chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; patient has received moderna bivalent after Pfizer bivalent,; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,) and NO ADVERSE EVENT (No Adverse Event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary dose 1) on 10-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Primary dose 2) on 31-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Booster) on 02-Oct-2021, PFIZER BIONTECH COVID-19 VACCINE (Bivalent booster) on 15-Sep-2022 and Influenza vaccine today. Past adverse reactions to the above products included No adverse event with Influenza vaccine today, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has received moderna bivalent after Pfizer bivalent,).    Concomitant products were not reported.  It was reported that patient received other vaccines in 4 weeks prior to COVID-19 vaccine. Patient came back 15 mins later receiving the Moderna bivalent.  Treatment medications were not reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; I got the wrong dose, that I got pediatric dose 6yr to 11yrs dose; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (I got the wrong dose, that I got pediatric dose 6yr to 11yrs dose) and NO ADVERSE EVENT (No Adverse Event) in a 69-year-old 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. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (I got the wrong dose, that I got pediatric dose 6yr to 11yrs dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (I got the wrong dose, that I got pediatric dose 6yr to 11yrs dose) 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 (I got the wrong dose, that I got pediatric dose 6yr to 11yrs dose).    No concomitant drug information was provided.  It was reported that the patient had received the vaccine (booster) last week on Friday 21Dec2022. The next day on 22DEC2022, patient was called and informed that patient was administered pediatric dose 6yr to 11yrs dose.  No treatment medication information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: patient received an expired dose; Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose), PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU vaccine. Past adverse reactions to the above products included No adverse event with FLU vaccine.    On 20-Dec-2022, the patient received fourth 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 EXPIRED PRODUCT ADMINISTERED (patient received an expired dose), PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose), PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022) 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 EXPIRED PRODUCT ADMINISTERED (patient received an expired dose) and PRODUCT STORAGE ERROR (Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022).    53-year-old patient received an expired dose of Moderna COVID-19 vaccine on 20DEC2022. Vial was Moved from Freezer to refrigerator on 18NOV2022 and administered on 20DEC2022 ( Lot# 043H22A & MFG Exp. Date: 08JUN2023). Dose administered after 30-day Use By Date: Product. Bivalent 4th Shot Lot number: ( Lot# 043H22A & MFG Exp. Date: 08JUN2023) Individual vials or intact cartons: Inside Carton Vial size: 0.4 mL, 2.5 mL or 5.5 mL: 2.5 ml.  No concomitant medication was provided. No treatment medication was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received a dose administered 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose administered 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011h22a) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 11-Jun-2022 and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 23-Dec-2022 at 11:28 AM, 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 23-Dec-2022 at 11:28 AM,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose administered 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose administered 12 hours post puncture) 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 (Patient received a dose administered 12 hours post puncture).    No relevant concomitant medications were reported.   Date the vial was initially stored in the refrigerator 14-Dec-2022.  Date and time vial was first punctured 22-Dec-2022 3:42PM.  Date and time of administration of vaccine 23-Dec-2022 11:28 AM.  The vial was stored at room temperature post puncture.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 20 hours.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 69-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.     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 (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) 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.   No concomitant medications were reported. Patient called to report her own reaction. Inadvertently, she reported that she saw on the internet that there were other people whom developed Skin reactions with blisters on their skin after the Moderna Bivalent booster. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:HCP states "I don't have the recipient's initials or DOB. I lost my notes." Also admits this administration occurred "4 weeks ago".     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 (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose) 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 (instead of the 1st dose, got a Moderna Covid-19 Vaccine, Bivalent booster dose).    It was reported that patient admits this administration occurred 4 weeks ago. Concomitant medication was not provided. Treatment medication information was not provided by the reporter. Age at Time of Onset of Reaction reported as zero years.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Administered a booster instead of a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered a booster instead of a second dose) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062S22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:No Allergy No Diseases.  Concomitant products included ELASOMERAN (SPIKEVAX) for COVID-19 prophylaxis.    On 27-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Administered a booster instead of a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered a booster instead of a second dose) 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 (Administered a booster instead of a second dose).    Concomitant medication was not reported. Patient had no allergy.  Patient does not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment drug was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Cellulitis, Computerised tomogram head normal, Computerised tomogram neck, Intensive care
