chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dispensed dose of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna Covid-19 vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient neither diagnosed with COVID-19 nor tested positive. 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 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed dose of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were taken by the patient. The vial did not undergo any temperature excursion and it was unknown when the vial initially stored in the refrigerator.  It was reported that patient did not experienced any adverse events. The results of moderna stability study showed proper activity againt COVID-19   Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 06-Apr-2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. It was reported that Patient was not diagnosed or tested positive for COVID-19. It was reported that patient had no acute illness at the time of vaccination. It was reported that patient had no Chronic or long-standing health condition. It was reported that patient did not take any medication, dietary supplement, or herbal remedies at the time of vaccination. On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine on 06-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. Vial did not undergo any temperature excursions. No adverse event was reported. The vaccine given had a expiry date 18-MAr-2022 but the Moderna stability study showed the vaccine was active against COVID-19 for that date. No treatment medications was provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Vaccination site erythema, Vaccination site mass
Clinical narrative: Feeling very run down; Large red bump on her arm at injection site; Large red bump on her arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling very run down), VACCINATION SITE MASS (Large red bump on her arm at injection site) and VACCINATION SITE ERYTHEMA (Large red bump on her arm at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension (Primary pulmonary arterial hypertension). Concomitant products included TADALAFIL and MACITENTAN (OPSUMIT) for an unknown indication.   On 13-Oct-2020, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose four times per day. On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced FATIGUE (Feeling very run down), VACCINATION SITE MASS (Large red bump on her arm at injection site) and VACCINATION SITE ERYTHEMA (Large red bump on her arm at injection site). At the time of the report, FATIGUE (Feeling very run down), VACCINATION SITE MASS (Large red bump on her arm at injection site) and VACCINATION SITE ERYTHEMA (Large red bump on her arm at injection site) outcome was unknown.      No treatment medication information provided.   This case was linked to MOD-2021-102229 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: itchy in the body; body was really hot/ feeling the heat; started breaking out in hives; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy in the body), FEELING HOT (body was really hot/ feeling the heat), URTICARIA (started breaking out in hives) and RASH (rash) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No other vaccine was administered to the patient 1 month prior to Moderna COVID-19 vaccination. The patient had no allergies to medications, food and other products.  The patient's past medical history included COVID-19 in January 2021.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy in the body), FEELING HOT (body was really hot/ feeling the heat), URTICARIA (started breaking out in hives) and RASH (rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy in the body), FEELING HOT (body was really hot/ feeling the heat), URTICARIA (started breaking out in hives) and RASH (rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  The patient experienced the adverse events after 3 days of receiving the first booster dose/third dose of the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Migraine, SARS-CoV-2 test, Vomiting
Clinical narrative: Migraine severe after 2nd dose; Sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine severe after 2nd dose), ILLNESS (Sick) and VOMITING (Vomiting) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cancer, Concussion (history of previous concussion age 16 MVA behind right eye (rolled and hit tree),), Vertigo, Headache, ADHD (ADHD/ADD (briefly took medication as adult).), Motor vehicle accident (MVA age 27 sideswiped. Also had 4 other MVA's. All of which felt better within a fewdays) and Hysterectomy (Hysterectomy at the age of 30, due to ovarian cancer) on 14-Mar-2008. Concurrent medical conditions included Migraine (Behind right eye  (average about 1-2 per month)) since 1987, Irritable bladder (Ibs hypothyroidism) since 01-Nov-2000, Hypothyroidism (Ibs hypothyroidism) since 01-Nov-2000, Allergy to nuts (Tree nuts), Drug allergy (Morphine), Claustrophobia and Cystitis interstitial (IC). Concomitant products included URIBEL for Cystitis interstitial, LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL (CLIMARA [ESTRADIOL]) and SUMATRIPTAN for an unknown indication.   On 16-Apr-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021 at 2:00 AM, the patient experienced MIGRAINE (Migraine severe after 2nd dose), ILLNESS (Sick) and VOMITING (Vomiting). At the time of the report, MIGRAINE (Migraine severe after 2nd dose), ILLNESS (Sick) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No treatment information was provided.   This case was linked to MOD-2021-083105 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 patients administed a dose of Moderna from a vial that had been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients administed a dose of Moderna from a vial that had been punctured for more than 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients administed a dose of Moderna from a vial that had been punctured for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients administed a dose of Moderna from a vial that had been punctured for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Vail was punctured around 11:50/11:52 AM on 19-Apr-2022 and first booster dose was administered to patient on 20-Apr-2022 around 11:51 AM Treatment information was not provided.   This case was linked to MOD-2022-545341, MOD-2022-546074.
