chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pfizer COVID19 Vaccine received a week before Moderna booster; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine received a week before Moderna booster) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Patient had received Pfizer COVID19 Vaccine on 23-OCT-2021) on 23-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine received a week before Moderna booster). On 06-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pfizer COVID19 Vaccine received a week before Moderna booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Really bad chills; sore arm at the injection site; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Really bad chills), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (Exhaustion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (horrible asthma) and Kidney disorder (kidney issues).   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Really bad chills), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (Exhaustion). At the time of the report, CHILLS (Really bad chills), VACCINATION SITE PAIN (sore arm at the injection site) and FATIGUE (Exhaustion) outcome was unknown.            Patient stated that she can't take Ibuprofen because of the kidney issue. No concomitant medications were provided. Treatment for the events were not provided.   This case was linked to MOD-2021-382447 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Genital herpes
Clinical narrative: Had a general herpes outbreak; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HERPES (Had a general herpes outbreak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 036A21A) for COVID-19 vaccination. Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.No Medical History information was reported.On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 20-Sep-2021, the patient started VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) at an unspecified dose. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GENITAL HERPES (Had a general herpes outbreak). At the time of the report, GENITAL HERPES (Had a general herpes outbreak) outcome was unknown. Patient  was scheduled to get a booster (half dose) on 11 Nov 2021.No Concomitant medication were reported.No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient only received half dose instead of full third dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient only received half dose instead of full third dose) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient only received half dose instead of full third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient only received half dose instead of full third dose) had resolved.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant and no treatment information was provided .Pharmacist accidentally gave an immunocompromised individual a booster 0.25ML shot instead of the 3rd full dose (0.5ML).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Low grade fever (Not Measured) after 2nd dose; Body aches after 2nd dose; Chills after 2nd dose\chills for 1 day.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever (Not Measured) after 2nd dose), MYALGIA (Body aches after 2nd dose) and CHILLS (Chills after 2nd dose\chills for 1 day.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 037K20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included LOSARTAN for Blood pressure management.On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 23-Feb-2021, the patient experienced PYREXIA (Low grade fever (Not Measured) after 2nd dose), MYALGIA (Body aches after 2nd dose) and CHILLS (Chills after 2nd dose\chills for 1 day.). On 24-Feb-2021, PYREXIA (Low grade fever (Not Measured) after 2nd dose), MYALGIA (Body aches after 2nd dose) and CHILLS (Chills after 2nd dose\chills for 1 day.) had resolved. No Treatment information was reported.This case was linked to MOD-2021-383015 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site reactions; Still feels the shot on the right arm/ had reactions with pain at injection or muscle; Low grade fever; Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness; Tiredness; Chills for 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), CHILLS (Chills for 18 hours), PYREXIA (Low grade fever) and MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO) for Clot blood, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), CHILLS (Chills for 18 hours), PYREXIA (Low grade fever), MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) and FATIGUE (Tiredness). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), PYREXIA (Low grade fever), MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) and FATIGUE (Tiredness) outcome was unknown and CHILLS (Chills for 18 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-383406 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Vaccination site reactions; Still feels the shot on the right arm/ had reactions with pain at injection or muscle; Low grade fever; Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness; Tiredness; Chills for 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), CHILLS (Chills for 18 hours), PYREXIA (Low grade fever) and MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 026L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO) for Clot blood, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), CHILLS (Chills for 18 hours), PYREXIA (Low grade fever), MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) and FATIGUE (Tiredness). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reactions), VACCINATION SITE PAIN (Still feels the shot on the right arm/ had reactions with pain at injection or muscle), PYREXIA (Low grade fever), MYALGIA (Has pain under her arm by the ribs and on the bottom side of the arms and muscles/ Only thing weird this time was that under the arm by the ribs was muscle soreness) and FATIGUE (Tiredness) outcome was unknown and CHILLS (Chills for 18 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-383406 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: Skin broke out on her face after 2nd dose (Moderna COVID-19 vaccine); First dose received with Jansen COVID-19 vaccine/Second dose administered more than 6 months after first shot (Jansen); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Skin broke out on her face after 2nd dose (Moderna COVID-19 vaccine)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received with Jansen COVID-19 vaccine/Second dose administered more than 6 months after first shot (Jansen)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 on 07-Mar-2021. Past adverse reactions to the above products included Chest discomfort with COVID-19 VACCINE NRVV AD26.On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received with Jansen COVID-19 vaccine/Second dose administered more than 6 months after first shot (Jansen)). On 10-Nov-2021, the patient experienced RASH (Skin broke out on her face after 2nd dose (Moderna COVID-19 vaccine)). On 09-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received with Jansen COVID-19 vaccine/Second dose administered more than 6 months after first shot (Jansen)) had resolved. At the time of the report, RASH (Skin broke out on her face after 2nd dose (Moderna COVID-19 vaccine)) outcome was unknown. Concomitant medications were not provided. Treatment medications were not provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The vial was initially stored in the refrigerator on 08-Nov-2021.Vials did not undergo any temperature excursion. No concomitant medications were provided. No treatment medications were provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported.No treatment information was reported by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided.Treatment medication were not reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided.No treatment medications were provided.Patient took booster dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported.No treatment drugs were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Headache; Nausea; Vomiting; Low grade fever; Fatigue; muscle ache; Swollen lymph node near the injection site (armpit); general pain at site of injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) 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 HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (muscle ache), LYMPHADENOPATHY (Swollen lymph node near the injection site (armpit)) and VACCINATION SITE PAIN (general pain at site of injection site). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (muscle ache), LYMPHADENOPATHY (Swollen lymph node near the injection site (armpit)) and VACCINATION SITE PAIN (general pain at site of injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant products were reported.No treatment drugs were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Headache; Nausea; Vomiting; Low grade fever; Fatigue; muscle ache; Swollen lymph node near the injection site (armpit); general pain at site of injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever) and FATIGUE (Fatigue) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) 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 HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (muscle ache), LYMPHADENOPATHY (Swollen lymph node near the injection site (armpit)) and VACCINATION SITE PAIN (general pain at site of injection site). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting), PYREXIA (Low grade fever), FATIGUE (Fatigue), MYALGIA (muscle ache), LYMPHADENOPATHY (Swollen lymph node near the injection site (armpit)) and VACCINATION SITE PAIN (general pain at site of injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.No concomitant products were reported.No treatment drugs were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event following immunisation
Clinical narrative: a little worse than the last time I had it; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (a little worse than the last time I had it) in a 61-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. In 2021, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (a little worse than the last time I had it). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (a little worse than the last time I had it) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported.No treatment medications were provided.This case was linked to MOD-2021-382988 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills
Clinical narrative: Severe chills, increased temp. My average daily temp is 97.0F (I know because I have to take it daily) and I had an increase of 2.8 degrees to 99.8F
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Blood test normal, Ultrasound scan normal
Clinical narrative: Stopped periods since COVID vaccination.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: MA was improperly giving the rotavirus monovalent vaccine and only giving the diluent of rotavirus vaccine instead of mixing the diluent with the vial of the rotavirus vaccine and administering that. The clinic was able to track back which patients this affected. Patients on this date may have gotten the diluent only or the proper vaccine based on counts of abnormal diluent and reconstitute vaccine vials. The mother of patient was notified 10/29/21. Provider discussed with patient family the patient should be vaccinated at 6 months visit.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular and heavy menstrual bleeding. This has occurred nonstop since 7/21/2021. It is. 11/18/21. All hormones and reproductive system are normal in this otherwise healthy and normal female.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Headache, Tinnitus
Clinical narrative: Hearing loss, tinnitus, headaches
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Deafness, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt stated that she couldn't hear or see. couldn't feel anything.  she was shaky and dizzy.  epi-pen was given to her. i had her lay down flat with legs up. she was able to see and felt a lot better after shot. she said she could breathe again.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Sensory loss, Tremor, Visual impairment
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Headache-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt stated that she couldn't hear or see. couldn't feel anything.  she was shaky and dizzy.  epi-pen was given to her. i had her lay down flat with legs up. she was able to see and felt a lot better after shot. she said she could breathe again.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported .
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Date the vial was initially stored in the refrigerator 08-NOV-2021.No concomitant medications are provided.No treatment medications are provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently given expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) had resolved. 2 patients who inadvertently received their booster dose from an expired lot. Question was raised for its effectiveness.No concomitant medications were provided.No treatment medications were provided.Most recent FOLLOW-UP information incorporated above includes:On 12-Nov-2021: Follow up contains non significant information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Myalgia
Clinical narrative: Slept for the most part 18hrs; Chills; Fatigue; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for the most part 18hrs), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 002A21A) for COVID-19 vaccination. No Medical history is reported.  Concomitant products included OMEPRAZOLE from 12-Jan-2018 to an unknown date for Reflux esophagitis.On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HYPERSOMNIA (Slept for the most part 18hrs), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and HEADACHE (Headache). On 26-Mar-2021, HYPERSOMNIA (Slept for the most part 18hrs), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and HEADACHE (Headache) had resolved. No treatment medications were provided. This case concerns a 79 year old female with no reported medial history, who experienced non-serious , unexpected AESI event of hypersomnia which occurred the day after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . This was also accompanied by other non-serious expected events. (chills, myalgia headache , fatigue). The re-challenge for this case is not applicable since the events happened after the 2nd dose and no more additional doses will be given. The benefit -risk relationship of mRNA-12763 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.This case was linked to MOD-2021-372887 (Patient Link). Sender's Comments: This case concerns a 79 year old female with no reported medial history, who experienced non-serious , unexpected AESI event of hypersomnia which occurred the day after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . This was also accompanied by other non-serious expected events. (chills, myalgia headache , fatigue). The re-challenge for this case is not applicable since the events happened after the 2nd dose and no more additional doses will be given. The benefit -risk relationship of mRNA-12763 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure abnormal, Blood pressure measurement, Headache, Heart rate
Clinical narrative: Blood pressure was 131/83; Legs hurt really bad; Lower back hurt really bad; Body aches; Headache; High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again.), BLOOD PRESSURE ABNORMAL (Blood pressure was 131/83), PAIN IN EXTREMITY (Legs hurt really bad), BACK PAIN (Lower back hurt really bad) and MYALGIA (Body aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 026B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported.On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PALPITATIONS (High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again.), PAIN IN EXTREMITY (Legs hurt really bad), BACK PAIN (Lower back hurt really bad), MYALGIA (Body aches) and HEADACHE (Headache). On 09-Nov-2021, the patient experienced BLOOD PRESSURE ABNORMAL (Blood pressure was 131/83). At the time of the report, PALPITATIONS (High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again.) had not resolved, BLOOD PRESSURE ABNORMAL (Blood pressure was 131/83) outcome was unknown and PAIN IN EXTREMITY (Legs hurt really bad), BACK PAIN (Lower back hurt really bad), MYALGIA (Body aches) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Blood pressure measurement: 131/83 (abnormal) 131/83.On 09-Nov-2021, Heart rate: 117 (High) 117 bpm.No concomitant medications are provided.Patient stated patient had rough 2 days and experienced almost all side effects.As a treatment patient drank plenty of fluids and rested.This case was linked to MOD-2021-383726 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Palpitations
Clinical narrative: Blood pressure was 131/83; Legs hurt really bad; Lower back hurt really bad; Body aches; Headache; High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again. This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again.), BLOOD PRESSURE ABNORMAL (Blood pressure was 131/83), PAIN IN EXTREMITY (Legs hurt really bad), BACK PAIN (Lower back hurt really bad) and MYALGIA (Body aches) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 026B21A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported.On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PALPITATIONS (High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again.), PAIN IN EXTREMITY (Legs hurt really bad), BACK PAIN (Lower back hurt really bad), MYALGIA (Body aches) and HEADACHE (Headache). On 09-Nov-2021, the patient experienced BLOOD PRESSURE ABNORMAL (Blood pressure was 131/83). At the time of the report, PALPITATIONS (High pulse and states her heart feels like it's racing/She still feel it today, her heart is still doing it, when she lays down, it gets better but when get up, it starts again.) had not resolved, BLOOD PRESSURE ABNORMAL (Blood pressure was 131/83) outcome was unknown and PAIN IN EXTREMITY (Legs hurt really bad), BACK PAIN (Lower back hurt really bad), MYALGIA (Body aches) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Blood pressure measurement: 131/83 (abnormal) 131/83.On 09-Nov-2021, Heart rate: 117 (High) 117 bpm.No concomitant medications are provided.Patient stated patient had rough 2 days and experienced almost all side effects.As a treatment patient drank plenty of fluids and rested.This case was linked to MOD-2021-383726 (Patient Link).
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: He developed hives and itching all over his body, face, everywhere/ bothersome; itching all over his body, face, everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He developed hives and itching all over his body, face, everywhere/ bothersome) and PRURITUS (itching all over his body, face, everywhere) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported.On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced URTICARIA (He developed hives and itching all over his body, face, everywhere/ bothersome) and PRURITUS (itching all over his body, face, everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (He developed hives and itching all over his body, face, everywhere/ bothersome) and PRURITUS (itching all over his body, face, everywhere) had not resolved. Concomitant medications were not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 14 patient administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patient administered expired vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported.In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patient administered expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patient administered expired vaccine) 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 provided.Patient has reported that she doesn't have allergy history and ever tested  positive for COVID-19. In addition, reported that she dose not have cute illness at of time of vaccination, and chronic health conditions as well.This case was linked to MOD-2021-385976 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; There was an excursion from the freezer/administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not know how to do the analysis. She stated that her team already knows the recommended temperatures and wanted to know if the vials were still okay to be used because they were administered to 118 patients.Concomitant medications were not reported. Treatment information was not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.No Medical History information was reported. On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medications were reported.No Treatment medications were reported.There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.No concomitant medication was provided. No treatment medication was provided.