chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022; expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     Patient was never diagnosed or tested positive with COVID -19.  Patient does not have any known drug allergies.  Patient does not have any acute illness at the time of vaccination and up to one month before.     On 30-Mar-2022 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (expired vaccine used) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 01-March-2022, and administered on 30-March-2022, which was expired on 19-March-2022).    It was unknown whether the patient took any prescriptions, over-the-counter medications, dietary supplements or herbal medicines at the time of vaccination or at the time of adverse event It was reported that the vials were initially stored in refrigerator on 01-March-2022. The vails does not undergo any temperature excursion No treatment medication information was given.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: general body aches; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (general body aches) and VACCINATION SITE PAIN (right arm was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 029L20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced MYALGIA (general body aches) and VACCINATION SITE PAIN (right arm was sore). In November 2021, MYALGIA (general body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (right arm was sore) outcome was unknown.            The  concomitant medications on use were not provided.  The patient felt general body aches for a day. The patient had no adverse reactions or side effects after her first and second Moderna covid-19 vaccine.   No treatment information was provided.   This case was linked to MOD-2022-535553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up information included no new information.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Feeling abnormal, Hypersomnia
Clinical narrative: general body aches; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (general body aches) and VACCINATION SITE PAIN (right arm was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 029L20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced MYALGIA (general body aches) and VACCINATION SITE PAIN (right arm was sore). In November 2021, MYALGIA (general body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (right arm was sore) outcome was unknown.            The  concomitant medications on use were not provided.  The patient felt general body aches for a day. The patient had no adverse reactions or side effects after her first and second Moderna covid-19 vaccine.   No treatment information was provided.   This case was linked to MOD-2022-535553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up information included no new information.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: general body aches; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (general body aches) and VACCINATION SITE PAIN (right arm was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 029L20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced MYALGIA (general body aches) and VACCINATION SITE PAIN (right arm was sore). In November 2021, MYALGIA (general body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (right arm was sore) outcome was unknown.            The  concomitant medications on use were not provided.  The patient felt general body aches for a day. The patient had no adverse reactions or side effects after her first and second Moderna covid-19 vaccine.   No treatment information was provided.   This case was linked to MOD-2022-535553 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up information included no new information.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long standing health conditions.     On 30-Mar-2022 at 10:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 10:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) to be not related.    Concomitant products were not provided.  It was reported that the patient neither diagnosed nor tested positive for COVID-19. It was reported that the event did not cause the patient to seek medical care.There were not any other potential causes for the event to occur and patient did not experienced a similar event in the past. It was reported that the vial was first stored in the refrigerator on 01-Mar-2022. The vial did not undergo any temperature excursion. No patients had reported having any adverse events for now.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial did not undergo any temperature excursions. Vial was initially stored in refrigerator on 07-Apr-2022. patient was given vaccine that Expired on Second.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow-up received contain non significant information
