chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Monovalent doses administered after the BUD to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in an adolescent patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medication information was reported. Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A. No treatment medication information was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Nausea
Clinical narrative: feeling nauseous; headache; received the expired dose as their second dose of their primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (feeling nauseous), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (received the expired dose as their second dose of their primary series) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Dec-2022, the patient experienced NAUSEA (feeling nauseous), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (received the expired dose as their second dose of their primary series). At the time of the report, NAUSEA (feeling nauseous), HEADACHE (headache) and EXPIRED PRODUCT ADMINISTERED (received the expired dose as their second dose of their primary series) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient did call 30 minutes ago saying she was feeling nauseous and headache. Individual vials or unbroken cartons: 1 vial, 1 dose 4. Vial size was 5 ml. Did the vial undergo any temperature excursions: Not that they were aware. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccines administered after temperature excursion; Product Storage Error; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after temperature excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event) in a 0-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after temperature excursion), PRODUCT STORAGE ERROR (Product Storage Error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after temperature excursion), PRODUCT STORAGE ERROR (Product Storage Error) 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 Route), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after temperature excursion) and PRODUCT STORAGE ERROR (Product Storage Error).    No concomitant medication information was reported. The vaccines administered after temperature excursion. 20 doses were administered of bivalent Moderna COVID-19 vaccine after this excursion on 15DEC2022. No treatment medication information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Myalgia, Neck pain
Clinical narrative: joint and muscle ache; pain is on neck; I can hardly walk; night chills; joint and muscle ache; pain is on neck and right side and up to my ear, radiates to shoulder and pulsates; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (night chills), MYALGIA (joint and muscle ache), PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates), ARTHRALGIA (joint and muscle ache) and NECK PAIN (pain is on neck) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Was there parental vaccine exposure?Answer:No.  Previously administered products included for an unreported indication: COVID-19 VACCINE on 22-Jan-2021, COVID-19 VACCINE on 19-Feb-2021 and COVID-19 VACCINE on 08-Nov-2021.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Additional Booster. On 16-Dec-2022, the patient experienced CHILLS (night chills), MYALGIA (joint and muscle ache) and PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates). On an unknown date, the patient experienced ARTHRALGIA (joint and muscle ache), NECK PAIN (pain is on neck) and GAIT DISTURBANCE (I can hardly walk). At the time of the report, CHILLS (night chills), MYALGIA (joint and muscle ache) and PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates) had not resolved and ARTHRALGIA (joint and muscle ache), NECK PAIN (pain is on neck) and GAIT DISTURBANCE (I can hardly walk) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. As per patient, Friday night chills, joint and muscle ache, pain is on neck and right side and up to patient ear, radiates to shoulder and pulsates. Patient was denying to take this vaccine again. No treatment medication was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: joint and muscle ache; pain is on neck; I can hardly walk; night chills; joint and muscle ache; pain is on neck and right side and up to my ear, radiates to shoulder and pulsates; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (night chills), MYALGIA (joint and muscle ache), PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates), ARTHRALGIA (joint and muscle ache) and NECK PAIN (pain is on neck) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Was there parental vaccine exposure?Answer:No.  Previously administered products included for an unreported indication: COVID-19 VACCINE on 22-Jan-2021, COVID-19 VACCINE on 19-Feb-2021 and COVID-19 VACCINE on 08-Nov-2021.    On 16-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Additional Booster. On 16-Dec-2022, the patient experienced CHILLS (night chills), MYALGIA (joint and muscle ache) and PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates). On an unknown date, the patient experienced ARTHRALGIA (joint and muscle ache), NECK PAIN (pain is on neck) and GAIT DISTURBANCE (I can hardly walk). At the time of the report, CHILLS (night chills), MYALGIA (joint and muscle ache) and PAIN (pain is on neck and right side and up to my ear, radiates to shoulder and pulsates) had not resolved and ARTHRALGIA (joint and muscle ache), NECK PAIN (pain is on neck) and GAIT DISTURBANCE (I can hardly walk) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. As per patient, Friday night chills, joint and muscle ache, pain is on neck and right side and up to patient ear, radiates to shoulder and pulsates. Patient was denying to take this vaccine again. No treatment medication was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-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 20-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (received Bivalent Moderna COVID-19 vaccine on 28SEP2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20DEC2022 by mistake).    