chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction
Clinical narrative: Passed away; Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away) and MYOCARDIAL INFARCTION (Heart attack) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke in 2018.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). The patient died on 13-Jan-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            The patient did not receive a second booster dose. The patient experienced a heart attack around holiday 2021. It was reported that the father's death was not in relation to the vaccine.   No concomitant medication was reported. No treatment medication was reported.  Company comment: This case concerns an 85-year-old male patient, who experienced unexpected, serious (medically significant) AESI of Myocardial infarction and who had a fatal outcome with unexpected serious event of Death. Onset latency cannot be determined as the start date of the events as well as the vaccination dates were not reported. The patient reportedly received 3 doses of mRNA-1273 vaccine Clinical course and treatment details are not available in this report.  Cause of death was not reported in this case. It is unknown if an autopsy was performed.  The event was considered unrelated to the mRNA-1273 vaccine as per the reporter's assessment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up documents contains no new information.; Sender's Comments: This case concerns an 85-year-old male patient, who experienced unexpected, serious (medically significant) AESI of Myocardial infarction and who had a fatal outcome with unexpected serious event of Death. Onset latency cannot be determined as the start date of the events as well as the vaccination dates were not reported. The patient reportedly received 3 doses of mRNA-1273 vaccine Clinical course and treatment details are not available in this report.  Cause of death was not reported in this case. It is unknown if an autopsy was performed.  The event was considered unrelated to the mRNA-1273 vaccine as per the reporter's assessment.  The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We gave 3 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses 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 reported. Patient received 1/2 dose ( 2nd booster ) on 14 Apr 2022. The vial was initially stored in the refrigerator was on 13 Apr 2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up information received contains no new information.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Number of doses/vials: 3. The vial was initially stored in the refrigerator on 13-Apr-2022. The vial did not undergo any temperature excursions. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up received contains no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation; Left arm red up to elbow/she experienced after receiving one of the first or second primary series; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation) and VACCINATION SITE ERYTHEMA (Left arm red up to elbow/she experienced after receiving one of the first or second primary series) in a 79-year-old female patient 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, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation) and VACCINATION SITE ERYTHEMA (Left arm red up to elbow/she experienced after receiving one of the first or second primary series). At the time of the report, VACCINATION SITE SWELLING (Left arm swelled up/she experienced after receiving one of the first or second primary series / Inflammation) and VACCINATION SITE ERYTHEMA (Left arm red up to elbow/she experienced after receiving one of the first or second primary series) had resolved.            No concomitant medication information reported. Treatment medication information reported as Antibiotic for inflammation.  Patient reported that the patient's doctor gave her an antibiotic to stop inflammation and it worked. Patient mentioned that patient will not receive another Moderna's covid-19 vaccine because of the side effects Patient experienced.   This case was linked to MOD-2022-541370 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm was a little swollen for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was a little swollen for 2-3 days) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020821A and 024320A) for COVID-19 vaccination.     The patient never had COVID positive test or COVID diagnosis. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Soap allergy, Alcohol allergy, Iron deficiency anemia (recent change in status was worsening), Renal impairment (22 percent; recent change in status was worsening), Solitary kidney (one kidney, 70 years old (kidney bled out or wasn't born with left kidney - worked 60%); recent change in status was worsening), Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (arm was a little swollen for 2-3 days). In April 2021, PERIPHERAL SWELLING (arm was a little swollen for 2-3 days) had resolved.            Concomitant medication of the patient also included unspecified blood pressure pills, unspecified vitamin and tumeric.  No treatment information was provided by the reporter.  In September 2021, the patient underwent cardiac stent (which was postponed from March 2021) and change in status for this condition was mentioned as improvement.  On 26-Nov-2021, the patient received the booster dose of Moderna COVID-19 vaccine at a dose of 0.25 mL (Lot number: 013F21A). After receiving the booster dose, now the patient was getting iron shots for kidney at a frequency of every other week (last got 2 weeks ago, i.e., 01-Apr-2022).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: we had vial that was "left open" and the patient got the vaccine from that vial; we had vial that was "left open" and the patient got the vaccine from that vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (we had vial that was "left open" and the patient got the vaccine from that vial) and EXPIRED PRODUCT ADMINISTERED (we had vial that was "left open" and the patient got the vaccine from that vial) 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 PRODUCT STORAGE ERROR (we had vial that was "left open" and the patient got the vaccine from that vial) and EXPIRED PRODUCT ADMINISTERED (we had vial that was "left open" and the patient got the vaccine from that vial). At the time of the report, PRODUCT STORAGE ERROR (we had vial that was "left open" and the patient got the vaccine from that vial) and EXPIRED PRODUCT ADMINISTERED (we had vial that was "left open" and the patient got the vaccine from that vial) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment medication was provided by reporter. Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore Arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Hypothyroidism, Anxiety and Drug allergy. Concomitant products included SERTRALINE for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter.   This case was linked to MOD-2022-541804 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia, Hypothyroidism and Drug allergy (Sulfa). Concomitant products included LISINOPRIL, ATORVASTATIN and LEVOTHYROXINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved. It was reported that patient never been tested positive or diagnosed with COVID-19. No treatment information was reported.   This case was linked to MOD-2022-541588, MOD-2022-541581, MOD-2022-538599 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration; After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) and PRODUCT STORAGE ERROR (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 083J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Apr-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) and PRODUCT STORAGE ERROR (After the BUD /the dose administered this morning spent more than 12 hours punctured prior to administration) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that, Date the vial was initially stored in the refrigerator was 12-Apr-2022. Date and time vial was first punctured was 13-Apr-2022 at 7:00 AM. Date and time of administration of vaccine was 14-Apr-2022 (this morning, probably prior to 9:00 AM). The vial was stored post puncture at Room temperature, drawn up into syringes.The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 16 hours. No concomitant medications were reported. No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Palpitations
Clinical narrative: High blood pressure; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure) and PALPITATIONS (Heart palpitations) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (High blood pressure) and PALPITATIONS (Heart palpitations). At the time of the report, HYPERTENSION (High blood pressure) and PALPITATIONS (Heart palpitations) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) has high blood pressure.   No concomitant medications were reported. It was reported that, patient was asking if it was necessary that she gets the 2nd booster, she stated that she had received all 3 shots and had high blood pressure, heart palpitations but unable to confirm if the symptoms started after patient received the vaccines. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Very bad toothache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Very bad toothache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 042B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (Very bad toothache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Toothache, at an unspecified dose and frequency. At the time of the report, TOOTHACHE (Very bad toothache) outcome was unknown.            No concomitant medications were reported by the reporter. Patient stated that it was her 1st Booster dose which was administered on 09-Nov-2021.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Very swollen left arm in the site of injection; Very sore left arm in the site of injection; Big lump in the left armpit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Very swollen left arm in the site of injection), VACCINATION SITE PAIN (Very sore left arm in the site of injection) and AXILLARY MASS (Big lump in the left armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059D21A and 088D21A) for COVID-19 vaccination.     The patient had no allergies. The patient had no medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination.    On 29-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced VACCINATION SITE SWELLING (Very swollen left arm in the site of injection), VACCINATION SITE PAIN (Very sore left arm in the site of injection) and AXILLARY MASS (Big lump in the left armpit). On 17-Oct-2021, VACCINATION SITE SWELLING (Very swollen left arm in the site of injection), VACCINATION SITE PAIN (Very sore left arm in the site of injection) and AXILLARY MASS (Big lump in the left armpit) had resolved.            No concomitant medications were reported. No other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine. The patient was never tested positive for COVID-19. The patient did not experience any similar event in the past.  The patient did not seek any medical care or took treatment.     This case was linked to MOD-2022-541694 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient were administered from a vaccine that experienced a temperature excursion; Patient were administered from a vaccine that experienced a temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered from a vaccine that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient were administered from a vaccine that experienced a temperature excursion) in a 48-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered from a vaccine that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered from a vaccine that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered from a vaccine that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient were administered from a vaccine that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The health care professional (HCP) reported a temperature excursion, the reporter believed that the vaccines were okay, but the department of health instructed to call Moderna. HCP stated that the vaccines went from frozen to refrigeration temperature, so HCP believed they were okay to use. Four patients had been administered from these vaccines.  No treatment information was provided.   This case was linked to MOD-2022-541803 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: he was out of breath while talking.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (he was out of breath while talking.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (7-year history of cancer) and Immunocompromised (immunocompromised due to his cancer).