chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered a dose that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 38-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 11th January 2023, the patient received the 1st dose of Havrix. On 11th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The medical assistant reported that the patient was administered with expired dose of Havrix. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 40-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The reporter was a clinic supervisor. The reporter asked for information regarding the administration of an expired dose of Twinrix to a patient. The reporter wanted to know about the information regarding revaccination. The reporter did consent to follow up. Additional supportive information: The patient received a Twinrix which was already expired, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The nurse called to report an expired dose of Bexsero was administered to a patient. The reporter consent to follow up via email. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN FEMORAL OF RIGHT LEG; This spontaneous report received from a patient concerned a 68 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: postmenopause, and other pre-existing medical conditions included: The patient never had past issues with clots. The patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A or 206AZ1A, expiry: unknown) dose was not reported, 1 total administered on 21-MAY-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855835, expiry: unknown) dose was not reported, 1 total administered on 03-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 68 years old. No concomitant medications were reported.  On 01-MAR-2022, the patient experienced blood clots in femoral of right leg, and was hospitalized (date unspecified) (Dose number in series 2). On the same day, the patient had 2 emergency surgeries (had emergency room visit). On 02-MAR-2022, the next day, the patient underwent 1 additional emergency surgery. Patient had 3 emergency surgeries due to blood clots in femoral of right leg. Patient had the 4th surgery scheduled on 10-MAR-2022 (next Tuesday). The number of days of hospitalization was reported as 16. The patient was on blood thinner apixaban (Eliquis) since surgery. The patient stated she was upset and life was going down hill.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in femoral of right leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230126072- blood clots in femoral of right leg.. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: M
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: LITTLE PAIN AND SORENESS; COVID POSITIVE; This spontaneous report received from a patient concerned an elderly male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis. The patient did not have any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total start therapy date was not reported for covid-19 prophylaxis.  The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced little pain and soreness, and was covid positive after about 6 months of booster dose (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little pain and soreness and covid positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000267015, 90000267016. This case, from the same reporter is linked to 20230129385 and 20230129371.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: FELT FAINT; FELT UNSTABLE FOR A LITTLE WHILE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced felt faint, and felt unstable for a little while. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, and felt unstable for a little while. This report was non-serious. This case, involving the same patient is linked to 20230129385. This case, from the same reporter is linked to 20230128189.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Lethargy, Nausea, Pyrexia
Clinical narrative: Extremely itchy rash on back  that keeps spreading across my back (Rash moving across my back; Extremely sore arm at injection site; Fever; Chills; Nausea; Lethargy; This case was reported by a consumer and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in 1971). Previously administered products included Shingles vaccine with an associated reaction of injection site pain (received 1st dose in September 2022, refer link case US2023AMR001909). Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine.   On 29th December 2022, the patient received the 2nd dose of Shingrix. On 1st January 2023, 3 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the patient experienced injection site pain, fever, chills, nausea and lethargy. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the injection site pain, fever, chills, nausea and lethargy were recovered/resolved.   It was unknown if the reporter considered the itchy rash, injection site pain, fever, chills, nausea and lethargy to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR001909   Additional Information: GSK receipt date: 06-JAN-2023 Reporter's comment:  The patient self-reported this case. The patient experienced rash moving across her back starting approximately on 1st January 2023, 3 days after vaccine was given. She had an extremely sore arm at injection site, fever, chills, nausea and lethargy for 24 hours.  The patient had similar but milder symptoms as first shot.  Except for this extremely itchy rash that kept spreading across her back. The symptoms were not treated. The reporter was consented to follow up via email.; Sender's Comments:  US-GSK-US2023AMR001909:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Extremely itchy rash on back  that keeps spreading across my back (Rash moving across my back; Extremely sore arm at injection site; Fever; Chills; Nausea; Lethargy; This case was reported by a consumer and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (in 1971). Previously administered products included Shingles vaccine with an associated reaction of injection site pain (received 1st dose in September 2022, refer link case US2023AMR001909). Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine.   On 29th December 2022, the patient received the 2nd dose of Shingrix. On 1st January 2023, 3 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the patient experienced injection site pain, fever, chills, nausea and lethargy. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the injection site pain, fever, chills, nausea and lethargy were recovered/resolved.   It was unknown if the reporter considered the itchy rash, injection site pain, fever, chills, nausea and lethargy to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR001909   Additional Information: GSK receipt date: 06-JAN-2023 Reporter's comment:  The patient self-reported this case. The patient experienced rash moving across her back starting approximately on 1st January 2023, 3 days after vaccine was given. She had an extremely sore arm at injection site, fever, chills, nausea and lethargy for 24 hours.  