chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after her 1st dose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid after her 1st dose) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Tested positive for Covid after her 1st dose). At the time of the report, COVID-19 (Tested positive for Covid after her 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported that patient has not gotten her 2nd dose. Patient wanted to know how long after testing negative could she get her 2nd dose. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 26 year old female patient with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred one month post vaccination with the dose 1 of mRNA-1273 vaccine. This patient test positive for SARS-COV 2 test last July 30, 2022. Treatment information , results of other  laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 26 year old female patient with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred one month post vaccination with the dose 1 of mRNA-1273 vaccine. This patient test positive for SARS-COV 2 test last July 30, 2022. Treatment information , results of other  laboratories/diagnostic procedures were not reported and there was no report if any medical consult was done. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Hepatomegaly, Herpes zoster, Influenza, Kidney enlargement
Clinical narrative: Zobie Human COVID vaccinated gone bad; Golf ball size area on top center of skull; Heart layer of shingles; Flu; Liver bladed knife-like line length liver; As for kidneys one pea size spot in each; Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu) and HEPATOMEGALY (Liver bladed knife-like line length liver) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu), HEPATOMEGALY (Liver bladed knife-like line length liver), KIDNEY ENLARGEMENT (As for kidneys one pea size spot in each) and PYREXIA (Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature). At the time of the report, FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu), HEPATOMEGALY (Liver bladed knife-like line length liver), KIDNEY ENLARGEMENT (As for kidneys one pea size spot in each) and PYREXIA (Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature) outcome was unknown. Not Provided          No concomitant medications were reported. It was reported that the patient had an unknown cellular mutation from the two shots of Moderna vaccine and its self-development in the different areas of human body and high temperature would kill brain area and illness. It was also reported that death would now be due to vaccines and booster ordering. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Skin mass
Clinical narrative: Zobie Human COVID vaccinated gone bad; Golf ball size area on top center of skull; Heart layer of shingles; Flu; Liver bladed knife-like line length liver; As for kidneys one pea size spot in each; Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu) and HEPATOMEGALY (Liver bladed knife-like line length liver) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu), HEPATOMEGALY (Liver bladed knife-like line length liver), KIDNEY ENLARGEMENT (As for kidneys one pea size spot in each) and PYREXIA (Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature). At the time of the report, FEELING ABNORMAL (Zobie Human COVID vaccinated gone bad), SKIN MASS (Golf ball size area on top center of skull), HERPES ZOSTER (Heart layer of shingles), INFLUENZA (Flu), HEPATOMEGALY (Liver bladed knife-like line length liver), KIDNEY ENLARGEMENT (As for kidneys one pea size spot in each) and PYREXIA (Small signs fever/Tip of nose, top center of skull and brain area had extremely high temperature) outcome was unknown. Not Provided          No concomitant medications were reported. It was reported that the patient had an unknown cellular mutation from the two shots of Moderna vaccine and its self-development in the different areas of human body and high temperature would kill brain area and illness. It was also reported that death would now be due to vaccines and booster ordering. No treatment medications were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: shortness of breath; lightheadedness; fatigue; headaches; brain fogginess; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (brain fogginess), DYSPNOEA (shortness of breath), DIZZINESS (lightheadedness), HEADACHE (headaches) and FATIGUE (fatigue) in a 25-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) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2022, the patient experienced FEELING ABNORMAL (brain fogginess). On 20-Jul-2022, the patient experienced HEADACHE (headaches). On 26-Jul-2022, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (lightheadedness) and FATIGUE (fatigue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (brain fogginess), DYSPNOEA (shortness of breath), DIZZINESS (lightheadedness), HEADACHE (headaches) and FATIGUE (fatigue) had not resolved.     No concomitant information was reported by the reporter. It was reported as after receiving third dose patient experienced brain fogginess within the15 minute waiting period and the next day she began to experience headaches, which persisted till the time, except for the Sunday after receiving the vaccine. Afterwards on Tuesday after receiving the vaccine patient started to had lightheadedness, fatigue, and shortness of breath. and she reported that these symptoms had periods where they increase and decrease but had been present since starting. She had been to the emergency room on Thursday and had a telehealth appointment and there was no clear indication if these symptoms were resulted of booster dose. Treatment includes rest and water.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Psoriasis, Therapeutic product effect decreased
Clinical narrative: Psoriasis aggravated; Condition aggravated; Drug effect decreased; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis aggravated), CONDITION AGGRAVATED (Condition aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PSORIASIS (Psoriasis aggravated), CONDITION AGGRAVATED (Condition aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased). At the time of the report, PSORIASIS (Psoriasis aggravated), CONDITION AGGRAVATED (Condition aggravated) and THERAPEUTIC PRODUCT EFFECT DECREASED (Drug effect decreased) outcome was unknown.            Concomitant Drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not reported.  Company Comment: This is a spontaneous case concerning  an elderly male patient with no reported medical history, who experienced the unexpected non-serious events of Psoriasis, Condition Aggravated and Therapeutic product effect decreased. Temporal association cannot be assessed due to onset of the events was not specified. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  an elderly male patient with no reported medical history, who experienced the unexpected non-serious events of Psoriasis, Condition Aggravated and Therapeutic product effect decreased. Temporal association cannot be assessed due to onset of the events was not specified. No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report.. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema, Rash, Rash pruritic