Clinical narrative: R sided Bells palsy developed early December. He did receive with fluzone in R deltoid 11/18/22. He has now been admitted to ICU with cellulitis of the L ear, face and neck with septic shock.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Septic shock
Clinical narrative: R sided Bells palsy developed early December. He did receive with fluzone in R deltoid 11/18/22. He has now been admitted to ICU with cellulitis of the L ear, face and neck with septic shock.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patient received the bivalent vaccine without receiving the primary series of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the vaccine) and NO ADVERSE EVENT (No Adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062f22a) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 29-Nov-2022, 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 29-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the 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 considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the bivalent vaccine without receiving the primary series of the vaccine).    Concomitant medication list was not provided. Patient received the bivalent vaccine without receiving the primary series of the vaccine or any other dose of any COVID19 vaccine. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Patient had a cold after receiving their last dose a year ago; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Patient had a cold after receiving their last dose a year ago) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Patient had a cold after receiving their last dose a year ago). At the time of the report, NASOPHARYNGITIS (Patient had a cold after receiving their last dose a year ago) 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 medication was reported. No treatment medication was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patients received the vaccines after the beyond use date/ 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccines after the beyond use date/ 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Patient had no known drug allergy. It was unknown if patient had any acute illnesses at the time of the vaccination and up to one month before or chronic or long standing health conditions.     On 13-Dec-2022 at 5:37 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccines after the beyond use date/ 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccines after the beyond use date/ 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) 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 EXPIRED PRODUCT ADMINISTERED (Patients received the vaccines after the beyond use date/ 10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    No relevant concomitant medications were reported.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689118 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Follow-up document received on 23-Dec-2022 with no new significant information. On 24-Dec-2022: Live significant follow-up document received on 24-Dec-2022 with patient details, reporter details and dosage information updated. ?; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689118:Master case
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes simplex
Clinical narrative: Herpes simplex on face; Taking acyclovir until blisters disappear; This case was reported by a consumer and described the occurrence of herpes simplex in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex (on her face and mouth ever since patient was child). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (had approximately 10 years ago). Concomitant products included rosuvastatin and lisinopril.   On 11th November 2022, the patient received Shingrix. On 20th December 2022, 39 days after receiving Shingrix, the patient experienced herpes simplex and blister. The patient was treated with acyclovir (Acyclovir Tablets). On an unknown date, the outcome of the herpes simplex and blister were not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: This report was submitted by public reporting. This report was submitted via the online direct entry reporting system. The reporter was the patient.  The patient previously had a shingles vaccine approximately 10 years ago and broken out shingles.  The patient had a history of herpes simplex on her face and mouth ever since the patient was a child. The patient took the new Shingrix shot a month ago and now had herpes simplex break out on her face. The patient did not had any itching or pain and still do not.  Fortunately, patient had some acyclovir tablets 400 mg so she took one today and will continue to take them until the blisters disappeared.  The patients next dose due in January 2023.  The reporter wanted to know if this was common reaction.  The reporter consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Oropharyngeal pain
Clinical narrative: sore throat; croaky voice; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and DYSPHONIA (croaky voice) 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 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 OROPHARYNGEAL PAIN (sore throat) and DYSPHONIA (croaky voice). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and DYSPHONIA (croaky voice) 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.  The reporter wanted to know if there are any side effects to the current booster if the vaccine was not thawed properly before administered. Reporter's boyfriend woke up the next day with a sore throat and a very croaky voice.  No treatment information was provided.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FX5095) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old) 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 INCORRECT DOSE ADMINISTERED (of 5 years old received monovalent vaccine Moderna COVID19 vaccine of 6 years to 11 years old).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Drug effect less than expected