The patient had similar but milder symptoms as first shot.  Except for this extremely itchy rash that kept spreading across her back. The symptoms were not treated. The reporter was consented to follow up via email.; Sender's Comments:  US-GSK-US2023AMR001909:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received the Moderna Bivalent vaccine instead of the Monovalent as the first dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent vaccine instead of the Monovalent as the first dose) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent vaccine instead of the Monovalent as the first dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent vaccine instead of the Monovalent as the first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Bivalent vaccine instead of the Monovalent as the first dose).    Concomitant product use was not provided by the reporter. No treatment information was provided. Patient received the Moderna Bivalent vaccine instead of the Monovalent as the first dose.   This case was linked to MOD-2023-696810 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bedridden
Clinical narrative: Arthritis flared up; She was in bed for a month; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRITIS (Arthritis flared up) and BEDRIDDEN (She was in bed for a month) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Arthritis.    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 ARTHRITIS (Arthritis flared up) and BEDRIDDEN (She was in bed for a month). At the time of the report, ARTHRITIS (Arthritis flared up) and BEDRIDDEN (She was in bed for a month) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  No treatment medication information was provided by the reporter.  Company comment.  This spontaneous case concerns an adult female patient, with current condition of arthritis, who received a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine and experienced the unexpected, non  serious AESI of arthritis. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that the patient received an additional booster dose and experienced an arthritis flare up from which she was in bed for a month. No further clinical details were provided for medical reviewing. Patient´s mentioned medical history remains as risk factor for the event since is it could be part of the natural course.  The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer; patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer), COVID-19 IMMUNISATION (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer), COVID-19 IMMUNISATION (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer) and NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer), COVID-19 IMMUNISATION (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer) and COVID-19 IMMUNISATION (patient received 1 Moderna COVID-19 vaccine in 2021 and for the 2nd dose they received Pfizer).    Concomitant products were not reported.  It was reported that patient received first dose from moderna and the second dose from Pfizer vaccine.   Treatment medications were not reported.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got COVID 1 week ago; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got COVID 1 week ago) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 004F21A, 013620A and 039K20-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2023, the patient experienced COVID-19 (got COVID 1 week ago). The patient was treated with MOLNUPIRAVIR (LAGEVRIO) in January 2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (got COVID 1 week ago) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2023, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  It was reported that, Patient started with nasal congestion about 1 week ago and COVID-19 home test was positive. Patient called the doctor and doctor kept patient on Lagevrio now patient was on 5th day of the medicine.   This case was linked to MODERNATX, INC.-MOD-2023-696187 (Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696187:Same Reporter (Husband case)
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: her husband's cousin got pericarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERICARDITIS (her husband's cousin got pericarditis) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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 PERICARDITIS (her husband's cousin got pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (her husband's cousin got pericarditis) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  It was unknown whether patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication information was not reported.   Reporter did not allow further contact; Reporter's Comments: Company comment: This spontaneous case concerns an adult male patient with no reported medical history who experienced the expected serious (medically significant) AESI of Pericarditis which occurred unknown days after administration of a dose of mRNA-1273.222 bivalent vaccine. Other details have not been reported. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Her arm now hurts; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Her arm now hurts) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis. Previously patient received four dosages of COVID-19 vaccination.     On 12-Jan-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PAIN IN EXTREMITY (Her arm now hurts). At the time of the report, PAIN IN EXTREMITY (Her arm now hurts) 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.   Concomitant product use was not provided by the reporter. Patient received additional booster dosage.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: recombinant Shingrix received today 12Jan2023 on 12-Jan-2023. Past adverse reactions to the above products included No adverse event with recombinant Shingrix received today 12Jan2023.    On 12-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.) 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 (Moderna bivalent booster today 12Jan2023, but she found out the patient already got the bivalent booster back in October.).    No relevant concomitant medications were reported. No treatment medication reported.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:HCP declined to share recipient's initials or DOB. Preference for contact: Phone or email.     On 12-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.) 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 (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.).    No concomitant medication information was provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication 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), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medication were reported. No treatment medication were reported.  It was reported as unknown whether the patient used product or not until 04-Jan-2023.