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 (3 patients received booster doses of Moderna COVID-19 vaccine from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (3 patients received booster doses from a vial that had been punctured for more than 12 hours/the vial was exposed to room temperature range for 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses of Moderna COVID-19 vaccine from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (3 patients received booster doses from a vial that had been punctured for more than 12 hours/the vial was exposed to room temperature range for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received booster doses of Moderna COVID-19 vaccine from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (3 patients received booster doses from a vial that had been punctured for more than 12 hours/the vial was exposed to room temperature range for 24 hours) 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 administered with first booster dose of the vaccine around 11:51 A.M or after that time. It was reported that the number of doses/vials that were affected and administered were 3 doses. The vial was initially stored in the refrigerator on 15-Apr-2022. The vial was first punctured at 11:50 A.M. on 19-Apr-2022. The vial was stored at room temperature post puncture. It was reported that the vial was left on counter top overnight. The total amount of time during which the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was 24 hours. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2022-546072, MOD-2022-545341 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for Prophylactic vaccination.     Patient had no known allergies.  Previously administered products included for Product used for unknown indication: Flu Shot. Past adverse reactions to the above products included No adverse event with Flu Shot. Concurrent medical conditions included Drug abuse (Drug abuse of penicillin that increases Serotonin such as Tramadol (Pain medication).).    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant  medications were reported by the reporter.  Patient received covid-19 vaccine ad26.cov.s for  second dose on 07-Apr-2022on left arm with batch number 1855190 and experienced wobbling unsteady when walking, felt shaky, numbness around right ear and lightheadedness on the same day. It was reported that patient felt the Jansen and Jansen injection was given very high on the arm. Outcome of these events were not reported.  No Treatment medications were reported by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (worsening of diverticulitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diverticulitis (10 years ago). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced DIVERTICULITIS (worsening of diverticulitis) (seriousness criterion medically significant). At the time of the report, DIVERTICULITIS (worsening of diverticulitis) outcome was unknown. No concomitant drug was reported. Treatment medication was reported as 10 day course of antibiotics to treat diverticulitis. Company comment: This is a spontaneous case concerning a female patient of an unknown age with concurrent medical condition of diverticulitis who received 3 doses of mRNA-1273 vaccine and experienced serious (medically significant), unexpected event of worsening of diverticulitis. Vaccination date and onset date of the event were not provided; hence, latency cannot be assessed. The patient stated that she was diagnosed with diverticulitis 10 years ago, but this was the first time she ever had to take an antibiotic to treat her diverticulitis. She wanted to know if it was okay to get the second booster dose since she was taking an antibiotic. No further details regarding clinical course or diagnostic tests were disclosed. Concurrent medical condition of diverticulitis remains a contributory factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with concurrent medical condition of diverticulitis who received 3 doses of mRNA-1273 vaccine and experienced serious (medically significant), unexpected event of worsening of diverticulitis. Vaccination date and onset date of the event were not provided; hence, latency cannot be assessed. The patient stated that she was diagnosed with diverticulitis 10 years ago, but this was the first time she ever had to take an antibiotic to treat her diverticulitis. She wanted to know if it was okay to get the second booster dose since she was taking an antibiotic. No further details regarding clinical course or diagnostic tests were disclosed. Concurrent medical condition of diverticulitis remains a contributory factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site irritation
Clinical narrative: The patient received a minor irritation in his injection site arm after each dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (The patient received a minor irritation in his injection site arm after each dose.) in an 87-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE IRRITATION (The patient received a minor irritation in his injection site arm after each dose.). At the time of the report, VACCINATION SITE IRRITATION (The patient received a minor irritation in his injection site arm after each dose.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-546141, MOD-2022-546147 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Followup received contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second booster to early) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 016J21-2A, 006B21A and 031M20A) for COVID-19 vaccination. It was unknown if patient had allergies (medications, food and other products) or had acute and chronic illnesses at the time of vaccination. It was unknown if patient had ever had COVID positive test or diagnosis. It was unknown if any  other COVID-19 vaccines given prior to Moderna vaccine. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second booster to early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second booster to early) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was unknown if patient had sought medical care (office visit, Urgent care, ER, hospitalized). No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow up contains contain No new information
