chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered vaccine which has been thawed for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccine which has been thawed for more than 30 days) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccine which has been thawed for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccine which has been thawed for more than 30 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got the moderna vaccine back in March. (One shot)  Never went back and got the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the moderna vaccine back in March. (One shot)  Never went back and got the second shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the moderna vaccine back in March. (One shot)  Never went back and got the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the moderna vaccine back in March. (One shot)  Never went back and got the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
Age: 0.25
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding) in a 3-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The mother's last menstrual period was on 05-Jun-2020 and the estimated date of delivery was 12-Mar-2021. On an unknown date, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The cesarean delivery occurred on 20-Mar-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. Mother experienced fetal distress on ultrasound, emergency caesarian section performed and delivered the baby. No perinatal complications for the infant, no abnormalities on delivery, no identified infant abnormalities 1 month postpartum. At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  No treatment information was provided.   Infant's mother got vaccine in her third trimester.  Upon internal review on 03-Nov-2021, birth type captured as normal pregnancy outcome and fetal outcome captured as delivered NOS.   This case was linked to MOD-2021-004512 (Parent-Child Link).   See case MOD-2021-004512 for details regarding the Parent case.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Somnolence, Vaccination site pain
Clinical narrative: dizziness; tiredness; Very sleepy; soreness in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tiredness), SOMNOLENCE (Very sleepy) and VACCINATION SITE PAIN (soreness in injection arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C214 and 008C21H) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN B COMPLEX (B COMPLEX (B50)), VITAMINS NOS (DAILY VITAMINS), CALCIUM and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), FATIGUE (tiredness), SOMNOLENCE (Very sleepy) and VACCINATION SITE PAIN (soreness in injection arm). At the time of the report, DIZZINESS (dizziness), FATIGUE (tiredness), SOMNOLENCE (Very sleepy) and VACCINATION SITE PAIN (soreness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes Ointment NOS.   This case was linked to MOD-2021-253194 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Pyrexia, Rash pruritic
Clinical narrative: dizziness; tiredness; fever; soreness in the injection arm through the back of the arm; chills; rash all over body/ looking like mosquito bits/very itchy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C214) 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 B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMINS NOS (DAILY VITAMINS) and CALCIUM for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm), CHILLS (chills) and RASH PRURITIC (rash all over body/ looking like mosquito bits/very itchy). At the time of the report, DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm) and CHILLS (chills) outcome was unknown and RASH PRURITIC (rash all over body/ looking like mosquito bits/very itchy) had not resolved.            Treatment drug includes ointment NOS   This case was linked to MOD-2021-253193.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: dizziness; tiredness; fever; soreness in the injection arm through the back of the arm; chills; rash all over body/ looking like mosquito bits/very itchy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C214) 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 B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMINS NOS (DAILY VITAMINS) and CALCIUM for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm), CHILLS (chills) and RASH PRURITIC (rash all over body/ looking like mosquito bits/very itchy). At the time of the report, DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm) and CHILLS (chills) outcome was unknown and RASH PRURITIC (rash all over body/ looking like mosquito bits/very itchy) had not resolved.            Treatment drug includes ointment NOS   This case was linked to MOD-2021-253193.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I feel a dull ache/i was awaken by the pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I feel a dull ache/i was awaken by the pain) 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.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (I feel a dull ache/i was awaken by the pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (I feel a dull ache/i was awaken by the pain) outcome was unknown. Not Provided          Concomitant medication was not provided.   This case was linked to MOD-2021-020901 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Inflammation, Lymph node pain, Lymphadenopathy, Nodule
