chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Headache, Pruritus, Rosacea
Clinical narrative: rosy cheeks every once in a while; some itchiness on her head; experience pain like someone is pressing knuckles into her head; Patient started to notice hair loss; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Patient started to notice hair loss), ROSACEA (rosy cheeks every once in a while), PRURITUS (some itchiness on her head) and HEADACHE (experience pain like someone is pressing knuckles into her head) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, D37B21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, the patient experienced ALOPECIA (Patient started to notice hair loss), PRURITUS (some itchiness on her head) and HEADACHE (experience pain like someone is pressing knuckles into her head). On an unknown date, the patient experienced ROSACEA (rosy cheeks every once in a while). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ALOPECIA (Patient started to notice hair loss), PRURITUS (some itchiness on her head) and HEADACHE (experience pain like someone is pressing knuckles into her head) had not resolved and ROSACEA (rosy cheeks every once in a while) outcome was unknown.            No concomitant medications were reported.   On an unspecified date in January the patient started to notice hair loss. She also continued to experience pain like someone was pressing knuckles into her head and some itchiness on her head. This was continued, off and on, up until the day of this report. The patient also had rosy cheeks every once in a while. The patient visited 2 internists and 2 dermatologists for her symptoms and was treated with topical steroids for 2 weeks and ibuprofen or aspirin a couple of times.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: Sore shoulder; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 BIVALENT (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 07-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder) and CHILLS (Chills). At the time of the report, ARTHRALGIA (Sore shoulder) and CHILLS (Chills) had not resolved.            No Concomitant medication was reported.  No treatment information was provided. The reporter reported that the reporter knew that these side effects were normal.
Sex: M
Vaccine: COVID19
Symptoms: Skin cancer
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of SKIN CANCER (skin cancer in the ear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced SKIN CANCER (skin cancer in the ear) (seriousness criterion medically significant). At the time of the report, SKIN CANCER (skin cancer in the ear) outcome was unknown. Concomitant product use was not provided by the reporter. Patient was diagnosed with skin cancer in the ear 1 month ago and needed surgery for that few days ago. Company comment: This spontaneous case reported by a patient concerns a male patient of unknown age with no reported medical history who experienced the unexpected serious (medically significant) event of Skin cancer (skin cancer in the ear). Patient received 4 doses of mRNA-1273 Vaccine. The event occurred unknown days after the mRNA-1273 Vaccine. Patient needed surgery for the skin cancer. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement. Sender's Comments: This spontaneous case reported by a patient concerns a male patient of unknown age with no reported medical history who experienced the unexpected serious (medically significant) event of Skin cancer (skin cancer in the ear). Patient received 4 doses of mRNA-1273 Vaccine. The event occurred unknown days after the mRNA-1273 Vaccine. Patient needed surgery for the skin cancer. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID in May; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (had COVID in May) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccinations (second dose) and Pfizer COVID-19 vaccinations (first dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccinations and Pfizer COVID-19 vaccinations.    In March 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (had COVID in May). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (had COVID in May) outcome was unknown.            No concomitant drug was reported. Patient received first Moderna COVID-19 booster dose. Company comment: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 2 months after administration of third dose of mRNA-1273, the specific date of administration of third dose of mRNA-1273 and onset of the event was not specified. Initial two doses of Pfizer were administered on unspecified dates. It has been reported that the patient was treated with Paxlovid at unspecified dose and frequency. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 2 months after administration of third dose of mRNA-1273, the specific date of administration of third dose of mRNA-1273 and onset of the event was not specified. Initial two doses of Pfizer were administered on unspecified dates. It has been reported that the patient was treated with Paxlovid at unspecified dose and frequency. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 4.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early) and NO ADVERSE EVENT (No adverse event) in a 4-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (We gave the 2nd dose of the Moderna Covid-19 Vaccine to a 4yo 1 week early).    No concomitant medications was reported. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (cancer) outcome was unknown. No concomitant medications were reported. She had her 4th shot back in May-2022. It was unknown whether the cancer was diagnosed prior to or after getting the vaccine. The patient was advised to get the bivalent booster dose before she starts with chemotherapy. No treatment medications were reported. Company comment: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) event of neoplasm malignant an unknown time after the fourth dose of mRNA-1273. Information regarding event onset (before or after vaccine), specific neoplasm, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) event of neoplasm malignant an unknown time after the fourth dose of mRNA-1273. Information regarding event onset (before or after vaccine), specific neoplasm, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Respondent received Moderna and stated they became very ill after receiving the vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Respondent received Moderna and stated they became very ill after receiving the vaccines) 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 ILLNESS (Respondent received Moderna and stated they became very ill after receiving the vaccines). At the time of the report, ILLNESS (Respondent received Moderna and stated they became very ill after receiving the vaccines) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient's race was reported as black/white. Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; 5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.) and NO ADVERSE EVENT (No Adverse event) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 vaccination.     No medical history was reported.     On 06-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.).    No concomitant and treatment medication was reported. The patient's height was 2ft 3 inch (68.58 cm). The patient received the vaccine after the 30 days use by date and the vial passed by 34 hours.  The vial was initially stored in the refrigerator on 05-Aug-2022. The vial did not undergo any temperature excursions. No adverse event was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-642057, US-MODERNATX, INC.-MOD-2022-642060, US-MODERNATX, INC.-MOD-2022-642052 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642052:Same reporter US-MODERNATX, INC.-MOD-2022-642060:Same reporter US-MODERNATX, INC.-MOD-2022-642057:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; bivalent booster administered at 0.25ml instead of 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (bivalent booster administered at 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 06-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (bivalent booster administered at 0.25ml instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (bivalent booster administered at 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 (bivalent booster administered at 0.25ml instead of 0.5ml).    No concomitant medications were reported.  Pharmacist reported that the patient was inadvertently given the Moderna bivalent vaccine at 0.25ml instead of 0.5ml on 06-Sep-2022.  No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Sep-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine). 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 a 3rd booster dose of the monovalent Moderna COVID-19 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a 3rd booster dose of the monovalent Moderna COVID-19 Vaccine).    Concomitant medications details were not reported by the reporter.  It was reported that the patient intended to receive a booster dose from the bivalent presentation, but did not.  No additional doses, medications or treatments had been administered at this time.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: she had horrible side effects from her second booster worse aches,pains; fatigue; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (she had horrible side effects from her second booster worse aches,pains), FATIGUE (fatigue) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (she had horrible side effects from her second booster worse aches,pains), FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (she had horrible side effects from her second booster worse aches,pains), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.            No concomitant medications were reported.  The patient took second booster and had horrible side effects like worst aches, pains, fatigue and fever. The patient was told to take Tylenol by pharmacist.  On 07-Sep-2022, the patient took Omicron Moderna booster and took a couple of Tylenol after that as a precaution. The patient did not report side effects after taking the bivalent booster.   This case was linked to MOD-2021-018845 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (He thinks the needle fell from the syringe. He is not sure if he got the appropriate dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant medications were reported.   It was reported that, when the patient was getting his booster shot, the person giving the dose to him said that something fell off and she scrambled. He thought the needle fell from the syringe. The patient was not sure if he got the appropriate dose. The patient had no side effects and he was fine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-642850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642850:Crosslinked with case (Wife case)
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Illness