Clinical narrative: all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them; This spontaneous case was reported by a consumer and describes the occurrence of DRUG EFFECT LESS THAN EXPECTED (all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 immunisation.     The patient's past medical history included Liver transplant. Concurrent medical conditions included Immunocompromised.    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 DRUG EFFECT LESS THAN EXPECTED (all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them). At the time of the report, DRUG EFFECT LESS THAN EXPECTED (all of the mRNA vaccines (including the Moderna bivalent) but mRNA does not work well for them) outcome was unknown.            Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.  Company comment: This spontaneous case concerns a male patient of unknown age with relevant medical history of Liver transplant and immunocompromised reported, who experienced the unexpected non serious event of Drug effect less than expected in the context of unspecified dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported that as all of the mRNA vaccines (including the Moderna bivalent), but mRNA does not work well for them. No further information on clinical course, investigations, treatment of the event, details of previous doses was available in the report. The outcome of the event was unknown. Relevant medical history may remain as confounder to the event. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with relevant medical history of Liver transplant and immunocompromised reported, who experienced the unexpected non serious event of 'Drug effect less than expected' in the context of unspecified dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. It was reported that as all of the mRNA vaccines (including the Moderna bivalent), but mRNA does not work well for them. No further information on clinical course, investigations, treatment of the event, details of previous doses was available in the report. The outcome of the event was unknown. Relevant medical history may remain as confounder to the event. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.).    No concomitant medication was reported. 26 doses were received with Lot 065K21A,.  No treatment medication was reported.   This case was linked to MOD-2022-691013 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation reaction
Clinical narrative: had some side effects/had a hard time; got the Moderna vaccine and it made her tired; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (had some side effects/had a hard time) and FATIGUE (got the Moderna vaccine and it made her tired) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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 (had some side effects/had a hard time) and FATIGUE (got the Moderna vaccine and it made her tired). At the time of the report, IMMUNISATION REACTION (had some side effects/had a hard time) outcome was unknown and FATIGUE (got the Moderna vaccine and it made her tired) had resolved.            No concomitant information was reported. It was reported that, Patient got the Moderna vaccine and it made her tired and it took her a long time to recover. Patient had some side effects. Patient got it twice and the second time patient had a hard time. No treatment information was reported.  It was reported that the Patient had some Premarin vaginal cream on her finger and touched her eye and it started swelling and itching and was red. Patient was trying to figure out if it was due to the cream or if it was something else.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Hypoaesthesia, Rash, Vaccination site reaction
Clinical narrative: Arms and legs falling a sleep everytime I sat; Sore joints; Rash; Felt like a drip from the shot spot to the top of my finger; Brain fog; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Felt like a drip from the shot spot to the top of my finger), FEELING ABNORMAL (Brain fog), HYPOAESTHESIA (Arms and legs falling a sleep everytime I sat), ARTHRALGIA (Sore joints) and RASH (Rash) 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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Felt like a drip from the shot spot to the top of my finger), FEELING ABNORMAL (Brain fog), HYPOAESTHESIA (Arms and legs falling a sleep every time I sat), ARTHRALGIA (Sore joints) and RASH (Rash). At the time of the report, VACCINATION SITE REACTION (Felt like a drip from the shot spot to the top of my finger), FEELING ABNORMAL (Brain fog), HYPOAESTHESIA (Arms and legs falling a sleep every time I sat), ARTHRALGIA (Sore joints) and RASH (Rash) had resolved. Patient got the symptoms that lasted from 2 weeks to 10.5 months. Patient had arms and legs falling a sleep every time when sat lasted for 10.5 months.  Patient did not end up in the hospital or die from the side effects. Patient will ever take another shot.  No concomitant medication reported. No treatment medication reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive on 10-Jun-2022; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 virus test positive on 10-Jun-2022) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Anxiety, Depression and Asthma. Concomitant products included LAMOTRIGINE and FLUOXETINE HYDROCHLORIDE (FLUOXITINE UNIMED) for Anxiety and Depression.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2022, the patient experienced COVID-19 (COVID-19 virus test positive on 10-Jun-2022). At the time of the report, COVID-19 (COVID-19 virus test positive on 10-Jun-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jun-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.   This case was linked to MOD-2022-689923 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Scan, Ventilation/perfusion scan
