chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Lung neoplasm malignant
Clinical narrative: recovering from lung cancer.; Have copd; This spontaneous case was reported by an other health care professional and describes the occurrence of LUNG NEOPLASM MALIGNANT (recovering from lung cancer.) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Lung cancer.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUNG NEOPLASM MALIGNANT (recovering from lung cancer.) (seriousness criterion medically significant) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Have copd). At the time of the report, LUNG NEOPLASM MALIGNANT (recovering from lung cancer.) was resolving and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Have copd) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. No treatment drug information was provided.  Company comment: This case concerns a 62-year-old, patient with unknown gender with concurrent medical condition of COPD and Lung cancer, who experienced the unexpected serious event of Lung neoplasm malignant (seriousness criterion medically significant) which occurred on unknown date after the (not specified) dose of mRNA 1273 Vaccine and outcome was reported as unknown. Patient's concurrent medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 62-year-old, patient with unknown gender with concurrent medical condition of COPD and Lung cancer, who experienced the unexpected serious event of Lung neoplasm malignant (seriousness criterion medically significant) which occurred on unknown date after the (not specified) dose of mRNA 1273 Vaccine and outcome was reported as unknown. Patient's concurrent medical condition remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Platelet level drop; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (Platelet level drop) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PLATELET COUNT DECREASED (Platelet level drop) (seriousness criterion medically significant). At the time of the report, PLATELET COUNT DECREASED (Platelet level drop) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: low (Low) Drop in platelet count.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 83-year-old, male patient with no reported medical history, who experienced the unexpected serious AESI event (seriousness criterion medically significant) of Platelet count decreased. The event occurred after the administration of the first dose of mRNA-1273 vaccine. Leukemia was diagnosed after the second dose, which would be a confounder factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-474448, MOD-2022-474427 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 83-year-old, male patient with no reported medical history, who experienced the unexpected serious AESI event (seriousness criterion medically significant) of Platelet count decreased. The event occurred after the administration of the first dose of mRNA-1273 vaccine. Leukemia was diagnosed after the second dose, which would be a confounder factor. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination. Concurrent medical conditions included HIV disease (All of them were under treatment for this illness). Concomitant products included Insulin Glargine (Toujeo), Benztropine [Benzatropine], Mirtazapine, Ritonavir, Amlodipine, Darunavir Ethanolate (Prezista), Dolutegravir Sodium (Tivicay) And Rosuvastatin Calcium (Crestor) for an unknown indication. On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had no known allergy. It was reported that the patient was administered Moderna COVD-19 Vaccine which was stored in the fridge for more than 30 days. Patients treatment details were not known to the reporter, as reporter did not know if any adverse events had occurred.
Sex: U
Vaccine: COVID19
Symptoms: Expired 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 (Temperature Excursion) and EXPIRED PRODUCT ADMINISTERED (one dose was administered after the second excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (one dose was administered after the second excursion). In January 2022, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (one dose was administered after the second excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. It was reported that 80 doses Moderna Covid-19 vaccines were exposed to 2 different temperature excursions. First excursion was occurred on 14-Jan-2022 for 30 minutes with maximum temperature (-) 7.8 degrees Celsius and minimum temperature (-) 21.9 degrees Celsius. Second excursion was occurred on 21-Jan-2022 for 15 minutes with maximum temperature (-) 13.2 degrees Celsius and minimum temperature (-) 22.1 degrees Celsius. They had a total of 10 vials on hand. Out of those 10, 2 were moved from the freezer to the refrigerator on 13-Jan-2022 and one was moved on 31-Jan-2022 (total of 3 vials moved to the refrigerator). 3 vials were in the refrigerator and 7 vials were in the freezer. Everything was normal per the HCP and no vaccine state change. 80 total doses from which one dose was already administered to a patient after the second excursion. No previous excursions prior to 14-Jan-2022 and one dose administered after being punctured but the HCP did not know how many doses are still unopened and sealed. No treatment medication was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Follow-up information received included significant information wherein case became valid as information received about one patient
