chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via Pfizer concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAR-2021 on left arm for covid-19 prophylaxis. Concomitant medications included statin. The patient received two doses of non-company suspect vaccine (Pfizer covid-19 vaccine) tozinameran (Dose number in series 2) (form of admin and route of admin were not reported, batch number: 330268D expiry: UNKNOWN) dose was not reported, administered on 08-NOV-2021 on left arm and patient received another dose (form of admin and route of admin were not reported, batch number: LP7139 expiry: UNKNOWN) administered on 01-AUG-2022 on left arm for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On 17-OCT-2022, the patient experienced (Mild symptoms and tested positive for COVID. Runny nose, slight fever and cough) confirmed covid-19 infection (Dose number in series 2) and had confirmed clinical vaccination failure (Dose number in series 1). On 18-OCT-2022, Laboratory data included: (Flowflex) COVID-19 virus test Positive (nasal swab). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000257175.; Sender's Comments: V0: 20221055802-confirmed clinical vaccination failure . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2020 and never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comments: The pharmacist reported via chat that a patient never received the second dose.   The reporter did not had the exact date of first dose, lot number and expiration date, or patient details.  At the time of reporting, the second dose had not been administered. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Fatigue, Lethargy, Pain, Pain in extremity
Clinical narrative: STILL FEELING PAIN as soon as she got off the Prednisone; FEELING LETHARGIC; Hand hurt; Feeling really/very tired as soon as she got off the Prednisone; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (STILL FEELING PAIN as soon as she got off the Prednisone), LETHARGY (FEELING LETHARGIC), PAIN IN EXTREMITY (Hand hurt) and FATIGUE (Feeling really/very tired as soon as she got off the Prednisone) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 11-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Feeling really/very tired as soon as she got off the Prednisone). On an unknown date, the patient experienced PAIN (STILL FEELING PAIN as soon as she got off the Prednisone), LETHARGY (FEELING LETHARGIC) and PAIN IN EXTREMITY (Hand hurt). At the time of the report, PAIN (STILL FEELING PAIN as soon as she got off the Prednisone) and FATIGUE (Feeling really/very tired as soon as she got off the Prednisone) had not resolved, LETHARGY (FEELING LETHARGIC) had resolved and PAIN IN EXTREMITY (Hand hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: numbers are just at where they need to be.   On unknown date, the patient experienced tired/a lot of fatigue. In 2022, tired recovered/resolved. Treatment detail was not reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.   This case was linked to MOD-2022-569498, MOD-2021-620959 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Sister in law died w/i 24 hrs of her first Moderna; This spontaneous case was reported by a non-health professional and describes the occurrence of DEATH (Sister in law died w/i 24 hrs of her first Moderna) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  This fatal spontaneous case concerns an unknown-year-old female patient with no medical history reported who experienced the unexpected seriousness criteria death event unknown days after the 1st. dose of the mRNA-1273. No further details were provided regarding the events. The reported cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns an unknown-year-old female patient with no medical history reported who experienced the unexpected seriousness criteria death event unknown days after the 1st. dose of the mRNA-1273. No further details were provided regarding the events. The reported cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Sister in law died w/i 24 hrs of her first Moderna
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Bivalent vaccine administered twice with 2 weeks apart between doses; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses) 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 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, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered twice with 2 weeks apart between doses).    No Concomitant drug information was provided by reporter.  No treatment information was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Weight decreased
Clinical narrative: weight loss/lost weight/can't get it back/legs look so skinny; very weak; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (weight loss/lost weight/can't get it back/legs look so skinny) and ASTHENIA (very weak) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2021.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (weight loss/lost weight/can't get it back/legs look so skinny) and ASTHENIA (very weak). At the time of the report, WEIGHT DECREASED (weight loss/lost weight/can't get it back/legs look so skinny) and ASTHENIA (very weak) outcome was unknown.            No relevant concomitant medications were reported.   It was reported that, Last year patient came down with COVID and went to the hospital (emergency room) for a couple days. They did not send her home with anything. She went back and they gave her an antibody infusion. Then they let her go back home that night. She did not take the vaccine before she got COVID. She had not gotten the booster. She wants to know if the infusion can cause weight loss. She lost weight and cannot get it back. Her legs looked so skinny. Her clothes did not fit anymore. She was very weak. The patient stated she took 2 Moderna shots after getting COVID and after the infusion. She thought it was 5 months later. She did not have the exact dates.   