR DISCOMFORT (having eye issues). In November 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), ASTHENOPIA (she felt her muscle into the eyes were very heavy to close, she had droopy eyes,) and OCULAR DISCOMFORT (having eye issues) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported as unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient received all the COVID-19 shots and patient visited 4 doctors and 1 neurologist but they told  there is nothing wrong with it and they could not explain if this was caused by the vaccine. No treatment medications were reported.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No Adverse Event) in a 24-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jan-2023, 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 08-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients.) and NO ADVERSE EVENT (No Adverse Event) in an 86-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, 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 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients.) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients.).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot number 037K20A, expiration date was 22-Jun-2021, route of administration: Right Arm ) on 29-Dec-2020, Moderna COVID-19 Vaccine (Lot number 043L20A, expiration date was 07-Jul-2021, route of administration: Right Arm ) on 26-Jan-2021, Moderna COVID-19 Vaccine (Booster dose, Lot number 047C21A, expiration date 7-Nov-2021, route of administration: Left Arm ) on 26-Oct-2021, Moderna COVID-19 Vaccine (2nd Booster dose, Lot number 066K21A, expiration date 7-Jul-2022 and route of administration: Left Arm ) on 25-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 17-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent Moderna Covid 19 bivalent vaccine booster dose instead of a bivalent booster dose on 1/17/2023).    No concomitant medicine were reported. It was reported that the patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose. No treatment medicine were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jan-2023, 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 08-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients).    No concomitant medicine were reported. No treatment medicine were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Bivalent vaccine was administered Beyond use by date to 6 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jan-2023, 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 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients) 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 EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccine was administered Beyond use by date to 6 patients).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment medication information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698131 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698131:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) 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. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, 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 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) 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 WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border).    This case contains information for 1st of 3 adult patients described by the reporter.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. NDC was provided. No concomitant product was reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698245, MODERNATX, INC.-MOD-2023-698247 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698245:2nd adult patient MODERNATX, INC.-MOD-2023-698247:3rd adult patient
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 2nd dose given more than 36 days after the 1st dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 36 days after the 1st dose) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M21A, 028K21A and 012M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Hypertension, Congestive heart failure, COPD and Bronchitis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jul-2021,  after starting , the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 36 days after the 1st dose). 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 dose given more than 36 days after the 1st dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 36 days after the 1st dose).    No concomitant medications were reported. No treatment medications were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin discolouration
Clinical narrative: On days that it is worst all his toes are red; Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning; One of his toes is purple; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning), SKIN DISCOLOURATION (One of his toes is purple) and ERYTHEMA (On days that it is worst all his toes are red) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 prophylaxis.     Patient had no allergies nor diseases.     On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced PRURITUS (Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning) and SKIN DISCOLOURATION (One of his toes is purple). On an unknown date, the patient experienced ERYTHEMA (On days that it is worst all his toes are red). At the time of the report, PRURITUS (Itchy burning skin at any place in the body randomly/ mostly on feet/ getting worse it started itching then progress to itching and burning) and SKIN DISCOLOURATION (One of his toes is purple) had not resolved and ERYTHEMA (On days that it is worst all his toes are red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Patient had itchy burning skin at any place in the body randomly. It happen mostly on feet, and it can be in other place of body at the same time. It was getting worse as it started itching then progress to itching and burning. One of patient's toes turned purple. On worst days, all toes turned red. Patient's feet felt like walking on hot coals.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: I want to know if there was a side effect that I have, I wait I don't want to just speak to you.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I want to know if there was a side effect that I have, I wait I don't want to just speak to you.) 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.) 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 IMMUNISATION REACTION (I want to know if there was a side effect that I have, I wait I don't want to just speak to you.). At the time of the report, IMMUNISATION REACTION (I want to know if there was a side effect that I have, I wait I don't want to just speak to you.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Paraesthesia
Clinical narrative: throbbing And major joint pain; tingling; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing And major joint pain), PARAESTHESIA (tingling) and ARTHRALGIA (joint pain) 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.     It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 PAIN (throbbing And major joint pain), PARAESTHESIA (tingling) and ARTHRALGIA (joint pain). At the time of the report, PAIN (throbbing And major joint pain), PARAESTHESIA (tingling) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No treatment information provided.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; they ministered a Moderna Bivalent 6 month dose Lot#215K22A today 17Jan2023 when it should have been the patient's first primary dose. First primary series dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they ministered a Moderna Bivalent 6 month dose Lot#215K22A today 17Jan2023 when it should have been the patient's first primary dose. First primary series dose.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Concomitant products included PEDIARIX, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HIB VACCINE CONJ (TET TOX) (HIBERIX) and ROTAVIRUS VACCINE LIVE ORAL 1V for an unknown indication.    On 17-Jan-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (they ministered a Moderna Bivalent 6 month dose Lot#215K22A today 17Jan2023 when it should have been the patient's first primary dose. First primary series dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they ministered a Moderna Bivalent 6 month dose Lot#215K22A today 17Jan2023 when it should have been the patient's first primary dose. First primary series dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 WRONG PRODUCT ADMINISTERED (they ministered a Moderna Bivalent 6 month dose Lot#215K22A today 17Jan2023 when it should have been the patient's first primary dose. First primary series dose.).    No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine) 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 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 WRONG PRODUCT ADMINISTERED (if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (if someone received a Bivalent Booster dose but has not completed the Primary doses of COVID vaccine) 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 did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 17-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old) 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 WRONG PRODUCT ADMINISTERED (A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that is 5 years old).    No concomitant product reported by reporter.  Patient received dose 1 of Spikevax on 27-Jun-2022 and dose 2 on 28-Jul-2022 for indication of COVID-19 prophylaxis. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. A dose of the 18 years of age and older bivalent Moderna COVID-19 vaccine was given to a patient that was 5 years old. No symptoms were experienced.  No treatment medication reported by reporter.
