chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Tremor
Clinical narrative: tired; Severe, heavy chills; A little sluggish/Sluggish; Mild arm pain; Could not stop shaking; tenderness; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness) and PYREXIA (Feverish) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish) and CHILLS (Severe, heavy chills). On 25-Apr-2021, the patient experienced FATIGUE (tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 25-Apr-2021, SLUGGISHNESS (A little sluggish/Sluggish), PAIN IN EXTREMITY (Mild arm pain), TREMOR (Could not stop shaking), TENDERNESS (tenderness), PYREXIA (Feverish) and CHILLS (Severe, heavy chills) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.            No concomitant product reported by reporter.   This case was linked to MOD-2021-403962, MOD-2021-403962 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Liquid product physical issue, Product administration error
Clinical narrative: received dose from vial that had black particulates in previous syringe; received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      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.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Liquid product physical issue, Product administration error
Clinical narrative: received dose from vial that had black particulates in previous syringe; received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe). At the time of the report, LIQUID PRODUCT PHYSICAL ISSUE (received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Liquid product physical issue, Product administration error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of LIQUID PRODUCT PHYSICAL ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced LIQUID PRODUCT PHYSICAL ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, LIQUID PRODUCT PHYSICAL ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided.No treatment medication was provided. Pharmacist called because when she withdraw the first dose of a Moderna vial. she thought she got a piece of rubber stopper in the syringe. Then, she looked better and there were like black specks floating in it. Pharmacist also referred to them as black things. Even though this particular syringe was not used on any patients, pharmacist withdraw from this same vial and administered to 14-15 patients.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant informations were reported.No treatment informations were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product quality issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, PRODUCT QUALITY ISSUE (Received dose from vial that had black particulates in previous syringe) and PRODUCT ADMINISTRATION ERROR (Received dose from vial that had black particulates in previous syringe) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe). On 01-Dec-2021, POOR QUALITY PRODUCT ADMINISTERED (Received dose from vial that had black particulates in previous syringe) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. It was reported that the pharmacist thought that she got a rubber stopper in the syringe. Then, she looked better and there were like black specks floating in it. Pharmacist also referred to them as black things. Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Mild reaction after first shot) and FEELING ABNORMAL (She felt like she was coming down with something for 2 hours only) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Double vision (on & off, before and after her cataract surgery) and Cataract operation (Cataract Surgery Summer 2021) in 2021. Concurrent medical conditions included Diabetes and Hypothyroidism. Concomitant products included METFORMIN for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, INSULIN GLARGINE (LANTUS) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Mild reaction after first shot). On 29-Jan-2021, the patient experienced FEELING ABNORMAL (She felt like she was coming down with something for 2 hours only). On 29-Jan-2021, VACCINATION COMPLICATION (Mild reaction after first shot) and FEELING ABNORMAL (She felt like she was coming down with something for 2 hours only) had resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication details were reported. This case was linked to MOD-2021-404058, MOD-2021-403866 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: Patient "did not feel great" the day afterwards.; soreness in her left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (Patient "did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in her left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Patient "did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in her left arm). At the time of the report, FEELING ABNORMAL (Patient "did not feel great" the day afterwards.) and VACCINATION SITE PAIN (soreness in her left arm) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case was linked to MOD-2021-404086, MOD-2021-404276 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 30-Jan-2021 and Dose 2 on 08-Mar-2021 (Outside window period)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Vomiting.On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 30-Jan-2021 and Dose 2 on 08-Mar-2021 (Outside window period)). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 30-Jan-2021 and Dose 2 on 08-Mar-2021 (Outside window period)) had resolved. No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2021-034395, MOD-2021-385693 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (elevated, pounding heart rate for a day or two) and HEART RATE INCREASED (elevated, pounding heart rate for a day or two) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (elevated, pounding heart rate for a day or two) and HEART RATE INCREASED (elevated, pounding heart rate for a day or two). In March 2021, PALPITATIONS (elevated, pounding heart rate for a day or two) and HEART RATE INCREASED (elevated, pounding heart rate for a day or two) had resolved. Concomitant medication use was unknown. Treatment information was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Patient did not feel great the next day) and VACCINATION SITE PAIN (sore left arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 FEELING ABNORMAL (Patient did not feel great the next day) and VACCINATION SITE PAIN (sore left arm). At the time of the report, FEELING ABNORMAL (Patient did not feel great the next day) and VACCINATION SITE PAIN (sore left arm) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-404066, MOD-2021-404276 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Having side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having side effects). At the time of the report, VACCINATION COMPLICATION (Having side effects) 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 medications reported. No treatment medications reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product use issue