No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original) and NO ADVERSE EVENT (No Adverse event) in a 60-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original) 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 WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ were supposed to get the bivalent vaccine, but they got the original).    No concomitant drug were reported.   Patient were supposed to get the bivalent vaccine, but they got the original. Date of administration was 17-Oct-2022. There were no temperature excursions involved, and the vaccine was not expired.   No treatment drug were reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666046:Same reporter
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 30-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.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included TOFACITINIB CITRATE (XELJANZ XR) for Ulcerative colitis.    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)) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2022, SARS-CoV-2 test: Positive.         Concomitant product use was not provider by the reporter.  Patient's all prior COVID vaccines were from Moderna.  Patient had been on Xeljanz XR 11 mg daily for approximately 1 year and was doing well.  Patient had not had any UC symptoms for over 1 year. Patient had mild headache which has resolved. Patient felt well and had been working remotely. The dose patient received on 10-Oct-2022 was 3rd booster.  Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches; Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches) and VACCINATION SITE RASH (Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches) and VACCINATION SITE RASH (Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches) outcome was unknown and VACCINATION SITE RASH (Moderna rash/It was an inch away from the injection site, itchy, and about 2 inches by 2 inches) had resolved.            No concomitant medication was reported.  Patient had 3 series of an injection of Euflexxa in her knee, on 10 Oct 2022, 17 Oct 2022, and 24 Oct 2022.  Patient had to go to the emergency room on 25 Oct 2022 because she had a reaction to that third shot in her knee.  They tested patient's heart because she had shortness of breath. Blood pressure went up to 196/111.  Patient reported that she got the Moderna rash. One time it lasted a couple weeks. One time it lasted 1 week.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received his 4th Monovalent COVID-19 vaccine instead of a Bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received his 4th Monovalent COVID-19 vaccine instead of a Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS71678) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received his 4th Monovalent COVID-19 vaccine instead of a 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 his 4th Monovalent COVID-19 vaccine instead of a Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.   The patient received 4th COVID-19 vaccine and his card states that they administered 100 MCG / 0.5 ml.  The patient had requested the Bivalent Booster and got the Monovalent vaccine.   No treatment medications were reported.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction, Pain
Clinical narrative: Mild Symptoms; felt a little sick for 12 hours; felt achy for 12 hours; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Mild Symptoms), ILLNESS (felt a little sick for 12 hours) and PAIN (felt achy for 12 hours) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031LZ0A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced IMMUNISATION REACTION (Mild Symptoms), ILLNESS (felt a little sick for 12 hours) and PAIN (felt achy for 12 hours). In February 2021, ILLNESS (felt a little sick for 12 hours) and PAIN (felt achy for 12 hours) had resolved. At the time of the report, IMMUNISATION REACTION (Mild Symptoms) outcome was unknown.            It was reported that patient received first Moderna Covid 19 vaccine on 13 FEB 2021 and on the same day felt a little sick, achy for 12 hours mild symptoms.  Patient received second Moderna Covid 19 vaccine on 13 MAR 2021 and on the same day felt a little sick and achy 12 hours mild Symptoms.  No treatment medications were provided.   This case was linked to MOD-2022-666026, MOD-2022-666027 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Malaise, Pyrexia
Clinical narrative: Did not feel well; Fever; chills; I felt like I had the virus I was sick; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Did not feel well), ILLNESS (I felt like I had the virus I was sick), PYREXIA (Fever) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 001B21A and 031LZ0A) for COVID-19 prophylaxis.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, 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 experienced MALAISE (Did not feel well), ILLNESS (I felt like I had the virus I was sick), PYREXIA (Fever) and CHILLS (chills). At the time of the report, MALAISE (Did not feel well), PYREXIA (Fever) and CHILLS (chills) outcome was unknown and ILLNESS (I felt like I had the virus I was sick) had resolved.            No medical history was reported by reporter.  The dose patient received on 01-Nov-2021 was patient's first Moderna Covid 19 vaccine booster.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666051 (Linked Report). This case was linked to MOD-2022-666023, MOD-2022-666027 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666051:Crosslinked with MOD22-028079 (Husband's case)
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient received second shot of primary series in another state but again received second shot as she did not remember when and where she received vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received second shot of primary series in another state but again received second shot as she did not remember when and where she received vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received second shot of primary series in another state but again received second shot as she did not remember when and where she received vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received second shot of primary series in another state but again received second shot as she did not remember when and where she received vaccine) 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 EXTRA DOSE ADMINISTERED (Patient received second shot of primary series in another state but again received second shot as she did not remember when and where she received vaccine).    No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia
Clinical narrative: fever; not able to sleep all night; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and INSOMNIA (not able to sleep all night) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In October 2022, the patient experienced PYREXIA (fever) and INSOMNIA (not able to sleep all night). At the time of the report, PYREXIA (fever) and INSOMNIA (not able to sleep all night) outcome was unknown.            No concomitant medication information provided. Reporter wanted to know if patient can take Tylenol. No treatment information provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient who received the bivalent dose instead of the 1st monovalent dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Treatment received: monoclonal antibody infusion.) in February 2021.    On 28-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 28-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient who received the bivalent dose instead of the 1st monovalent dose).    Over a year ago patient was tested positive for COVID-19 infection.  Concomitant product use was not provided by the reporter.  The patient received the bivalent dose instead of the 1st monovalent dose in error. The patient received the bivalent for 12 years and up.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; 1st dose given at 0.25ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (1st dose given at 0.25ml) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. In March 2022, the patient experienced ACCIDENTAL UNDERDOSE (1st dose given at 0.25ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (1st dose given at 0.25ml) 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 ACCIDENTAL UNDERDOSE (1st dose given at 0.25ml).    No concomitant medications were provided. Patient not had additional doses thereafter. No treatment medication was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.) 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 WRONG PRODUCT ADMINISTERED (Received doses out of the wrong vial/ supposed to get the bivalent vaccine, but they got the original.).    No concomitant medications were reported.  Reporter states that on 17-Oct-2022 six patients received doses out of the wrong vial. They were supposed to get the bivalent vaccine, but they got the original vaccine.   Temperature excursions was not involved, and the vaccine was not expired.  No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original.) 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 WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/supposed to get the bivalent vaccine, but they got the original).    No concomitant information was reported. It was reported that there were no temperature excursions involved, and the vaccine was not expired. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666042, US-MODERNATX, INC.-MOD-2022-666046, US-MODERNATX, INC.-MOD-2022-666016, US-MODERNATX, INC.-MOD-2022-666044, US-MODERNATX, INC.-MOD-2022-666045 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666042:Same reporter US-MODERNATX, INC.-MOD-2022-666046:Same reporter US-MODERNATX, INC.-MOD-2022-666016:Same reporter US-MODERNATX, INC.-MOD-2022-666044:Same reporter US-MODERNATX, INC.-MOD-2022-666045:Same reporter
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original) and NO ADVERSE EVENT (No Adverse event) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original) 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 WRONG PRODUCT ADMINISTERED (Patient received doses out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original).    No concomitant information was reported.  It was reported that there were no temperature excursions involved, and the vaccine was not expired.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666042, US-MODERNATX, INC.-MOD-2022-666046, US-MODERNATX, INC.-MOD-2022-666043, US-MODERNATX, INC.-MOD-2022-666045, US-MODERNATX, INC.-MOD-2022-666016 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666046:Same reporter US-MODERNATX, INC.-MOD-2022-666043:Same reporter US-MODERNATX, INC.-MOD-2022-666042:Same reporter US-MODERNATX, INC.-MOD-2022-666045:Same reporter US-MODERNATX, INC.-MOD-2022-666016:Same reporter