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient recieved dose from a vial which was initially stored in the refrigerator 01-Mar-2022 and administered on 30Mar2022 after 30-day Use By Date of expiry 19Mar2022; Patient was vaccinated on 30Mar2022 at 11:03 from vial that was expired on 19Mar2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated on 30Mar2022 at 11:03 from vial that was expired on 19Mar2022) and PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 01-Mar-2022 and administered on 30Mar2022 after 30-day Use By Date of expiry 19Mar2022) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     Patient don't have any acute illnesses at the time of vaccination and up to one month before and no chronic or long-standing health conditions. It was reported that patient has never been diagnosed or tested positive for COVID-19.  Concurrent medical conditions included Latex allergy.    On 30-Mar-2022 at 11:03 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 30-Mar-2022 at 11:03 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated on 30Mar2022 at 11:03 from vial that was expired on 19Mar2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 01-Mar-2022 and administered on 30Mar2022 after 30-day Use By Date of expiry 19Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated on 30Mar2022 at 11:03 from vial that was expired on 19Mar2022) and PRODUCT STORAGE ERROR (Patient recieved dose from a vial which was initially stored in the refrigerator 01-Mar-2022 and administered on 30Mar2022 after 30-day Use By Date of expiry 19Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient didn't seek medical attention. No patients had reported having any adverse events. Vial was initially stored in the refrigerator on 01-Mar-2022. The vial didn't undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013H21B) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before. Patient did not have any chronic illness or long standing health conditions.    On 30-Mar-2022 at 11:06 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Mar-2022 at 11:06 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.      For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that the patient did not experience similar event in the past. The potential cause for the event to occur was expired moderna vaccine. The event did not cause the patient to seek medical care. It was reported that the vial was first stored in the refrigerator on 01-Mar-2022. It was reported that vial did not undergo any temperature excursion.  Treatment medications were not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Pyrexia
Clinical narrative: fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Patient never had COVID-19 positive diagnosis or test and no allergy including medications, food and other products.  The patient's past medical history included Heart disease, unspecified (Started since 30 years ago and no recent change in status such as improvement or worsening.) and Open heart surgery. Previously administered products included for Product used for unknown indication: Flu shot (Flu shot were given one month ago.). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Type 2 diabetes mellitus (Started since 4 years ago and no recent change in status such as improvement or worsening.) and Blood pressure high (Started since 30 years ago and no recent change in status such as improvement or worsening.). Concomitant products included METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic effect.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (fever) and FATIGUE (fatigue). On 07-Feb-2021, PYREXIA (fever) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Heart rate: 90 and 100 (High) After 1 dose pulse raised between 90 and 100 for 3 days..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that patient did not experienced a similar event in the past and this adverse event didnt cause patient to seek medical care including office visit, Urgent care, ER and hospitalized. Other concomitant medicine: Beta Blockers for an unknown indication. No treatment information were provided by the reporter.   This case was linked to MOD-2022-535621, MOD-2022-535624, MOD-2022-535625 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Pyrexia, Tachycardia
Clinical narrative: Pulse raised between 90 and 100; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Pulse raised between 90 and 100), PYREXIA (Fever) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     The patient had no allergies, never had COVID-19 positive test or diagnosis. And patient was on diuretic therapy.  The patient's past medical history included Heart disease, unspecified (Since 30 years ago and no recent change in status such as improvement or worsening) and Open heart surgery. Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Type II diabetes mellitus (Since 4 years ago and no recent change in status such as improvement or worsening) and Blood pressure high (Since 30 years ago and no recent change in status such as improvement or worsening). Concomitant products included METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic therapy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TACHYCARDIA (Pulse raised between 90 and 100), PYREXIA (Fever) and FATIGUE (Fatigue). On 07-Mar-2021, TACHYCARDIA (Pulse raised between 90 and 100), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Heart rate: 90 to 100 Pulse raised between 90 and 100 for 3 days.         Other concomitant medication includes: Beta Blockers for an unknown indication. Patient stated that AE did not caused patient to seek medical care and the patient did not experienced similar events in the past. No treatment was given to the patient.   This case was linked to MOD-2022-535597, MOD-2022-535624, MOD-2022-535625 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: pulse raised to 100; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     Patient never had COVID-19 positive diagnosis or test and no allergy including medications, food and other products.  The patient's past medical history included Heart disease, unspecified (Started since 30 years ago and no recent change in status such as improvement or worsening.) and Open heart surgery. Previously administered products included for Product used for unknown indication: Flu shot (flu shot given 1 month ago). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Type 2 diabetes mellitus (Started since 4 years ago and no recent change in status such as improvement or worsening.) and Blood pressure high (Started since 30 years ago and no recent change in status such as improvement or worsening.). Concomitant products included METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic therapy.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue). On 28-Oct-2021, PYREXIA (fever) and FATIGUE (fatigue) had resolved. On 29-Oct-2021, HEART RATE INCREASED (pulse raised to 100) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: pulse raised to 100 for 4 days (High) Pulse raised to 100 for 4 days.         It was reported that patient did not experienced a similar event in the past and this adverse event didn't cause patient to seek medical care including office visit, Urgent care, ER and hospitalized. Other concomitant medicine: Beta Blockers for an unknown indication. No treatment information were provided by the reporter.   This case was linked to MOD-2022-535597, MOD-2022-535621, MOD-2022-535625, MOD-2022-535597 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: pulse raised to 100; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L21B, 026D21A, 030A21A and 038K20A) for COVID-19 vaccination.     Patient never had COVID-19 positive diagnosis or test and no allergy including medications, food and other products. It was reported patient was concerned because he had an open heart surgery.  Previously administered products included for Product used for unknown indication: Flu shot (Flu shot 1 month ago). Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Type 2 diabetes mellitus (Since 4 years ago and no recent change in status such as improvement or worsening), Blood pressure high (Since 30 years ago and no recent change in status such as improvement or worsening) and Heart disease, unspecified (Since 30 years ago and no recent change in status such as improvement or worsening). Concomitant products included METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, HYDROCHLOROTHIAZIDE for Diuretic therapy.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced HEART RATE INCREASED (pulse raised to 100), PYREXIA (fever) and FATIGUE (fatigue). On 05-Apr-2022, PYREXIA (fever) and FATIGUE (fatigue) had resolved. At the time of the report, HEART RATE INCREASED (pulse raised to 100) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2022, Heart rate: 100 (High) Pulse raised to 100 for 4 days.         Normal pulse of the patient was between 60 and 65. Other relevant concomitant medication included Beta blockers. Patient took 1st booster shot on 26Oct2021, and 2nd booster dose on 31Mar2022.  After 2nd booster dose, pulse raised also to 100 for 4 days, and currently then coming down and improving, but still not in the normal range and  patient did not experience a similar event in the past and the adverse event did not cause him to seek medical care including office visit, Urgent care, ER and hospitalized.  No treatment given for his symptoms.   This case was linked to MOD-2022-535597, MOD-2022-535621, MOD-2022-535624 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient recived expired Moderna Covid-19 vaccine; Patient recived expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patient recived expired Moderna Covid-19 vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient recived expired Moderna Covid-19 vaccine) in an 81-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced PRODUCT STORAGE ERROR (Patient recived expired Moderna Covid-19 vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient recived expired Moderna Covid-19 vaccine). At the time of the report, PRODUCT STORAGE ERROR (Patient recived expired Moderna Covid-19 vaccine) and EXPIRED PRODUCT ADMINISTERED (Patient recived expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown. Date the vial was initially stored in the refrigerator: 31-Mar-2022.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Therapeutic response unexpected
Clinical narrative: Then it came back/ now the double vision is back; after her second dose her double vision associated with graves eyes disease got better for 6 months; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (after her second dose her double vision associated with graves eyes disease got better for 6 months) and DIPLOPIA (Then it came back/ now the double vision is back) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001821A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica (PMR seemed not to go away completely, but numbers were high normal) in September 2015, Polymyalgia rheumatica in 2000 and Double vision (double vision associated with graves eyes disease). Concurrent medical conditions included Fruit allergy (Raspberry), Sulfonamide allergy (Sulfa drugs), Drug allergy (Metronidazole), Drug allergy (Rhopressa), Drug allergy (Alphagan Ophthalmic Solution), Hyperthyroidism (Start date: 2018-2019, Recent change in status: Normal) and Graves' disease (Start date: 2018-2019).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (after her second dose her double vision associated with graves eyes disease got better for 6 months) and DIPLOPIA (Then it came back/ now the double vision is back). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (after her second dose her double vision associated with graves eyes disease got better for 6 months) outcome was unknown and DIPLOPIA (Then it came back/ now the double vision is back) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient's height was reported as 5.6.  