chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 20-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 01-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-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 (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 29-Sep-2022 and vaccine administered on 01-Nov-2022).    No concomitant medication information was reported.  Vial size was of 2.5 mL and there were a total of 2 vials.  The vial did not undergo any temperature excursions.  No adverse events were reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart). 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 got 2 doses of the Moderna Covid-19 vaccine 21 days apart) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got 2 doses of the Moderna Covid-19 vaccine 21 days apart).    Concomitant medication was not provided.  Pharmacist stated that they have a patient who got their 1st 2 doses of the Moderna Covid-19 vaccine 21 days apart last year. They want to know if they should give them a 2nd primary dose or the bivalent booster. No further information was provided.  Treatment information was not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 23-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown Route) was unknown.   For mRNA-1273 (Spikevax) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Author investigated 7 COVID-19 and 6 post-mRNA vaccination patients with myocardial injury and found nearly identical alterations in gene expression that would predispose to inflammation, coagulopathy, and myocardial dysfunction. Company comment: This literature non-study case concerns a 23-year-old female patient, with no reported medical history, who experienced the expected and serious (medically significant) AESI of myocarditis, after an unspecified dose of mRNA-1273 vaccine. The exact vaccination date and the event´s onset date were not reported; hence, latency could not be properly assessed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non-study case concerns a 23-year-old female patient, with no reported medical history, who experienced the expected and serious (medically significant) AESI of myocarditis, after an unspecified dose of mRNA-1273 vaccine. The exact vaccination date and the event´s onset date were not reported; hence, latency could not be properly assessed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Woke up around 3 am with body aches; Headache; Woke up around 3 am with chills; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Woke up around 3 am with body aches), HEADACHE (Headache) and CHILLS (Woke up around 3 am with chills) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced MYALGIA (Woke up around 3 am with body aches), HEADACHE (Headache) and CHILLS (Woke up around 3 am with chills). At the time of the report, MYALGIA (Woke up around 3 am with body aches) and HEADACHE (Headache) had not resolved and CHILLS (Woke up around 3 am with chills) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  On 01-Nov-2022 around 3:30 pm, patient received the bivalent COVID booster shot.  At the night around 3 am, patient woke up with chills and body aches. Patient still had body aches and a headache in the morning.
Sex: U
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 4 inch red swelling; 4 inch red swelling; 4 inch red swelling and itching; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (4 inch red swelling), SWELLING (4 inch red swelling) and PRURITUS (4 inch red swelling and itching) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (4 inch red swelling), SWELLING (4 inch red swelling) and PRURITUS (4 inch red swelling and itching). At the time of the report, ERYTHEMA (4 inch red swelling), SWELLING (4 inch red swelling) and PRURITUS (4 inch red swelling and itching) had resolved.            No concomitant product reported by reporter.  Patient had 4 inch red swelling and itching lasted 4 to 5 days.  No treatment medication reported by reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Colonoscopy, Diarrhoea, Haemoglobin, Muscle spasms
Clinical narrative: Anemic; CRAMPING; FREQUENCY AND URGENCY TO USE BATHROOM/DIARRHEA ALL TIME; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemic), MUSCLE SPASMS (CRAMPING) and DIARRHOEA (FREQUENCY AND URGENCY TO USE BATHROOM/DIARRHEA ALL TIME) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 4782590 and 4782590) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    NO KNOWN ALLERGIES.  Concurrent medical conditions included Blood pressure and Ulcerative colitis. Concomitant products included MESALAMINE for Ulcerative colitis, ZOLPIDEM TARTRATE (STILNOX) and LOSARTAN POTASSIUM for an unknown indication.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 160 milligram every two weeks. On 20-May-2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 80 milligram. In June 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient experienced ANAEMIA (Anemic), MUSCLE SPASMS (CRAMPING) and DIARRHOEA (FREQUENCY AND URGENCY TO USE BATHROOM/DIARRHEA ALL TIME). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, ANAEMIA (Anemic) and MUSCLE SPASMS (CRAMPING) had not resolved and DIARRHOEA (FREQUENCY AND URGENCY TO USE BATHROOM/DIARRHEA ALL TIME) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2022, Haemoglobin: 8.9. On an unknown date, Colonoscopy: Ulcerative colitis.         It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the events of anemic, cramping, frequency and urgency to use bathroom/diarrhea all time and humira not helping for low hemoglobin level with adalimumab solution for injection was not provided.  