chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023; No adverse event; Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023), PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023), PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023) and PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023).    No concomitant drug was reported. Vial size reported as 5.5 ml. It was reported that the vial did not undergo any temperature excursions. No side effect reported. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716329, US-MODERNATX, INC.-MOD-2023-716138 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716329:Same reporter US-MODERNATX, INC.-MOD-2023-716138:Same reporter US-MODERNATX, INC.-MOD-2023-716138:
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023; No adverse event; Primary series vaccines Expired on 02/28/2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023), PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 083822A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023), PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Primary series vaccines Expired on 02/28/2023) and PRODUCT STORAGE ERROR (The vaccines Expired on 02/28/2023, vial was initially stored in the refrigerator on 7Mar2023, Date of administration of vaccine 17Mar2023).    No concomitant medication were reported.  The vaccines expired on 28-FEB-2023 but was not delivered to pharmacy until 07-MAR-2023 and 3 patients were administered this vaccine on 17-MAR-2023 and no side effects were reported. Vial size was 5.5 mL. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716139, US-MODERNATX, INC.-MOD-2023-716329 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716139: US-MODERNATX, INC.-MOD-2023-716329:same reporter
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent vaccine was administered the vaccine was beyond the BUD; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered the vaccine was beyond the BUD) and NO ADVERSE EVENT (No adverse event) 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. 062F22A) 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 EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered the vaccine was beyond the BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was administered the vaccine was beyond the BUD) 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 (Bivalent vaccine was administered the vaccine was beyond the BUD).    No concomitant medications were reported.  No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP mentioned that they accidentally administered a patient with the expired vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP mentioned that they accidentally administered a patient with the expired vaccine.).    No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dyspnoea, Palpitations
Clinical narrative: Immediate cough; shortness of breath; racing heart; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Immediate cough), DYSPNOEA (shortness of breath) and PALPITATIONS (racing heart) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Dec-2022, the patient experienced COUGH (Immediate cough), DYSPNOEA (shortness of breath) and PALPITATIONS (racing heart). At the time of the report, COUGH (Immediate cough), DYSPNOEA (shortness of breath) and PALPITATIONS (racing heart) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had immediate cough, shortness of breath, racing heart from 07-Dec-2022 and still pressent. Much testing done. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine expired on 12-Feb-2023/removed from freezer to thaw on 20-Mar-2023).    No concomitant medications was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patients had shots around 8:30 in morning. No side effects have been reported. The vial did not undergone any temperature excursions. Level 5 incarcerated inmates. Reporter says they will monitor the inmates.   No treatment medications was reported.  This case contains information for the 1 of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716277, US-MODERNATX, INC.-MOD-2023-716279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716279:Patient 3 out of 3 Patients US-MODERNATX, INC.-MOD-2023-716277:Patient 2 out of 3 Patients
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; The vaccine expired Feb-2023 and dose administered after manufacturer date of expiry; The vial was removed from freezer to thawed on 20-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine expired Feb-2023 and dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was removed from freezer to thawed on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired Feb-2023 and dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was removed from freezer to thawed on 20-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine expired Feb-2023 and dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was removed from freezer to thawed on 20-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The vaccine expired Feb-2023 and dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was removed from freezer to thawed on 20-Mar-2023).    Concomitant medication was not provided.   It was reported that the vial were 3 doses. The vial was removed from freezer to thawed on 20-Mar-2023 and was administered to 3 patient on 20-Mar-2023. The vial did not undergo any temperature excursion. Treatment information was not provided. This case contains information for the 3rd patient out of 3 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716275 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716275:Patient 1 out of 3 Patients US-MODERNATX, INC.-MOD-2023-716277:Patient 2 out of 3 Patients