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (he was out of breath while talking.). At the time of the report, DYSPNOEA (he was out of breath while talking.) outcome was unknown. No concomitant product reported by reporter. The patient stated that he has received 3 doses of the moderna vaccine in the recommended time frame and his doctor wanted him to get the 4th dose. The patient stated that when he called to make an appointment, he was told that he would be getting spikevax for his 4th dose. During the call, the patient was unsure but stated that he may have gotten a full dose of Moderna vaccine for his 3rd dose which he stated was the 1st booster dose. No treatment information was provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered from a vaccine that experienced a temperature excursion; Patient was administered from a vaccine that experienced a temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from a vaccine that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from a vaccine that experienced a temperature excursion) in an 82-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from a vaccine that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from a vaccine that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered from a vaccine that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered from a vaccine that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that the health care professional (HCP) was calling to report a temperature excursion, the reporter believed that the vaccines were okay, but the department of health instructed to call Moderna. HCP stated that the vaccines went from frozen to refrigeration temperature, so HCP believed they were okay to use. Four patients had been administered from these vaccines.  No treatment information was provided.   This case was linked to MOD-2022-541733, MOD-2022-541805, MOD-2022-541808 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to sulfur), Allergy to antibiotic (Allergic to Erythromycin), Hypothyroidism and Anxiety. Concomitant products included SERTRALINE for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) outcome was unknown.            The patient called to report some side effects which the patient experienced after receiving second dose. The patient experienced Sore arm and Chills. It was also reported that the patient had never tested positive for Covid-19 and did not receive any other vaccine within 1 month prior to Moderna Covid-19 vaccine.  Reportedly, the patient did not seek for medical care attention.  No treatment information was provided.   This case was linked to MOD-2022-541551, MOD-2022-541806, MOD-2022-541807 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 4 patients were administered from a vaccine that experienced a temperature excursion; 4 patients were administered from a vaccine that experienced a temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion) in a 70-year-old female patient 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 POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  It was reported that vaccines went from frozen to refrigeration temperature.  No treatment were reported.   This case was linked to MOD-2022-541803 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 011A21A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy), Allergy to antibiotic (Erythromycin allergy), Hypothyroidism and Anxiety. Concomitant products included SERTRALINE for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Sep-2021, received third 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 CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and CHILLS (Chills) outcome was unknown. On 26-Sep-2021, the patient received a first booster dose (Lot: 014F21A) of Moderna vaccine. Patient had never tested positive for COVID-19 and she did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine. Patient did not seek for medical care attention and she did not experienced a similar event on the past. No treatment  medications were reported. This case was linked to MOD-2022-541551, MOD-2022-541804, MOD-2022-541807 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Rash
Clinical narrative: Middle chest hurt/chest pain appear again; Middle chest tight like when something is stucked on her throat; Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Middle chest hurt/chest pain appear again), CHEST DISCOMFORT (Middle chest tight like when something is stucked on her throat) and RASH (Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 014F21A, 011A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfur), Allergy to antibiotic (Erythromycin), Hypothyroidism (chronic illnesses) and Anxiety (chronic illnesses). Concomitant products included SERTRALINE for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 26-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, the patient experienced CHEST PAIN (Middle chest hurt/chest pain appear again), CHEST DISCOMFORT (Middle chest tight like when something is stucked on her throat) and RASH (Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Middle chest hurt/chest pain appear again), CHEST DISCOMFORT (Middle chest tight like when something is stucked on her throat) and RASH (Bad rash on trunk/Bad rash on palms/Bad rash on eyes/Rash appear again) had not resolved.            Patient had never tested positive for Covid-19 and Patient did not received any other vaccine within 1 month prior to Moderna Covid-19 vaccine.  Patient received first dose, second dose, first booster dose and second booster dose. It was reported that on 15-Apr-2022 patient again experienced symptoms of rash and chest pain.  Patient did not seek for medical care attention for events. Patient took Benadryl for symptoms and symptoms went away.   This case was linked to MOD-2022-541551, MOD-2022-541804 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 4 patients were administered from a vaccine that experienced a temperature excursion; 4 patients were administered from a vaccine that experienced a temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (4 patients were administered from a vaccine that experienced a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (4 patients were administered from a vaccine that experienced a temperature excursion) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. This case was linked to MOD-2022-541803 (Patient Link).
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Product administered to patient of inappropriate age, Vaccination site anaesthesia, Vaccination site paraesthesia
Clinical narrative: numbness in his arm at the injection site; He also complained of shortness of breath; tingling in his arm at the injection site; One of my LPNs administered a dose of Moderna Covid-19 vaccine 0.25mL booster to a 14 yo patient.; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ANAESTHESIA (numbness in his arm at the injection site), DYSPNOEA (He also complained of shortness of breath), VACCINATION SITE PARAESTHESIA (tingling in his arm at the injection site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (One of my LPNs administered a dose of Moderna Covid-19 vaccine 0.25mL booster to a 14 yo patient.) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (2nd dose (full dose)) and Pfizer (1st dose (full dose)). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Jan-2022, the patient experienced VACCINATION SITE ANAESTHESIA (numbness in his arm at the injection site), DYSPNOEA (He also complained of shortness of breath), VACCINATION SITE PARAESTHESIA (tingling in his arm at the injection site) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (One of my LPNs administered a dose of Moderna Covid-19 vaccine 0.25mL booster to a 14 yo patient.). At the time of the report, VACCINATION SITE ANAESTHESIA (numbness in his arm at the injection site), DYSPNOEA (He also complained of shortness of breath) and VACCINATION SITE PARAESTHESIA (tingling in his arm at the injection site) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (One of my LPNs administered a dose of Moderna Covid-19 vaccine 0.25mL booster to a 14 yo 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.  No treatment medications were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; Tested positive for COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (Tested positive for COVID-19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Apple), Drug allergy (Codeine), Fruit allergy (Peach) and Allergy to nuts (Pistachio nut).   On 17-Mar-2021 at 8:07 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Apr-2021 at 6:09 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Dec-2021, the patient experienced VACCINATION FAILURE (Vaccination failure). 30-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive (Rapid test).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This spontaneous case concerns a 37-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by Rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-503875 (Patient Link). Sender's Comments: This spontaneous case concerns a 37-year-old female patient with no reported medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 8 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by Rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: currently taking Mobic (meloxicam) and want to get 4th injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (currently taking Mobic (meloxicam) and want to get 4th injection) 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 VACCINATION COMPLICATION (currently taking Mobic (meloxicam) and want to get 4th injection). The patient was treated with MELOXICAM (MOBIC) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (currently taking Mobic (meloxicam) and want to get 4th injection) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Reportedly, patient was currently taking Mobic (meloxicam) and wanted to get 4th injection. Since Mobic is an NSAID, it was enquired if it would reduce the effectiveness of the vaccine similar to Advil or other NSAIDs.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain
Clinical narrative: headache; Chills; sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VACCINATION SITE PAIN (sore injection site right arm) and HEADACHE (headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 026L20A and B070H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient experienced CHILLS (Chills) and VACCINATION SITE PAIN (sore injection site right arm). On 28-Jan-2022, the patient experienced HEADACHE (headache). At the time of the report, CHILLS (Chills), VACCINATION SITE PAIN (sore injection site right arm) and HEADACHE (headache) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided. The patient was trying to make an appointment with Pharmacy for her second Moderna Covid- 19 vaccine booster dose. The patient received her first primary dose of the Moderna Covid-19 vaccine and reported no side effects or adverse reactions. The patient received her second primary Moderna Covid-19 booster dose and got the chills late on 27 Jan 2022 The patient also had a sore injection site right arm starting 27 Jan 2022 and a headache starting on 28 Jan 2022. The patient received her first Moderna Covid-19 vaccine booster dose on and had no side effects or adverse reactions after her booster dose.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received contains no new information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; tested positive for COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Nitrous Oxide).   On 15-Apr-2021 at 10:44 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-May-2021 at 10:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-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 medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns a 48-year-old, female patient, with no relevant medical history reported, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive which occurred 6 months 2 days after the first dose of mRNA-1273. Drug ineffective was an additional event. SARS-CoV-2 test was positive as on 17-Oct-2021.Ongoing pandemic of COVID-19  remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-538939 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient, with no relevant medical history reported, who experienced the unexpected non serious AESI event of SARS-CoV-2 test positive which occurred 6 months 2 days after the first dose of mRNA-1273. Drug ineffective was an additional event. SARS-CoV-2 test was positive as on 17-Oct-2021.Ongoing pandemic of COVID-19  remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.