Clinical narrative: Redness on upper body (Front & Back) and face a few days after the 2nd shot; Rash on upper body (Front & Back) and face a few days after the 2nd shot; Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness on upper body (Front & Back) and face a few days after the 2nd shot), RASH (Rash on upper body (Front & Back) and face a few days after the 2nd shot) and RASH PRURITIC (Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism (since 5 years ago). Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced ERYTHEMA (Redness on upper body (Front & Back) and face a few days after the 2nd shot), RASH (Rash on upper body (Front & Back) and face a few days after the 2nd shot) and RASH PRURITIC (Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot). At the time of the report, ERYTHEMA (Redness on upper body (Front & Back) and face a few days after the 2nd shot), RASH (Rash on upper body (Front & Back) and face a few days after the 2nd shot) and RASH PRURITIC (Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Blood test: Apparently it is an immune response..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that A few days after the 2nd shot, patient had a rash on upper body (Front and Back) and face. The rash area rarely itched. The rash area was not  itching all the time.   It was also reported that Initially the doctor prescribed oral antibiotics. patient did not remember the name of the antibiotic.patient did not recall anything else being prescribed for rash.  It was also reported that the reaction had not resolved more than a year after the 2nd shot also patient redness still there today
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging, Neck pain, Paraesthesia
Clinical narrative: Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness; Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness; Headaches; Neck pain; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Neck pain), PARAESTHESIA (Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness), HYPOAESTHESIA (Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness) and HEADACHE (Headaches) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2022, the patient experienced NECK PAIN (Neck pain) and HEADACHE (Headaches). On an unknown date, the patient experienced PARAESTHESIA (Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness) and HYPOAESTHESIA (Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness). At the time of the report, NECK PAIN (Neck pain), PARAESTHESIA (Had tingling and numbness in my nerves/ 1 month later she started to experience tingling and numbness), HYPOAESTHESIA (Had tingling and numbness in my nerves/  1 month later she started to experience tingling and numbness) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Magnetic resonance imaging: Bunch of MRI's with no remarkable findings.         No concomitant medications were reported. Patient had seen multiple healthcare professionals including 2-3 internal medicine doctors, a rheumatologist, a gastroenterologist, and a neurologist for the symptoms. Patient had been taking muscle relaxants and anti-inflammatories for the symptoms.   Reporter did not allow further contact
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     No medical history was reported.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), VIBEGRON (GEMTESA), OMEPRAZOLE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 02-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range was over about 24 hours and 30 minutes).    Patient did not report being immunocompromised.  Patient received the 2nd booster of the Moderna vaccine.  Date the vial 09:30  am. Date of administration of vaccine was on 1st 02Aug2022 at 10 am and administered every 15 minutes after 10 am until 11 am. The vial stored in room temperature post puncture. The vial did not undergone any temperature excursions.  Patient did not report having side effects.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was stored at room temperature post puncture for more than 24 hrs; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (vial was stored at room temperature post puncture for more than 24 hrs).    Patient did not report being immunocompromised.  Patient did not have any medication record. No concomitant medications information was reported. It was reported that 1 vial was involved. 1st vaccine was administered on 02-AUG-2022 at 10 am and the remaining were administered every 15 minutes after 10 am until 11 am. The vial was initially stored in the refrigerator on 01-AUG-2022 at 09:30 am. The vial was stored in room temperature post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degrees to 25 degree Celsius) was just over 24 hours about 24 hours and 30 minutes. Patient did not report having side effects.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: post puncture vaccine was left at room temperature for over 24 hours; No adverse event; Patients received the vaccine after 24 hours at room temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C22A) for COVID-19 prophylaxis.     Concomitant products included CITALOPRAM for an unknown indication.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature), PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine after 24 hours at room temperature) and PRODUCT STORAGE ERROR (post puncture vaccine was left at room temperature for over 24 hours).    No Medical History information was reported. The patient did not report being immunocompromised. The vial was first punctured on 01-Aug-2022 at 9: 30 am. Post puncture the vial was stored at room temperature. First administration was done at 02-Aug-2022 at 10 am, then administered every 15 minutes after 10 am until 11 am. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degrees to 25 degree Celsius) was just over 24 hours about 24 hours and 30 minutes. The patient received first booster dose. Patient did not report having side effects No treatment drug was reported.