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever/feeling feverish; nausea; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever/feeling feverish) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/feeling feverish) and NAUSEA (nausea). At the time of the report, PYREXIA (fever/feeling feverish) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient wanted to report negative side effects of the Moderna COVID19 vaccine. Patient only received 2 doses. The caller discarded his vaccination card -1st dose when it was available, and 2nd dose when it was available. Following vaccination with the Moderna COVID19 immediately after the 2nd dose within a day patient experienced fever, nausea and feeling feverish. The duration of the symptoms: The symptoms never went away. The two weeks experiencing bad fever nauseas made the patient to take a magnesium Zn supplement and only with that did it subside and furthermore still had to take the supplement because if it stop taking them within 3 days his symptoms begin again.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Underdose
Clinical narrative: No adverse event; The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023; The patient received only 0.2 ml of second dose; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023), UNDERDOSE (The patient received only 0.2 ml of second dose) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1417B and AS1417B) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 27-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .2 milliliter. On 20-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023) and UNDERDOSE (The patient received only 0.2 ml of second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023), UNDERDOSE (The patient received only 0.2 ml of second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the first dose on 27-Feb-2023 and second dose on 20-Mar-2023) and UNDERDOSE (The patient received only 0.2 ml of second dose).    No concomitant medications were provided. The patient had received Influenza vaccine also on 27-Feb-2023. The medical assistant needs to know if there were any contraindications of getting the COVID vaccine 7 days early.  The patient did not experienced any adverse reactions. No treatment medication was provided.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 27-Feb-2023, 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 27-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient also received a dose on Feb 27, 2023 booster bivalent dose as second dose).    No concomitant medications were reported.  Patient was looked for a second dose of the booster, patient asked for documentation that stated that a second dose was not approved to provide to a doctor. Caller only received a 1st COVID vaccine in 2021 Caller does not have patient previous vaccination card, as patient wanted to re start patient's vaccination process.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered pediatric vaccine to adult patient; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered pediatric vaccine to adult patient) 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. AS1412B) 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, the patient experienced WRONG PRODUCT ADMINISTERED (Administered pediatric vaccine to adult patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered pediatric vaccine to adult patient) 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 (Administered pediatric vaccine to adult patient).    No concomitant medication was reported.    No treatment information was reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 034F21A, 012A21A and 026L20A) for COVID-19 prophylaxis.     The patient's past medical history included Leg amputation.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced RASH PRURITIC (had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching). At the time of the report, RASH PRURITIC (had a rash which keeps getting worse/ /the itching momentarily, but as soon as it's dry it continued itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had been to the clinic where they gave him a couple different things to try but nothing was working. It started to clear up but then came right back. He had gone onto a website and seen some other people reported the same thing. This rash was initially down his chest and stomach. Now it had extended down his right leg, foot, buttocks, chest, and stomach. It was everywhere but his face. He had been using a topical medication prescribed to him and a lotion he got from Walmart. Applied this medication morning and night. This relieved the itching momentarily, but as soon as it's dry it continued itching.   No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: got soreness in the arm only after the second one but that went away in a day or two. No redness at site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (got soreness in the arm only after the second one but that went away in a day or two. No redness at site) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (got soreness in the arm only after the second one but that went away in a day or two. No redness at site). At the time of the report, VACCINATION SITE PAIN (got soreness in the arm only after the second one but that went away in a day or two. No redness at site) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Patient received 4 shots. Original two, booster and bivalent booster, all Moderna. Patient had the Bivalent with no reaction.   Reporter mentioned on the line that they had the Moderna vaccine and got soreness in the arm only after the second one but that went away in a day or two. No redness at site.   No treatment drug was reported.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; little triredness after getting the vaccines; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (little triredness after getting the vaccines) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Dec-2022, the patient received fifth 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 IN EXTREMITY (sore arm) and FATIGUE (little triredness after getting the vaccines). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (little triredness after getting the vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient has tolerated the vaccines well. No treatment drug details was reported.   This case was linked to MOD-2023-716296 (Patient Link).   Reporter did not allow further contact
