chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache
Clinical narrative: chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 013M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose). At the time of the report, CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) had resolved.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. It was reported that patient had chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose.   This case was linked to MOD-2022-656706 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills
Clinical narrative: chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose; slight headache for 1-2 days after the most recent booster dose; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) and HEADACHE (slight headache for 1-2 days after the most recent booster dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 013F21A, 013M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient experienced HEADACHE (slight headache for 1-2 days after the most recent booster dose). On an unknown date, the patient experienced CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose). In June 2022, HEADACHE (slight headache for 1-2 days after the most recent booster dose) had resolved. At the time of the report, CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 23-Nov-2021, the patient received first booster dose.  On 10-Jun-2022, the patient received second booster dose.  Patient had chills from her upper thigh near her hip all the way down her legs for 4-6 months following each dose. She also experienced a slight headache for 1-2 days after the most recent booster dose.  Patient spoke with her HCP about her symptoms who did not provide any recommendations.  Treatment information was not provided.   This case was linked to MOD-2022-656644 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache
Clinical narrative: chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose; slight headache for 1-2 days after the most recent booster dose; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) and HEADACHE (slight headache for 1-2 days after the most recent booster dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 013F21A, 013M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient experienced HEADACHE (slight headache for 1-2 days after the most recent booster dose). On an unknown date, the patient experienced CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose). In June 2022, HEADACHE (slight headache for 1-2 days after the most recent booster dose) had resolved. At the time of the report, CHILLS (chills from her upper thigh near her hip all they way down her legs for 4-6 months following each dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 23-Nov-2021, the patient received first booster dose.  On 10-Jun-2022, the patient received second booster dose.  Patient had chills from her upper thigh near her hip all the way down her legs for 4-6 months following each dose. She also experienced a slight headache for 1-2 days after the most recent booster dose.  Patient spoke with her HCP about her symptoms who did not provide any recommendations.  Treatment information was not provided.   This case was linked to MOD-2022-656644 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Administered first dose 0n 15th apr and second dose on 23rd may; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose 0n 15th apr and second dose on 23rd may) and NO ADVERSE EVENT (no adverse event) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 005C21A) for COVID-19 prophylaxis.     The patient's past medical history included Vertigo.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose 0n 15th apr and second dose on 23rd may). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered first dose 0n 15th apr and second dose on 23rd may) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            Patient weight was reported as 150. Concomitant medication was not reported. No acute illnesses at the time of vaccination and up to one month before. Treatment drug was not reported.   This case was linked to MOD-2022-646794, MOD-2022-646300 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent) 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)) for COVID-19 vaccination.     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) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent) 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 (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent).    No concomitant medications were reported.  Reporter states that when they got the Moderna bivalent booster dose, the pharmacy manager told them that that is what they were now supposed to give, and they set aside their monovalent vaccines. One week ago, a patient came in for their 1st DOSE of the vaccine and they gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent.   Reporter did not allow further contact
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: some of the vaccine leaked down his arm; During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (some of the vaccine leaked down his arm) and DEVICE CONNECTION ISSUE (During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Oct-2022, the patient experienced UNDERDOSE (some of the vaccine leaked down his arm) and DEVICE CONNECTION ISSUE (During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm). At the time of the report, UNDERDOSE (some of the vaccine leaked down his arm) and DEVICE CONNECTION ISSUE (During this IM injection part of the needle may have disconnected from the syringe and some of the vaccine leaked down his arm) outcome was unknown.        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.   No concomitant medication was reported. No treatment details was reported. It was reported that the patient had received his 5th Moderna bivalent COVID-19 vaccine. Patient had not reported any symptoms.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands after 3rd full shot; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swollen glands after 3rd full shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia since 2012.   In May 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced LYMPHADENOPATHY (Swollen glands after 3rd full shot). At the time of the report, LYMPHADENOPATHY (Swollen glands after 3rd full shot) outcome was unknown.            No concomitant drug information was provided.  It was reported that had received 3 full doses and 1 half booster dose. Patient didn't experience any side effects after first two doses and half booster dose.  No treatment drug information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM; no adverse event; received a dose 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose 12 hours after puncture), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM) and NO ADVERSE EVENT (no adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On 10-Oct-2022 at 12:00 PM, 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 10-Oct-2022 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose 12 hours after puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose 12 hours after puncture), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM) 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 (received a dose 12 hours after puncture) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM).    