chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; No Adverse event; 14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-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 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.), PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) 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 (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.) and PRODUCT STORAGE ERROR (14 patients who were administered a dose from vials that were stored in the refrigerator past 30 days.).    No concomitant drug information was provided.  It was reported that 14 patient had received the vaccine which was in refrigerator past 30 days.  the vaccine used by date was 26NOV2022 however vaccine was administered on 1DEC2022.   No treatment drug details were provided.  The case contains the details of one of the 14 adult patients who had received an expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-685126 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-685126:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022; No adverse event; adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022) 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. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-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 (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022).    No concomitant product reported by reporter.  Patient received expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date. Vaccine was initially stored in refrigerator on 04-Nov-2022. Affected vial was individual vial with vial size of 5.5 ml with red cap. Vial did not undergo any temperature excursion issue.  No treatment medication reported by reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date; Question:Is Moderna authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification?Answer:Yes;Question:Does our Safety team have your consent for follow-up with you?Answer:Yes;Question:Please describe all safety information associated to the adverse event(s) you experienced by the vaccine recipient (signs & symptoms, possible causes and progression).Answer:HCP stated they administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date. Patient identifiers for patient are documented in this case. No AEs were reported.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AEs were reported.; Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported.) in a 72-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. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-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 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No AEs were reported.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.) and NO ADVERSE EVENT (No AEs were reported.) 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 AEs were reported.) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.).    Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No Adverse Event; This spontaneous case was reported by a patient and describes the occurrence of NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-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 NO ADVERSE EVENT (No Adverse Event). At the time of the report, 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 concomitant medications were reported. No treatment medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered a dose of the monovalent vacccine which was past beyond 30 day use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose of the monovalent vacccine which was past beyond 30 day use date) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose of the monovalent vacccine which was past beyond 30 day use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose of the monovalent vacccine which was past beyond 30 day use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered a dose of the monovalent vacccine which was past beyond 30 day use date).    Concomitant medications details were not reported by the reporter.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, Vial was initially placed on the refrigerator on 24-Oct-2022 and the vaccine was administered on 05-Nov-2022.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received 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 NO ADVERSE EVENT (No Adverse Event). At the time of the report, NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 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 concomitant medications were reported.  The patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown.  No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-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 07-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior) 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 (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior).    No concomitant medications were reported. Health care professional stated that a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior.  The patient has not reported any adverse reactions to this dose at this time. No treatment medications were reported.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; received a dose of Moderna COVID-19 Vaccine Biavlent before he got his 2 doses of the primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (received a dose of Moderna COVID-19 Vaccine Biavlent before he got his 2 doses of the primary series) and NO ADVERSE EVENT (No adverse event) in an 18-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Nov-2022, the patient experienced INCORRECT DOSE ADMINISTERED (received a dose of Moderna COVID-19 Vaccine Biavlent before he got his 2 doses of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received a dose of Moderna COVID-19 Vaccine Biavlent before he got his 2 doses of the primary series) 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 INCORRECT DOSE ADMINISTERED (received a dose of Moderna COVID-19 Vaccine Biavlent before he got his 2 doses of the primary series).    Concomitant medications details were not reported by the reporter.  Reportedly, Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment details were not reported by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) 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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date) 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 (administered 13 doses of Moderna COVID-19 Vaccine Bivalent after more than 30-day use by date).    No concomitant medication was provided.  No adverse events were reported.  Treatment medication was not provided by the reporter.  It was reported that identifiers for patient were documented in this case.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse Event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    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 EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date), PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) 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 (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date) and PRODUCT STORAGE ERROR (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date).    Concomitant products were not reported.  Patient identifiers for patient number 5 are documented in this case.  Treatment medications were not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.) and NO ADVERSE EVENT (No Adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.) 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 (administered 13 doses of Moderna COVID-19 Vaccine after more than 30-day use by date.).    It was reported patient identifier was patient number 10.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia
Clinical narrative: Patient complained of pain in her knees following covid booster vaccine. Reported that pain started soon after vaccine and was still there (although much reduced) 1 week later at time of this report. Just pain, no inflammation or swelling present. Patient also states that she does have arthritic pain for which she undergoes physical therapy for, but had not had pain like this before.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: IT WAS DISCOVERED AFTER THE DOSE WAS GIVEN THAT THE VACCINE WAS PAST THE DISCARD DATE OF 10 WEEKS AT REFRIGERATION TEMPERATURES.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19 pneumonia, Metabolic encephalopathy, Pneumonia bacterial
Clinical narrative: Patient received Moderna COVID vaccine on 3/3/21, 3/31/21, and 8/25/21. On 12/5/22, patient admitted to our inpatient facility (med/surg unit) with COVID-19 pneumonia, superimposed bacterial PNA, acute hypoxic respiratory failure, severe sepsis, acute metabolic encephalopathy, and AKI. As of today (12/9/22), patient is still admitted in the med/surg unit.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Superinfection
Clinical narrative: Patient received Moderna COVID vaccine on 3/3/21, 3/31/21, and 8/25/21. On 12/5/22, patient admitted to our inpatient facility (med/surg unit) with COVID-19 pneumonia, superimposed bacterial PNA, acute hypoxic respiratory failure, severe sepsis, acute metabolic encephalopathy, and AKI. As of today (12/9/22), patient is still admitted in the med/surg unit.