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023) and NO ADVERSE EVENT (No adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to 12 year old on 03/14/2023Vaccine expired 03/12/2023).    No concomitant medications were reported.  The event expired vaccine used was coded conservatively as there was mention of two conflicting dates for the vaccine expiration. Administered expired vaccine to 12-year-old on 14-Mar-2023 Vaccine expired 12-Mar-2023 vaccines were pulled from freezer 10-Mar-2023 Nurse who pulled vaccines noted they were set for expiration 30 days from that date which is 09-Apr-2023.  No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Therapeutic response unexpected
Clinical narrative: weakness; chills; After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (weakness), CHILLS (chills) and THERAPEUTIC RESPONSE UNEXPECTED (After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Headache dull, Chest heaviness and Angina pectoris.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), CHILLS (chills) and THERAPEUTIC RESPONSE UNEXPECTED (After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.). At the time of the report, ASTHENIA (weakness) and CHILLS (chills) had resolved and THERAPEUTIC RESPONSE UNEXPECTED (After I got my 1st shot, It cleared up most of those issues. After 2nd dose, the issues were completely gone.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Patient had chills and weakness with both doses of the vaccine. Before the shot, patient had already been dealing with a dull headache, heaviness in chest, some angina and some other things.  No treatment drug was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Product storage error; Poor quality vaccine administered; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     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 PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications details were reported.  It was reported that, there was a question about vaccine that was given and was stored in the fridge instead of the freezer.  No treatment medications details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Mar-2023: Follow-up received includes non significant information
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023; No adverse event; Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023), PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023), PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 28-Feb-2023 was administered to patient on 17-Mar-2023) and PRODUCT STORAGE ERROR (The vial which was expired on 28-Feb-2023 was initially stored in refrigerator on 07-Mar-2023 and was administered to patient on 17-Mar-2023).    Concomitant drugs were not reported.  It was reported that monovalent vial of 5.5 ml size was not delivered to pharmacy until 07-Mar-2023. The vial was not exposed to any temperature excursion. No side effects were reported.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716139, US-MODERNATX, INC.-MOD-2023-716138 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716139:same reporter US-MODERNATX, INC.-MOD-2023-716138:same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of a monovalent vaccine).    Patient relevant medical history conditions, allergy, concomitant diseases and risk factor were unknown. No concomitant medication was reported.    HCP stated no AEs were reported. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: rash; 1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0119l1a and 041l20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021). On an unknown date, the patient experienced RASH (rash). At the time of the report, RASH (rash) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RASH (rash) to be related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna 28-Jan-2021 and 2nd dose Moderna 16-Feb-2021).    No concomitant medications were reported.     Following vaccination patient started to experience not right after, in Feb or March 2021 a terrible rash. Patient went to the dermatologist, had several creams and treatments Patient received the booster dose of Moderna COVID-19 vaccine on 11-Nov-2021 (lot number: 013f21a) and booster dose of Moderna COVID-19 vaccine, Bivalent on 22-Dec-2022 (lot number: 043h22a). Patient believed it was related to the vaccine as she never had that before.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) 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 EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.) 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 (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.).    No concomitant medication was reported.    Patient received Additional Booster dose. No treatment information was reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 20-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A second dose of the Moderna COVID-19 vaccines was given after the published expiration date on 20-MAR-2023).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Concurrent medical conditions included High cholesterol, Thyroid disorder and Urinary retention. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Urinary retention.    On 19-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). In December 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Negative.     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.   The patient was taking a generic statin for high cholesterol and medication for thyroid.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient received Moderna COVID-19 Vaccine 1st dose on 05-FEB-2021, 2nd dose on 04-MAR-2021, 1st booster on 01-APR-2021. Patient got mild COVID-19 on 06-DEC-2022, even after receiving bivalent booster. Symptoms experienced by patient included chills, achiness, headache, congestion of nose, cough and nasal drip. Patient came negative 9 or 10 days later. No treatment was given.   This case was linked to MOD-2021-304506 (Patient Link).