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation) and NO ADVERSE EVENT (No adverse event) in an 18-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Aug-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation) 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 INCORRECT DOSE ADMINISTERED (Patient was 18 month old that was given 0.25 ml of the 12 year and up formulation).    Concomitant product use was not provided by the reporter.  It was reported that an 18 month old that was given 0.25 mL of the 12 year and up formulation. They vaccinated patient from a vial that was supposed to be 6 month to 5 year but it was actually for 12 year and up.   Nothing has been reported by parent. Patient was healthy at the time of reporting.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Tremor
Clinical narrative: Had the vaccine and every time, she got very very sick; After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Had the vaccine and every time, she got very very sick) and TREMOR (After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Had the vaccine and every time, she got very very sick) and TREMOR (After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,). At the time of the report, ILLNESS (Had the vaccine and every time, she got very very sick) and TREMOR (After second dose, she got the shakes, and could not stop shaken, and had to get  into the water to stop shaking,) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included unspecified thyroid medication.  The patient never had COVID positive test or diagnosis.  No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine  AE caused patient to seek medical care.  The patient had not experienced a similar event in the past.  Unknown if symptoms improved or worsened.  Treatment information was not provided.   This case was linked to MOD-2022-619371, MOD-2021-009124 (Patient Link).
Age: 4.0
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 27-jun-2022 and was administered on 3-aug-2022; No adverse event; Received expired first dose, after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose, 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 27-jun-2022 and was administered on 3-aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first dose, after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired first dose, after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 27-jun-2022 and was administered on 3-aug-2022).    No concomitant medication was reported. Date the vial was initially stored in the refrigerator 27-JUN-2022. The vial does not undergone any temperature excursion. No treatment medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.; 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 (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) 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 (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 5-May-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.).    No concomitant medications were reported.  On 5-May-2022, the patient received a fourth dose (booster dose)(Lot: 022J21A) of Moderna vaccine. The vial were initially stored in the refrigerator on 5May2022, 6May2022,19May2022, 02Jun2022, 09Jun2022 and 23June2022. vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. The vial did not undergone any temperature excursions.   No treatment medications were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Movement disorder, Splenomegaly
Clinical narrative: could not get out of the couch; she has a enlarge spleen; had the vaccine and every time, she got very very sick/ Got sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (had the vaccine and every time, she got very very sick/ Got sick), MOVEMENT DISORDER (could not get out of the couch) and SPLENOMEGALY (she has a enlarge spleen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, the patient experienced ILLNESS (had the vaccine and every time, she got very very sick/ Got sick). On an unknown date, the patient experienced MOVEMENT DISORDER (could not get out of the couch) and SPLENOMEGALY (she has a enlarge spleen). At the time of the report, ILLNESS (had the vaccine and every time, she got very very sick/ Got sick), MOVEMENT DISORDER (could not get out of the couch) and SPLENOMEGALY (she has a enlarge spleen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had no history relating to mentioned adverse event. Patient did not have any acute and chronic illnesses at the time of vaccination.  Patient never had COVID positive test or diagnosis.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant medication included unspecified thyroid medication.  Patient received booster dose.  Patient sought medical care and went to the treating physician.  Patient had enlarged spleen and had to get surgery to get it out, and the reason for the enlarged spleen could not be found. Patient wanted to know if the vaccine affects the spleen.  Patient did not experience any similar event in the past.  No treatment information was provided.   This case was linked to MOD-2021-009124, MOD-2022-619331 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator; No adverse event; Dose administered after manufacturer date of expiry to 12 patients; 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 to 12 patients), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to 12 patients) and PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator).    No concomitant medication were reported.   Number of doses/vials: 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022, 6-May-2022, 19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-June-2022. Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and the unused portion was put back in refrigerator. The vial did not undergo any temperature excursions No treatment information was provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator; No adverse event; Dose administered after manufacturer date of expiry to  patient; 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 to  patient), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to  patient), PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator) 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 (Dose administered after manufacturer date of expiry to  patient) and PRODUCT STORAGE ERROR (vaccine that expired on 24April2022, vial was initially stored in the refrigerator on 5May2022, unused portion was put in refrigerator).    No concomitant medication were reported.   Number of doses/vials: 200 doses 20 vials. The vial was initially stored in the refrigerator on 5-May-2022. It was explained that vaccines were removed from the freezer on date of appointments to be used, and the unused portion was put back in refrigerator. The vial did not undergo any temperature excursions No treatment information was provided by the reporter.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022; No adverse event; Dose administered after manufacturer date of expiry to patient; 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 to patient), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to patient) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 19-May-2022 after expiration date 24-Apr-2022).    No concomitant medications were reported. Number of doses/vials were reported as 200 doses 20 vials. Date the vial was initially stored in the refrigerator were reported as 05-May-2022, 06-May-2022,19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-Jun-2022. Office manager explained that vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. Date(s) of administration of vaccine was reported as 05-May-2022, 06-May-2022,19-May-2022, 02-Jun-2022, 09-Jun-2022 and 23-Jun-2022 to12 patients. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.; no adverse event; Dose administered after manufacturer date of expiry to the patient; 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 to the patient), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to the patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to the patient), PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry to the patient) and PRODUCT STORAGE ERROR (The vaccine that expired on 24-April-2022 was administered on 19-MAY-2022, vial was initially stored in the refrigerator on 5-May-2022, unused portion was put in refrigerator.).    No concomitant medications were reported.  The vial was initially stored in the refrigerator on 5May2022, 6May2022,19May2022, 02Jun2022, 09Jun2022 and 23June2022. vaccines were removed from the freezer on date of appointments to be used, and any unused portion was put in refrigerator. The vial did not undergo any temperature excursions.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-619547 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-619547: