chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: FELT KIND OF LIGHT HEADED; This spontaneous report received from a patient concerned a 4 decade old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 31-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 37 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced felt kind of light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt kind of light headed. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Completed suicide, Pain
Clinical narrative: KILLED THEMSELVES; ADVERSE EVENT NOS; TREMENDOUS PAIN; This spontaneous report received from a consumer concerned multiple patients (27 patients).  The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy dates were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients killed themselves because of adverse event to vaccines (coded as adverse event nos) and had tremendous pain daily. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tremendous pain and adverse event nos was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221134051.; Sender's Comments: V0- 20221134487-Covid-19 vaccine ad26.CoV-2.s. -Killed themselves -The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable; Reported Cause(s) of Death: SUICIDE
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: FEEL LIKE CRAP; WIPED OUT; This spontaneous report received from a consumer via other manufacturer (Novavax) concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after the booster shot, the patient was wiped out and felt like crap (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wiped out and feel like crap was not reported. This report was non-serious.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: placed in the fridge and given beyond the 30-day expiration to 7 patients; No adverse event; dose given beyond 30-day expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date), PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose given beyond 30-day expiration date) and PRODUCT STORAGE ERROR (placed in the fridge and given beyond the 30-day expiration to 7 patients).    No concomitant medication was reported.  The caller called and said that the vials were initially stored in the refrigerator on 06-Jul-2022. It was unknown if individual vials or unbroken cartons were used. The vial size was unknown. The caller needed information on stability after 30 days and if there were recommendations on revaccination.  The vials did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2022: Live Follow-up contains suspect product information updated. On 10-Nov-2022: Live Follow-up contains patient demographic added.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pruritus
Clinical narrative: 20 minutes after the dose patient felt a little sore arm and an itchy feeling all over; 20 minutes after the dose patient felt a little sore arm and an itchy feeling all over; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) and PAIN IN EXTREMITY (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, 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 14-Nov-2022, the patient experienced PRURITUS (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) and PAIN IN EXTREMITY (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) had not resolved and PAIN IN EXTREMITY (20 minutes after the dose patient felt a little sore arm and an itchy feeling all over) outcome was unknown.            No concomitant medications were reported.  Patient previously had received Moderna COVID-19 vaccines by Intramuscular Injection on 02-Mar-2021 with lot number 030A21A, on 30-Mar-2021 with lot number 019B21A, and on 20-Nov-2021. Expiration dates were not known. Patient took a Benadryl which helped, though itching had persisted. After last dose patient had no troubles while breathing.   This case was linked to MOD-2021-031887 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Received Monovalent booster instead of Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of Bivalent).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-672558, US-MODERNATX, INC.-MOD-2022-672557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672558:1st Elderly patient US-MODERNATX, INC.-MOD-2022-672557:1st Elderly patient
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022; No adverse event; Expired dose given/ Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired dose given/ Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 06-Oct-2022, the refrigerator expiration was on 06-Nov-2022 and date of administration was on 07-Nov-2022).    No concomitant medication information provided. The vial did not undergo any temperature excursions. No treatment information provided.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; 3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.) and NO ADVERSE EVENT (no adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Nov-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (3 yr old received 0.25 mL Moderna Bivalent vaccine as a booster.).    No concomitant medications were reported. No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Flu Like symptoms after the first primary dose for 3 days; A lot of Pain all over the body after the first primary dose for 3 days; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms after the first primary dose for 3 days) and PAIN (A lot of Pain all over the body after the first primary dose for 3 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms after the first primary dose for 3 days) and PAIN (A lot of Pain all over the body after the first primary dose for 3 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In July 2021, INFLUENZA LIKE ILLNESS (Flu Like symptoms after the first primary dose for 3 days) and PAIN (A lot of Pain all over the body after the first primary dose for 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. The patient had received 2 primary doses of Moderna COVID-19 vaccine. The patient had dose 2 Primary monovalent dose on unknown date (Lot and Expiry Date: unknown). After the 2nd dose, she did not had any side effects.