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 positive on 25-Dec-2021; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Covid-19 positive on 25-Dec-2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no known drug allergies and the patient did not have history of cancer, Leukemia, HIV or AIDS or any other condition that weakens the Immune system. The patient did not have history of myocarditis or pericarditis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021, the patient experienced COVID-19 (Covid-19 positive on 25-Dec-2021). At the time of the report, COVID-19 (Covid-19 positive on 25-Dec-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive (PCR).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient had no acute illnesses at the time of vaccination and up to one month before vaccination.  No treatment information was provided.  Company Comment: This is a Spontaneous case concerning a 57-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred in the context of the administration of a dose of the mRNA-1273 vaccine of an unknown dose and schedule of vaccination. Relevant test was performed: PCR positive for COVID-19. Very limited information is available regarding clinical course and diagnostic work-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.   This case was linked to MOD-2022-531910 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 57-year-old male patient, with no medical history reported, who experienced the non-serious unexpected AESI of COVID-19. The event occurred in the context of the administration of a dose of the mRNA-1273 vaccine of an unknown dose and schedule of vaccination. Relevant test was performed: PCR positive for COVID-19. Very limited information is available regarding clinical course and diagnostic work-up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (minor irritation in his injection site arm after each dose.) in an 87-year-old male patient 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 SITE IRRITATION (minor irritation in his injection site arm after each dose). At the time of the report, VACCINATION SITE IRRITATION (minor irritation in his injection site arm after each dose) outcome was unknown. No concomitant drug information was provided. No treatment drug information was provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received contains no new information.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccines that experienced a T excursion). On 18-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Storage condition at the time of the excursion was reported as refrigerator. Maximum temperature reached was reported as 64°F. Excursion duration was reported as approximately 7 hours. Date vial moved from freezer to refrigerator was reported as unknown. They were returned to the refrigerator. No changes on visual inspection noting vaccine state. At the time they were unpunctured. The patient not had any adverse events post injection. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 14-Apr-2022, the patient experienced ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in April 2022 due to ATRIAL FIBRILLATION. At the time of the report, ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ATRIAL FIBRILLATION (she was having heart palpitations, then diagnosis her with AFIB) to be related. No concomitant medication details were provided.  Patient went to emergency room because she was having heart palpitations. 4th dose, patient stated that she had irregular heart beat and was hospitalized for observation. She was kept over night for observation, then diagnosis with AFIB. No treatment medication details were provided. Company comment: This is a spontaneous case concerning a 76-year-old female patient with no medical history reported who experienced the unexpected and serious (hospitalization and medically significant) AESI atrial fibrillation the same day a dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Patient went to ER because she was having heart palpitations. She was kept overnight for observation and was then diagnosed AFIB. Patient´s age remains as a contributory risk factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with no medical history reported who experienced the unexpected and serious (hospitalization and medically significant) AESI atrial fibrillation the same day a dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Patient went to ER because she was having heart palpitations. She was kept overnight for observation and was then diagnosed AFIB. Patient´s age remains as a contributory risk factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from vaccine that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from vaccine that experienced a T excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient did not have any adverse events post injection. It was reported that the storage condition at the time of the excursion was at refrigerator. Maximum temperature reached was 64-degree Fahrenheit, and excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. Temperature excursion occurred on 10 Mar 2022. As per source document the Tran date was reported as 15-Mar-2022. No treatment medication information was given.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 16-Jun-21 and second dose on 4-Aug-21; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Jun-21 and second dose on 4-Aug-21) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 047A21A) for COVID-19 vaccination.     No acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Drug allergy (Vancomycin), Type 2 diabetes mellitus, Hypertension, Gastrooesophageal reflux disease and Asthma. Concomitant products included ECONAZOLE from 17-Jan-2022 to an unknown date for Fungal infection, LIDOCAINE from 29-Mar-2022 to an unknown date for Pain, SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA) from 19-Oct-2020 to an unknown date, ISOPROPANOL (ALCOHOL PREP PADS) from 25-Feb-2022 to an unknown date, AMLODIPINE from 19-Jan-2022 to an unknown date, ATORVASTATIN from 01-Mar-2022 to an unknown date, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE AND VITAMIN D3) from 28-Feb-2022 to an unknown date, FAMOTIDINE from 01-Mar-2022 to an unknown date, FERROUS SULFATE from 28-Feb-2022 to an unknown date, FLUTICASONE PROPIONATE from 24-Feb-2022 to an unknown date, GABAPENTINE from 14-Mar-2022 to an unknown date, GLIMEPIRIDE from 24-Feb-2022 to an unknown date, HYDROCHLOROTHIAZIDE from 01-Mar-2022 to an unknown date, ACETAMINOPHEN;HYDROCODONE from 12-Apr-2022 to an unknown date, HYDROXYZINE PAMOATE from 11-Dec-2001 to an unknown date, INSULIN GLARGINE (LANTUS) from 01-Apr-2022 to an unknown date, LISINOPRIL from 19-Jan-2022 to an unknown date, MELOXICAM from 16-Jun-2020 to an unknown date, METFORMIN from 22-Mar-2022 to an unknown date, OMEPRAZOLE from 01-Mar-2022 to an unknown date and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) from 14-Mar-2022 to an unknown date for an unknown indication.   On 16-Jun-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Aug-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Jun-21 and second dose on 4-Aug-21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Jun-21 and second dose on 4-Aug-21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Accu-chek guide L1-L2 control solution, Accu-chek guide test strip, clevar choice comfort ex pen needle 31gx5mm misc and pharmacist choice ultra thine lancets 31g misc.  