Didn't had any parental vaccine exposure.  Concomitant product use was not provided by the reporter.   Patient didn't received any other vaccines on the 4 weeks prior to COVID-19 vaccine.  It was reported that on 20-Dec-2022 at 11:53 AM, pharmacist called to report about 2 patients, were received Bivalent Moderna COVID-19 vaccine on 28-Sep-2022. Another HCP from the same company administered a 2nd Bivalent Booster on 20-Dec-2022 by mistake.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689943 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689943:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: received an adult bivalent dose administered more than 12 hours post puncture; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an adult bivalent dose administered more than 12 hours post puncture) 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 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 (received an adult bivalent dose administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an adult bivalent dose administered more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received an adult bivalent dose administered more than 12 hours post puncture).    Concomitant product use was not provided by the reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP wanted to know why is it only 12 hours, the limit to administer a dose after the vial was punctured, and what happens to the dose itself HCP is investigating a possible scenario but nothing has been confirmed. There could be one individual that might have received an adult bivalent dose administered more than 12 hours post puncture. No treatment information was provided.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: hard lump at and around the injection site; around the injection site that occasionally itched; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Patient had no known allergies and there was no parental vaccine exposure.  The patient's past medical history included Idiopathic thrombocytopenic purpura (child acute ITP when they were like 27 months old but is on no medication). Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 16-Dec-2022 to an unknown date for an unknown indication.    On 16-Dec-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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched). At the time of the report, VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched) 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.   Patient took first dose on 14-Jan-2021, Lot number 026L20A, took second dose on 11-Feb-2021 Lot number 032L20A.  No treatment information was provided.   This case was linked to MOD-2022-690523 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: hard lump at and around the injection site; around the injection site that occasionally itched; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Patient had no known allergies and there was no parental vaccine exposure.  The patient's past medical history included Idiopathic thrombocytopenic purpura (child acute ITP when they were like 27 months old but is on no medication). Previously administered products included for Product used for unknown indication: Influenza. Past adverse reactions to the above products included No adverse event with Influenza. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) from 16-Dec-2022 to an unknown date for an unknown indication.    On 16-Dec-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) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched). At the time of the report, VACCINATION SITE MASS (hard lump at and around the injection site) and VACCINATION SITE PRURITUS (around the injection site that occasionally itched) 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.   Patient took first dose on 14-Jan-2021, Lot number 026L20A, took second dose on 11-Feb-2021 Lot number 032L20A.  No treatment information was provided.   This case was linked to MOD-2022-690523 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.) 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. 013H22A) 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 (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date.).    No concomitant medications were reported. 7 doses of Moderna Covid-19 Vaccine, Bivalent were administered after 30-day Use By Date. Dates/number of doses: 03-Dec-2022: 3 doses, 08-Dec-2022: 1 dose, 14-Dec-2022: 1 dose and 19-Dec-2022: 2 doses. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood Glucose continues to be around 300 / patients glucose started to increase to 372; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood Glucose continues to be around 300 / patients glucose started to increase to 372) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS716813) for COVID-19 prophylaxis.     No previous Covid-19 infection.  Previously administered products included for Product used for unknown indication: Shingles Vaccine. Past adverse reactions to the above products included No adverse event with Shingles Vaccine. Concurrent medical conditions included Diabetes.    