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Disturbance in attention, Erectile dysfunction, Pollakiuria
Clinical narrative: can not get erection; constantly itching on the sides of the face and other areas of body; cannot focus; get confused about stuff; feel weak; urinate about 20 to 30 times a day; urinate about 20 to 30 times a day and it smells horrible; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (can not get erection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (can not get erection) (seriousness criterion medically significant), PRURITUS (constantly itching on the sides of the face and other areas of body), DISTURBANCE IN ATTENTION (cannot focus), CONFUSIONAL STATE (get confused about stuff), ASTHENIA (feel weak), POLLAKIURIA (urinate about 20 to 30 times a day) and URINE ODOUR ABNORMAL (urinate about 20 to 30 times a day and it smells horrible). At the time of the report, ERECTILE DYSFUNCTION (can not get erection), PRURITUS (constantly itching on the sides of the face and other areas of body), DISTURBANCE IN ATTENTION (cannot focus), CONFUSIONAL STATE (get confused about stuff), ASTHENIA (feel weak), POLLAKIURIA (urinate about 20 to 30 times a day) and URINE ODOUR ABNORMAL (urinate about 20 to 30 times a day and it smells horrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.  It was reported that the patient had some medical side effects due to Moderna vaccine. The patient had none of these problems prior to taking vaccine.  Company comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Erectile dysfunction unspecified days after receiving unspecified dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Erectile dysfunction unspecified days after receiving unspecified dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urine odour abnormal
Clinical narrative: can not get erection; constantly itching on the sides of the face and other areas of body; cannot focus; get confused about stuff; feel weak; urinate about 20 to 30 times a day; urinate about 20 to 30 times a day and it smells horrible; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (can not get erection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (can not get erection) (seriousness criterion medically significant), PRURITUS (constantly itching on the sides of the face and other areas of body), DISTURBANCE IN ATTENTION (cannot focus), CONFUSIONAL STATE (get confused about stuff), ASTHENIA (feel weak), POLLAKIURIA (urinate about 20 to 30 times a day) and URINE ODOUR ABNORMAL (urinate about 20 to 30 times a day and it smells horrible). At the time of the report, ERECTILE DYSFUNCTION (can not get erection), PRURITUS (constantly itching on the sides of the face and other areas of body), DISTURBANCE IN ATTENTION (cannot focus), CONFUSIONAL STATE (get confused about stuff), ASTHENIA (feel weak), POLLAKIURIA (urinate about 20 to 30 times a day) and URINE ODOUR ABNORMAL (urinate about 20 to 30 times a day and it smells horrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.  It was reported that the patient had some medical side effects due to Moderna vaccine. The patient had none of these problems prior to taking vaccine.  Company comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Erectile dysfunction unspecified days after receiving unspecified dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Erectile dysfunction unspecified days after receiving unspecified dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Fatigue, Pain in extremity, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma (Patient reports he does have asthmatic attacks sometimes in the spring, but is not sure if his hives are related to the vaccine or not). On 02-Dec-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (hives). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigue). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Adverse event, at a dose of 3 days; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 milligram and CORTISONE for Adverse event, at a dose of 1% cream. At the time of the report, URTICARIA (hives), ABDOMINAL DISCOMFORT (stomach upset), PAIN IN EXTREMITY (pain in the arm) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Doctor did a blood test after he told her about his reactions. No concomitant drug details were reported. This case was linked to MOD-2022-476845 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered (after 30 day Use By Date)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination. No Medical History information was reported. In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered (after 30 day Use By Date)). In January 2022, EXPIRED PRODUCT ADMINISTERED  (Expired doses administered (after 30 day Use By Date)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Drug details were reported. No Treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt a little sick after the first shot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced MALAISE (Felt a little sick after the first shot). On 30-Dec-2020, MALAISE (Felt a little sick after the first shot) had resolved. No concomitant and treatment and medication were use was provided. This case was linked to MOD-2022-477106 (Patient Link).
