chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022; No Adverse Event; Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 09-Aug-2022).    No concomitant product use was reported. The number of doses/vials -around 50 doses from 5 vials. On 08-Jul-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 07-Aug-2022 until the 11-Aug-2022 Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
Age: 1.83
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 22-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 09-Aug-2022).    No concomitant medications was provided by the reporter. The vial did not undergo the temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment medications was provided by the reporter.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022; No Adverse Event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 09-Aug-2022).    No concomitant medication was reported.  On 08-Jul-2022, the vials were initially stored in the refrigerator.  Vial did not undergo any temperature excursions.  The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was administered 47h 15m after vial removed from refrigeration; No adverse reaction; administered 47h 15m after vial removed from refrigeration/room temperature 37h 15m prior to dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 47h 15m after vial removed from refrigeration/room temperature 37h 15m prior to dose administered), PRODUCT STORAGE ERROR (Vaccine was administered 47h 15m after vial removed from refrigeration) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 47h 15m after vial removed from refrigeration/room temperature 37h 15m prior to dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered 47h 15m after vial removed from refrigeration) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 47h 15m after vial removed from refrigeration/room temperature 37h 15m prior to dose administered), PRODUCT STORAGE ERROR (Vaccine was administered 47h 15m after vial removed from refrigeration) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered 47h 15m after vial removed from refrigeration/room temperature 37h 15m prior to dose administered) and PRODUCT STORAGE ERROR (Vaccine was administered 47h 15m after vial removed from refrigeration).    Concomitant drugs were not reported.  Date the vial was initially stored in the refrigerator: 02-Aug-2022  The vial did not undergo any temperature excursions other than being brought to room temperature 37h 15m prior to dose administered. Room temperature was 68-72F during this entire 37h 15m time. fridge temp 40F.  Treatment medications were not given.   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2022: Significant live follow-up received included narrative, batch number updated.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Rhinorrhoea
Clinical narrative: runny nose; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (runny nose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005m21A, 005m21a and 005m21A) for COVID-19 prophylaxis.     The patient had no drug allergy. The patient had previously received a COVID-19 Vaccine.  Concurrent medical conditions included Blood pressure high. Concomitant products included ATENOLOL, AMLODIPINE, HYDROXYCHLOROQUINE and OMEPRAZOLE for an unknown indication.   On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022 at 5:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2022, Body temperature: patient had temperature.         Concomitant medication active drug substances included Atenolol, Amlodipine, Hydroxychloroquine and Omeprazole.  No treatment medications were reported.  The patient had temperature on 12-Aug-2022. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain in extremity
Clinical narrative: high blood pressure; arm a little sore; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (arm a little sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Warts (since approximately 5 years ago she had 18 warts in her 2 thumbs). Concurrent medical conditions included Blood pressure high (Started since she was 30 years old; high blood pressure for a couple of days after 1st and 2nd dose), Acid reflux (esophageal), Diabetes (started 3 years ago, there were no recent changes in status such as improvement or worsening), Allergy to antibiotic and Asthma (since she was 50 years old; there were no recent changes in status such as improvement or worsening). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), LISINOPRIL for Blood pressure high, METFORMIN for Diabetes, INSULIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (arm a little sore). On 05-Mar-2021, HYPERTENSION (high blood pressure) and PAIN IN EXTREMITY (arm a little sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that, after the vaccines were given, patient just had her arm a little sore and had high blood pressure for a couple of days, but it went back to normal.  It was reported that patient ever had not COVID + tested or diagnosed. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-629209 (E2B Linked Report). This case was linked to MOD-2022-629204 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-629209:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022; No adverse event; vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 03H21A, 029L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (vaccinated 6 patients after the 30 day use by date on the Moderna Covid-19 vaccine had passed) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022, vial was administered on 02-Aug-2022).    No concomitant drug was reported. The patient received first dose on left arm shoulder deltoid muscle. On 09-Dec-2021, patient received first booster dose. On 02-Aug-2022, patient received second booster dose. No adverse reactions were known after receiving first, second, first booster dose and second booster dose of vaccine. No treatment drug was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022; No adverse event; 6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 060H21A, 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 patients received Moderna Covid-19 vaccine past the 30 day beyond use date.) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022).    No concomitant medications information was reported.   The vial was initially stored in the refrigerator on 2-Jun-2022.  Not the pharmacist aware of vial was undergo any temperature excursions. . It was reported that there were no known adverse events.  No treatment medications were provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022; No adverse event; patient received Moderna Covid-19 vaccine past the 30 day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 041L20A, 029L20A and 060H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine past the 30 day beyond use date.) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022).    No concomitant medication was reported.   Patient stated no adverse reactions were known from the received doses. Patient was administered with Second booster dose. Date the vial was initially stored in the refrigerator on 02-JUN-2022.The pharmacist was not aware of if vial undergo any temperature excursions. No treatment information was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm a little sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm a little sore) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 007B21A and 022M20A) for COVID-19 vaccination.     