chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 39-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 26-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 26-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: experiencing blood clotty like symptoms; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (experiencing blood clotty like symptoms) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for an unknown indication.    It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On 01-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (experiencing blood clotty like symptoms) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (experiencing blood clotty like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received a dose of the Johnson &J vaccine on 25-Mar-2021 and had been experiencing blood clotty like symptoms. Then after that patient received Moderna Vaccine on 01-Nov-2021. No treatment details were reported.  Company comment: This spontaneous case concerns an adult patient of unspecified age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) AESI of Thrombosis (reported as experiencing blood clotty like symptoms) that occurred in the context of mRNA-1273 vaccine in COVID-19 vaccination series. Latency could not be assessed as the exact date of onset of event was unknown. Patient had previously received a dose of COVID-19 VACCINE JANSSEN. No further information on risk factors, medical history, concurrent condition, clinical course, concomitant medication, investigations and treatment received were provided. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Gout
Clinical narrative: After the 1st dose he had more frequent gout attacks.; This spontaneous case was reported by a patient and describes the occurrence of GOUT (After the 1st dose he had more frequent gout attacks.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient received  other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Seasonal allergy, Bladder cancer, Barrett's esophagitis, Osteoarthritis and Thyroiditis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced GOUT (After the 1st dose he had more frequent gout attacks.). At the time of the report, GOUT (After the 1st dose he had more frequent gout attacks.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to MOD-2023-713982 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Arthritis, Condition aggravated, Inflammation
Clinical narrative: After the 1st dose he had more frequent gout attacks.; This spontaneous case was reported by a patient and describes the occurrence of GOUT (After the 1st dose he had more frequent gout attacks.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient received  other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Seasonal allergy, Bladder cancer, Barrett's esophagitis, Osteoarthritis and Thyroiditis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced GOUT (After the 1st dose he had more frequent gout attacks.). At the time of the report, GOUT (After the 1st dose he had more frequent gout attacks.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to MOD-2023-713982 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023; No Adverse Event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 23Jan2023 and administered on 23Feb2023).    No concomitant medicine were reported. It was reported that 6 patients administered bivalent doses after the BUD.  Vaccine  administered on 23-Feb-2023 after initially being stored in the refrigerator on 23-Jan-2023 from the bivalent Moderna covid-19 vaccine. No treatment medicine were reported. This case pertains to 4th out of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-713876 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2023: Live Significant follow up-(Batch/lot number received, Case narrative updated received); Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713876:(Master Case pt 1 of 6)
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (Dose 1, 0.5 ml) on 10-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, 0.5 ml) on 10-Mar-2021, Moderna COVID-19 Vaccine (Dose 3 and 0.25 ml) on 04-Dec-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 03-Mar-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713877, US-MODERNATX, INC.-MOD-2023-713958 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713877:Patient 3 case US-MODERNATX, INC.-MOD-2023-713958:Patient 2 case
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST today 3Mar2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 today 3Mar2023) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna COVID-19 Vaccine (First dose 0.5 mL) on 05-Mar-2021, Moderna COVID-19 Vaccine (Second dose 0.5 mL) on 01-Apr-2021, Moderna COVID-19 Vaccine (Monovalent dose 0.25 mL) on 08-Nov-2021 and Moderna COVID-19 Vaccine (Moderna monovalent dose 0.25 mL) on 17-Aug-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 03-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST today 3Mar2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 patients were given monovalent vaccine instead of the bivalent booster around 10:00 CST today 3Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were provided. Treatment medications were provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713899:same reporter US-MODERNATX, INC.-MOD-2023-713958:Patient 3 case
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patients were given monovalent vaccine instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, 0.3 ml) on 27-Jan-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and  0.3 ml) on 17-Feb-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   On 26-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2023, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 03-Mar-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patients were given monovalent vaccine instead of the bivalent booster).    The concomitant medication was not reported. The treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713899, US-MODERNATX, INC.-MOD-2023-713877 ( Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713899:Patient 1 case US-MODERNATX, INC.-MOD-2023-713877:Patient 3 case