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. In August 2022, the patient experienced ARTHRALGIA (shoulder pain). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). In 2022, ARTHRALGIA (shoulder pain) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.            Concomitant medications were not reported.   Patient received Moderna covid-19 vaccine (details unknown).  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the events of Flu like symptoms and shoulder pain with Adalimumab Solution for Injection was No Reasonable Possibility.  The reporter's causality for the event(s) of Flu like symptoms and shoulder pain with Moderna COVID-19 vaccine (Elasomeran) was No Reasonable Possibility.  AbbVie's opinion was that the causality for the event(s) of Flu like symptoms and shoulder pain with Adalimumab Solution for Injection was Not Provided.  AbbVie's opinion was that the causality for the event(s) of Flu like symptoms and shoulder pain with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.  HUMIRA 40MG/0.4ML Shoulder pain, Non-Health Care Professional, Not Related  Treatment medications were not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Sciatica
Clinical narrative: sciatic pain; COVID-19; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (sciatic pain), COVID-19 (COVID-19) and ILLNESS (Sickness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782590) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 and ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced ILLNESS (Sickness). On 30-Aug-2021, the patient experienced COVID-19 (COVID-19). On 19-Aug-2022, the patient experienced SCIATICA (sciatic pain). At the time of the report, SCIATICA (sciatic pain) had not resolved, COVID-19 (COVID-19) had resolved and ILLNESS (Sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  There was no reported medical history.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. On 2021-08-23, the patient experienced sciatic pain. On unknown date, sciatic pain recovered/resolved. The reporter's causality for the event(s) of covid-19, sciatic pain and sciatic pain with Adalimumab Solution for Injection was No Reasonable Possibility.  HUMIRA COVID-19, Non-Health Care Professional, Global Introspection, Not Related. HUMIRA Sciatica, Non-Health Care Professional, Global Introspection, Not Related  Agency's opinion was that the causality for the event(s) of covid-19, sciatic pain, sciatic pain and sick with paxlovid (nirmatrelvir;ritonavir) was not provided.  Agency's opinion was that the causality for the event(s) of covid-19, sciatic pain, sciatic pain and sick with adalimumab solution for injection was not provided  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) 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. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    No concomitant medications were reported. 27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.                                 No treatment information was reported. This case is for the 1st patient out of 27 adult patients described by the reporter.
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet; they cannot find a facility where it is currently available; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet), PRODUCT AVAILABILITY ISSUE (they cannot find a facility where it is currently available) and NO ADVERSE EVENT (No adverse event) in an 11-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet), PRODUCT AVAILABILITY ISSUE (they cannot find a facility where it is currently available) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient was told to come back for the 2nd dose after 9-10 weeks/1st dose was on 21-Aug-2022, no 2nd dose yet), PRODUCT AVAILABILITY ISSUE (they cannot find a facility where it is currently available) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Fatigue, Feeling abnormal, Influenza like illness, Myalgia
Clinical narrative: My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes; my bones hurt; felt like I'd been run over by a truck; I felt tired, like the flu; My muscles were sore; I felt tired; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and MYALGIA (My muscles were sore) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: DPT. Past adverse reactions to the above products included Near death experience with DPT. Concurrent medical conditions included COPD.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu), MYALGIA (My muscles were sore) and FATIGUE (I felt tired). In August 2021, the patient experienced FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes). On 18-Jul-2021, FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and FATIGUE (I felt tired) had resolved. At the time of the report, FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt) and MYALGIA (My muscles were sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided  Reported that patient had COPD, stamina and endurance, all that gone at the time of report. When patient got the inoculation, DPT, when he was a kid, patient almost died. When patient went to get the 1st dose patient told them about that. They put him off for a few months. On 16Jul2021 patient got the 1st dose of the Moderna Covid-19 vaccine. A couple of hours later, patient felt like he would been run over by a truck. Patient felt tired, like the flu, patient felt like that for 3 days. Muscles were sore, patients bones hurt and soul was hurt. August 2021 a month later, patient felt changes. Patients shins felt like he jumped off a 10 story building.   