Clinical narrative: She even hallucinated; The vaccine made her very sick; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (She even hallucinated) in a 57-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (She even hallucinated) (seriousness criterion medically significant) and ILLNESS (The vaccine made her very sick). At the time of the report, HALLUCINATION (She even hallucinated) and ILLNESS (The vaccine made her very sick) had resolved.        The action taken with mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Treatment information was not provided.  Company comment: This spontaneous case concerns a 57-years-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) Hallucination that occurred in context to a dose of mRNA-1273.222 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding medical history and treatment details. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 57-years-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) Hallucination that occurred in context to a dose of mRNA-1273.222 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No additional information is available regarding medical history and treatment details. The event outcome was resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: administered 0.25 ml of the bivalent dose instead of 0.50 ml; No Adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 (administered 0.25 ml of the bivalent dose instead of 0.50 ml).    No Concomitant medications were provided. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-643040 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-643040:1st patient case
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml; No Adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) in an elderly male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 (Patient was administered 0.25 ml of the bivalent dose instead of 0.50 ml).    No concomitant medications were provided by the reporter. The patient was administered 0.25 ml instead of 0.50 ml of the bivalent vaccine. No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-642993 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642993:1st patient case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she felt crummy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (she felt crummy) in a 75-year-old female patient who received mRNA-1273 BIVALENT (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: Pfizer (3 Pfizers), Pfizer (3 Pfizers) and Pfizer (3 Pfizers). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (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 (she felt crummy). At the time of the report, FEELING ABNORMAL (she felt crummy) outcome was unknown.            No concomitant medications were reported.  It was reported that the patient received 3 Pfizers and 1 Moderna. Patient thought that Moderna worked better because patient felt crummy afterwards.  Patient was a pro vaccination individual. It was came to light that Moderna was using the dark blue cap with gray writing on the new bivalent omicron vaccine that was coming out. The patient read last time for adults for the regular vaccines, but that the same dark blue cap was what was used for children 6-11. There was concern that there were going to be confusion and mishandling of these particular vaccines. As a very mature adult at 75, patient was not interested in getting something that would help a 6-11 year old child. Patient did not understood why Moderna would not do something with more common sense involved and had like a purple top for the newest one, or an orange top - something that was absolutely different and nobody could make a mistake. A lot of these people who were administering shots were very busy and stressed, and they might not take a look at what was actually in the vial and grab the wrong one. Patient was reading that the caps on the Pfizer and Moderna weren't completely different. Patient also called Pfizer.   No treatment information was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Live follow up received quality complaint number added. On 08-Sep-2022: Live follow up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FALL (Fall). At the time of the report, FALL (Fall) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of FALL was not provided for HUMIRA. No treatment medications were provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event, Product availability issue
Clinical narrative: No adverse event; patient received the monovalent booster instead of bivalent booster; received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster) and PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster), PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (patient received the monovalent booster instead of bivalent booster) and PRODUCT AVAILABILITY ISSUE (received the monovalent booster, instead of the bivalent booster due to no availability of the bivalent on 02-SEP-2022).    No relevant concomitant medications were reported.   The patient was traveling who was requiring booster. The patient was traveling before the bivalent booster became available.  The patient have not reported any adverse reactions.  It was reported that no expired dose was given to the patient on 02-SEP-2022.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product label confusion
Clinical narrative: The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received sixth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT LABEL CONFUSION (The Pharmacist is confused about the dosing of the Moderna Covid- 19 bivalent 6th dose which is 0.25 or 0.5 ml.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medications details were not reported.  It was reported that the Pharmacist would like to know if the 0.5 or 0.25 could be given as an immunocompromised booster dose. The pharmacist was confused because the bivalent vial said that was for 0.25 or 0.5 ml. However, the vial did not indicate who was getting which dose. They used 0.25 ml for the previous boosters, and that was ingrained in everyone's brains. The pharmacist mentioned that for Pfizer that was easy because the same dosage was used.  No treatment medication was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever of 100.5; chills; Arm was hurting very badly; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting very badly), PYREXIA (fever of 100.5) and CHILLS (chills) in an 81-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Sep-2022, the patient experienced PAIN IN EXTREMITY (Arm was hurting very badly). On 08-Sep-2022 at 5:00 AM, the patient experienced PYREXIA (fever of 100.5) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 08-Sep-2022 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was hurting very badly) and CHILLS (chills) outcome was unknown and PYREXIA (fever of 100.5) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2022, Body temperature: 100.5. On 08-Sep-2022, SARS-CoV-2 test: (Negative) Negative.         Patient received 4 doses of the Moderna COVID-19 vaccine by intramuscular injection on 6FEB2021 (lot number 023M20A), On 26MAR2021 (lot number 018B21A), On 29OCT2021 (lot number 014F21A), and  On 4APR2022 (lot number 048L21A).  No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: breakthrough infection; This spontaneous case was reported by a consumer and describes the occurrence of BREAKTHROUGH COVID-19 (breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT (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 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (breakthrough infection). At the time of the report, BREAKTHROUGH COVID-19 (breakthrough infection) outcome was unknown. Not Provided          Patient was not a clinical trial participant.  No concomitant medications were reported.  It was reported that patient had a breakthrough infection after having Moderna booster vaccine.  No treatment information was reported.  Company comment: This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Breakthrough COVID-19 that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. The details of previous 2 vaccines and date of current administration were not provided. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. Ongoing COVID-19 pandemic could be a confounder for the event Breakthrough COVID-19. The benefit-risk relationship of mRNA-1273.222  Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Breakthrough COVID-19 that occurred unknown days after receiving the third dose (booster ) of mRNA-1273.222 vaccination in COVID-19 vaccination series. The details of previous 2 vaccines and date of current administration were not provided. No further details on risk factors, medical history, clinical course, additional vaccination details, concomitant medications and treatment details were provided. The outcome of the report was unknown at the time of report. Ongoing COVID-19 pandemic could be a confounder for the event Breakthrough COVID-19. The benefit-risk relationship of mRNA-1273.222  Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive) in a male 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. In June 2022, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  The patient had appointment for tryout on 16-Jun-2022 but unfortunately he could not be present as tested positive during that week.   Company comment: This spontaneous case reported by a patient concerns a male patient of unknown age with no reported medical history who experienced the unexpected non-serious AESI of SARS-CoV-2 test positive. The event occurred unknown days after the mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a male patient of unknown age with no reported medical history who experienced the unexpected non-serious AESI of SARS-CoV-2 test positive. The event occurred unknown days after the mRNA-1273 Vaccine. Other details are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Symptom recurrence
Clinical narrative: SYMPTOMS STARTED GETTING BACK AGAIN; This spontaneous case was reported by a patient and describes the occurrence of SYMPTOM RECURRENCE (SYMPTOMS STARTED GETTING BACK AGAIN) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced SYMPTOM RECURRENCE (SYMPTOMS STARTED GETTING BACK AGAIN). At the time of the report, SYMPTOM RECURRENCE (SYMPTOMS STARTED GETTING BACK AGAIN) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  The reporter's causality for the event(s) of symptoms started getting back again with Humira (adalimumab) was a reasonable possibility and with mRNA-1273 (Spikevax) as possibly related.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial stored at room temperature on counter under a cup and away from light after post puncture for 21 hrs; No adverse event; Moderna vaccine administered over 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered over 12 hours post puncture), PRODUCT STORAGE ERROR (Vial stored at room temperature on counter under a cup and away from light after post puncture for 21 hrs) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 006M21A and 052B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 09-Sep-2022 at 9:30 AM, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 09-Sep-2022 at 9:30 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered over 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored at room temperature on counter under a cup and away from light after post puncture for 21 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered over 12 hours post puncture), PRODUCT STORAGE ERROR (Vial stored at room temperature on counter under a cup and away from light after post puncture for 21 hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered over 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial stored at room temperature on counter under a cup and away from light after post puncture for 21 hrs).    No concomitant medications were reported. It was stated that Moderna vaccine was removed from fridge on 08-Sep-2022, at 12:03 PM, was not discarded at midnight, morning on 09-Sep-2022, vaccine was administered to a patient at 9:30 AM, which was more than 12 hours. The vaccines received were thawed with a use by date. But they removed from their refrigerator on 08-Sep-2022. Post puncture vial was stored at room temperature on counter under a cup, away from light. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 21 hours. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2022: Follow-up received included patient date of birth updated.