chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dyspnoea
Clinical narrative: shortness of breath while walking; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath while walking) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Previously administered products included for Drug use for unknown indication: Enbrel. Past adverse reactions to the above products included No adverse event with Enbrel. Concurrent medical conditions included Rheumatoid arthritis.   In September 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath while walking). At the time of the report, DYSPNOEA (shortness of breath while walking) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. On January 2022, the patient had to go to the emergency room due to her inability to catch her breath. She was diagnosed with 2 blood clots in her lungs. After further testing it was determined that the blood clots were due to the Moderna Covid vaccine. She stated that after her first dose she was having shortness of breath while walking and after the second dose it was much harder to breathe.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-658035 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: gave the Bivalent booster vaccine but they did it as .25; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25) 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. AS716513) 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 ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave the Bivalent booster vaccine but they did it as .25).    No concomitant medications were reported.  Reporter had only given this to one patient.  No treatment information was reported.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered with the monovalent vaccine 6-11years instead of the bivalent booster).    No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022; No Adverse event; patient received their 2nd primary dose 4 days after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022) and NO ADVERSE EVENT (No Adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received their 2nd primary dose 4 days after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 06-SEP-2022 and administered on 10-OCT-2022).    No concomitant medication was reported.  It was reported as patient received vaccine from individual vial and vial size was 5.5 ml. On 06-SEP-2022 vial was initially stored in refrigerator and vaccine was administered on 10-oct-2022 and vial didn't undergo any temperature excursions.  Patient dose information was also reported as Dose number 2, Moderna, Lot number 083B22A, 0.5ml on 09-Feb-2021.  No treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 1st adult patient out of 15 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658152, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658158, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658160, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658168, US-MODERNATX, INC.-MOD-2022-658173 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658149:Adult patient 2 US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658152:Adult patient 4 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5 US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6 US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7 US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658158:Adult patient 9 US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10 US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11 US-MODERNATX, INC.-MOD-2022-658161:Adult patient 12 US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13 US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14 US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Vaccine-associated immune thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.      No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IMMUNE THROMBOCYTOPENIA (Vaccine-associated immune thrombocytopenia) to be related.    Treatment and concomitant medications were not reported  Company Comment: This is a Literature-non-study case concerning a 66-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Immune thrombocytopenia, which occurred on an unknown date after mRNA-1273 vaccine, administered as third dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-658059; Sender's Comments: This is a Literature-non-study case concerning a 66-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Immune thrombocytopenia, which occurred on an unknown date after mRNA-1273 vaccine, administered as third dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-658059:83 YO Male
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 3rd adult patient out of 15 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658160 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658149:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658161:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658159:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658162:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658160:Adult patient 3
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: NOTISABLE SWELLING OF THE LEFT ARM AND SLIGHT REDNESS,  NO MOTION DIFFICULTIES.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injury associated with device
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Inflammation, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: has shortness of breath, weakness, and inflammation of the body
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Tremor
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: has shortness of breath, weakness, and inflammation of the body
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant drugs were not reported.  It was reported that patient received 0.25 mL of bivalent booster dose instead of 0.5 mL and stated that reporter called the CDC and were instructed to go ahead and administer the other half of the dose on the same day.  Treatment medications were not provided.  This case was reported for the adult patient 4.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Dizziness, Fatigue, Flushing, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in bilateral arms.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Hyperhidrosis, Hypotension, Lethargy, Nausea, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in bilateral arms.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Severe, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling in bilateral arms.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever 101.6 at 8 a.m. dropped to 99.9 by 8:40 a.m.  (after tylenol)
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Joint range of motion decreased, Limb injury
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Shoulder injury- patient describes pain and limited range of motion
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Additional Details: swelling at the injection site
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Bilateral hand tremor starting 1-2 weeks after administration of vaccine
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 vaccination. No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant medication details was not reported. Treatment details was not reported.  The reporter reported that they called the CDC and were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day. This case contains information for the fifth adult patient out of 15 adult patients as described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658173, US-MODERNATX, INC.-MOD-2022-658168 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658161:Adult patient 12, same reporter US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10, same reporter US-MODERNATX, INC.-MOD-2022-658149:Adult patient 2, same reporter US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1, same reporter US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13, same reporter US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3, same reporter US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6, same reporter US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7, same reporter US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8, same reporter US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15, same reporter US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14, same reporter
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Unable to Sleep-Severe, Additional Details: unsual discomfort
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lethargy, Pain, Rash, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Unable to Sleep-Severe, Additional Details: unsual discomfort
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 22.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medication details was reported. That case contains information for the 8th of 15 adult patients described by the reporter. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658154 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658159:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658139:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658162:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658161:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658149:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 8
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Arthritis, Condition aggravated, Gait disturbance, Joint stiffness
Clinical narrative: Started with body aches and joint pain after the vaccine, but joint pain worsened throughout the first week after vaccination.  Then bilateral knees became swollen and quite painful, bilateral ankles and hips became stiff.  Bilateral knee pain and swelling was bad enough to cause me to limp when walking. After 2 weeks of worsening inflammatory arthritis exacerbation, a message was sent to rheumatologist. Prednisone taper prescribed.  Joint pain and swelling is slowly resolving but not completely gone yet.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint swelling, Pain
Clinical narrative: Started with body aches and joint pain after the vaccine, but joint pain worsened throughout the first week after vaccination.  Then bilateral knees became swollen and quite painful, bilateral ankles and hips became stiff.  Bilateral knee pain and swelling was bad enough to cause me to limp when walking. After 2 weeks of worsening inflammatory arthritis exacerbation, a message was sent to rheumatologist. Prednisone taper prescribed.  Joint pain and swelling is slowly resolving but not completely gone yet.