On 13-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Dec-2022,  after starting , the patient experienced BLOOD GLUCOSE INCREASED (Blood Glucose continues to be around 300 / patients glucose started to increase to 372). At the time of the report, BLOOD GLUCOSE INCREASED (Blood Glucose continues to be around 300 / patients glucose started to increase to 372) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2022, Blood glucose: started to increase to 372.     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 relevant concomitant medications were reported.   Patient received her first Moderna Covid-19 vaccine on 11-February-2021 lot number 004M20A Expiration date is not known. Patient received the vaccine in her left arm. No adverse reactions. Patient received her second Moderna Covid-19 vaccine on 12-March-2021 lot number 023M20A Expiration date is not known. Patient received the vaccine in her left arm no adverse reactions. Patient received her first Moderna Covid-19 vaccine booster dose on 27-October-2021 lot number 048C21A Expiration date is not known. Patient received the vaccine in her left arm no adverse reactions.   No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles like rash on my chest; Shingles like rash on my chest; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (Shingles like rash on my chest) and RASH (Shingles like rash on my chest) in a 57-year-old female 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.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Concomitant products included TRIAMCINOLONE DIACETATE (PROCTOSTEROID) for an unknown indication.   On 20-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started INFLUENZA VACCINE (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced HERPES ZOSTER (Shingles like rash on my chest) and RASH (Shingles like rash on my chest). At the time of the report, HERPES ZOSTER (Shingles like rash on my chest) and RASH (Shingles like rash on my chest) was resolving.        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.   The patient had no medical history, concomitant disease or risk factor. Patient had shingles like rash on chest appeared on or about 30-Nov-2022. Received the shingles vaccine in Feb 2022 and June 2022 (2 shot regmine). It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Applied steroid cream for 2 days 2x per day.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot/many people have gotten clots and died from it; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot/many people have gotten clots and died from it) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot/many people have gotten clots and died from it) (seriousness criteria death and medically significant). The cause of death was not reported. It is unknown if an autopsy was performed.        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 medications were not reported.  No treatment information was provided by the reporter.  Company comment  This spontaneous case reported by a consumer, concerns a child patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Fatal, medically significant) AESI event of Thrombosis (blood clot/many people have gotten clots and died from it), on an unspecified day after receiving an unspecified dose of mRNA-1273 vaccine. Further details on the comorbidities, medical history, clinical course, diagnostics, concomitant and treatment details were not reported. The event was reported with a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns a child patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Fatal, medically significant) AESI event of Thrombosis (blood clot/many people have gotten clots and died from it), on an unspecified day after receiving an unspecified dose of mRNA-1273 vaccine. Further details on the comorbidities, medical history, clinical course, diagnostics, concomitant and treatment details were not reported. The event was reported with a fatal outcome. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A); This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 22-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)) 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 EXTRA DOSE ADMINISTERED (accidentally got two updated boosters/Moderna bivalent booster on 28Sep2022 and 22Dec2022 (lot number 011H22A)).    It was reported that patient did not receive any vaccine four weeks prior to covid-19 vaccine and had no information about Covid-19 vaccination dose.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  It was reported that the pharmacist states the patient did not have her previous vaccinations at her pharmacy, so she doesn't have the records. She does not have an email address, so consent was given for safety to contact the pharmacist by phone.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, No adverse event
Clinical narrative: No adverse event; Giving a bivalent booster and it leaked out of the syringe; Accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. 020H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1), Moderna COVID-19 Vaccine (Dose 3) and Spikevax (Dose 2); for Flu vaccination: flu in the last 14 days (in the last 14 days.). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Spikevax, Spikevax and flu in the last 14 days.    On 21-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Dec-2022, the patient experienced DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe) and ACCIDENTAL UNDERDOSE (Accidental underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe) and ACCIDENTAL UNDERDOSE (Accidental underdose).    No concomitant medication was reported.  Reportedly, patient had received 2 primary shots and 2 booster shots from Moderna.  