Abbvie's opinion was that the causality for the events of anemic, cramping, frequency and urgency to use bathroom/diarrhea all time and humira not helping for low hemoglobin level with adalimumab solution for injection was not provided.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received bivalent dose >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received bivalent dose >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received bivalent dose >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 bivalent dose >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 bivalent dose >12 hours post puncture).    No concomitant medication was reported.    Date the vial was initially stored in the refrigerator on 02-Nov-2022. Date and time vial was first punctured on 02-Nov-2022 at 4pm. The time of administration of vaccine was around 10 o'clock.  The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Lethargy, Malaise
Clinical narrative: feeling lethargic; not feeling well at all; which she was sick for 4 days with body aches; headache; chills; which she was sick for 4 days with body aches; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (feeling lethargic), MALAISE (not feeling well at all), ILLNESS (which she was sick for 4 days with body aches), HEADACHE (headache) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds (Mold), Dust allergy (Dust), Pollen allergy (pollen), Allergy to animal dander (pet dander), Allergy (mildew allergy), Perfume sensitivity (perfume), Chemical sensitivity (bleach), Type 1 diabetes mellitus (Start Date: 50 years ago Recent change in status such as improvement or worsening: Stable) and Celiac disease (Recent change in status such as improvement or worsening: Stable) since 2014.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, the patient experienced LETHARGY (feeling lethargic), MALAISE (not feeling well at all), ILLNESS (which she was sick for 4 days with body aches), HEADACHE (headache), CHILLS (chills) and MYALGIA (which she was sick for 4 days with body aches). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 26-Apr-2021, LETHARGY (feeling lethargic), MALAISE (not feeling well at all), ILLNESS (which she was sick for 4 days with body aches), HEADACHE (headache), CHILLS (chills) and MYALGIA (which she was sick for 4 days with body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.         No concomitant medication was reported.  On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 0.5 milliliter with lot number 016B21A.   This case was linked to MOD-2022-668645, MOD-2022-668640 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: feeling lethargic; not feeling well at all; which she was sick for 4 days with body aches; headache; chills; which she was sick for 4 days with body aches; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (feeling lethargic), MALAISE (not feeling well at all), ILLNESS (which she was sick for 4 days with body aches), HEADACHE (headache) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to molds (Mold), Dust allergy (Dust), Pollen allergy (pollen), Allergy to animal dander (pet dander), Allergy (mildew allergy), Perfume sensitivity (perfume), Chemical sensitivity (bleach), Type 1 diabetes mellitus (Start Date: 50 years ago Recent change in status such as improvement or worsening: Stable) and Celiac disease (Recent change in status such as improvement or worsening: Stable) since 2014.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, the patient experienced LETHARGY (feeling lethargic), MALAISE (not feeling well at all), ILLNESS (which she was sick for 4 days with body aches), HEADACHE (headache), CHILLS (chills) and MYALGIA (which she was sick for 4 days with body aches). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 26-Apr-2021, LETHARGY (feeling lethargic), MALAISE (not feeling well at all), ILLNESS (which she was sick for 4 days with body aches), HEADACHE (headache), CHILLS (chills) and MYALGIA (which she was sick for 4 days with body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.         No concomitant medication was reported.  On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 0.5 milliliter with lot number 016B21A.   This case was linked to MOD-2022-668645, MOD-2022-668640 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse Event; gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .3 milliliter. On 02-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.).    No concomitant medication details was reported. No treatment medication details was reported. It was reported that HCP travelled to different counties and used to giving the Pfizer, which was 0.3mL.   Reporter did not allow further contact
Age: 39.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was administered Moderna vial instead of the Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered Moderna vial instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered Moderna vial instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered Moderna vial instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered Moderna vial instead of the Bivalent booster).    No concomitant medications were reported.  It was reported that the patient had already received the primary vaccination series and received vaccine from Moderna vial instead of Bivalent booster dose. The reporter had a couple of vials of the primary series in stock, out of which it was administered.   No treatment details was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Back pain