Clinical narrative: Nodule; Inflammation localised; Armpit pain; lymph nodes still swollen/ lymph nodes on left side remained swollen; lymph nodes still swollen and sore; This spontaneous case was reported by a patient and describes the occurrence of NODULE (Nodule), INFLAMMATION (Inflammation localised), AXILLARY PAIN (Armpit pain), LYMPHADENOPATHY (lymph nodes still swollen/ lymph nodes on left side remained swollen) and LYMPH NODE PAIN (lymph nodes still swollen and sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 025B21A) for COVID-19 vaccination.     The patient's past medical history included Oophorectomy bilateral (removal of one ovary at the age of 40). Concurrent medical conditions included Tumor and Hot flashes (every 7 minutes began after removal of one ovary). Concomitant products included ESTROGEN NOS;PROGESTERONE;TESTOSTERONE from 01-Sep-2004 to an unknown date for Hot flush, Hormone replacement therapy and Oophorectomy.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NODULE (Nodule), INFLAMMATION (Inflammation localised), AXILLARY PAIN (Armpit pain), LYMPHADENOPATHY (lymph nodes still swollen/ lymph nodes on left side remained swollen) and LYMPH NODE PAIN (lymph nodes still swollen and sore). At the time of the report, NODULE (Nodule) had resolved, INFLAMMATION (Inflammation localised) and AXILLARY PAIN (Armpit pain) outcome was unknown and LYMPHADENOPATHY (lymph nodes still swollen/ lymph nodes on left side remained swollen) and LYMPH NODE PAIN (lymph nodes still swollen and sore) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   laboratory data included - ultrasound scan was done, Patient denied mammography suggested by physician as it was not covered in the medical insurance.  Patients lymph nodes on left side remained swollen and sore even still.  No treatment medication was provided.   This case was linked to MOD-2021-074756.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant followup: Reporter details added, Events added as lymph nodes were still swollen/ lymph nodes on left side remain swollen, lymph nodes were still swollen and sore.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm very sore and tires; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm very sore and tires) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TDAP on 26-Feb-2021. Concurrent medical conditions included Drug allergy (Tetracycline), Drug allergy (Imitrex), Drug allergy (Xanax), Drug allergy (Fentanyl Patch), Migraine since 2008 and Pain (Shingle Pain) since 2008. Concomitant products included AMITRIPTYLINE, VERAPAMIL, ACETYLSALICYLIC ACID (ASPRIN) and CAFFEINE for Migraine, GABAPENTIN for Pain.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (Arm very sore and tires). On 21-Feb-2021, MYALGIA (Arm very sore and tires) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided Butaita 325mg  was taken as concomitant medication.. MRI results was awaiting and patient was scheduled for appointment.   This case was linked to MOD-2021-057843 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: got COVID after both doses of the 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 COVID-19 (got COVID after both doses of the vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID after both doses of the vaccine). At the time of the report, COVID-19 (got COVID after both doses of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medications were provided. No treatment medications were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Swelling, Vaccination complication
Clinical narrative: Slightly swollen; Itchy; Big red splash; Hot; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Slightly swollen), PRURITUS (Itchy), ERYTHEMA (Big red splash), FEELING HOT (Hot) and VACCINATION COMPLICATION (covid arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced SWELLING (Slightly swollen), PRURITUS (Itchy), ERYTHEMA (Big red splash), FEELING HOT (Hot) and VACCINATION COMPLICATION (covid arm). At the time of the report, SWELLING (Slightly swollen), PRURITUS (Itchy), ERYTHEMA (Big red splash), FEELING HOT (Hot) and VACCINATION COMPLICATION (covid arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Reporter reported that patient was taking other medication.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Head discomfort, Hypoaesthesia, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: numbness,numbness persisted for several hours,on and off numbness in the left arm; pressure in my left side; pressure was felt along my carotid artery,pressure was felt toward the back of my neck; pressure was felt up toward the base of my skull; tingling in my lips; my left hand experiencing a strange pain in my fingers; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness,numbness persisted for several hours,on and off numbness in the left arm), DISCOMFORT (pressure in my left side), MUSCULOSKELETAL DISCOMFORT (pressure was felt along my carotid artery,pressure was felt toward the back of my neck), HEAD DISCOMFORT (pressure was felt up toward the base of my skull) and PARAESTHESIA ORAL (tingling in my lips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness,numbness persisted for several hours,on and off numbness in the left arm), DISCOMFORT (pressure in my left side), MUSCULOSKELETAL DISCOMFORT (pressure was felt along my carotid artery,pressure was felt toward the back of my neck), HEAD DISCOMFORT (pressure was felt up toward the base of my skull), PARAESTHESIA ORAL (tingling in my lips), PAIN IN EXTREMITY (my left hand experiencing a strange pain in my fingers) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, HYPOAESTHESIA (numbness,numbness persisted for several hours,on and off numbness in the left arm), DISCOMFORT (pressure in my left side), MUSCULOSKELETAL DISCOMFORT (pressure was felt along my carotid artery,pressure was felt toward the back of my neck), HEAD DISCOMFORT (pressure was felt up toward the base of my skull), PARAESTHESIA ORAL (tingling in my lips), PAIN IN EXTREMITY (my left hand experiencing a strange pain in my fingers) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-253095 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia oral, Vaccination site pain