No treatment information provided   This case was linked to MOD-2022-672550 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes; my bones hurt; felt like I'd been run over by a truck; I felt tired, like the flu; My muscles were sore; I felt tired; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and MYALGIA (My muscles were sore) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: DPT. Past adverse reactions to the above products included Near death experience with DPT. Concurrent medical conditions included COPD.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu), MYALGIA (My muscles were sore) and FATIGUE (I felt tired). In August 2021, the patient experienced FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes). On 18-Jul-2021, FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and FATIGUE (I felt tired) had resolved. At the time of the report, FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt) and MYALGIA (My muscles were sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided  Reported that patient had COPD, stamina and endurance, all that gone at the time of report. When patient got the inoculation, DPT, when he was a kid, patient almost died. When patient went to get the 1st dose patient told them about that. They put him off for a few months. On 16Jul2021 patient got the 1st dose of the Moderna Covid-19 vaccine. A couple of hours later, patient felt like he would been run over by a truck. Patient felt tired, like the flu, patient felt like that for 3 days. Muscles were sore, patients bones hurt and soul was hurt. August 2021 a month later, patient felt changes. Patients shins felt like he jumped off a 10 story building.   No treatment information provided   This case was linked to MOD-2022-672550 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Migraine, Pain
Clinical narrative: My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes; my bones hurt; felt like I'd been run over by a truck; I felt tired, like the flu; My muscles were sore; I felt tired; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and MYALGIA (My muscles were sore) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: DPT. Past adverse reactions to the above products included Near death experience with DPT. Concurrent medical conditions included COPD.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced BONE PAIN (my bones hurt), FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu), MYALGIA (My muscles were sore) and FATIGUE (I felt tired). In August 2021, the patient experienced FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes). On 18-Jul-2021, FEELING ABNORMAL (felt like I'd been run over by a truck), INFLUENZA LIKE ILLNESS (I felt tired, like the flu) and FATIGUE (I felt tired) had resolved. At the time of the report, FEELING ABNORMAL (My shins felt like I jumped off a 10 story building/my soul hurt/I felt changes), BONE PAIN (my bones hurt) and MYALGIA (My muscles were sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided  Reported that patient had COPD, stamina and endurance, all that gone at the time of report. When patient got the inoculation, DPT, when he was a kid, patient almost died. When patient went to get the 1st dose patient told them about that. They put him off for a few months. On 16Jul2021 patient got the 1st dose of the Moderna Covid-19 vaccine. A couple of hours later, patient felt like he would been run over by a truck. Patient felt tired, like the flu, patient felt like that for 3 days. Muscles were sore, patients bones hurt and soul was hurt. August 2021 a month later, patient felt changes. Patients shins felt like he jumped off a 10 story building.   No treatment information provided   This case was linked to MOD-2022-672550 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received a Bivalent booster before they got their primary series today; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a Bivalent booster before they got their primary series today).    No concomitant medications were reported.  Reported that a patient received a Bivalent booster before he got his primary series of vaccine on 14-Nov-2022. The dose was supposed to be his first dose however they were under the understanding the patient had received the previous vaccines and gave Bivalent booster dose to the patient.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Nov-2022: Follow-up information received includes patient demographics (initial, gender and date of birth) and suspect vaccine details (lot number and start date) were added. Reporter details and I-narrative supplement were updated.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Arm blew up; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Arm blew up) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (booster) and flu. Past adverse reactions to the above products included No adverse event with Pfizer and flu. Concurrent medical conditions included Egg allergy.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm blew up). At the time of the report, LIMB DISCOMFORT (Arm blew up) had resolved.            Concomitant medications were not reported.  