No treatment medication was reported   This case was linked to MOD-2022-544225 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion/she reported an excursion about a month ago) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) 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 trans date was given as 18-Mar-2022. HCP was calling because she reported an excursion about a month ago, at the time she did not ask for a stability report but now she had been asked to send the stability report, HCP also mentioned that the excursion duration was 7 hours instead 5 min (previously stated). Storage condition at the time of the excursion: Refrigerator. Maximum or minimum temperatures reached, as applicable (specify temp is in C or F): Max Temperature reached 64°F. Excursion duration: Approximately 7 hours. They were returned to the refrigerator. Visual inspection noting any vaccine state change: (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all): No changes. Pertinent details: whether the vial(s) were punctured, any previous excursions with the impacted vial(s): At the time they were unpunctured. The patient did not have any adverse events post injection. No treatment information was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient had been administered from vaccine that experienced Temperature excursion; Patient had been administered from vaccine that experienced Temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered from vaccine that experienced Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered from vaccine that experienced Temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 17-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered from vaccine that experienced Temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered from vaccine that experienced Temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient had been administered from vaccine that experienced Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient had been administered from vaccine that experienced Temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The temperature excursion was occurred on 10-Mar-2022. Storage condition at the time of the excursion was refrigerator; maximum or minimum temperatures reached was max temperature reached 64-degree Fahrenheit; excursion duration was 7 hours instead 5 min (previously stated); date the vial was moved from freezer to refrigerator was unknown by the reporter; upon visual inspection no changes of vaccine state was observed and at the time of excursion the vials were unpunctured.  The patient did not experience any adverse events post injection.  The reporter was yet to receive the temperature stability report.  No treatment information was provided by the reporter.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients administered from vaccines that experienced a Temperature excursion; Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered from vaccines that experienced a Temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered from vaccines that experienced a Temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine from a vial which came across temperature excursion with duration of 7 hours) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter informed that an excursion occured about a month ago, at the time she didn't ask for a stability report but now she has been asked to send the stability report, The reporter also mentioned that the excursion duration was 7 hours instead 5.  Date of temperature excursion was 10-Mar-2022. Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 16-Mar-2022 and vials were returned to the refrigerator. Tran date was 16-Mar-2022.The patient did not experience any adverse events post injection.   This case was linked to MOD-2022-54617.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion vaccine was administered to patient; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). On 23-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Excursion vaccine was administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter informed that an excursion occurred about a month ago, at the time the reporter didn't ask for a stability report but now has been asked to send the stability report, The reporter also mentioned that the excursion duration was 7 hours instead 5.  Maximum or minimum temperatures reached was 64 degrees Fahrenheit. Excursion duration was approximately 7 hours. The vaccine was stored in refrigerator at the time of the excursion. There were no changes in visual inspection. Pertinent details: At the time they were unpunctured. Vaccine was administered on 23-Mar-2022 and vials were returned to the refrigerator. Tran date was 23-Mar-2022.The patient did not experience any adverse events post injection.  No treatment medication was reported.   This case was linked to MOD-2022-545986 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a temperature excursion; Patients have been administered from vaccines that experienced a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion). On 22-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Storage condition at the time of the excursion was reported as refrigerator. Maximum temperature reached was reported as 64°F. Excursion duration was reported as approximately 7 hours. Date vial moved from freezer to refrigerator was reported as unknown. They were returned to the refrigerator. No changes on visual inspection noting vaccine state. At the time they were unpunctured. The patient not had any adverse events post injection. The Tran date was reported as 23-Mar-2022.  No treatment information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccine that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered from vaccine that experienced a T excursion) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccine that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered from vaccine that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient have been administered from vaccine that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient have been administered from vaccine that experienced a T excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was given. The patient did not have any adverse events post injection. It was reported that the storage condition at the time of the excursion was at refrigerator. Maximum temperature reached was 64-degree Fahrenheit, and excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. As per source document the Tran date was reported as 25-Mar-2022.