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.).    Concomitant medication was not provided.   Treatment information was not provided.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: shakes; stiff neck; muscle pain; headache; fatigue; nausea; chills; shivers; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache) and FATIGUE (fatigue) in a 92-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose and lot number 028L20A) on 05-Feb-2021, COVID-19 VACCINE (2nd dose and lot number 023M20A) on 05-Mar-2021, COVID-19 VACCINE (3rd dose and lot number 071F21A) on 04-Nov-2021 and COVID-19 VACCINE (4th dose and lot number 057M21A) on 05-May-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (Allergies), COPD and Skin disorder.    On 13-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Feb-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), CHILLS (chills) and CHILLS (shivers). On an unknown date, the patient experienced TREMOR (shakes). At the time of the report, TREMOR (shakes), MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), CHILLS (chills) and CHILLS (shivers) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Tremor
Clinical narrative: shakes; stiff neck; muscle pain; headache; fatigue; nausea; chills; shivers; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache) and FATIGUE (fatigue) in a 92-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose and lot number 028L20A) on 05-Feb-2021, COVID-19 VACCINE (2nd dose and lot number 023M20A) on 05-Mar-2021, COVID-19 VACCINE (3rd dose and lot number 071F21A) on 04-Nov-2021 and COVID-19 VACCINE (4th dose and lot number 057M21A) on 05-May-2022. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy (Allergies), COPD and Skin disorder.    On 13-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 13-Feb-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), CHILLS (chills) and CHILLS (shivers). On an unknown date, the patient experienced TREMOR (shakes). At the time of the report, TREMOR (shakes), MUSCULOSKELETAL STIFFNESS (stiff neck), MYALGIA (muscle pain), HEADACHE (headache), FATIGUE (fatigue), NAUSEA (nausea), CHILLS (chills) and CHILLS (shivers) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Product storage error; no adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Product storage error) 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 (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  Dose of Monovalent vaccine which was expired on 26-Feb-2023, was administered to the patient. There were 1 dose 4 of unknown size vial was there. The vial was initially stored in the refrigerator on 03-Mar-2023. The vial did not undergo any temperature excursions.  No treatment details were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was administered with Covid 19 vaccine 15 days after expiration date.; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No Adverse Event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Covid 19 vaccine 15 days after expiration date.).    Concomitant medications details were not reported by the reporter. Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Treatment details was not reported by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown that patient receive other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 03-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 03-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023,) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse manager reporting that they accidently administered Monovalent dose to a patient from a lot that expired in February2023).    No concomitant medication details was reported. It was reported that Individual vials was used and vial size was 5.5ml. The vial was initially stored in the refrigerator on 03-Mar-2023.  The vial did not undergo any temperature excursions. No treatment medication details was reported.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: cannot determine if he patient took the bivalent or monovalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71448) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (cannot determine if he patient took the bivalent or monovalent).    No concomitant medications was reported.  Dosage text of suspect Spikevax Bivalent was reported as Initial Booster. Patient was trying to get booster but the HCP cannot determine if patient took the bivalent or monovalent at the time of the patients last vaccination. The HCP was not sure if the 'S is the letter 's' or the number 5. No symptoms or signs but notated AE for confusion of which vaccine the patient received.  No treatment medications was reported.   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 2 days after expiration date).    It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was administered with vaccine 2 days after expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine 2 days after expiration date) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine 2 days after expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine 2 days after expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine 2 days after expiration date).    No concomitant medications were provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Interchange of vaccine products