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Arthralgia, COVID-19, Chills, Fatigue, Oropharyngeal pain
Clinical narrative: On November 30 I began to feel in the evening chills and fever.  I then had a sore throat, fatigue and joint aches on the same evening.  The next day, December 1st I tested positive for COVID-19 on a home test.  I visited the clinic and got a PCR that was positive.  I had telehealth visit with my doctor and was prescribed Paxlovid. After I began taking this, I would wake up with a medicinal taste in the back your throat.  As of today, the only symptom I still have is fatigue.
Age: 45.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: On November 30 I began to feel in the evening chills and fever.  I then had a sore throat, fatigue and joint aches on the same evening.  The next day, December 1st I tested positive for COVID-19 on a home test.  I visited the clinic and got a PCR that was positive.  I had telehealth visit with my doctor and was prescribed Paxlovid. After I began taking this, I would wake up with a medicinal taste in the back your throat.  As of today, the only symptom I still have is fatigue.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Malaise, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Covid-19 symptoms were sore throat, headache, body aches and fever. No cough. Took Paxlovid treatment.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test
Clinical narrative: Covid-19 symptoms were sore throat, headache, body aches and fever. No cough. Took Paxlovid treatment.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Pfizer Covid Vaccine Bivalent 5-11yr was mistakenly mixed with too little diluent. Medical Assistant only used .13ml diluent instead of 1.3ml diluent to mix the vaccine, so vaccine administered was concentrated too strong. Dose drawn up and administered was .2ml. Parent notified and watched child for any additional symptoms post vaccine, but did not report any between 12-6-22 and 12-9-22.
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: injected 0.3ml of childrens covid bivalent vaccine undiluted.  patient was supposed to receive 0.3ml of adult covid bivalent vaccine.  I called pfizer.  conclusion: 0.3ml of undiluted child vaccine is equal to 0.3ml of adult vaccine.  patient received proper dose by chance.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Tinnitus began in both ears, but stronger in the right ear the same evening, approx. 2-3 hours after vaccination. As of this date (Dec 9, 2022) the tinnitus has not resolved. It is stronger in the right ear. It is nonstop.  Note that tinnitus was experienced with 1st/2nd dose of the Pfizer COVID vaccine in Spring of 2021, but had resolved after about 8 months, prior to the 3rd (booster) injection. Refer to VAERS ID: 1656053 E-Report Number: 629587
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Feeling abnormal, Pyrexia, Urinary tract infection
Clinical narrative: I had a low-grade fever on 11/18/22 with chills going to the bathroom every five minutes. The next day I felt bad, no fever or chills, started feeling better on 11/20/22. By 11/21/22 the symptoms came back, I called the doctor's office and got an appointment with the nurse practioner the next day. During the telehealth visit she diagnosed me with an UTI and prescribed Macrobid, I am feeling
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test positive, Dermatitis, Eczema nummular, Pruritus, Skin irritation
Clinical narrative: Developed progressive itching, generalized, Increasing numular eczema with itching, but itching was not limited to the areas of dermatitis. Symptoms started about a week after Moderna booster. Went first to dermatologist on July 15. Given triamcincalone 0.1%, discontinued all meds for 1 month, started Allegra 180  QD and benadryl 25mg at his. Refrained from use of the pool, which I ha been using for 19 years. Symptoms greatly improved over that month. (Trimamcinalone less effective than oral meds). In retrospect, previous covid #2 shot was on 11/9/21 and I began itching with new onset numular eczema in December. It was not until the booster that I began to think about the correlation with  the covid shot. Today, 12/9/2022, I have 3 eczematous lesions that remain (out of 12-15 previously), and no generalize itching. I still use triamcinalone occasionally. I had my bivalent booster today and will observe for any symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Nasal congestion, Pain, Respiratory tract congestion