Clinical narrative: backache; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (backache) 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 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (backache). At the time of the report, BACK PAIN (backache) outcome was unknown.            No concomitant information provided The patient stated she got a vaccination this morning 3-Nov-2022 and she was fine. She was told she could take a Tylenol.  But she wanted to know if she could take Advil for back ache. No further information provided.  No treatment information provided
Sex: M
Vaccine: COVID19-2
Symptoms: Dysgeusia
Clinical narrative: Developed a metallic taste in his mouth; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Developed a metallic taste in his mouth) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-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 October 2022, the patient experienced DYSGEUSIA (Developed a metallic taste in his mouth). At the time of the report, DYSGEUSIA (Developed a metallic taste in his mouth) had not resolved.            No concomitant medications were reported.  On 03-Oct-2022, patient got the booster dose of Moderna COVID-19 vaccine, Bivalent. Felt fine after. In the last 2 weeks patient developed a metallic taste in mouth that won't go away.  No treatment medications were reported.   Reporter did not allow further contact
Age: 67.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a patient was administered 0.5mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent).    No Concomitant medications were provided. It was reported that a patient was administered 0.5 mL of Moderna Covid-19 vaccine, instead of the Moderna Covid-19 Vaccine, Bivalent. No treatment medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Oral discomfort, Oral herpes
Clinical narrative: Cold; Achy; Fever blisters; Burning bottom lip; Fatigue/ Felt rundown; The patient experienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient experienced COVID), NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters) and ORAL DISCOMFORT (Burning bottom lip) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   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) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2022, the patient experienced COVID-19 (The patient experienced COVID). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters), ORAL DISCOMFORT (Burning bottom lip) and FATIGUE (Fatigue/ Felt rundown). At the time of the report, COVID-19 (The patient experienced COVID), NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters), ORAL DISCOMFORT (Burning bottom lip) and FATIGUE (Fatigue/ Felt rundown) outcome was unknown.            No concomitant medication was reported.  Moderna's agency was reported as PRIVATE.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  No treatment medication was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Cold; Achy; Fever blisters; Burning bottom lip; Fatigue/ Felt rundown; The patient experienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient experienced COVID), NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters) and ORAL DISCOMFORT (Burning bottom lip) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis).   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) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2022, the patient experienced COVID-19 (The patient experienced COVID). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters), ORAL DISCOMFORT (Burning bottom lip) and FATIGUE (Fatigue/ Felt rundown). At the time of the report, COVID-19 (The patient experienced COVID), NASOPHARYNGITIS (Cold), PAIN (Achy), ORAL HERPES (Fever blisters), ORAL DISCOMFORT (Burning bottom lip) and FATIGUE (Fatigue/ Felt rundown) outcome was unknown.            No concomitant medication was reported.  Moderna's agency was reported as PRIVATE.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort
Clinical narrative: ended up having some issues with his heart; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISCOMFORT (ended up having some issues with his heart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISCOMFORT (ended up having some issues with his heart). At the time of the report, CARDIAC DISCOMFORT (ended up having some issues with his heart) outcome was unknown.            No concomitant medication were reported. Patient had been looking online to see if there were any reported side effects associated with the 2 lot numbers of vaccine had received. He received 2 doses of the Moderna COVID-19 vaccine in August 2021 and September 2021 (lot numbers and expiration dates were unknown). Patient ended up having some issues with his heart.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Received Moderna Covid 19 Bivalent booster instead of  second primary series; Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 39-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. 014H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-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) 1 dosage form. On 29-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022) 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 WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Bivalent booster instead of  second primary series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 25-Aug-2022 and second dose on 29-Oct-2022).    Concomitant medication was not provided. The patient received the first dose on 25-Aug-2022 Treatment information was not provided.
Sex: M
Vaccine: COVID19-2
Symptoms: Pain
Clinical narrative: More aches than usual; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (More aches than usual) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (More aches than usual). At the time of the report, PAIN (More aches than usual) 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 medication details was reported.  No treatment medication details was reported.