Clinical narrative: numbness,numbness persisted for several hours,on and off numbness in the left arm; pressure in my left side; pressure was felt along my carotid artery,pressure was felt toward the back of my neck; pressure was felt up toward the base of my skull; tingling in my lips; my left hand experiencing a strange pain in my fingers; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness,numbness persisted for several hours,on and off numbness in the left arm), DISCOMFORT (pressure in my left side), MUSCULOSKELETAL DISCOMFORT (pressure was felt along my carotid artery,pressure was felt toward the back of my neck), HEAD DISCOMFORT (pressure was felt up toward the base of my skull) and PARAESTHESIA ORAL (tingling in my lips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness,numbness persisted for several hours,on and off numbness in the left arm), DISCOMFORT (pressure in my left side), MUSCULOSKELETAL DISCOMFORT (pressure was felt along my carotid artery,pressure was felt toward the back of my neck), HEAD DISCOMFORT (pressure was felt up toward the base of my skull), PARAESTHESIA ORAL (tingling in my lips), PAIN IN EXTREMITY (my left hand experiencing a strange pain in my fingers) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, HYPOAESTHESIA (numbness,numbness persisted for several hours,on and off numbness in the left arm), DISCOMFORT (pressure in my left side), MUSCULOSKELETAL DISCOMFORT (pressure was felt along my carotid artery,pressure was felt toward the back of my neck), HEAD DISCOMFORT (pressure was felt up toward the base of my skull), PARAESTHESIA ORAL (tingling in my lips), PAIN IN EXTREMITY (my left hand experiencing a strange pain in my fingers) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-253095 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Vaccination site pain; Triedness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Triedness) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Triedness). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Triedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes - Ointment   This case was linked to MOD-2021-253210 (Patient Link).
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received 1st dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours when administered.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 09-Jul-2021 and does not contain any new information.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pain
Clinical narrative: soreness in injection arm; rash over entire body/looking like mosquito bits/being very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in injection arm) and RASH PRURITIC (rash over entire body/looking like mosquito bits/being very itchy) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer since an unknown date. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for an unknown indication.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness in injection arm) and RASH PRURITIC (rash over entire body/looking like mosquito bits/being very itchy). At the time of the report, VACCINATION SITE PAIN (soreness in injection arm) outcome was unknown and RASH PRURITIC (rash over entire body/looking like mosquito bits/being very itchy) had not resolved.            Treatment medication include ointment.   This case was linked to MOD-2021-253206 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash for second dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash for second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash for second dose). At the time of the report, RASH PRURITIC (itchy rash for second dose) outcome was unknown. Not Provided          No Treatment was reported. No concomitant medication was reported.   This case was linked to MOD-2021-024676 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: pharmacist administered a moderna vaccine to a patient that was thawed for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pharmacist administered a moderna vaccine to a patient that was thawed for more than 30 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pharmacist administered a moderna vaccine to a patient that was thawed for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pharmacist administered a moderna vaccine to a patient that was thawed for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09 Jul 2021 contains non-significant information. Patient demographics updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Soreness in injection arm; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection arm), CHILLS (Chills) and PYREXIA (Fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21H and 021C214) for COVID-19 vaccination.     Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), VITAMIN E [VITAMIN E NOS], CALCIUM and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in injection arm), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Soreness in injection arm), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Patient was treated with ointment and allergy pills.   This case was linked to MOD-2021-253218 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood test, Fatigue, Magnetic resonance imaging head, Pain in extremity