Clinical narrative: She got injected with Pfizer vaccines 1st and 2nd dose last Mar2021 and Apr2021, respectively, and a Moderna booster shot last Dec2021.; tightness of chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number: unknown, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion), administration date: Mar2021, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "She got injected with Pfizer vaccines 1st and 2nd dose last Mar2021 and Apr2021, respectively, and a Moderna booster shot last Dec2021."; CHEST DISCOMFORT (non-serious) with onset Dec2021, outcome "not recovered", described as "tightness of chest". It was unknown if therapeutic measures were taken as a result of chest discomfort.  Additional information: Reporter type stated as Pfizer employee. The patient is an acquaintance. In a recent conversation, she mentioned that she experienced tightness of chest after taking her covid vaccine booster shots and the condition persists until today. Upon reporter further inquiry, reporter found out that she got injected with Pfizer vaccines 1st and 2nd dose last Mar2021 and Apr2021, respectively, and a Moderna booster shot last Dec2021. Reporting this in case this is considered an adverse event - since prior the Moderna booster shot, she took Pfizer vaccine shots for her 1st and 2nd Dose. If covid prior vaccination or tested post vaccination stated as unknown. Dose 2 Lot unknown reason stated as Not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Hepatic enzyme increased, Laboratory test
Clinical narrative: elevated liver enzymes/ALT 42; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (batch/lot number: FD7218), in right arm for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Exparel, reaction: "known allergies possibly". Vaccination history included: Bnt162b2 (dose 2, batch/lot EL9269, vaccine location right arm), for COVID-19 immunization, reaction: "broken ankle", "has been quite doozy", "headaches", "highly elevated liver enzymes", "nausea", "high fever", "vomiting"; Bnt162b2 (dose 1, batch/lot EL9262, vaccine location right arm), for COVID-19 immunization, reaction: "felt little poorly for 24 hours", "slight fever". The following information was reported: HEPATIC ENZYME INCREASED (hospitalization), outcome "recovering", described as "elevated liver enzymes/ALT 42". The patient was hospitalized for hepatic enzyme increased (hospitalization duration: 4 day). The event "elevated liver enzymes/alt 42" required emergency room visit. The patient underwent the following laboratory tests and procedures: ALT: 42; liver enzymes: elevated. Clinical course: The reporter informed that facility type vaccine was at doctor's office/urgent care. The patient had no covid prior vaccination. The reporter informed that the patient experienced elevated liver enzymes after each Covid vaccine and after 3 dose, ALT was 42. The reporter informed that the AE resulted in emergency room/department or urgent care and treatment was 4-day hospital stay. The patient was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300090366 same patient/product, different dose/events;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 14Jul2022 ; Pfizer / BioNTech, Date: 07Nov2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Mar2021 as dose 1, single (Lot number: 010A21A), in left arm, on 07Apr2021 as dose 2, single (Lot number: 018B21A), in left arm, on 30Nov2021 as dose 3 (booster), single (Lot number: EW0183), in left arm and on 14Jul2022 as dose 4 (booster), single (Lot number: 016B22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Irritable Bowel syndrome" (unspecified if ongoing); "interstitial cystitis" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ibuprofen, reaction(s): "Known allergies:Ibuprofen". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Nov2022, outcome "unknown", described as "Moderna, Date: 14Jul2022 ; Pfizer / BioNTech, Date: 07Nov2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment: PAXLOVID from 22Feb2023 to 27Feb2023 as Treatment of COVID-19.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing). Concomitant medication included: SILODOSIN, start date: 11Oct2015, stop date: 02Mar2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid illness/COVID-19; Covid illness/COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XELJANZ XR oral, start date: 08Oct2019 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "Covid illness/COVID-19". Clinical course: Patient reported that she has had breaks from Xeljanz XR when getting Covid vaccines and due to covid illness in Jul2022. Stated her doctor recommended she take a week off before her vaccine and a week after. Patient can't recall when she last received a vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: I have arm pain at the injection site where I got the Pfizer shot; She had previously had two shots and two booster doses of Moderna. She got the last one as a Pfizer Booster because Moderna didn't make that last booster per the caller; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna covid vaccine (DOSE 1, SINGLE, Lot Number: 007B21A), administration date: 10Apr2021, when the patient was 57-year-old, for Covid-19 immunization; moderna covid vaccine (DOSE 2, SINGLE, Lot Number: 038A21A), administration date: 07May2021, when the patient was 58-year-old, for Covid-19 immunization; moderna covid vaccine (DOSE 3 (BOOSTER), SINGLE, Lot Number: 013F21A), administration date: 01Dec2021, when the patient was 58-year-old, for Covid-19 immunization; moderna covid vaccine (DOSE 4 (BOOSTER), SINGLE, Lot Number: 0510M21A), administration date: 07Jun2022, when the patient was 59-year-old, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Dec2022, outcome "unknown", described as "She had previously had two shots and two booster doses of Moderna. She got the last one as a Pfizer Booster because Moderna didn't make that last booster per the caller"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "I have arm pain at the injection site where I got the Pfizer shot".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "polycystic ovarian syndrome" (unspecified if ongoing); "hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.