Clinical narrative: I had low grade fever under 100, fatigue, body ache, nasal congestion, and head congestion. I tested positive for COVID-19 at home. I talked to my doctor, and she did not prescribe me anything.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had low grade fever under 100, fatigue, body ache, nasal congestion, and head congestion. I tested positive for COVID-19 at home. I talked to my doctor, and she did not prescribe me anything.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: tech pulled incorrect imz from fridge;  I did not check identity of imz.  I injected 0.3ml of undiluted covid covalent children's vaccine instead of 0.3ml of adult vaccine.  I called pfizer.  got lucky.  0.3ml of undiluted child bivdalent vaccine is same dose as 0.3ml of adult  bivalent covid vaccine
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: There were on adverse events. However, he was administered with the BOOSTER shot and he did not have the PRIMARY SERIES yet. The pharmacy had administered him with wrong vaccine shot.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exposure to SARS-CoV-2, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: I had a really sore throat, fatigue, headache and muscle aches. I took three Covid-19 tests all of which came back negative. My husband was testing positive though.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I had a really sore throat, fatigue, headache and muscle aches. I took three Covid-19 tests all of which came back negative. My husband was testing positive though.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Highly likely mother received infant/toddler Pfizer monovalent vaccine versus receiving intended Adult Pfizer bivalent vaccine.
Age: 5.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: none
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: I administered 0.3ml of undiluted childrens bivalent covid vaccine instead of 0.3ml of adult bivalent vaccine.  I called pfizer.  I got lucky.  0.3ml of undiluted children's bivalent covid vaccine is same as 0.3ml of adult bivalent covid vaccine.   patient received correct dose
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Our intern was administering the Moderna vaccine to this patient. She inserted the needle into his arm and the BD syringe plunger malfunctioned so none of the vaccine went into his body, it all came out of the barrel instead of entering his body. None of it entered his body so she re-administered the vaccination. There were no issues with the vaccine itself, just a faulty syringe.
Age: 11.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Overweight, Product administered to patient of inappropriate age
Clinical narrative: The patient is 11 years 9 months and was given the incorrect vaccine. He should have received the 5 to 11 year old solution 0f 0.2 ml. Instead he received the 12 t solution of 0.3 ml the child is robust and overweight
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Pyrexia, Rhinorrhoea
Clinical narrative: I received the Pfizer booster for COVID-19 on 9/8/2022. On 12/3/2022, I developed a scratchy throat. It persisted into 12/4/2022. I then developed fever, sneezing, cough, and runny nose that evening. I had fever and chills overnight and into 12/5/2022. I took two home antigen tests and both yielded positive results. I contacted my clinician, who prescribed PAXLOVID. I took the PAXLOVID and gradually got better. I am due to take my last dose on 12/10/2022. I was a little better on 12/08/2022 and markedly better on 12/9/2022.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sneezing, Throat irritation
Clinical narrative: I received the Pfizer booster for COVID-19 on 9/8/2022. On 12/3/2022, I developed a scratchy throat. It persisted into 12/4/2022. I then developed fever, sneezing, cough, and runny nose that evening. I had fever and chills overnight and into 12/5/2022. I took two home antigen tests and both yielded positive results. I contacted my clinician, who prescribed PAXLOVID. I took the PAXLOVID and gradually got better. I am due to take my last dose on 12/10/2022. I was a little better on 12/08/2022 and markedly better on 12/9/2022.