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Moderna vials for the primary series and they were administered instead of the Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster).    No concomitant medication information provided.  It was reported that the patients had already completed their primary series. and reported would like to know can they be revaccinated with the Bivalent at any time.  No treatment information provided.     This case considered of patient 2.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Moderna vials for the primary series and they were administered instead of the Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna vials for the primary series and they were administered instead of the Bivalent booster).    No concomitant medications were reported.  It was reported that the patient had already received the primary vaccination series and received vaccine from Moderna vial instead of Bivalent booster dose. The reporter had a couple of vials of the primary series in stock, out of which it was administered.   No treatment details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-668653, US-MODERNATX, INC.-MOD-2022-668670 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668653:Patient 1, Same reporter US-MODERNATX, INC.-MOD-2022-668670:Patient 2, Same reporter
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Pruritus, Rash, Rash erythematous, Skin burning sensation
Clinical narrative: Red rash on interior chest, Chest felt hot 4 days after vaccination 10pm evening. skin on my chest was swollen burning and itching.  I applied triamcimolone cream 0.01%. Rash only appeared at night, cream applied made help reduce redness by morning.  Doctor provided oral steroids prednisone.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Skin swelling
Clinical narrative: Red rash on interior chest, Chest felt hot 4 days after vaccination 10pm evening. skin on my chest was swollen burning and itching.  I applied triamcimolone cream 0.01%. Rash only appeared at night, cream applied made help reduce redness by morning.  Doctor provided oral steroids prednisone.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Back pain, Dizziness, Erythema, Flushing
Clinical narrative: She received an influenza vaccine and several minutes later felt flushed with reddening of skin on chest; then developed pain shooting up her back.  She then felt anxious and hyperventilated resulting in tingling in her hands and developed upper abdominal/lower chest ' pushing' sensation.  She felt light headed as though she was almost ready to lose consciousness.  She now feels well.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Hyperventilation, Pain, Paraesthesia, Presyncope, Sensory disturbance
Clinical narrative: She received an influenza vaccine and several minutes later felt flushed with reddening of skin on chest; then developed pain shooting up her back.  She then felt anxious and hyperventilated resulting in tingling in her hands and developed upper abdominal/lower chest ' pushing' sensation.  She felt light headed as though she was almost ready to lose consciousness.  She now feels well.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Frustration tolerance decreased, Impaired quality of life, Injected limb mobility decreased
Clinical narrative: Within 24 hours of receiving 2nd Booster of Moderna, the injection site (left arm) swelled up.  It was red, hot and swollen for at least 3 weeks.  Very slowly, over time, I noticed generalized pain in my left arm and restricted range of motion in my left arm.  On Aug 1st, I had a medical physical with my physician and I described my problems with my arm that had appeared since I received my 2nd booster.  She said it sounded like my shoulder and prescribed PT.  From Aug-Sept 2022, I received 16 sessions of PT and did my required exercises daily.  Instead of improving, my ROM and pain increased from Level 1 to Level 4-5.  They discharged me due to limits of my PT sessions and they recommended Acupuncture.  In Oct, I started Acupuncture to try to improve my condition.  It has been slow going and I have increased nerve pain throughout my upper left arm.  This impacts on my ability to dress without pain, put on my seatbelt, reach for objects on the side and high up, lift heavy objects, etc....  It is very debilitating, and I'm upset that it impacts on my quality of life.  Moreover, I just turned 65 and retired and Medicare doesn't cover Acupuncture so I'm paying for it out of pocket.  I don't know if Acupuncture will work or not and if not, what is my next step?  Its frustrating because I'm pro Covid vaccination and I had 3 Pfizer shots and no issues at all.  I feel that this condition is totally under reported and that is why I'm reporting it myself.  I have heard other people have had shoulder issues too since getting the vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Loss of personal independence in daily activities, Neuralgia
Clinical narrative: Within 24 hours of receiving 2nd Booster of Moderna, the injection site (left arm) swelled up.  It was red, hot and swollen for at least 3 weeks.  Very slowly, over time, I noticed generalized pain in my left arm and restricted range of motion in my left arm.  On Aug 1st, I had a medical physical with my physician and I described my problems with my arm that had appeared since I received my 2nd booster.  She said it sounded like my shoulder and prescribed PT.  From Aug-Sept 2022, I received 16 sessions of PT and did my required exercises daily.  Instead of improving, my ROM and pain increased from Level 1 to Level 4-5.  They discharged me due to limits of my PT sessions and they recommended Acupuncture.  In Oct, I started Acupuncture to try to improve my condition.  It has been slow going and I have increased nerve pain throughout my upper left arm.  This impacts on my ability to dress without pain, put on my seatbelt, reach for objects on the side and high up, lift heavy objects, etc....  It is very debilitating, and I'm upset that it impacts on my quality of life.  