Concomitant medications were not reported.  Vial size was 2.5 ml. The vial stored at room temperature post puncture and did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range for 48 hours. Treatment medications were not reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours) and NO ADVERSE EVENT (no adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2022 at 9:30 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 09-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours).    No concomitant medication information was provided.  The reporter reported that a patient was administered a dose of the Moderna COVID-19 bivalent vaccine from a vial that had been punctured for more than 12 hours. She would like to know the validity of this dose that was administered to this patient.  The vial size was 2.5 mL.  The vial was initially stored in the refrigerator on 08-Oct-2022.  The vial was first punctured on 08-Oct-2022 at 2:30 P.M.  The vial was stored in the fridge post its puncture.  The vial did not undergo any temperature excursions.  The vial was exposed to room temperature range for a period less than or equal to 24 hours.  The patient had not reported any adverse reactions at that time.  No treatment information was provided.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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 COVID-19 (Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before). The patient was treated with IVERMECTIN for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient got COVID-19 but unspecified if he got Moderna COVID-19 Vaccine before) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.         No concomitant medications were reported. It was reported that patient got COVID-19 but he took Ivermectin and 2 days later he tested negative. It was unknown whether he had received Moderna COVID-19 Vaccine.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; primary series vaccine/booster doses today to patients who intended to received bivalent vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (primary series vaccine/booster doses today to patients who intended to received bivalent vaccines).    Concomitant medications were not reported.  All doses were given by intramuscular injection at 0.5mL between 8:30-9:00 AM today. The patient was intended to receive the bivalent dose but were given monovalent vaccine as booster dose.  All these patients were over the age of 65 and were males.  This case contains information for the 1st  of 3 male patients described by the reporter.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-656976, US-MODERNATX, INC.-MOD-2022-656975 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656975:(Same reporter) US-MODERNATX, INC.-MOD-2022-656976:Same Reporter
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; body aches; bad headache ever since/very very very bad/worse than a migraine; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), MYALGIA (body aches) and HEADACHE (bad headache ever since/very very very bad/worse than a migraine) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson (First dose). Past adverse reactions to the above products included No adverse event with Johnson & Johnson.   On 07-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), MYALGIA (body aches) and HEADACHE (bad headache ever since/very very very bad/worse than a migraine). At the time of the report, CHILLS (chills), MYALGIA (body aches) and HEADACHE (bad headache ever since/very very very bad/worse than a migraine) outcome was unknown.      Concomitant medications details were not reported by the reporter.  Reportedly, patient wishes to never take the shot and new booster dose was received on Friday. It was reported that patient received two moderna booster doses followed by first dose of Pfizer vaccines.  Treatment details were not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (primary series vaccine/ Patient had received Moderna COVID-19 vaccines with monovalent presentation as booster doses on 10 oct 2022 who intended to received bivalent vaccines).    No concomitant medication was provided.  The patient was above 65 years of age.  The dose was given by intramuscular injection at 0.5mL between 8:30-9:00 AM on the day of this report. The patient was intended to receive the bivalent dose but were given monovalent vaccine as booster dose.  Treatment medication was not provided by the reporter.  This case contains information for the 2nd of 3 male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-656971, US-MODERNATX, INC.-MOD-2022-656976 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656971:(Same reporter) US-MODERNATX, INC.-MOD-2022-656976:(Same reporter)
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; primary series vaccine/booster dose to patient who intended to received bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (primary series vaccine/booster dose to patient who intended to received bivalent vaccine).    Concomitant medications were not reported. The patient was above 65 years of age. The dose was given by intramuscular injection at 0.5mL between 8:30-9:00 AM on the day of this report. The patient was intended to receive the bivalent dose but were given monovalent vaccine as booster dose. No treatment information was provided by the reporter.  This case contains information for the  3rd of 3 male patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-656971, US-MODERNATX, INC.-MOD-2022-656975 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656971:Same Reporter US-MODERNATX, INC.-MOD-2022-656975:Same Reporter
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry skin, Pyrexia, Rash
Clinical narrative: skin was dry; chills; fever; rash on chest; This spontaneous case was reported by a patient and describes the occurrence of DRY SKIN (skin was dry), CHILLS (chills), PYREXIA (fever) and RASH (rash on chest) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-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 DRY SKIN (skin was dry), CHILLS (chills), PYREXIA (fever) and RASH (rash on chest). At the time of the report, DRY SKIN (skin was dry), CHILLS (chills), PYREXIA (fever) and RASH (rash on chest) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided.  Patient had received second dose on 06 Mar 2021 and first booster on 22 Oct 2021.  Treatment medications included skin lotion which was used for dry skin.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: caught COVID 2 weeks after getting last booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (caught COVID 2 weeks after getting last booster) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2022, the patient experienced COVID-19 (caught COVID 2 weeks after getting last booster). At the time of the report, COVID-19 (caught COVID 2 weeks after getting last booster) outcome was unknown.            No concomitant medication information was provided.  The patient had received the 4th booster dose of Moderna vaccine.  The reporter was enquiring about when the patient would be eligible to receive the bivalent booster dose, was it after 90 days from the 4th booster dose or was it after 90 days from the COVID event.  No treatment information was provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscular weakness