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; received doses out of the wrong vial/get the bivalent vaccine, but they got the original.; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) in a 71-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/get the bivalent vaccine, but they got the original.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/get the bivalent vaccine, but they got the original.) 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 WRONG PRODUCT ADMINISTERED (received doses out of the wrong vial/get the bivalent vaccine, but they got the original.).    No concomitant information was reported. It was reported that there were no temperature excursions involved, and the vaccine was not expired. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-666042 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666042:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.) and NO ADVERSE EVENT (No Adverse event) in a 74-year-old female patient who received mRNA-1273 (Spikevax) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.) 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 WRONG PRODUCT ADMINISTERED (Patient received dose out of the wrong vial/Patient supposed to get the bivalent vaccine, but they got the original.).    No concomitant medications were reported. It was reported that there were no temperature excursions involved, and the vaccine was not expired. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna) and NO ADVERSE EVENT (No Adverse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) 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 (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna) 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 (Moderna COVID-19 bivalent administered to patient instead of 1st primary dose of Moderna).    No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Headache, Pyrexia
Clinical narrative: Brain fog / same thing happened when taking the Moderna vaccine for a booster; Bedridden / same thing happened when taking the Moderna vaccine for a booster; Headache / same thing happened when taking the Moderna vaccine for a booster; Fever / same thing happened when taking the Moderna vaccine for a booster; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Brain fog / same thing happened when taking the Moderna vaccine for a booster), BEDRIDDEN (Bedridden / same thing happened when taking the Moderna vaccine for a booster), HEADACHE (Headache / same thing happened when taking the Moderna vaccine for a booster) and PYREXIA (Fever / same thing happened when taking the Moderna vaccine for a booster) 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 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer Covid-19 Vaccine (dose 1, brain fog for 3 days), Pfizer Covid-19 Vaccine (dose 1, bad headache for 3 days), Pfizer Covid-19 Vaccine (After dose 2, was bedridden for 3 days with a fever.), Pfizer Covid-19 Vaccine (After dose 2 and was bedridden for 3 days.). Past adverse reactions to the above products included Bedridden with Pfizer Covid-19 Vaccine; Fever with Pfizer Covid-19 Vaccine; Foggy feeling in head with Pfizer Covid-19 Vaccine; and Headache with Pfizer Covid-19 Vaccine.  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 FEELING ABNORMAL (Brain fog / same thing happened when taking the Moderna vaccine for a booster), BEDRIDDEN (Bedridden / same thing happened when taking the Moderna vaccine for a booster), HEADACHE (Headache / same thing happened when taking the Moderna vaccine for a booster) and PYREXIA (Fever / same thing happened when taking the Moderna vaccine for a booster). At the time of the report, FEELING ABNORMAL (Brain fog / same thing happened when taking the Moderna vaccine for a booster), BEDRIDDEN (Bedridden / same thing happened when taking the Moderna vaccine for a booster), HEADACHE (Headache / same thing happened when taking the Moderna vaccine for a booster) and PYREXIA (Fever / same thing happened when taking the Moderna vaccine for a booster) had resolved.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that all events were lasted for 5 days. No treatment medications were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture) and NO ADVERSE EVENT (No Adverse Event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination.     It was unknown if the patient ever been diagnosed with or tested positive for COVID-19.  It was unknown if the patient had any acute illness and chronic illnesses at the time of vaccination.  It was unknown other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose.  Concurrent medical conditions included Drug allergy (sulfas).    On 28-Oct-2022 at 10:03 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 28-Oct-2022 at 10:03 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 1 dose of Moderna COVID-19 bivalent 19 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 (Administered 1 dose of Moderna COVID-19 bivalent 19 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 (Administered 1 dose of Moderna COVID-19 bivalent 19 hours post puncture).    It is unknown if patient was under any concomitant or regular medication.  Details of the first and second dose were unknown.  On 27-Dec-2021, the patient received booster dose (lot number 070H21A, expiration date 18-Mar-2022).  The individual vial size was 2.5 ml.  On 24-Oct-2022, the vial was initially stored in the refrigerator.  On 27-Oct-2022, at 5:18 PM, the vial was first puncture.  On 28-Oct-2022, at 10:03 AM, the vaccine was administered.  Post puncture the vial was stored at RT.  Vial did not undergone any temperature excursions.  Total amount of time the vial was exposed to room temperature range was 19 hours.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patient.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patient.).    No concomitant medications were provided. It was reported that 18 elderly patients received 0.25 mL dose instead of 0.5 mL dose The patients have not reported any adverse reactions at this time.  No treatment medication was provided. This case contains information for the 2nd of 18 elderly patients described by the reporter.