Patient had neither tested nor diagnosed with COVID in the past.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  AE caused patient to seek medical care. Doctors were amazed that her double vision went away.  No treatment details were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection Site hurting after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection Site hurting after 2nd booster) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced VACCINATION SITE PAIN (Injection Site hurting after 2nd booster). At the time of the report, VACCINATION SITE PAIN (Injection Site hurting after 2nd booster) had not resolved.            No concomitant product use was reported.   The patient reported that he received 4 Moderna COVID-19 vaccines ( 2 primary and 2 booster shots). He also stated that after the 2nd booster yesterday (at the time of report), his left arm was hurting.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Back pain, Heart rate increased, Neck pain
Clinical narrative: her arm started to shake; Felt pain in the neck; a little bit of pain in the low back; rapid heart beats; anxiety; nervousness; pain in the shoulder/pain almost to the elbow, like if some nerves were damaged; really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (her arm started to shake), NECK PAIN (Felt pain in the neck), BACK PAIN (a little bit of pain in the low back), HEART RATE INCREASED (rapid heart beats) and ANXIETY (anxiety) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (her arm started to shake), NECK PAIN (Felt pain in the neck), BACK PAIN (a little bit of pain in the low back), HEART RATE INCREASED (rapid heart beats), ANXIETY (anxiety), NERVOUSNESS (nervousness), ARTHRALGIA (pain in the shoulder/pain almost to the elbow, like if some nerves were damaged) and VACCINATION SITE PAIN (really sore arm). At the time of the report, TREMOR (her arm started to shake), NECK PAIN (Felt pain in the neck), BACK PAIN (a little bit of pain in the low back), HEART RATE INCREASED (rapid heart beats), ANXIETY (anxiety), NERVOUSNESS (nervousness), ARTHRALGIA (pain in the shoulder/pain almost to the elbow, like if some nerves were damaged) and VACCINATION SITE PAIN (really sore arm) had not resolved.            No concomitant medication information was provided.  The patient took  first booster dose of Moderna COVID-19 Vaccine and experienced really sore arm, arm started to shake, and felt pain in the neck, in the low back a little bit, shoulder and almost to the elbow, like if some nerves were damaged; rapid heart beats, anxiety and nervousness.  No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Nervousness, Tremor, Vaccination site pain
Clinical narrative: her arm started to shake; Felt pain in the neck; a little bit of pain in the low back; rapid heart beats; anxiety; nervousness; pain in the shoulder/pain almost to the elbow, like if some nerves were damaged; really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (her arm started to shake), NECK PAIN (Felt pain in the neck), BACK PAIN (a little bit of pain in the low back), HEART RATE INCREASED (rapid heart beats) and ANXIETY (anxiety) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (her arm started to shake), NECK PAIN (Felt pain in the neck), BACK PAIN (a little bit of pain in the low back), HEART RATE INCREASED (rapid heart beats), ANXIETY (anxiety), NERVOUSNESS (nervousness), ARTHRALGIA (pain in the shoulder/pain almost to the elbow, like if some nerves were damaged) and VACCINATION SITE PAIN (really sore arm). At the time of the report, TREMOR (her arm started to shake), NECK PAIN (Felt pain in the neck), BACK PAIN (a little bit of pain in the low back), HEART RATE INCREASED (rapid heart beats), ANXIETY (anxiety), NERVOUSNESS (nervousness), ARTHRALGIA (pain in the shoulder/pain almost to the elbow, like if some nerves were damaged) and VACCINATION SITE PAIN (really sore arm) had not resolved.            No concomitant medication information was provided.  The patient took  first booster dose of Moderna COVID-19 Vaccine and experienced really sore arm, arm started to shake, and felt pain in the neck, in the low back a little bit, shoulder and almost to the elbow, like if some nerves were damaged; rapid heart beats, anxiety and nervousness.  No treatment medication were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Colonoscopy, Computerised tomogram, Magnetic resonance imaging, Tremor
Clinical narrative: Lose 12 pounds  (From 162 lbs to 148 lbs); Weakness in her left arm and hand; Tremor; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)), ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and O26A21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy. Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL CHLORTHALIDONE) for Blood pressure, PRAVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor). In January 2022, the patient experienced WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)). At the time of the report, WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)) outcome was unknown and ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported. Patient mentioned that from 162 pounds she was now at 148 pounds. Patient states she prefers to be contacted through phone.