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling, Rash macular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spot in his arm), PERIPHERAL SWELLING (Arm swelled up and was half-dollar size, Swelling was down his whole arm) and DYSPNOEA (Shortness of breath/Difficulty breathing) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shortness of breath, Stent placement in 2013 and Angiogram (patient has allergy to the dye for angiogram). Concurrent medical conditions included Diabetes. On 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Red spot in his arm), PERIPHERAL SWELLING (Arm swelled up and was half-dollar size, Swelling was down his whole arm) and DYSPNOEA (Shortness of breath/Difficulty breathing). At the time of the report, RASH MACULAR (Red spot in his arm), PERIPHERAL SWELLING (Arm swelled up and was half-dollar size, Swelling was down his whole arm) and DYSPNOEA (Shortness of breath/Difficulty breathing) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that patient was allergic to dye for angiogram and stated that patient did not have a positive COVID test or diagnosis. Concomitant medications include unspecified blood thinner and antibiotics before the 1st dose. After receiving the shot, the patient subsequently had a red spot in his arm, and everything was fine per the caller except the arm swelled up and was half-dollar size. The swelling was down his whole arm but did not have pain after the shot. The caller reported shortness of breath before the shot when he goes out in cold weather but had difficulty breathing when sleeping and shortness of breath over the course of the week after the shot. No treatment was provided by the reporter.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Herpes zoster, Hypersensitivity, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (2 days after the vaccine, he got shingles), PAIN (Pain), HYPERSENSITIVITY (allergic reaction to 3rd dose for Moderna COVID vaccine) and FATIGUE (fatigue) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ENZALUTAMIDE for Malignant neoplasm of prostate. Concurrent medical conditions included Malignant neoplasm of prostate. In May 2021, the patient started ENZALUTAMIDE (Oral) 160 milligram once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (2 days after the vaccine, he got shingles). an unknown date, the patient experienced PAIN (Pain), HYPERSENSITIVITY (allergic reaction to 3rd dose for Moderna COVID vaccine) and FATIGUE (fatigue). At the time of the report, HERPES ZOSTER (2 days after the vaccine, he got shingles), PAIN (Pain), HYPERSENSITIVITY (allergic reaction to 3rd dose for Moderna COVID vaccine) and FATIGUE (fatigue) outcome was unknown. The patient was enrolled in a sponsored patient support program: Enzalutamide PSP (Enzalutamide Patient Support Program). No concomitant medication information was provided. It was unknown if the physician was aware of the events. No lab test information was provided. Action taken with enzalutamide treatment in response to the events was no change. No treatment information was provided by the reporter. The patient assessed the following events with respect to enzalutamide: Allergic reaction to the 3rd dose for Moderna COVID vaccine (seriousness: Not Reported; causality: Not Assessed). Shingles (seriousness: Not Reported; causality: Not Assessed). Pain (seriousness: Not Reported; causality: Not Assessed). Fatigue (seriousness: Not Reported; causality: Not Assessed). Sender Comment: Product: Enzalutamide: Allergic reaction, Shingles, Pain and Fatigue were assessed as Non-Serious. Non-Serious as the event does not meet any of the RA seriousness criteria. Regulatory Authority assessed Allergic reaction, Shingles, Pain and Fatigue as Not Related, as it could be attributed to the 3rd dose of COVID vaccination. Elderly age could be confounder. Reporter did not allow further contact
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had Covid-19 after the 1st dose of Moderna/Covid in December, 2021) and PRODUCT DOSE OMISSION ISSUE (Has been more than 5-6 months since 1st dose/2nd dose not yet received) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced COVID-19 (Patient had Covid-19 after the 1st dose of Moderna/Covid in December, 2021). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has been more than 5-6 months since 1st dose/2nd dose not yet received). At the time of the report, COVID-19 (Patient had Covid-19 after the 1st dose of Moderna/Covid in December, 2021) had resolved and PRODUCT DOSE OMISSION ISSUE (Has been more than 5-6 months since 1st dose/2nd dose not yet received) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a 61 year old male patient with no reported medical history who experienced the unexpected non serious AESI of Covid-19 , unspecified days after receiving the first dose of mRNA-1273 vaccine. The patient is reported to have missed the second dose since the event. The Covid-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 61 year old male patient with no reported medical history who experienced the unexpected non serious AESI of Covid-19, unspecified days after receiving the first dose of mRNA-1273 vaccine. The patient is reported to have missed the second dose since the event. The Covid-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a 2nd dose of the Moderna COVID-19 vaccine from a vial that was punctured 23 hours) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2022 at 9:40 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2022 at 9:40 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a 2nd dose of the Moderna COVID-19 vaccine from a vial that was punctured 23 hours). On 08-Feb-2022 at 9:40 AM, EXPIRED PRODUCT ADMINISTERED (received a 2nd dose of the Moderna COVID-19 vaccine from a vial that was punctured 23 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Date of vial was initially stored in refrigerator was 22-Jan-2022 and vial was stored in fridge post puncture. Date of vial was first punctured was 07-Feb-2022 at 10:15 AM. Vial did not undergo any temperature excursions. No concomitant medication was provided. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Inappropriate schedule of product administration, Polymerase chain reaction, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (bad taste in mouth), PYREXIA (Sporadic Low grade fever), FATIGUE (tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Janssen vaccine and Dose 2 Moderna) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine (Dose number 1, batch number 1802072 and left arm with expiry date 31Dec2021. Patient experienced 102 degree fever and outcome was unknown) on 06-Mar-2021. Past adverse reactions to the above products included Fever with Janssen COVID-19 Vaccine. Concurrent medical conditions included Heart block bundle branch (not on pacemaker). On 23-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Janssen vaccine and Dose 2 Moderna). On 24-Oct-2021, the patient experienced TASTE DISORDER (bad taste in mouth). On an unknown date, the patient experienced PYREXIA (Sporadic Low grade fever) and FATIGUE (tired). At the time of the report, TASTE DISORDER (bad taste in mouth), PYREXIA (Sporadic Low grade fever) and FATIGUE (tired) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Janssen vaccine and Dose 2 Moderna) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 102 (High) 102 degree Fahrenheit. On an unknown date, Polymerase chain reaction: negative (Negative) Negative. No concomitant medications were reported. The patient was unsure if the patient had enough immunity because they said if patient got 2 doses of vaccine, so will get immunity. Patent asked doctor for another dose, but doctor did not responded. Patent called the health department and then the man said patient would be eligible for another dose until 23Jan2022. The patient lay on couch for a minute and after 3min get back up from couch. It was reported that patient would be visiting cardiology in March. No treatment medications were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (bad taste in mouth), PYREXIA (Sporadic Low grade fever), FATIGUE (tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Janssen vaccine and Dose 2 Moderna) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine (Dose number 1, batch number 1802072 and left arm with expiry date 31Dec2021. Patient experienced 102 degree fever and outcome was unknown) on 06-Mar-2021. Past adverse reactions to the above products included Fever with Janssen COVID-19 Vaccine. Concurrent medical conditions included Heart block bundle branch (not on pacemaker). On 23-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Janssen vaccine and Dose 2 Moderna). On 24-Oct-2021, the patient experienced TASTE DISORDER (bad taste in mouth). On an unknown date, the patient experienced PYREXIA (Sporadic Low grade fever) and FATIGUE (tired). At the time of the report, TASTE DISORDER (bad taste in mouth), PYREXIA (Sporadic Low grade fever) and FATIGUE (tired) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 Janssen vaccine and Dose 2 Moderna) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 102 (High) 102 degree Fahrenheit. On an unknown date, Polymerase chain reaction: negative (Negative) Negative. No concomitant medications were reported. The patient was unsure if the patient had enough immunity because they said if patient got 2 doses of vaccine, so will get immunity. Patent asked doctor for another dose, but doctor did not responded. Patent called the health department and then the man said patient would be eligible for another dose until 23Jan2022. The patient lay on couch for a minute and after 3min get back up from couch. It was reported that patient would be visiting cardiology in March. No treatment medications were provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Vaccination worker inadvertently administered 0.25 