Clinical narrative: vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients); vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients)) and PRODUCT USE ISSUE (vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients)) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F51A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients)) and PRODUCT USE ISSUE (vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients)). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients)) and PRODUCT USE ISSUE (vial sat out in room temperature more than 24hr and were not discarded/Vial was punctured 22 times (punctured 2additional times for the 2 patients)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.  Two Moderna vials were taken out of their refrigerator on 30-Nov-2021 at 09:00 am and punctured. They sat out in room temperature for more than 24 hours and were not discarded as they should have been. They also inadvertently administered two patients doses of the vaccine from expired vials on 02-DEC-2021 administered at 9:30 am. The vials impacted have been discarded. The number of doses/vials was 7.5 mL vial - 1 vial. The date the vial was initially stored in the refrigerator on 29-Nov-2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-404102 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-404102:Same reporter
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: some leaked out/some of the vaccine leaked out of the patient's arm; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (some leaked out/some of the vaccine leaked out of the patient's arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced UNDERDOSE (some leaked out/some of the vaccine leaked out of the patient's arm). On 02-Dec-2021, UNDERDOSE (some leaked out/some of the vaccine leaked out of the patient's arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she has not experienced any symptoms. No additional doses have been administered at this time to her. She has not taken any medications or treatments No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow-up received Updated Non-Significant Information
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Diarrhea; Body ache; Flu; Swelling  in the injection site; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling  in the injection site), VACCINATION SITE PAIN (Pain in the injection site) and MYALGIA (Body ache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and AMLODIPINE BESILATE, VALSARTAN (AMLOSARTAN [AMLODIPINE BESILATE;VALSARTAN]) for Blood pressure.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 INFLUENZA (Flu), DIARRHOEA (Diarrhea), VACCINATION SITE SWELLING (Swelling  in the injection site), VACCINATION SITE PAIN (Pain in the injection site) and MYALGIA (Body ache). At the time of the report, INFLUENZA (Flu), VACCINATION SITE SWELLING (Swelling  in the injection site) and VACCINATION SITE PAIN (Pain in the injection site) had resolved and DIARRHOEA (Diarrhea) and MYALGIA (Body ache) outcome was unknown.            Patient was taking steroids for COPD. Ammonium was used for two weeks to treat the diarrhea.   This case was linked to MOD-2021-404117 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Oropharyngeal pain
Clinical narrative: Patient started to feel chills like a cold symptom; throat pain; Patient felt chilling; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Patient started to feel chills like a cold symptom), OROPHARYNGEAL PAIN (throat pain) and CHILLS (Patient felt chilling) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN for Hypertension.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced FEELING COLD (Patient started to feel chills like a cold symptom), OROPHARYNGEAL PAIN (throat pain) and CHILLS (Patient felt chilling). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING COLD (Patient started to feel chills like a cold symptom), OROPHARYNGEAL PAIN (throat pain) and CHILLS (Patient felt chilling) outcome was unknown.            evening of 03Dec2021 patient felt the symptoms, noted.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The vial was initially stored in the refrigerator on 29OCT2021 and did not undergo any temperature excursions.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dizziness, Dyspnoea, Echocardiogram, Ejection fraction
Clinical narrative: About a month after his 2nd dose he had cardiac issues including; shortness of breath/wasn't able to walk his dog or mow his grass without getting short of; dizziness; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC DISORDER (About a month after his 2nd dose he had cardiac issues including), DYSPNOEA (shortness of breath/wasn't able to walk his dog or mow his grass without getting short of), DIZZINESS (dizziness) and FATIGUE (fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20 and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Mobitz type II (Patient has a history of Mobitz heart block type 1 that progressed then to stage 2), Bifascicular block (Bi-fascicular Heart Block) and Heart disorder (The patient had heart related issues for about 20 years.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In March 2021, the patient experienced CARDIAC DISORDER (About a month after his 2nd dose he had cardiac issues including), DYSPNOEA (shortness of breath/wasn't able to walk his dog or mow his grass without getting short of), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, CARDIAC DISORDER (About a month after his 2nd dose he had cardiac issues including), DYSPNOEA (shortness of breath/wasn't able to walk his dog or mow his grass without getting short of), DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal (abnormal) showed a decrease ejection fraction % from 50 to 15%.. On an unknown date, Ejection fraction: 15% (Low) ejection fraction from 50 to 15%.     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. No treatment information was provided.  About a month after his 2nd dose the patient experienced cardiac issues including shortness of breath, dizziness, fatigue, & wasn't able to walk his dog or mow his grass without getting short of breath.Patient's cardiologist said there was no evidence or myocarditis or pericarditis & was unsure if the vaccine had anything to do with this. Patient had a pacemaker put in 4 or 5 months ago & felt better now.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: About a month after his 2nd dose he had cardiac issues including; shortness of breath/wasn't able to walk his dog or mow his grass without getting short of; dizziness; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC DISORDER (About a month after his 2nd dose he had cardiac issues including), DYSPNOEA (shortness of breath/wasn't able to walk his dog or mow his grass without getting short of), DIZZINESS (dizziness) and FATIGUE (fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20 and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Mobitz type II (Patient has a history of Mobitz heart block type 1 that progressed then to stage 2), Bifascicular block (Bi-fascicular Heart Block) and Heart disorder (The patient had heart related issues for about 20 years.).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In March 2021, the patient experienced CARDIAC DISORDER (About a month after his 2nd dose he had cardiac issues including), DYSPNOEA (shortness of breath/wasn't able to walk his dog or mow his grass without getting short of), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, CARDIAC DISORDER (About a month after his 2nd dose he had cardiac issues including), DYSPNOEA (shortness of breath/wasn't able to walk his dog or mow his grass without getting short of), DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal (abnormal) showed a decrease ejection fraction % from 50 to 15%.. On an unknown date, Ejection fraction: 15% (Low) ejection fraction from 50 to 15%.     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. No treatment information was provided.  