Age: 3.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.; A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.), POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.), POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.), POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.) and POOR QUALITY PRODUCT ADMINISTERED (A three year old received a monovalent spikevax pediatric dose 25 microgram that has been 35 days out of freezer.).    No concomitant medications details were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2023: Follow-up received wherein updated from location to alternate location. .
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 11-Jan-2023, 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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11-Jan-2023, lot numbers unknown to the HCP.  No concomitant medication reported. No treatment medication reported.  This case pertains to 37th of the total 100 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient 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 11-Jan-2023, 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not reported.  Nurse reported that patient received bivalent booster from vials that were put in the fridge and after that refrozen and thawed again. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP. HCP wanted to know if the vaccine was ok or if they should be revaccinated.  This case contains information for the 4th of 100 adult male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient) 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. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jan-2023, 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 16-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient).    No concomitant medications were reported.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jan-2023: Follow-up information included reporter added, patient's age group added and product details updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Polyarteritis nodosa
Clinical narrative: polyarteritis nodosa; This literature-non-study case was reported in a literature article and describes the occurrence of POLYARTERITIS NODOSA (polyarteritis nodosa) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced POLYARTERITIS NODOSA (polyarteritis nodosa) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (intravenous) at a dose of 500 milligram once a day and METHOTREXATE (oral) for Immunosuppressant drug therapy, at a dose of 12.5 milligram once a day. At the time of the report, POLYARTERITIS NODOSA (polyarteritis nodosa) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: Revealed the presence of numerous vascular irregularities in the celiac axis, bilateral renal arteries, and inferior mesenteric artery consistent with polyarteritis nodosa (PAN), a medium vessel vasculitis..     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient developed diffuse abdominal pain two days after receiving the mRNA-1273 COVID-19 vaccine (Moderna). The patient was placed on oral methotrexate for immunosuppressive maintenance treatment.  The author explained that until now, a limited number of cases of polyarteritis nodosa secondary to the COVID-19 vaccine was reported. Major mechanisms of postvaccine autoimmunity were molecular mimicry and autoantibody production. Rare adverse events from COVID-19 vaccination were possible, however there remained an immense benefit to vaccination in preventing COVID-19-related morbidity and mortality.  Company Comment: This is a literature non-study case concerning a 59-year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of polyarteritis nodosa. The event occurred approximately 2 days after receiving the second dose of mRNA-1273 vaccine. A computed tomography (CT) angiogram of the abdomen and pelvis revealed the presence of numerous vascular irregularities in the celiac axis, bilateral renal arteries, and inferior mesenteric artery consistent with polyarteritis nodosa (PAN). Treatment received included intravenous methylprednisolone 500 mg daily for three days followed by oral methotrexate (MTX) 12.5 mg daily for immunosuppressive maintenance. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Tinnitus
Clinical narrative: So far I've had a shingles outbreak; ringing in my ear after COVID boosters; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (So far I've had a shingles outbreak) and TINNITUS (ringing in my ear after COVID boosters) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (So far I've had a shingles outbreak) and TINNITUS (ringing in my ear after COVID boosters). At the time of the report, HERPES ZOSTER (So far I've had a shingles outbreak) and TINNITUS (ringing in my ear after COVID boosters) outcome was unknown.            No concomitant medication information provided.  It was reported that patient had taken the Moderna COVID shots and had a shingles outbreak and ringing in ear after COVID boosters. Not planning to take anymore.  No treatment information provided.