mL vaccine as the third primary dose instead of 0.5mL to an immunocompromised patient) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 08-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (Vaccination worker inadvertently administered 0.25 mL vaccine as the third primary dose instead of 0.5mL to an immunocompromised patient). At the time of the report, ACCIDENTAL UNDERDOSE (Vaccination worker inadvertently administered 0.25 mL vaccine as the third primary dose instead of 0.5mL to an immunocompromised patient) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Lost usage of her right arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Immunocompromised (Caller believes she has a weak immune system because she gets sick easily) and Sickness. Concurrent medical conditions included Lactose intolerant (Sensitivities to lactose). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 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 VACCINATION SITE MOVEMENT IMPAIRMENT (Lost usage of her right arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Lost usage of her right arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: never shown positive (Negative) Has been tested but never shown positive for COVID. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that patient had received all Moderna for her vaccines and not had the card available to provide lot numbers. It was reported that patient got the second dose in last year at the end of May. Treatment medication information: The patient got a steroid shot in right shoulder from doctor and the lost usage of her right arm got better. This case was linked to MOD-2022-478203 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (dose administered more than 12 hours post puncture) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 10, 2022, at 9:30 am, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 10, 2022, patient administered expired product (dose administered more than 12 hours post puncture). At the time of the report, administered expired product (dose administered more than 12 hours post puncture) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vial was left out on the counter overnight (it was not refrigerated), and opened on Feb 9, 2022, around 2:15 pm. They gave one dose out of it on Feb 10, 2022, around 9:30 in the morning. Post puncture, the vial was stored at room temperature. The vial did not undergo any temperature excursions.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles outbreaks from the vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles outbreaks from the vaccine). At the time of the report, HERPES ZOSTER (Shingles outbreaks from the vaccine.) outcome was unknown. Not Provided, The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported. This case was linked to MOD-2022-478940 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Pain in extremity, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm / pain goes down her arm / pain is in the upper arm mostly / still have issues on arm), JOINT INJURY (elbow feels like it needs to pop) and VACCINATION SITE PAIN (pain in same arm where got injection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (amoxicillin), Allergy to antibiotic (Keflex) and Allergy to antibiotic (Avelox). On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm / pain goes down her arm / pain is in the upper arm mostly / still have issues on arm), JOINT INJURY (elbow feels like it needs to pop) and VACCINATION SITE PAIN (pain in same arm where got injection). At the time of the report, PAIN IN EXTREMITY (pain in arm / pain goes down her arm / pain is in the upper arm mostly / still have issues on arm), JOINT INJURY (elbow feels like it needs to pop) and VACCINATION SITE PAIN (pain in same arm where got injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had lost sense of taste and smell in October 2021. No Concomitant Medications were provided by the Reporter. No Treatment Information were provided by the Reporter.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced herpes zoster (shingles). At the time of the report, herpes zoster (shingles) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported. This case linked to MOD-2022-478437 (patient link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Malaise, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MALAISE (Malaise), ILLNESS (got really sick for booster dose), HEADACHE (Headache) and VOMITING (Vomited) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Keratosis, Fractured vertebra, White coat hypertension and Fall. Concurrent medical conditions included Lyme disease, Drug allergy (Allergy to sulfa drugs) and Relapsing-remitting multiple sclerosis. Concomitant products included Duloxetine; Losartan Potassium; Methotrexate; Zinc; Oxycodone; Vitamin D3 for an unknown indication. On 19-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), MALAISE (Malaise), ILLNESS (got really sick for booster dose), HEADACHE (Headache) and VOMITING (Vomited). At the time of the report, ASTHENIA (Weakness), MALAISE (Malaise), ILLNESS (got really sick for booster dose), HEADACHE (Headache) and VOMITING (Vomited) outcome was unknown. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (felt nauseated) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and NAUSEA (felt nauseated). At the time of the report, HEADACHE (headache) outcome was unknown and NAUSEA (felt nauseated) had resolved. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. The patient was a foot doctor. Reporter did not allow further contact.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Pruritus, Rash, Scar