Reporter stated that, she was giving a patient the bivalent booster in patient's arm, but it leaked out of the syringe. The pharmacist stated that the patient did not report any side effects.  No treatment information was provided.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; dose was administered 12-hour after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered 12-hour after puncturing the vial) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered 12-hour after puncturing the vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was administered 12-hour after puncturing the vial) 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 (dose was administered 12-hour after puncturing the vial).    No concomitant medications were reported.  The information was unknown whether patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The HCP stated that a patient received Moderna vaccine for 6m-5y in morning on 22-Dec-2022 around 11 AM. The dose was administered 12-hour after puncturing the vial. The patient and parents were aware and did not report any side effects, but it only just happened 2 hours ago.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The pharmacist states she just gave a patient a booster but the patient needed the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the second dose).    No concomitant information provided  Moderna was authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Safety team have your consent for follow-up with the reporter No information was provided about previous COVID-19 vaccination pharmacist does not have the information The pharmacist stated that she gave a patient a booster but the patient needed the second dose. What were her next steps. The lot number given was 060F22A and dose was 0.5 ml. The pharmacist did not feel comfortable giving patient information. She stated the patient was crying. She gave consent for safety to contact her.  No treatment information provided   Reporter did not allow further contact
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Past lot that had been expired, administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had been expired, administered to patient) 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 (Past lot that had been expired, administered to patient).    NDCID number was reported as 80777027399. Patient age was reported as 79 years and 07 months. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Taste disorder
Clinical narrative: This is day 6 of change in taste
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash after receiving 2nd dose. rash spread over whole body. treated with antihistamines and cortisone. acute flares for about 1year, small patches persist up to today.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose drawn up 12/21/22 to be given before discharge.  Discharge delayed so not given but not discarded.  12/23 discharge planned so new dose drawn up but nurse gave expired product instead.  Room temp for 2 days.  No adverse effects.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event or signs symptoms at time of vaccination or after. Was given Flublok influenza vaccine prior to age 18.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site nodule, Injection site pain, Neck pain
Clinical narrative: Pt experienced pain in right arm from elbow to neck, bruising from elbow to injection site and a knot at injection site,
Age: 35.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Keloid scar, Pain, Skin lesion
Clinical narrative: I have pictures of the event. My immune system cannot fight off illness, it is overactive. From what I read, the intradermal regimen of the jynneos vaccine was not recommended for individuals who are immunocompromised.  The vaccine spot turned into an approximately 7cm reaction to a 0.1mg intradermal vaccine. I kept it covered with a bandaid for several days. I sleep with my arm under my thigh and the spot on my arm transferred a new spot to my thigh. The vaccine is non-replicating but my body has difficulty defending against pathogens. Because the take spread from my right fore arm to my right thigh on the medial surface, I had another lesion develop on the back of my left arm prior to the second dose of the jynneos regimen. The second dose was properly administered as the subcutaneous dose and method 28 days after the initial intradermal dose.  I have shown the lesions to several doctors at routine appointments and the only thing to do is let the lesions run their course and resolve. I am worried about scarring, which is a concern prior to the first dose and the nurse at the clinic refused to give me the appropriate regimen of the jynneos vaccine because I was unable to show her a keloid scar in a public clinic where I would have had to take off my clothes to show scars. I do get keloid scars, they can be painful. They are so ugly and angry-looking that people have mistaken my keloid scars for blood or a new injury, they are painful so I rub them until they break up and go away and are less apparent.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia
Clinical narrative: Hospitalized for weakness.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac failure congestive, SARS-CoV-2 test positive
Clinical narrative: Test positive on 12/16/22. Also noted to have acute hypoxic respiratory failure probably due to CHF per MD note. IV therapy initiated and hospital stay.
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5yr-11yr vaccine given to adult.  No known adverse outcome.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5yr-11 yr vaccine given to 13 year old.  No known adverse outcome.