They put ice on patient arm and next day arm was okay. Treatment medications were not reported.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included COVID-19 (1st COVID on 04 or 11-Mar-2022 tested positive, Paxlovid taken for 5 days felt better shortly.) in March 2022. Previously administered products included for Flu vaccination: Flu vaccine (Flu yearly (around October)) on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided.  The Patient received first dose on 26-Jan-2021 with lot number 030L20A, second dose on 23-Feb-2021 with lot number 031L20A, 1st booster dose on 21-Nov-2021 with lot number 034F21A, 2nd booster dose on 08-Apr-2022 with lot number 002M21A.  She states that this was the 2nd time she got the COVID after getting the Moderna COVID-19 vaccine. She says that she thanks Moderna for the vaccine but she was quite disappointed because she had all the doses and yet she ended up getting it twice.  The AE cause patient to seek medical care at office consult only no hospitalization.  The symptoms were still ongoing.  It was reported that prescribed with Mucinex DM by doctor, day 4 of illness at the time of call.   This case was linked to US-MODERNATX, INC.-MOD-2022-672539 (Linked Report). This case was linked to MOD-2022-672560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672539:Husband's case
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Chills, Cough, Oropharyngeal pain, Pyrexia
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included COVID-19 (1st COVID on 04 or 11-Mar-2022 tested positive, Paxlovid taken for 5 days felt better shortly.) in March 2022. Previously administered products included for Flu vaccination: Flu vaccine (Flu yearly (around October)) on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided.  The Patient received first dose on 26-Jan-2021 with lot number 030L20A, second dose on 23-Feb-2021 with lot number 031L20A, 1st booster dose on 21-Nov-2021 with lot number 034F21A, 2nd booster dose on 08-Apr-2022 with lot number 002M21A.  She states that this was the 2nd time she got the COVID after getting the Moderna COVID-19 vaccine. She says that she thanks Moderna for the vaccine but she was quite disappointed because she had all the doses and yet she ended up getting it twice.  The AE cause patient to seek medical care at office consult only no hospitalization.  The symptoms were still ongoing.  It was reported that prescribed with Mucinex DM by doctor, day 4 of illness at the time of call.   This case was linked to US-MODERNATX, INC.-MOD-2022-672539 (Linked Report). This case was linked to MOD-2022-672560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672539:Husband's case
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included COVID-19 (1st COVID on 04 or 11-Mar-2022 tested positive, Paxlovid taken for 5 days felt better shortly.) in March 2022. Previously administered products included for Flu vaccination: Flu vaccine (Flu yearly (around October)) on 27-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 21-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications were provided.  The Patient received first dose on 26-Jan-2021 with lot number 030L20A, second dose on 23-Feb-2021 with lot number 031L20A, 1st booster dose on 21-Nov-2021 with lot number 034F21A, 2nd booster dose on 08-Apr-2022 with lot number 002M21A.  She states that this was the 2nd time she got the COVID after getting the Moderna COVID-19 vaccine. She says that she thanks Moderna for the vaccine but she was quite disappointed because she had all the doses and yet she ended up getting it twice.  The AE cause patient to seek medical care at office consult only no hospitalization.  The symptoms were still ongoing.  It was reported that prescribed with Mucinex DM by doctor, day 4 of illness at the time of call.   This case was linked to US-MODERNATX, INC.-MOD-2022-672539 (Linked Report). This case was linked to MOD-2022-672560 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672539:Husband's case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Monovalent booster instead of Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Monovalent booster instead of Bivalent).    No concomitant information was reported. No treatment information was provided. The case was reported for elderly patient 2 out of 3.   This case was linked to US-MODERNATX, INC.-MOD-2022-672558, US-MODERNATX, INC.-MOD-2022-672524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672558:3rd Elderly patient US-MODERNATX, INC.-MOD-2022-672524:1st Elderly patient
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine) 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 (4 year old received the pediatric Moderna vaccine instead of the toddler Moderna vaccine).    Concomitant medications details were not reported by the reporter. It was reported that patient height and weight were unknown. Treatment details was not reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 030L20A, 031L20A and 034F21A) for COVID-19 vaccination.     The patient had no allergies. There was no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (tested positive for Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: Positive.         Concomitant medications details were not reported by the reporter. Patient got COVID in May-2022 (11-14) shortly after she got the second booster dose. Patient took Paxlovid for 5 days felt better shortly.   This case was linked to US-MODERNATX, INC.-MOD-2022-672539 (E2B Linked Report). This case was linked to MOD-2022-672556 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-672539:Husband case