Clinical narrative: Shortness of breath/ breathing problem/ not being able to catch my breath; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath/ breathing problem/ not being able to catch my breath) 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.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced DYSPNOEA (Shortness of breath/ breathing problem/ not being able to catch my breath). At the time of the report, DYSPNOEA (Shortness of breath/ breathing problem/ not being able to catch my breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: Nothing showed up. On an unknown date, Ventilation/perfusion scan: Nothing showed up.         No concomitant medications were reported.  Patient thought that, it was the fourth day before Thanksgiving, the patient developed a breathing problem. Later, the patient had a scan of heart and lungs, but nothing showed up. The patient still had the problem at the time of report. Patient further stated that, sometimes it was worse than others and was wondering if this was a result of having had the booster.  No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise
Clinical narrative: the patient experienced flu; Patient did not feel well after fourth Moderna covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (the patient experienced flu) and MALAISE (Patient did not feel well after fourth Moderna covid 19 vaccine) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In 2022, the patient received fourth 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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. In 2022, the patient experienced MALAISE (Patient did not feel well after fourth Moderna covid 19 vaccine). On an unknown date, the patient experienced INFLUENZA (the patient experienced flu). In 2022, MALAISE (Patient did not feel well after fourth Moderna covid 19 vaccine) had resolved. At the time of the report, INFLUENZA (the patient experienced flu) was resolving.            No concomitant medication was reported.     On an unknown date, the patient received first dose of Moderna vaccine (Intramuscular). On an unknown date, the patient received second dose of Moderna vaccine  (Intramuscular).  On an unknown date, the patient received third dose of Moderna vaccine  (Intramuscular).  MPID for Moderna was reported as 4782589.  The reporter's causality for the events of the patient experienced flu and patient did not feel well after fourth Moderna Covid 19 vaccine with Adalimumab (solution for injection) was no reasonable possibility.  No treatment information was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Caller tested positive for covid Thursday and its more sinus symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caller tested positive for covid Thursday and its more sinus symptoms) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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 COVID-19 (Caller tested positive for covid Thursday and its more sinus symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at a dose of 3 pills at atime. At the time of the report, COVID-19 (Caller tested positive for covid Thursday and its more sinus symptoms) 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.       The patient was prescribed Paxlovid 3 pills at a time. Patient told that it was very large pills, and simply cannot swallow them. Patient was asking that paxlvoid could be made smaller so that  she could take 6 pills. Patient was told that cannot crush or cut the Paxlovid. The patient could not get them down, they were not going anywhere. The patient had talked to one other person at the doctor office and had the same problem, had a horrible time with Paxlovid. Patient was told  to take 3 pills each dose and they were all about the same size except the white is bigger not everyone had the problem with big pills, but certain people do and would like to take it to be on safe side. The patient was vaccinated and double boosted all Moderna Covid vaccines.  At her age patient would be nice to had something. Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia, Vaccination site erythema, Vaccination site rash
Clinical narrative: my arm has a hot; I have not felt good; my arm has a red circle; my arm has a rash; have a slight fever 99.6; Headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash) and PYREXIA (have a slight fever 99.6) 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. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash), PYREXIA (have a slight fever 99.6) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash), PYREXIA (have a slight fever 99.6) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: Slight fever 99.6.   No concomitant medications were reported.  It was reported patient had let my dr know.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: my arm has a hot; I have not felt good; my arm has a red circle; my arm has a rash; have a slight fever 99.6; Headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash) and PYREXIA (have a slight fever 99.6) 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. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash), PYREXIA (have a slight fever 99.6) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash), PYREXIA (have a slight fever 99.6) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: Slight fever 99.6.   No concomitant medications were reported.  It was reported patient had let my dr know.  No treatment medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: he experienced an unexplained symptom (unspecified); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (he experienced an unexplained symptom (unspecified)) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced IMMUNISATION REACTION (he experienced an unexplained symptom (unspecified)). At the time of the report, IMMUNISATION REACTION (he experienced an unexplained symptom (unspecified)) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) 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. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) 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 WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster).    Concomitant product use was not provided by the reporter. This case was for patient 15 of 16. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-692175 (Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2022-692175:master case(same reporter)