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.) 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 PRODUCT ADMINISTRATION INTERRUPTED (first dose more than 34 days ago. The pharmacist reports that a patient missed her second dose for a whole year. Her first dose of Moderna was on 28Apr2022.).    No concomitant product was reported. It was reported that the patient missed her second dose for a whole year. Her first dose was on 28-Apr-2022. The patient had not received the second dose yet. The patient did not receive any vaccines in the last 4 weeks. No treatment information was reported.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose administered >12 hours post puncture; 1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1417B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Dec-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Jan-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 12-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered &gt;12 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st  dose was given on 05Dec2022 and 2nd done was 12Jan2023).    No concomitant medication was reported. No treatment medication was reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AS1417B) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:None.     On 12-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On 12-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered &gt;12 hours post puncture).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Viral load abnormal
Clinical narrative: I was sick for about a week; my viral load was not high enough to show positive on a test.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick for about a week) and VIRAL LOAD ABNORMAL (my viral load was not high enough to show positive on a test.) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-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 an unknown date, the patient experienced ILLNESS (I was sick for about a week) and VIRAL LOAD ABNORMAL (my viral load was not high enough to show positive on a test.). At the time of the report, ILLNESS (I was sick for about a week) and VIRAL LOAD ABNORMAL (my viral load was not high enough to show positive on a test.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had 5 total shots of the Moderna vaccine. Patient last shot was Sept 20, 2022, which makes it about 4 months since the last latest booster. Patient was sick for about a week, but  patient suspect that the  viral load was not high enough to show positive on a test. Patient  believed Moderna did it's job and protected the patient.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Delusion of grandeur, Dyspnoea, Gene mutation, Vaccination site pain, Weight
Clinical narrative: Grandiose visions and thoughts; trouble breathing; shot altered his DNA; injection site hurt; This spontaneous case was reported by a consumer and describes the occurrence of DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt). At the time of the report, DELUSION OF GRANDEUR (Grandiose visions and thoughts), DYSPNOEA (trouble breathing), GENE MUTATION (shot altered his DNA) and VACCINATION SITE PAIN (injection site hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: weight gain.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products reported.  It was reported that the patient had trouble breathing and weight gain after receiving his Primary Series of the Moderna Covid 19 booster dose. The patient received his first Moderna Covid in the winter of 2021. Patient did not had his Immunization card. Patient did not had lot numbers, dates of administration or expiration dates. The patient took his Primary Series of the Moderna Covid -19 shots because he moved and he felt that he had to take the shot. The patient had a lot of Grandiose visions and thoughts. He thought that the shot might had been given to him to kill him. The patient was concerned that the shot altered his DNA. The patient received his second Moderna Covid-19 vaccine in the winter of 2021 about 30 days later. Patient said that his injection site hurt. Patient breathing was not the same.  No treatment products reported.   Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered; No adverse event; Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered), PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023 at 10:11 AM, 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-Jan-2023 at 10:11 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered), PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered) and PRODUCT STORAGE ERROR (Moderna Bivalent dose administered to 1 patient after 12 hours post puncture Dose administered).    Concomitant medications were not reported.  It was reported that the Moderna Bivalent dose administered to 1 patient after 12 hours post puncture dose administered greater than 12/24 hours post puncture.  Individual vial with size 2.5 mL.  On 10-Jan-2023 at 9:00 AM, the vial was first punctured, and vial was stored at room temperature post puncture. The vial exposed to room temperature for more than 24 hours. On 11-Jan-2023 at 10:11 AM, vaccine was administered.  The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Alien limb syndrome, Blood pressure measurement, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Alien Arm Syndrome; feel off when it happens; I feel Dizzy/Light headedness; she felt tired; Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases), ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens), DIZZINESS (I feel Dizzy/Light headedness) and FATIGUE (she felt tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases). On an unknown date, the patient experienced ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens), DIZZINESS (I feel Dizzy/Light headedness) and FATIGUE (she felt tired). At the time of the report, HYPERTENSION (Blood Pressure went up really high/ blood pressure increased to >200/102 mmHg/ BP increases) and DIZZINESS (I feel Dizzy/Light headedness) had not resolved and ALIEN LIMB SYNDROME (Alien Arm Syndrome), FEELING ABNORMAL (feel off when it happens) and FATIGUE (she felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2022, Blood pressure measurement: increased to >200/102 mmHg.. On 15-Mar-2022, Electrocardiogram: Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient reported that she received 3 doses of Moderna COVID-19 vaccine. After the first 2 vaccines she felt tired and she did not have any symptoms. After the 3rd shot her Blood Pressure went up really high and after that she started having symptoms every month right before her period. She went to the doctor and was diagnosed with Alien Arm Syndrome but that was not exactly what was happening. That was the closest diagnosis they could come up with. She stated, her symptoms restarted every month right before the period, Blood pressure increased, felt dizzy, light Headed, and felt off when it happened.  No treatment information was provided.