chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (diagnosed in late 2005 and underwent unspecified surgery in Feb-2006) since 2005 and Emphysema. Concomitant products included LANSOPRAZOLE, THEOPHYLLINE, PRAVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) was resolving.            Patient's height was 5.3 (160.02 cm). It was reported that the patient had no allergies and COVID-19 in the past.  The patient experienced sore arm  and fatigue after vaccination, however felt better in 24.  Treatment information was not provided.   This case was linked to MOD-2022-528604, MOD-2022-528619, MOD-2022-528626 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 045J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson Covid-19 Vaccine on 18-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson Covid-19 Vaccine.   On 23-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got a dose of the Johnson and Johnson Covid-19 Vaccine, then got 2 full doses of Moderna Covid-19 Vaccine 2 months apart) outcome was unknown.            No concomitant medications reported.  Patient states that he got a first dose of the Johnson & Johnson Covid-19 Vaccine on 18-Mar-2021. No treatment information was provided.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given the Moderna vaccine to a 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (given the Moderna vaccine to a 14 year old) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (given the Moderna vaccine to a 14 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (given the Moderna vaccine to a 14 year old) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter was not sure if it was the patient's first or second dose. Everything was okay.  No treatment medication was reported.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.; Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022 and administered on 31-Mar-22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The vial was initially stored in the refrigerator was on 31 March 2022. The vial did not undergo any temperature excursion. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Non Significant Follow-up appended on 31-Mar-22, included No new information.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of; Moderna Covid-19 vaccine that expired on 20Mar2022 was initially stored in the refrigerator on 31-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20Mar2022 was initially stored in the refrigerator on 31-Mar-2022) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20Mar2022 was initially stored in the refrigerator on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20Mar2022 was initially stored in the refrigerator on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the total number of doses/vials present were 8 doses(0.25 ml booster) It was reported that vial was initially stored in refrigerator on 31-Mar-2022. It was reported that vial did not undergo any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow up received includes no new information.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of. Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20-Mar-2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 20-Mar-2022 was initially stored in the refrigerator on 31-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The vial was initially stored in the refrigerator on 31 Mar 2022. The vial did not undergo temperature excursion.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document included no new information.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: After the second shot, she felt sleepy for a 3 days. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (After the second shot, she felt sleepy for a 3 days.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Seasonal Migraine on & off triggered by Florescent light and changes in weather. not under medication.).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (After the second shot, she felt sleepy for a 3 days.). On 30-Apr-2021, SOMNOLENCE (After the second shot, she felt sleepy for a 3 days.) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-530707, MOD-2022-530742 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: After the second shot, she felt sleepy for a 3 days. This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (After the second shot, she felt sleepy for a 3 days.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Seasonal Migraine on & off triggered by Florescent light and changes in weather. not under medication.).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (After the second shot, she felt sleepy for a 3 days.). On 30-Apr-2021, SOMNOLENCE (After the second shot, she felt sleepy for a 3 days.) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-530707, MOD-2022-530742 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Basedow's disease, Blood glucose abnormal, Blood test abnormal, Blood testosterone increased, Blood thyroid stimulating hormone
Clinical narrative: Symptoms of hyperthyroidism began a couple of days after the 2nd dose.  Rapid heart rate, night sweats and weight loss primarily.  Blood test confirmed hyperthyroidism in May, 2021 and Graves disease was diagnosed by radioactive iodine test in July.  I am being treated with medication and the endocrinologist is recommending radioactive treatment or thyroid removal.  I had my testosterone and estrogen levels checked a couple of weeks ago and the test revealed the testosterone level to be 1720.  I am undergoing testing to find out what is happening to my adrenal and pituitary glands to cause this.  The only reason this was discovered is because of the unusual blood work.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperthyroidism, Laboratory test abnormal, Night sweats, Thyroxine free
Clinical narrative: Symptoms of hyperthyroidism began a couple of days after the 2nd dose.  Rapid heart rate, night sweats and weight loss primarily.  Blood test confirmed hyperthyroidism in May, 2021 and Graves disease was diagnosed by radioactive iodine test in July.  I am being treated with medication and the endocrinologist is recommending radioactive treatment or thyroid removal.  I had my testosterone and estrogen levels checked a couple of weeks ago and the test revealed the testosterone level to be 1720.  I am undergoing testing to find out what is happening to my adrenal and pituitary glands to cause this.  The only reason this was discovered is because of the unusual blood work.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tri-iodothyronine free, Weight decreased
Clinical narrative: Symptoms of hyperthyroidism began a couple of days after the 2nd dose.  Rapid heart rate, night sweats and weight loss primarily.  Blood test confirmed hyperthyroidism in May, 2021 and Graves disease was diagnosed by radioactive iodine test in July.  I am being treated with medication and the endocrinologist is recommending radioactive treatment or thyroid removal.  I had my testosterone and estrogen levels checked a couple of weeks ago and the test revealed the testosterone level to be 1720.  I am undergoing testing to find out what is happening to my adrenal and pituitary glands to cause this.  The only reason this was discovered is because of the unusual blood work.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other symptoms or other AE reported; dose of VARIVAX was given following temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  A temperature excursion of varicella virus vaccine live (oka/merck) (VARIVAX) was registered as 7.4 degrees Fahrenheit for 10 minutes on 01-MAR-2022. On 14-MAR-2022, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route were not provided) with lot # U022732 and expiration date of 20-JUL-2023 for prophylaxis. There was no previous temperature excursion. No other symptoms or other adverse event (AE) reported.  This is one of four cases received from the same reporter.; Sender's Comments:  US-009507513-2203USA010197: US-009507513-2203USA010326: US-009507513-2203USA010401:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a patient was administered PROQUAD after a temperature excursion; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 12-JAN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) 0.5 milliliter, lot #U019287, expiration date: 15-DEC-2022 (strength, and route of administration were not provided) for prophylaxis, after a temperature excursion (product storage error). The temperature excursion was 12.4 degrees Fahrenheit (F) for 20 minutes. The previous temperature excursion was 6 F to 14 F (11.6F) for 25 minutes. No additional adverse event (AE) reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA010794: US-009507513-2203USA010696: US-009507513-2203USA010795: US-009507513-2203USA010654: US-009507513-2203USA010652: US-009507513-2203USA010658: US-009507513-2203USA010686:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180503, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (patient tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 2020. Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure high.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced COVID-19 (patient tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, COVID-19 (patient tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment was provided.  No prior vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient did not seek any medical care (office visit, Urgent care, ER, hospitalized).  Company comment: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure is also noted in the case and considered as an event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Investigations and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-527132 (Patient Link).; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID 19. Vaccination failure is also noted in the case and considered as an event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Investigations and treatment details were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose past 12 hour post puncture) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29March2022, Date and time vial was first punctured on 29 March 2022 at 10am, Date and time of administration of vaccine 30 March 2022 at 10:35AM.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2022 at 10:35 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2022 at 10:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose past 12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29March2022, Date and time vial was first punctured on 29 March 2022 at 10Am, Date and time of administration of vaccine 30 March 2022 at 10:35AM.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose past 12 hour post puncture) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 29March2022, Date and time vial was first punctured on 29 March 2022 at 10Am, Date and time of administration of vaccine 30 March 2022 at 10:35AM.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug reported. No treatment information was provided by the reporter. Vial was stored post puncture at Room temperature. Vial didn't undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 24hr.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose administered to patient; Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022). On 30-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that expired on 17-Mar-2022 was initially stored in the refrigerator on 29-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist stated that, they shipped out 5 vials of the Moderna vaccine to one of their nursing home facilities on 29 Mar 2022 evening and stored them in the refrigerator. On 30-Mar-2022 morning, 3 doses of the Moderna vaccine were administered to 3 staff members at the facility. After administration, it was found out that the doses given had expired on 17 Mar 2022. At this time, no adverse reactions have been reported by the patient.  The vial was initially stored in the refrigerator on 29 Mar 2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: That is how they get back at us for killing her daughter with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (That is how they get back at us for killing her daughter with the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Treatment information was not provided. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, fatal outcome of Death. The dates of administration of mRNA-1273 and onset of event were not specified, hence latency could not be assessed. There was no information provided on the dosing regimen, circumstances leading to death, clinical course, concurrent diseases, medical history and autopsy details. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, fatal outcome of Death. The dates of administration of mRNA-1273 and onset of event were not specified, hence latency could not be assessed. There was no information provided on the dosing regimen, circumstances leading to death, clinical course, concurrent diseases, medical history and autopsy details. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever after first dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Breathing difficult (as a kid), Allergy (couldn't figure out the source), Welts (red welts) in 2020 and Tonsillectomy (tonsil surgery).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On an unknown date, the patient experienced PYREXIA (Mild fever after first dose). At the time of the report, PYREXIA (Mild fever after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  The patient had not diagnosed or tested positive for COVID.  The patient had not received any vaccine 1 month prior to Moderna COVID-19 vaccine.  After the first dose, the patient did not had any allergic reaction.  No treatment medications were reported.  The patient states he has not reported this to Moderna, but he did report it . His report number is 1914373. The e-report number is 731387.   This case was linked to MOD-2022-529326 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Biopsy, Immunisation reaction, Pruritus, Rash
Clinical narrative: Mild fever after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever after first dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Breathing difficult (as a kid), Allergy (couldn't figure out the source), Welts (red welts) in 2020 and Tonsillectomy (tonsil surgery).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On an unknown date, the patient experienced PYREXIA (Mild fever after first dose). At the time of the report, PYREXIA (Mild fever after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  The patient had not diagnosed or tested positive for COVID.  The patient had not received any vaccine 1 month prior to Moderna COVID-19 vaccine.  After the first dose, the patient did not had any allergic reaction.  No treatment medications were reported.  The patient states he has not reported this to Moderna, but he did report it . His report number is 1914373. The e-report number is 731387.   This case was linked to MOD-2022-529326 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin, Urticaria
Clinical narrative: Mild fever after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever after first dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Breathing difficult (as a kid), Allergy (couldn't figure out the source), Welts (red welts) in 2020 and Tonsillectomy (tonsil surgery).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 100 microgram. On an unknown date, the patient experienced PYREXIA (Mild fever after first dose). At the time of the report, PYREXIA (Mild fever after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  The patient had not diagnosed or tested positive for COVID.  The patient had not received any vaccine 1 month prior to Moderna COVID-19 vaccine.  After the first dose, the patient did not had any allergic reaction.  No treatment medications were reported.  The patient states he has not reported this to Moderna, but he did report it . His report number is 1914373. The e-report number is 731387.   This case was linked to MOD-2022-529326 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site swelling
Clinical narrative: had very bad reaction for those two injection/had a very bad reaction; for three days they have swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling). At the time of the report, VACCINATION COMPLICATION (had very bad reaction for those two injection/had a very bad reaction) and VACCINATION SITE SWELLING (for three days they have swelling) had resolved.            No concomitant medication information was provided.  It was reported that the patient had two shots of the Moderna COVID 19 vaccines and had very bad reaction for those two injections and wants to take the booster on the hip or somewhere else on that is not the arm, because they had a very bad reaction, for three days they had swelling and was very concern, but it went away. Treatment information was not provided.   This case was linked to MOD-2022-528827 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Diagnosed with PMR; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Diagnosed with PMR) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) 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 POLYMYALGIA RHEUMATICA (Diagnosed with PMR). At the time of the report, POLYMYALGIA RHEUMATICA (Diagnosed with PMR) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2022-529262, MOD-2022-529267 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clothing after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clothing after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) 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 THROMBOSIS (blood clothing after getting the vaccine) (seriousness criteria disability and medically significant). The patient was treated with Surgery (hand amputation) for Thrombosis. At the time of the report, THROMBOSIS (blood clothing after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was reported.  Caller mentioned some local woman got her hand amputated from a blood clothing after getting the vaccine.  No other treatment medications were reported.  Company Comment: This spontaneous case concerns a female patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant, disability) AESI Thrombosis. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course was not provided in the case although the reporter mentioned hand amputation as result of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no reported medical history, who experienced the unexpected, serious (medically significant, disability) AESI Thrombosis. The event occurred on an unspecified date after receiving a dose of mRNA-1273 vaccine. Clinical course was not provided in the case although the reporter mentioned hand amputation as result of the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022; Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine on 31-Mar-2022, but it had expired on 20-Mar-2022) and PRODUCT STORAGE ERROR (Vial expired on 20-Mar-2022 but was stored in the refrigerator upto 31Mar2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Vial expired on 20-Mar-2022 but it was initially stored in the refrigerator on 31MAR 2022 and administered booster dose on 31 MAR 2022.   The vial did not undergo any temperature excursions.  Treatment details were not given.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow up received contains no new information.
Age: 90.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine was expired on 20 Mar 2022 and it was stored in refrigerator on 31 Mar 2022; We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (vaccine was expired on 20 Mar 2022 and it was stored in refrigerator on 31 Mar 2022) in a 90-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was expired on 20 Mar 2022 and it was stored in refrigerator on 31 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that expired on 20Mar2022 that we gave a few doses of.) and PRODUCT STORAGE ERROR (vaccine was expired on 20 Mar 2022 and it was stored in refrigerator on 31 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  Dose was administered after 30-day Use By Date or after manufacturer date of expiry. 8 doses were given from the expired vials. Initially vial was stored in refrigerator on 31 Mar 2022  Vial did not undergo any temperature excursion.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow up received contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Cold sweat, Computerised tomogram, Constipation
Clinical narrative: Severe pain in the left hip, groin and leg, lack of mobility and flexibility, stiffness, extreme constipation with  discolored stool and mucus after taking any form of laxative, weight loss, intermittent clamminess and warmth throughout the body
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Faeces discoloured, Feeling hot, Groin pain, Laboratory test, Mobility decreased
Clinical narrative: Severe pain in the left hip, groin and leg, lack of mobility and flexibility, stiffness, extreme constipation with  discolored stool and mucus after taking any form of laxative, weight loss, intermittent clamminess and warmth throughout the body
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mucous stools, Musculoskeletal stiffness, Pain in extremity, Spinal myelogram, Ultrasound scan
Clinical narrative: Severe pain in the left hip, groin and leg, lack of mobility and flexibility, stiffness, extreme constipation with  discolored stool and mucus after taking any form of laxative, weight loss, intermittent clamminess and warmth throughout the body
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased, X-ray, X-ray of pelvis and hip
Clinical narrative: Severe pain in the left hip, groin and leg, lack of mobility and flexibility, stiffness, extreme constipation with  discolored stool and mucus after taking any form of laxative, weight loss, intermittent clamminess and warmth throughout the body
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Oropharyngeal pain
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: throat pain but no difficulty breathing-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Additional Details: Patient had me call mother. Patient was responsive, monitored her breathing until her sister arrived 15-20 minutes. Patient stated she has vasovagal syncope & mother advised I not call ambulance. I did not since patient was breathing and was responsive. Gave patient apple juice and held her until sister arrived. She stated she was fine and her sister & I walked her to the car.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis
Clinical narrative: Systemic: Flushed / Sweating-Mild
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Fever-Medium, Additional Details: pt came into a different sotre  to get her second booster.  she had received 2 primary doses reported she got 0.5 ml of Moderna even though she is not immunocompromised.  she admitted to making the online appoinment herself.  She communicated that she felt she experienced stronger side effects because of the incorrect dose which she herself made an appointment for.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired on 3.17.22
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse effects
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse effects
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Peripheral swelling, Pyrexia, Rash pruritic, Skin warm
Clinical narrative: She stated she developed a 101 fever, low appetite, her arm swelled up down to her write, had itchy rash, arm is warm and tender to touch. Reaction subsided after 4 days.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: She stated she developed a 101 fever, low appetite, her arm swelled up down to her write, had itchy rash, arm is warm and tender to touch. Reaction subsided after 4 days.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Injection site pain, Muscular weakness
Clinical narrative: Patient received COVID19 vaccine 3/2021, and began having pain at the site that evening. Has progressively worsened over time. Now she has weakness RUE.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Body mass index, Body surface area, Body temperature
Clinical narrative: Patient received COVID19 vaccine 3/2021, and began having pain at the site that evening. Has progressively worsened over time. Now she has weakness RUE.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Initial insomnia, Injection site pain, Mammogram, Middle insomnia, Mobility decreased
Clinical narrative: Patient received COVID19 vaccine 3/2021, and began having pain at the site that evening. Has progressively worsened over time. Now she has weakness RUE.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity, Swelling
Clinical narrative: Patient received COVID19 vaccine 3/2021, and began having pain at the site that evening. Has progressively worsened over time. Now she has weakness RUE.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Adverse reaction, Tinnitus
Clinical narrative: Developed tiNNitis - Both ears 1 day after getting 2nd dose of Covid vaccine went to be evaluated on 10-1-21 BY Dr. After having my hearing checked he determined that my tiNNitus is most Likley from my 2nd Dose of Covid-19. but in his report to my primary Dr. Dr said it wasN't due to the vaccine! No treatment no pRedNisone only could give me ativAN which I refused. He did Not report the adverse reactioN To my Knoledge. Dr. Believed Dr.'s report so didn't report it. He said I could report it. So I am. I Have had Tinnitus Now for 1 yearand I believe it was caused by the Covid vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient is eleven years old but given adult dose (0.3mg) of Pfizer vaccine. Pt. observed 15 minutes per protocol, no adverse event occured.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Skin warm
Clinical narrative: 17:50 pt. given Pfizer Covid 19 Booster. 18:00 pt. c/o "tingling" lips. Dr. notified and instructed RN to give Benadryl 25mg plus pepcid x 2 p.o. + observe 20 min and call back. 18:05 BP 133/83 P. 99 Po2 100% 18:20 pt. c/o slight improvement, denies respiratory Sx. skin warm, dry, no apparent rash. 18:20 Dr. called w/ update. advised to discuss 2/ pt. emergency protocol and comfort level if d.c'd. Pt. d-c'd. BP 130/86 P 98 Po2 100%
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Rash
Clinical narrative: The next day I had and still have inflammation of my fingers and shoulders several days later I had a rash on my arms which has not returned  I regret taking the booster
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Injected limb mobility decreased, Muscle spasms, Pain in extremity, Weight bearing difficulty
Clinical narrative: Constant pain in upper arm that is unresolved and does not dissipate even with Tylenol, unable to lift arm above 90 degrees, unable to carry a purse or bag on left shoulder without additional pain, unable to carry items with left arm, unable to drive with left arm. Since an Xray was ordered by my insurance instead of an MRI, I have more pain and now muscle spasms from raising my arm for an extended period of time for the images 4/1/22. This pain in my arm started the day of injection 10/1/21 and has not dissipated or lessened in any way. If anything it has continued to be more painful.