About a month after his 2nd dose the patient experienced cardiac issues including shortness of breath, dizziness, fatigue, & wasn't able to walk his dog or mow his grass without getting short of breath.Patient's cardiologist said there was no evidence or myocarditis or pericarditis & was unsure if the vaccine had anything to do with this. Patient had a pacemaker put in 4 or 5 months ago & felt better now.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Unknown number of patient dosed with vaccine from a syringe >12 hrs; The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Unknown number of patient dosed with vaccine from a syringe >12 hrs) and EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Unknown number of patient dosed with vaccine from a syringe >12 hrs) and EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture). At the time of the report, PRODUCT STORAGE ERROR (Unknown number of patient dosed with vaccine from a syringe >12 hrs) and EXPIRED PRODUCT ADMINISTERED (The vaccine was stored in syringes in the refrigerator and administered for up to 24 hours from the time of puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported. No adverse event reported.  It was reported that provider has had lot numbers 051F21A, 025C21A, and 040B21A.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and 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 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). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reactions; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (reactions) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reactions). At the time of the report, VACCINATION COMPLICATION (reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment information were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Rash
Clinical narrative: Burning sensation; the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster; really tired for two days after booster; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), RASH (the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster) and FATIGUE (really tired for two days after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced FATIGUE (really tired for two days after booster). On 02-Dec-2021, the patient experienced RASH (the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation), RASH (the rash is on her hands and feet, palms and soles/ rash on palm and sole after booster) and FATIGUE (really tired for two days after booster) outcome was unknown.            Concomitant medication details were not reported by the reporter.   This case was linked to MOD-2021-404181, MOD-2021-404182 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The first shot didn't affect her much; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The first shot didn't affect her much) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The first shot didn't affect her much). At the time of the report, VACCINATION COMPLICATION (The first shot didn't affect her much) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-404167, MOD-2021-404182 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills and fever after second dose; chills and fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills and fever after second dose) and PYREXIA (chills and fever after second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-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 CHILLS (chills and fever after second dose) and PYREXIA (chills and fever after second dose). At the time of the report, CHILLS (chills and fever after second dose) and PYREXIA (chills and fever after second dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.     This case was linked to MOD-2021-404181, MOD-2021-404167 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: felt so ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt so ill) 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 ILLNESS (felt so ill). At the time of the report, ILLNESS (felt so ill) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Non significant follow up contains no new information
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the expiration date) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A, 012M20A and 032H20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the expiration date). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The patient did not experienced any symptoms and not taken any treatments.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: bad pain in neck and shot down to shoulder where got the shot; stiff neck; arm hurts; bad pain in neck and shot down to shoulder where got the shot; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (bad pain in neck and shot down to shoulder where got the shot), MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm hurts) and VACCINATION SITE PAIN (bad pain in neck and shot down to shoulder where got the shot) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced NECK PAIN (bad pain in neck and shot down to shoulder where got the shot), MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm hurts) and VACCINATION SITE PAIN (bad pain in neck and shot down to shoulder where got the shot). At the time of the report, NECK PAIN (bad pain in neck and shot down to shoulder where got the shot), MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm hurts) and VACCINATION SITE PAIN (bad pain in neck and shot down to shoulder where got the shot) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of abnormal heart rate (since getting the booster on Friday, heart rate high 90 low 100 and usually resting heart rate is 60) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had an abnormal heart rate (since getting the booster on Friday, heart rate high 90 low 100 and usually resting heart rate is 60). At the time of the report, abnormal heart rate (since getting the booster on Friday, heart rate high 90 low 100 and usually resting heart rate is 60) outcome: unknown. Diagnostic results: On an unknown date, heart rate: high 90 low 100 and resting heart rate 60 (normal). No concomitant medication or treatment information reported. Reporter did not allow further contact.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F21A, 044A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had received expired dose of vaccine from the vial which was opened about 28 hours prior to the administration, it was unknown if the patient had experienced any events.  Number of doses/vials: 1 dose, vial was initially stored in the refrigerator on 01-Dec-2021. Vial was first punctured on 01-Dec-2021 at 11:20 am CST, post punctured, vial was stored back in the refrigerator, 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): Only exposed when shots were given.  No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a dose of expired Moderna Covid-19 vaccine was administered to one of our employees; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose of expired Moderna Covid-19 vaccine was administered to one of our employees) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose of expired Moderna Covid-19 vaccine was administered to one of our employees). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (a dose of expired Moderna Covid-19 vaccine was administered to one of our employees) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.