Clinical narrative: leg went out; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULAR WEAKNESS (leg went out) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included MS. Concurrent medical conditions included Autoimmune disorder.    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 MUSCULAR WEAKNESS (leg went out). At the time of the report, MUSCULAR WEAKNESS (leg went out) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 10-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (before 8 weeks/The final dose was bivalent vaccine given less than 2 months after the completion of the primary series.).    A patient has received 3 doses of the Moderna COVID-19 vaccines by intramuscular injection. First dose on 26-JUL-2022 (lot number 051B22A, expiration date unknown), second dose on 23-AUG-2022 (lot number 044C22A, expiration date unknown) and the final dose was bivalent vaccine which given less than 2 months after the completion of the primary series.  No concomitant medications was reported. No symptoms have been reported. No additional doses, medications, or treatments have been administered.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent vaccine administered after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 12 hours post puncture) 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)) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Oct-2022 at 8:30 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 06-Oct-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine administered after more than 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 (Bivalent vaccine administered after 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 (Bivalent vaccine administered after more than 12 hours post puncture).    No concomitant medications were reported. It was reported that individual vials and vial size was 5.5 ml. On 05-OCT-2022 vial was initially stored in the refrigerator. Post puncture vial was stored in room temperature. Vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius i.e 46 to 77 degree Fahrenheit) was 22 hours. No adverse events were reported.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: No adverse event; Not sure if the patient received Bivalent or Monovalent Booster; This spontaneous case was reported by a nurse and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster) 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. AS7144B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 17-Sep-2022, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Not sure if the patient received Bivalent or Monovalent Booster).    No concomitant medication were reported. The reporter (nurse) mentioned that a MD recorded the lot number on the patient chart and vaccination card for a booster shot. The reporter mentioned that because of the date, she was sure that the shot was Bivalent but did not have proof. The reporter mentioned that they are not sure if this shot was bivalent or monovalent             No treatment information was provided by the reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received 0.5ml of the "regular" Moderna COVID19 vaccine instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received 0.5ml of the "regular" Moderna COVID19 vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received 0.5ml of the "regular" Moderna COVID19 vaccine instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received 0.5ml of the "regular" Moderna COVID19 vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received 0.5ml of the "regular" Moderna COVID19 vaccine instead of the bivalent booster).    No concomitant medication was reported.     No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657011 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657011:Case for patient patient 2.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received 0.5ml of the regular Moderna COVID19 vaccine instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received 0.5ml of the regular Moderna COVID19 vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received 0.5ml of the regular Moderna COVID19 vaccine instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received 0.5ml of the regular Moderna COVID19 vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received 0.5ml of the regular Moderna COVID19 vaccine instead of the bivalent booster).    No concomitant information was reported. It was unknown that which dose was given to the patient. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-657007 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657007:Case for patient patient 2
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: My husband caught Covid in the beginning of July 2022.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (My husband caught Covid in the beginning of July 2022.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065421A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (My husband caught Covid in the beginning of July 2022.). At the time of the report, COVID-19 (My husband caught Covid in the beginning of July 2022.) outcome was unknown.            No concomitant medications were reported. Patient received the second booster dose on 3-Apr-2022. No treatment medications were reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 040A21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). At the time of the report, PAIN IN EXTREMITY (My arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient also experienced sore arm on 18-Mar-2021 and 23-Oct-2021 after administration of 2nd dose and 1st booster respectively.  No treatment medications were reported.   This case was linked to MOD-2022-657153 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pain in extremity
Clinical narrative: My arm was sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 040A21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). At the time of the report, PAIN IN EXTREMITY (My arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Patient also experienced sore arm on 18-Mar-2021 and 23-Oct-2021 after administration of 2nd dose and 1st booster respectively.  No treatment medications were reported.   This case was linked to MOD-2022-657153 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pruritus
Clinical narrative: After 1st dose patient experienced like a burn in the left arm and back; Itching under the skin real bad without rash; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash). On 26-Feb-2021, BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-657196 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: After 1st dose patient experienced like a burn in the left arm and back; Itching under the skin real bad without rash; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash). On 26-Feb-2021, BURNING SENSATION (After 1st dose patient experienced like a burn in the left arm and back) and PRURITUS (Itching under the skin real bad without rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-657196 (Patient Link).