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial flutter, Echocardiogram abnormal, Electrocardiogram abnormal, Heart rate irregular
Clinical narrative: I had no symptoms. I went for a normal check up on 10/28/2022. They found an irregular heart rhythm, they detected and confirmed atrial flutter. 11/07/20222, I took another ECG and echocardiogram with a specialist. They gave me the option to take medication for the rest of my life or a procedure. I elected the procedure, called ablation which I will be taking in January 2023. I don't feel any symptoms.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Myalgia, Nausea
Clinical narrative: Muscle Aches, chills, nausea
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Contusion, Injection site erythema, Menstrual disorder, Oligomenorrhoea, Pain in extremity
Clinical narrative: The day of and the following morning I had sever pain in my right arm. I also had a large red bump that was hot to the touch. It turned into a bruise that lasted for 12 days. In addition my mensural cycle was 16 day late, and once my mensuration began it lasted 9 days. This is not normal for my cycles at all.  I took pictures of the site of the injection with the redness.
Age: 47.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Skin reaction, Skin warm
Clinical narrative: The day of and the following morning I had sever pain in my right arm. I also had a large red bump that was hot to the touch. It turned into a bruise that lasted for 12 days. In addition my mensural cycle was 16 day late, and once my mensuration began it lasted 9 days. This is not normal for my cycles at all.  I took pictures of the site of the injection with the redness.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Confusional state, Diarrhoea
Clinical narrative: It seemed to have greatly amplified the adverse effects of Cipro, resulting in extreme brain fog, confusion, disorientation, nausea, uncontrolable diarrhea, and I could not walk because my legs were not working. EMS had to wheel me out of my house. I was hospitalized for four days.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Disorientation, Feeling abnormal, Gait inability, Musculoskeletal disorder, Nausea
Clinical narrative: It seemed to have greatly amplified the adverse effects of Cipro, resulting in extreme brain fog, confusion, disorientation, nausea, uncontrolable diarrhea, and I could not walk because my legs were not working. EMS had to wheel me out of my house. I was hospitalized for four days.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Skull X-ray
Clinical narrative: It seemed to have greatly amplified the adverse effects of Cipro, resulting in extreme brain fog, confusion, disorientation, nausea, uncontrolable diarrhea, and I could not walk because my legs were not working. EMS had to wheel me out of my house. I was hospitalized for four days.
Age: 68.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: VACCINATION WAS ADMINISTERED LOWER THAN RECOMENDED IN BOTH ARMS DUE TO PT REFUSING TO PULL UP SWEATSHIRT TO ADMINISTER PROPERLY INTO DELTOID. PATIENT COMPLAINS OF BOTH ARMS HAVING PAIN ALL THE WAY DOWN INTO HIS ELBOW. HE SAID HE WAS VACCINATED IN HIS TENDON AND THATS WHY HE THINKS THE PAIN IS RADIATING DOWN HIS ARMS.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Bell's palsy, Drooling, Dyskinesia, Eyelid function disorder
Clinical narrative: Bels Palsy- unable to close right eye completely nor lift the eyebrow, not able to open my mouth wide enough and fluid drooled on my right lips. Meds prescribed by the dr. Prednisone and cyclovir for 7 days.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: The RN accidentally administered a Tdap on 12/02/2022 despite the patient already having Tdap on 05/2022. Right after the incident, the RN notified the incident to the patient. She didn't have any symptoms at the time and left her home. The RN sent a secure message to the patient three days later; she opened the message but did not respond.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Decreased appetite, Productive cough, Pyrexia
Clinical narrative: On Tuesday, December 6, 2022, my symptoms began as I woke up with a runny nose and a bit of a cough that was starting. I took a COVID-19 test and it was positive. I had a low-grade fever on and off. It would go up and down. As of today, I have not had a fever at all. I had chills occasionally. My appetite decreased. I had a telehealth visit with my doctor. I started PAXLOVID on Wednesday and have a few more days left. I am feeling much better today. I have had a productive cough and a runny nose.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On Tuesday, December 6, 2022, my symptoms began as I woke up with a runny nose and a bit of a cough that was starting. I took a COVID-19 test and it was positive. I had a low-grade fever on and off. It would go up and down. As of today, I have not had a fever at all. I had chills occasionally. My appetite decreased. I had a telehealth visit with my doctor. I started PAXLOVID on Wednesday and have a few more days left. I am feeling much better today. I have had a productive cough and a runny nose.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Nasal congestion, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: I had nasal congestion and a cough. I took a COVID-19 test at home and it was positive. I talked to my doctor and because my symptoms were so mild, he did not prescribe me anything. My doctor checked on me everyday to log my symptoms. I checked my fever for 6 days, but I did not have fever. My doctor told me to try to stay away from people for a couple of weeks because I still may have COVID-19 particles. I am still having sinus issues.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (COVID vaccine issue/Sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.          No concomitant and treatment medications were reported.  It was reported that female patient with events of non-serious COVID vaccine issue/Sore arm, and maternal exposure during pregnancy with Adalimumab solution for injection, single dose pen.   No medical history was reported. The fetus was exposed to maternal use of Humira in utero. It was unknown if patient was enrolled in COVID-19-Vaccine trial.  It was reported that Humira 40MG/0.4ml was citrate free. Moderna COVID-19 vaccine was also considered as suspect.
Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014A22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient never diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Rash all over (Patient applied several topical ointments but rash was not better appeared after first vaccine.) since 11-Feb-2021. Concomitant products included ATORVASTATIN for Prophylaxis.   On 02-Nov-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 and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 02-Nov-2022, the patient experienced RASH (Rash). On 07-Nov-2022, RASH (Rash) had resolved.            On 11-Feb-2021 at 02:30 PM, the patient received dose 1 of Moderna vaccine with batch number 010M20R in the arm, on 11-Mar-2021 at 02:30 PM, the patient received dose 2 of Moderna vaccine with batch number 026A21A in the arm and on 29-Dec-2021, the patient received dose 3 of Moderna vaccine with batch number 032A21A in the arm.  The event was not caused patient to seek medical care. It was unknown if there was any other potential cause. The patient was not experienced similar event in the past.  No treatment information was provided.   This case was linked to MOD-2022-669152 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (had terrible vertigo) and DIZZINESS (was so dizzy/the dizziness became more severe after Moderna, to the point where she had to sit on ground, or she would fall) 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 immunization.     The patient's past medical history included Vertigo (She usually had mild vertigo from Meniere's) and Meniere's disease (she had for 6-7 years). Previously administered products included for Drug use for unknown indication: Pfizer (patient was affected for months with side effects from the boosters she received (one Pfizer)). Past adverse reactions to the above products included Adverse event NOS with Pfizer.    On an unknown date, 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 VERTIGO (had terrible vertigo) and DIZZINESS (was so dizzy/the dizziness became more severe after Moderna, to the point where she had to sit on ground, or she would fall). At the time of the report, VERTIGO (had terrible vertigo) and DIZZINESS (was so dizzy/the dizziness became more severe after Moderna, to the point where she had to sit on ground, or she would fall) was resolving.              Treatment drug was not reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Chest discomfort, Chest pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Chest tightness), ARTHRALGIA (Left shoulder pain), PYREXIA (Fever) and CHEST PAIN (chest pain) 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.     The patient's past medical history included Pericarditis and Atrial septal defect repair (Operative closure of ASD back in mid Aug, complicated by pericarditis). Previously administered products included for Pericarditis: COLCHICINE (For about two weeks with complete resolution.). Past adverse reactions to the above products included No adverse event with COLCHICINE.         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.   On 30-Nov-2022, the patient received booster dose of mRNA-1273 BIVALENT .222. Concomitant medications was not reported. Patient spoke to physician on Tuesday (06-Dec-2022) who thought it was likely musculoskeletal. He has been asked to come to his cardiologist office for evaluation out concern for peri or myocarditis. Treatment information was not reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; They accidentally administered a patient with the Moderna Covid 19 bivalent as a primary dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (They accidentally administered a patient with the Moderna Covid 19 bivalent as a primary dose.) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     There was no parental vaccine exposure.     On 22-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 22-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 (They accidentally administered a patient with the Moderna Covid 19 bivalent as a primary dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They accidentally administered a patient with the Moderna Covid 19 bivalent as a primary 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 (They accidentally administered a patient with the Moderna Covid 19 bivalent as a primary dose.).    No concomitant medications were reported.   No treatment details were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (experienced raised, pink, itchy, and painful welts in the area of his Moderna shot),  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)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-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 07-Dec-2022, the patient experienced VACCINATION SITE PRURITUS (experienced raised, pink, itchy, and painful welts in the area of his Moderna shot),      Concomitant product use was not provided by the reporter.