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant drugs were not reported. It was reported that patient received 0.25 mL of bivalent booster dose instead of 0.5 mL and stated that reporter called the CDC and were instructed to go ahead and administer the other half of the dose on the same day. Treatment medications were not provided. This case was reported for the adult patient 9.   This case was linked to US-MODERNATX, INC.-MOD-2022-658160 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658160:Adult patient 9
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 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 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml (instead of 0.5 ml) Bivalent booster dose of Moderna COVID-19 vaccine).    Concomitant medication details was not reported. Treatment details was not reported.  The reporter reported that they called the CDC and were instructed to go ahead and administer the other half of the dose (0.25ml) on the same day.  This case contains information for the tenth adult patient out of 15 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658160, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658168, US-MODERNATX, INC.-MOD-2022-658173 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1, same reporter US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3, same reporter US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5, same reporter US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6, same reporter US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7, same reporter US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8, same reporter US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11, same reporter US-MODERNATX, INC.-MOD-2022-658162:Adult patient 13, same reporter US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14, same reporter US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15, same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medications was reported. No treatment medications was reported.  This case contains information for the 13th adult patient out of 15 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658160, US-MODERNATX, INC.-MOD-2022-658168, US-MODERNATX, INC.-MOD-2022-658173 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658149:Adult patient 2 US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10 US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1 US-MODERNATX, INC.-MOD-2022-658161:Adult patient 12 US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5 US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6 US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7 US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11 US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14 US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). Concomitant medications were not reported. No treatment information was provided by the reporter. That case contains information for the 14th adult patients out of 15 adult patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-658139 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 14.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: no adverse event; received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose) and NO ADVERSE EVENT (no adverse event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received half the dose of a bivalent Moderna COVID19 vaccine as a first booster dose).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administration error, Product preparation error
Clinical narrative: No Adverse event; excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine; excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine), PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milligram. On 07-Oct-2022, the patient experienced PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine) and PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine), PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent 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 assessments were provided for PRODUCT PREPARATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine) and PRODUCT ADMINISTRATION ERROR (excess pool from multiple vials/Two patients received pooled vaccine from the Moderna bivalent vaccine).    Concomitant product use was not provided by the reporter.   The patient had 1st dose on 22-Oct-2021, Lot Number reported as 014F21A and Expired date reported as 23-Jan-2022. The patient had 2nd dose on 17-Dec-2021 Lot Number reported as 051F21A Expired date reported as 25-Mar-2022.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-658075 (E2B Linked Report). This case was linked to MOD-2022-658264 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2022: Live follow up received included patient identifiers updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658075:patient 2( bivalent)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patient experienced little rash on her stomach from COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient experienced little rash on her stomach from COVID-19 vaccine.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis and Crohn's disease. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced RASH (Patient experienced little rash on her stomach from COVID-19 vaccine.). The patient was treated with FOLIC ACID at an unspecified dose and frequency and BIOTIN at an unspecified dose and frequency. At the time of the report, RASH (Patient experienced little rash on her stomach from COVID-19 vaccine.) had not resolved.            Patient reported a little rash on her stomach after taking COVID-19 Moderna vaccine. It has never gone away, fades sometimes and gets dark again.   This case was linked to MOD-2022-658237 (Patient Link).