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 5yr-11yr vaccine given to 13 year old.  No known adverse outcome.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle twitching, Ophthalmic migraine
Clinical narrative: Ocular Migraines Muscle twitching buttock
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthritis, Aspiration joint, Blood iron decreased, Blood test
Clinical narrative: Widespread muscle and tendon pain as well as stiffness in neck, shoulders, groin, low back. Extreme fatigue. Swelling of hands, fingers and knees. Low iron. Diagnosed with Inflammatory Arthritis. Treated with Gastroenteritis and abdominal bloating eventually treated by Gastroenterologist due to small intestine bacterial overgrowth with constipation. Worsening symptoms through rejection of two initial antiinflammatory medications prescirbed by another rheumatologist elsewhere used to treat Inflammatory Arthritis. Somewhat improving with Plaquenil started 11/26/2022 together with oral prednisonel. Continuing gastroenteritis after treatment with Xifaxin for SIBO. Low iron treated with one dose of ferheme iron infusion.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Fatigue, Gastroenteritis, Gastrointestinal bacterial overgrowth, Joint swelling
Clinical narrative: Widespread muscle and tendon pain as well as stiffness in neck, shoulders, groin, low back. Extreme fatigue. Swelling of hands, fingers and knees. Low iron. Diagnosed with Inflammatory Arthritis. Treated with Gastroenteritis and abdominal bloating eventually treated by Gastroenterologist due to small intestine bacterial overgrowth with constipation. Worsening symptoms through rejection of two initial antiinflammatory medications prescirbed by another rheumatologist elsewhere used to treat Inflammatory Arthritis. Somewhat improving with Plaquenil started 11/26/2022 together with oral prednisonel. Continuing gastroenteritis after treatment with Xifaxin for SIBO. Low iron treated with one dose of ferheme iron infusion.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Tendon pain, X-ray
Clinical narrative: Widespread muscle and tendon pain as well as stiffness in neck, shoulders, groin, low back. Extreme fatigue. Swelling of hands, fingers and knees. Low iron. Diagnosed with Inflammatory Arthritis. Treated with Gastroenteritis and abdominal bloating eventually treated by Gastroenterologist due to small intestine bacterial overgrowth with constipation. Worsening symptoms through rejection of two initial antiinflammatory medications prescirbed by another rheumatologist elsewhere used to treat Inflammatory Arthritis. Somewhat improving with Plaquenil started 11/26/2022 together with oral prednisonel. Continuing gastroenteritis after treatment with Xifaxin for SIBO. Low iron treated with one dose of ferheme iron infusion.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pressure increased
Clinical narrative: When I went for my annual physical my blood pressure was elevated. I monitored for 4 weeks and returned to the doctor. It was still elevated. I started medication Losartan Pot 25 mg. Will return for a recheck.
Age: 1.5
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Pt in clinic for dose #1 of Covid vaccine.  Staff accidentally drew up and administered a bivalent vial instead of a monovalent vial.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Blood test
Clinical narrative: June 1 2021 , I loss my  senses of taste  still up to today
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Contusion
Clinical narrative: Severe bruising
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Vaccine error administered by other provider discovered upon chart review. A five year old patient received the Pfizer 5 - 11 year monovalent covid vaccine instead of the recommended Pfizer 6 month - 4 year monovalent covid vaccine for their second dose. The patient was 4 years at the time of their first covid vaccination so current CDC guidance for persons who turn from 4 to 5 years during the series and began their covid vaccine series with the Pfizer 6 month - 4 year vaccine is for the person to complete two doses of the Pfizer 6 month - 4 year monovalent vaccine and then a third dose of the Pfizer 6 month - 4 year bivalent vaccine at least 8 weeks after the second dose. The patient has experience no adverse effects. The error was reported to and reviewed with the mother of the patient today.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given pfizer bivalent booster dose of 0.2mL for his second dose of his vaccination series.  Patient was suppose to recieve a monovalent dose for his second dose.  No actual advere ever happened, incorrect valent vaccine was used for second dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Underdose
Clinical narrative: The patient was mistakenly given the moderna primary dose for pediatric patients, as the bottle is still labeled "for booster dose only", but was supposed to get the moderna bivalent booster. The patient was informed of the mistake and did not have any adverse reactions. She decided to delay getting the bivalent booster in January after the holidays.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient was mistakenly given the moderna primary dose for pediatric patients, as the bottle is still labeled "for booster dose only", but was supposed to get the moderna bivalent booster. The patient was informed of the mistake and did not have any adverse reactions. She decided to delay getting the bivalent booster in January after the holidays.