It was reported as patient never had COVID positive test or diagnosis and no other vaccines given within one month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Warts (5 years ago patient had 18 warts and on 20-SEP-2021 warts turned black and after one or two weeks disappeared.). Concurrent medical conditions included Drug allergy (Patient is allergic to cipro), Diabetes (since 3 years ago No change in status such as improvement or worsening), Asthma (since she was 50 years old No change in status such as improvement or worsening) and Blood pressure high (since she was 30 years old blood pressure for a couple of days after 1st and 2nd dose). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (esophageal), METFORMIN for Diabetes, LISINOPRIL for Hypertension, ESCITALOPRAM OXALATE (LEXAPRO) and INSULIN for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced PAIN IN EXTREMITY (arm a little sore). On 12-Dec-2021, PAIN IN EXTREMITY (arm a little sore) had resolved. Patient height reported as 5'6 and it was reported patient did not experienced similar event in past and AE doesn't cause patient seek medical care (office visit, Urgent care, ER, hospitalized). It was reported that the patient was not tested positive to COVID-19.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  It was also reported as Insulin recent medication, she was not taking it when warts disappeared. No treatment information were reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-629204, US-MODERNATX, INC.-MOD-2022-629199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-629204: US-MODERNATX, INC.-MOD-2022-629199:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 2JUNE2022, Date of administration of vaccine on 2AUG2022; No adverse event; Patient received Moderna Covid-19 vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine past the 30 day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 2JUNE2022, Date of administration of vaccine on 2AUG2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A22A, 041L20A and 029L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine past the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 2JUNE2022, Date of administration of vaccine on 2AUG2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine past the 30 day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 2JUNE2022, Date of administration of vaccine on 2AUG2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine past the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 2JUNE2022, Date of administration of vaccine on 2AUG2022).    No concomitant medications were provided. The vial did not undergo any temperature excursions. Patient did not experienced any adverse reactions with first, second and first booster vaccinations. No treatment medications were reported.   This case was linked to MOD-2022-629212 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022; No adverse event; patient received moderna covid-19 vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received moderna covid-19 vaccine past the 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer Covid-19 vaccine (Primary series), Pfizer Covid-19 vaccine (first booster dose) and Pfizer Covid-19 vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Pfizer Covid-19 vaccine, Pfizer Covid-19 vaccine and Pfizer Covid-19 vaccine.    On 02-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received moderna covid-19 vaccine past the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received moderna covid-19 vaccine past the 30 day beyond use date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received moderna covid-19 vaccine past the 30 day beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 02-Jun-2022 and administered on 02-Aug-2022).    No concomitant medications information was reported.   The vial was initially stored in the refrigerator on 2-Jun-2022.  Not the pharmacist aware of vial was undergo any temperature excursions. . It was reported that there were no known adverse events.  No treatment medications were provided.   This case was linked to MOD-2022-629202, MOD-2022-629210 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 13-Jul-2022 and was administered on 15-Aug-2022; No adverse event; Vaccine was administered beyond the used by dayof 12-Aug-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the used by dayof 12-Aug-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 and was administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Aug-2022 at 9:30 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Aug-2022 at 9:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the used by dayof 12-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 and was administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the used by dayof 12-Aug-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 and was administered on 15-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered beyond the used by dayof 12-Aug-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Jul-2022 and was administered on 15-Aug-2022).    No concomitant product use was provided. Patient was not immunocompromised Patient did not reported having side effects. HCP was not aware of incident. Patient was not on medication according to nurse knowledge Dose of the Moderna vaccine was administered beyond the used by day of 12-Aug-22. The vial was initially stored in the refrigerator on 13Jul2022 at 3 pm. The date of administration of vaccine was on 15-Aug-2022 around 9:30 pm. The vial did not undergo any temperature excursion. No treatment medication was provided.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.) 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 EXPIRED PRODUCT ADMINISTERED (One of our Medical assistants has given an expired booster dose of Moderna Covid-19 vaccine.).    Patient Allergies with medications, food and other products was reported as unknown.  Patient ever had COVID positive test or diagnosis was reported as unknown.  Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of Vaccination was reported as unknown   Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as unknown.  AE cause patient to seek medical care office visit, Urgent care, ER, hospitalized was reported as unknown.   The patient experienced a similar event in the past was reported as unknown.   The vial did not underwent any temperature excursion.  No concomitant medication were reported.   No treatment drug were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: Sick, in bed/ in the bed for 5 or 6 days, kind of nasty; After all the vaccines she was in pain; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty) and PAIN (After all the vaccines she was in pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012220A) for COVID-19 prophylaxis.     Concurrent medical conditions included Thyroid disorder NOS (Thyroid thing for 25 years), Night terrors, Dry eyes, Anxiety, Pollen allergy (Outdoor allergies pollen) and Allergy to plants (Pine trees). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, CICLOSPORIN (RESTASIS) for Dry eyes, CLONAZEPAM for Night terrors, CETIRIZINE HYDROCHLORIDE (ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]) for Pollen allergy and Allergy to plants, LEVOTHYROXINE for Thyroid disorder NOS, ALIROCUMAB (PRALUENT), EZETIMIBE, METOPROLOL SUCCINATE and VITAMINS NOS for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty) and PAIN (After all the vaccines she was in pain). At the time of the report, ILLNESS (Sick, in bed/ in the bed for 5 or 6 days, kind of nasty) and PAIN (After all the vaccines she was in pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication include Fish gel pills and centrum vitamins everyday.  It was reported that the patient was sick, in bed, complaining. No treatment information was reported.   This case was linked to MOD-2022-629219, MOD-2022-629221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Aug-2022: Live follow up received contains non-significant information.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a second Moderna booster and is not immunocompromised.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second Moderna booster and is not immunocompromised.) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second Moderna booster and is not immunocompromised.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a second Moderna booster and is not immunocompromised.) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  The patient received a second Moderna booster and later found out that they did not qualify for it. The patient was not immunocompromised.   No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: TOOK SECOND COVID BOOSTER AND WAS FEELING BLAH; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (TOOK SECOND COVID BOOSTER AND WAS FEELING BLAH) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced FEELING ABNORMAL (TOOK SECOND COVID BOOSTER AND WAS FEELING BLAH). At the time of the report, FEELING ABNORMAL (TOOK SECOND COVID BOOSTER AND WAS FEELING BLAH) was resolving.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was reported.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up) in a 68-year-old male 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-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) at an unspecified dose. In 2022, the patient experienced PSORIASIS (Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up). At the time of the report, PSORIASIS (Flare up of psoriasis cleared but came back on scalp / Psoriasis flare-up) had not resolved.    No concomitant medications were provided by the reporter. Patient had taken Humira drug in the form  of Solution for injection in pre-filled pen. No treatment information were provided.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), PAIN (Generalized aching), INFLUENZA (Flu) and MOBILITY DECREASED (Mobility decreased) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product VALPROATE SEMISODIUM (DEPAKOTE) tablet for an unknown indication. Concurrent medical conditions included Abstains from alcohol (Abstains from alcohol), Tobacco user (A pack of cigarette a day (started 1976)) since 1976 and Drug allergy (Antidepressants allergy). On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VALPROATE SEMISODIUM (DEPAKOTE) (Oral) 500 milligram. In May 2021, the patient experienced PAIN IN EXTREMITY (Leg pain), PAIN (Generalized aching) and INFLUENZA (Flu). In June 2021, the patient experienced MOBILITY DECREASED (Mobility decreased). In May 2021, PAIN IN EXTREMITY (Leg pain), PAIN (Generalized aching) and INFLUENZA (Flu) had resolved. In June 2021, MOBILITY DECREASED (Mobility decreased) had resolved.  No concomitant medications were reported. Indication was reported as chemical imbalance. No treatment medications were reported. This case was linked to MOD-2022-629405 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: Foggy feeling in head; Inappropriate schedule of vaccine administered; Mobility decreased/ Could not move; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy feeling in head), MOBILITY DECREASED (Mobility decreased/ Could not move) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product VALPROATE SEMISODIUM (DEPAKOTE) tablet for Hormonal imbalance.    Patient was not an alcohol user. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Concurrent medical conditions included Cigarette smoker (A pack of cigarette per day) since 1976 and Drug allergy.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-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 VALPROATE SEMISODIUM (DEPAKOTE) (Oral) 500 milligram. In June 2021, the patient experienced MOBILITY DECREASED (Mobility decreased/ Could not move). On 28-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In March 2022, the patient experienced FEELING ABNORMAL (Foggy feeling in head). In June 2021, MOBILITY DECREASED (Mobility decreased/ Could not move) had resolved. At the time of the report, FEELING ABNORMAL (Foggy feeling in head) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication was reported by reporter.  Primary reporter did not have the lot number information, because the packaging was discarded.  The reporter's causality for Depakote for brain fog was not provided, for leg pain, body ache, flu and could not move was no reasonable possibility.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-629402 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Patient experienced Brain fog; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient experienced Brain fog) in a 57-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 04-May-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, solution for injection in pre-filled pen. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2022, the patient experienced FEELING ABNORMAL (Patient experienced Brain fog). At the time of the report, FEELING ABNORMAL (Patient experienced Brain fog) had not resolved.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of Patient experienced Brain fog with humira was not provided.  Treatment details were not given.   Reporter did not allow further contact
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (Nasopharyngitis) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 30-Jun-2022 at 5:59 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jul-2022, the patient experienced NASOPHARYNGITIS (Nasopharyngitis). At the time of the report, NASOPHARYNGITIS (Nasopharyngitis) had resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2022-612804 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cross sensitivity reaction
Clinical narrative: Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of CROSS SENSITIVITY REACTION (Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CROSS SENSITIVITY REACTION (Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine). At the time of the report, CROSS SENSITIVITY REACTION (Patient had a cross sensitivity to an ingredient, aluminum, in the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient had to finish the COVID-19 vaccination with Janssen. No treatment medication was reported by reporter.