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Lose 12 pounds  (From 162 lbs to 148 lbs); Weakness in her left arm and hand; Tremor; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)), ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and O26A21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy. Concomitant products included ATENOLOL, CHLORTALIDONE (ATENOLOL CHLORTHALIDONE) for Blood pressure, PRAVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor). In January 2022, the patient experienced WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)). At the time of the report, WEIGHT DECREASED (Lose 12 pounds  (From 162 lbs to 148 lbs)) outcome was unknown and ASTHENIA (Weakness in her left arm and hand) and TREMOR (Tremor) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported. Patient mentioned that from 162 pounds she was now at 148 pounds. Patient states she prefers to be contacted through phone.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients were administered from vaccines that experienced a T excursion; Patients were administered from vaccines that experienced a T excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients were administered from vaccines that experienced a T excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients were administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients were administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  HCP stated they had a temperature excursion and patients have been administered from these affected vaccines but did not have more information about the patients. The vaccines reached a Maximum temperature of 1.6 °C for 1 hour and 12 min.  Storage condition at the time of the excursion was refrigerated. Maximum or minimum temperatures reached, as applicable was Minimum 1.6 °C on 24-Mar-2022. Excursion duration was Hour and 12 min. Date vial(s) moved from freezer to refrigerator was 13-Mar-2022. The vials were stored in refrigerator now. Number of vials/doses impacted was 4 vials. Pertinent details, whether the vial(s) were punctured, any previous excursions with the impacted vial(s) was unpunctured and no excursions before.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2022: Non-significant follow up information received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: administered 2nd booster dose to a 48 year old; non immunocompromised patient; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (administered 2nd booster dose to a 48 year old; non immunocompromised patient) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065A21A, 071F21A, 045B21A and 093A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-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 .25 milliliter. On 08-Apr-2022, the patient experienced EXTRA DOSE ADMINISTERED (administered 2nd booster dose to a 48 year old; non immunocompromised patient). At the time of the report, EXTRA DOSE ADMINISTERED (administered 2nd booster dose to a 48 year old; non immunocompromised patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was not immunocompromised and received 1st booster dose on 10Nov2021and 2nd booster dose on 08Apr2022. No concomitant details were reported. No treatment information was provided.   This case was linked to MOD-2022-536386 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep walking (She had one episode of sleep walking 40 years ago, but has no history of sleep walking since then).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient was on concomitant medications, but did not specify the names. No treatment medications were reported.   This case was linked to MOD-2022-535838, MOD-2022-535842, MOD-2022-535849 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: My right arm was red and sore at the injection site; My right arm was red and sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (My right arm was red and sore at the injection site) and VACCINATION SITE PAIN (My right arm was red and sore at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur (from past 20 years) and Drug allergy (Trazodone).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (My right arm was red and sore at the injection site) and VACCINATION SITE PAIN (My right arm was red and sore at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (My right arm was red and sore at the injection site) and VACCINATION SITE PAIN (My right arm was red and sore at the injection site) had resolved.            No concomitant medication was provided. No treatment medication was provided.  The patient had not experienced any side effects with first dose of Moderna COVID-19 vaccine.  The patient had denied COVID positive test or diagnosis. AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized) for the adverse events. Symptoms were reported to improved.   This case was linked to MOD-2022-535852 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M02A and 032L20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.). At the time of the report, SOMNOLENCE (Felt sleepy. Patient usually wakes up at 6AM. Slept until 9AM the next day.) outcome was unknown.            No medical history information was provided.   The patient received his booster dose of Moderna Covid-19 vaccine on 29-Nov-2022 (lot number : 939909)The patient received his booster dose in his left arm. Patient did not report any side effects or adverse reactions to his first dose or booster dose.  No treatment medication was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sleep walking (one episode of sleep walking 40 years ago, but had no history of sleep walking since then).    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.            The patient was on concomitant medication, but the reporter did not specify the names.  After the second dose, the patient did not experience any unusual side effects.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-535830, MOD-2022-535842, MOD-2022-535849 (Patient Link).