Clinical narrative: short term memory loss; Sore arm; feeling very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (short term memory loss), PAIN IN EXTREMITY (Sore arm) and FATIGUE (feeling very fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m20A and 016B21A) for COVID-19 vaccination.     Patient medical history were not provided.  Concurrent medical conditions included Drug allergy. Concomitant products included COLECALCIFEROL (VIT D3), KRILL OIL and ASCORBIC ACID (VIT C) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (feeling very fatigued). On an unknown date, the patient experienced AMNESIA (short term memory loss). At the time of the report, AMNESIA (short term memory loss) outcome was unknown and PAIN IN EXTREMITY (Sore arm) and FATIGUE (feeling very fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: normal (normal) pretty normal.         Patient reported that few weeks after receiving the vaccine patient was feeling very fatigued. Weak legs and arms. Patient wasTotally not herself. This continued for a couple months and as of the end of July patient noticed her energy coming back. Not completely but better than before. She started going back over the months trying to figure out why she felt this way. She also was very fuzzy headed for the duration of time frame above. Patient couldn't concentrate and read as she could not get her thoughts together. She was even uncomfortable driving because of this. As per patient only thing that stood out that could have caused this was the vaccine. Her Dr even ordered and MRI of my brain which showed pretty normal. She do not know for certain what caused this except the Moderna vaccine was the only thing different that she did and it started after this. Patient stated feeling better and thoughts and focus have returned to almost normal. Patient also takes ginger capsules as concomitant medications. No treatment medication information was provided. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was Not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow-up Patient details (gender, race, allergy added), suspect dosage details (dose1 and dose 2, vaccine facility details added), concomitant medications and events added.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site pain
Clinical narrative: rash over entire body/ looking like mosquito bits/being very itchy; Soreness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash over entire body/ looking like mosquito bits/being very itchy) and VACCINATION SITE PAIN (Soreness in the injection arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C214) for COVID-19 vaccination.     No medication history information was reported .  Concomitant products included VITAMIN E NOS, CALCIUM and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash over entire body/ looking like mosquito bits/being very itchy) and VACCINATION SITE PAIN (Soreness in the injection arm). At the time of the report, RASH PRURITIC (rash over entire body/ looking like mosquito bits/being very itchy) had not resolved and VACCINATION SITE PAIN (Soreness in the injection arm) had resolved.            Concomitant medication include B-complex. Treatment medication include ointments & allergy pills.   This case was linked to MOD-2021-253215 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site reaction
Clinical narrative: issues with numbness; issues with circulation in/around the injection site; 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 HYPOAESTHESIA (issues with numbness) and VACCINATION SITE REACTION (issues with circulation in/around the injection site) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (issues with numbness) and VACCINATION SITE REACTION (issues with circulation in/around the injection site). At the time of the report, HYPOAESTHESIA (issues with numbness) and VACCINATION SITE REACTION (issues with circulation in/around the injection site) outcome was unknown.        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: Pulpitis dental, Toothache
Clinical narrative: Wisdom tooth is coming out/have very inflamed; Painful; This spontaneous case was reported by a consumer and describes the occurrence of PULPITIS DENTAL (Wisdom tooth is coming out/have very inflamed) and TOOTHACHE (Painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULPITIS DENTAL (Wisdom tooth is coming out/have very inflamed) and TOOTHACHE (Painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM (FLANAX NOCTO) ongoing since an unknown date at an unspecified dose and frequency and KETOROLAC ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PULPITIS DENTAL (Wisdom tooth is coming out/have very inflamed) and TOOTHACHE (Painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Muscle spasms, Myalgia, Visual impairment
Clinical narrative: Body aches/these symptoms worsened including vision problems; late cramps; Body aches/these symptoms worsened including vision problems; she was off work for a month; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (she was off work for a month), VISUAL IMPAIRMENT (Body aches/these symptoms worsened including vision problems), MUSCLE SPASMS (late cramps) and MYALGIA (Body aches/these symptoms worsened including vision problems) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product PEGINTERFERON BETA-1A (PLEGRIDY) for an unknown indication.    Previously administered products included for Multiple sclerosis: Aubagio (Nails were thin and she was experiencing hair loss. Teriflunomide was stopped and there was improvement noted.) from 12-Aug-2016 to 01-Mar-2020. Past adverse reactions to the above products included Adverse event with Aubagio. Concurrent medical conditions included Multiple sclerosis, Restless leg syndrome (onset 2016 or 2017), Urinary urgency, Nail thinning, Ache (body aches) and Hair loss. Concomitant products included TOLTERODINE for Urinary urgency.   In March 2020, the patient started PEGINTERFERON BETA-1A (PLEGRIDY) (unknown route) at an unspecified dose. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (she was off work for a month), VISUAL IMPAIRMENT (Body aches/these symptoms worsened including vision problems), MUSCLE SPASMS (late cramps) and MYALGIA (Body aches/these symptoms worsened including vision problems). The patient was treated with TERIFLUNOMIDE (AUBAGIO) (oral) ongoing from 01-May-2021 for Multiple sclerosis, Pain worsened and Vision abnormal aggravated, at a dose of 14 mg once a day and MAGNESIUM in January 2021 for Cramp, at a dose of 1 dosage form. At the time of the report, IMPAIRED WORK ABILITY (she was off work for a month) had resolved and VISUAL IMPAIRMENT (Body aches/these symptoms worsened including vision problems), MUSCLE SPASMS (late cramps) and MYALGIA (Body aches/these symptoms worsened including vision problems) was resolving.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: found no antibodies in her system; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (found no antibodies in her system) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Rheumatoid arthritis. Concomitant products included METHOTREXATE for Autoimmune disorder and Rheumatoid arthritis, ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Autoimmune disorder.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced VACCINATION FAILURE (found no antibodies in her system). At the time of the report, VACCINATION FAILURE (found no antibodies in her system) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient had her second dose of Moderna Covid-19 vaccine on 04-Mar-2021.  No treatment information was provided.  Company Comment: This is a case of a 78 year old female with reported adverse event of Vaccination failure after completion  of two doses vaccination with mRNA 1273. There is  very limited information regarding  this event that   has  been provided at this time. No further information  is expected at this time.; Sender's Comments: This is a case of a 78 year old female with reported adverse event of Vaccination failure after completion  of two doses vaccination with mRNA 1273. There is very limited information regarding  this event that   has  been provided at this time. No further information  is expected at this time.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: unspecified infection; This spontaneous case was reported by a health care professional and describes the occurrence of INFECTION (unspecified infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products MACITENTAN for an unknown indication and ILOPROST for an unknown indication.    Concurrent medical conditions included Pulmonary hypertension. Concomitant products included RIOCIGUAT (ADEMPAS) and WARFARIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, MACITENTAN (Oral) 10 mg once a day and ILOPROST (unknown route) 5 mcg. On an unknown date, the patient experienced INFECTION (unspecified infection). At the time of the report, INFECTION (unspecified infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen) 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 PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen). At the time of the report, PAIN IN EXTREMITY (sore arm) and PERIPHERAL SWELLING (swollen) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Feeling abnormal, Nausea, Sneezing
Clinical narrative: Doesnot feel quite herself; kind of fogginess; Feels like if she sneezes; Might experience diarrhea; Nausea, nausea she is currently experiencing is on both sides of the; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Doesnot feel quite herself; kind of fogginess), SNEEZING (Feels like if she sneezes), DIARRHOEA (Might experience diarrhea) and NAUSEA (Nausea, nausea she is currently experiencing is on both sides of the) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 13-Nov-2018, the patient started TREPROSTINIL SODIUM (IV drip) .06 microgram/kilogram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Doesnot feel quite herself; kind of fogginess), SNEEZING (Feels like if she sneezes), DIARRHOEA (Might experience diarrhea) and NAUSEA (Nausea, nausea she is currently experiencing is on both sides of the). At the time of the report, FEELING ABNORMAL (Doesnot feel quite herself; kind of fogginess), SNEEZING (Feels like if she sneezes), DIARRHOEA (Might experience diarrhea) and NAUSEA (Nausea, nausea she is currently experiencing is on both sides of the) outcome was unknown.            Concomitant medication use was unknown No treatment was provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Intense vomiting; Ongoing nausea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Intense vomiting) and NAUSEA (Ongoing nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 VOMITING (Intense vomiting) and NAUSEA (Ongoing nausea). At the time of the report, VOMITING (Intense vomiting) and NAUSEA (Ongoing nausea) had not resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Nausea, Vaccination site erythema, Vaccination site induration
Clinical narrative: Vaccination site induration; Vaccination site erythema; Fatigue; NAUSEATED; Threw up 1 or 2 times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung transplant (Immune suppressive therapy for double lung transplant.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times). At the time of the report, VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE ERYTHEMA (Vaccination site erythema), FATIGUE (Fatigue), NAUSEA (NAUSEATED) and VOMITING (Threw up 1 or 2 times) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative negative (Negative) Negative.         No concomitant and treatment medications were reported. Patient has stated that she does not to fill out any forms or give her mail as she is in a study and looking after her issues.   This case was linked to MOD-2021-019772 (Patient Link).