Moreover, I just turned 65 and retired and Medicare doesn't cover Acupuncture so I'm paying for it out of pocket.  I don't know if Acupuncture will work or not and if not, what is my next step?  Its frustrating because I'm pro Covid vaccination and I had 3 Pfizer shots and no issues at all.  I feel that this condition is totally under reported and that is why I'm reporting it myself.  I have heard other people have had shoulder issues too since getting the vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Within 24 hours of receiving 2nd Booster of Moderna, the injection site (left arm) swelled up.  It was red, hot and swollen for at least 3 weeks.  Very slowly, over time, I noticed generalized pain in my left arm and restricted range of motion in my left arm.  On Aug 1st, I had a medical physical with my physician and I described my problems with my arm that had appeared since I received my 2nd booster.  She said it sounded like my shoulder and prescribed PT.  From Aug-Sept 2022, I received 16 sessions of PT and did my required exercises daily.  Instead of improving, my ROM and pain increased from Level 1 to Level 4-5.  They discharged me due to limits of my PT sessions and they recommended Acupuncture.  In Oct, I started Acupuncture to try to improve my condition.  It has been slow going and I have increased nerve pain throughout my upper left arm.  This impacts on my ability to dress without pain, put on my seatbelt, reach for objects on the side and high up, lift heavy objects, etc....  It is very debilitating, and I'm upset that it impacts on my quality of life.  Moreover, I just turned 65 and retired and Medicare doesn't cover Acupuncture so I'm paying for it out of pocket.  I don't know if Acupuncture will work or not and if not, what is my next step?  Its frustrating because I'm pro Covid vaccination and I had 3 Pfizer shots and no issues at all.  I feel that this condition is totally under reported and that is why I'm reporting it myself.  I have heard other people have had shoulder issues too since getting the vaccination.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site erythema
Clinical narrative: redness at injection site, mom thought it was an allergic reaction.  No other symptoms of allergic reaction noticed, assessed patients skin and didn't notice anything.  No shortness of breath, itching, or swelling anywhere else.  Mom wanted him to have children's benadryl which he received 5mLs of.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Febrile convulsion
Clinical narrative: 24 hours later, febrile seizure occurred. Patient has never seized, nor had any reaction with Covid-19 vaccines #1 or #2.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test normal, Chest X-ray normal, Echocardiogram normal, Electrocardiogram normal, Syncope
Clinical narrative: On trip to see daughter. Experienced cardiac syncope after walking up five flights of stairs after dinner. First time - no history of problem. Do have a heart murmur since childhood but standard tests (EKG, echocardiograms, etc.) are all normal. Ambulance called and taken to local ER.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin increased
Clinical narrative: On trip to see daughter. Experienced cardiac syncope after walking up five flights of stairs after dinner. First time - no history of problem. Do have a heart murmur since childhood but standard tests (EKG, echocardiograms, etc.) are all normal. Ambulance called and taken to local ER.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient reported rash in armpit of left arm, that has spread to her breast and private areas on 11/4/22
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Pt presented to the clinic for a flu shot and booster COVID 19 vaccine. Flu shot given without incident, but at 9:30am, NP inadvertently gave Pfizer COVID 19 bivalent peds 0.3mL to pt. Pt tolerated both vaccines well and left the clinic. NP contacted her manager when she realized her mistake, and then notified the pt (2:20pm). Pt states he is doing well and was understanding of the mistake. NP informed pt to f/u as needed and that he may be contacted as a result of this error. Pt verbalized understanding.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: 101 fever, chills, malaise about 24 hours after receiving vacccine
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: The patient requested a booster dose of COVID vaccine,  PFIZER COVID BIVAL ( 12Y UP)  but vaccinated  PFIZER COVID (12Y UP).   the patient has not experienced any adverse events so far.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Polymerase chain reaction positive, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: mild sore throat, mild congestion, lasted about a week. No other symptoms.
Age: 3.0
Sex: F
Vaccine: COVID19, DTAP, FLU4, HEP, IPV
Symptoms: Incorrect dose administered, Malaise, Product preparation error, Pyrexia
Clinical narrative: In addition to the 4 vaccines given above, see #17 - Covid 19 Pfizer-BioNTeck Vaccine 0.2 ml dose given  (age 6 mo to less than 5 years old).  Dose given was not diluted, resulting in 15 mcg being administered instead of 3 mcg which is the normal diluted dose. MD was notified assoon as discovered the day the dose administered, but after the patient left the clinic. There was no reaction in the 15 min observation period in the clinic after administration. MD documented 11/4/22 reassessment of patient via phone call with parents who denied any side effects other than 1-2 days febrile and feeling acutely ill, which is now fully resolved. MD recommended follow up in 304 months for rest of her vaccines.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: None - pt was administered monovalent when bivalent vaccine was indicated, no adverse reaction or symptoms.
Age: 3.0
Sex: F
Vaccine: HIBV, MMRV, PNC13, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: It was reported by Mother that child had low grade fever and was vomiting the evening  that the vaccine was administered.