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PAIN IN EXTREMITY (sore arm), PRURITUS (hives are itchy/itching), FEELING HOT (hives are hot) and SCRATCH (She has been scratching) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (diagnosis date was 24th March of unknown year). On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PRURITUS (hives are itchy/itching) and FEELING HOT (hives are hot). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), SCRATCH (She has been scratching), SCAR (has scars), SLEEP DISORDER (itching has also impacted her sleep) and RASH (rash). At the time of the report, URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PAIN IN EXTREMITY (sore arm), PRURITUS (hives are itchy/itching), FEELING HOT (hives are hot), SCRATCH (She has been scratching), SCAR (has scars), SLEEP DISORDER (itching has also impacted her sleep) and RASH (rash) outcome was unknown. The patient did not have any significant past medical history and no allergies. Concomitant medication of the patient was not reported. The patient had seen other people online confirming similar symptoms as of her. She had an appointment with 2 different dermatologists who were unable to help her because the rash was not present upon their assessment. She was given an anti-itch cream and an oral medication (unknown medication, possibly starts with an H) for her symptoms which had not helped. She also spoke to her primary care physician who referred her to an allergist.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch, Sleep disorder, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PAIN IN EXTREMITY (sore arm), PRURITUS (hives are itchy/itching), FEELING HOT (hives are hot) and SCRATCH (She has been scratching) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (diagnosis date was 24th March of unknown year). On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PRURITUS (hives are itchy/itching) and FEELING HOT (hives are hot). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), SCRATCH (She has been scratching), SCAR (has scars), SLEEP DISORDER (itching has also impacted her sleep) and RASH (rash). At the time of the report, URTICARIA (random hives, that recur constantly all day, occurring in 20-30 minute episodes/hives are raised big circles), PAIN IN EXTREMITY (sore arm), PRURITUS (hives are itchy/itching), FEELING HOT (hives are hot), SCRATCH (She has been scratching), SCAR (has scars), SLEEP DISORDER (itching has also impacted her sleep) and RASH (rash) outcome was unknown. The patient did not have any significant past medical history and no allergies. Concomitant medication of the patient was not reported. The patient had seen other people online confirming similar symptoms as of her. She had an appointment with 2 different dermatologists who were unable to help her because the rash was not present upon their assessment. She was given an anti-itch cream and an oral medication (unknown medication, possibly starts with an H) for her symptoms which had not helped. She also spoke to her primary care physician who referred her to an allergist.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, SARS-CoV-2 test, Underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The patient's past medical history included Fatty liver on 05-Jan-2010 and Dyslipidemia. Previously administered products included for Product used for unknown indication: J&J (J&J 1808980; 0.5mL; Intramuscular-Arm.) on 09-Apr-2021. Past adverse reactions to the above products included No adverse reaction with J&J. Concurrent medical conditions included Diabetes since 2010 and Hypertension. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN XR), INSULIN ASPART and INSULIN GLARGINE for Diabetes, ATORVASTATIN for Dyslipidemia, CANDESARTAN for Hypertension. On 24-Jan-2022 at 8:50 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022 at 8:50 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL). On 24-Jan-2022 at 8:50 AM, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive Type of test - Unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 09-Apr-2021, second dose on 24-Jan-2022) and UNDERDOSE (Second dose 0.25 mL). Allergic history was reported as none. No treatment information was reported.