chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the 2nd dose between 25-35 days of the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of the 1st dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (Recovering from a bad pneumonia during the first dose).    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose between 25-35 days of the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported  Treatment information was not reported
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave three doses from one expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave three doses from one expired vial) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, METFORMIN, MIRTAZAPINE (REMERON) and KETOCONAZOLE for an unknown indication.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave three doses from one expired vial). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Gave three doses from one expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received with no new information.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: soreness of arm and back and he was super sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of arm and back and he was super sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 MYALGIA (soreness of arm and back and he was super sore). At the time of the report, MYALGIA (soreness of arm and back and he was super sore) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I had a technician administer a vaccine 17 hours after the vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of (I had a technician administer a vaccine 17 hours after the vial was punctured) 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 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (I had a technician administer a vaccine 17 hours after the vial was punctured). At the time of the report, (I had a technician administer a vaccine 17 hours after the vial was punctured) 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 medications were not provided.  Treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Various side effects; 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 VACCINATION COMPLICATION (Various side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Various side effects). At the time of the report, VACCINATION COMPLICATION (Various side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided. No concomitant medication provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore left arm between Shoulder and Elbow after first shot; Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm between Shoulder and Elbow after first shot) and MYALGIA (Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm between Shoulder and Elbow after first shot) and MYALGIA (Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain). At the time of the report, PAIN IN EXTREMITY (Sore left arm between Shoulder and Elbow after first shot) and MYALGIA (Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the Second dose on14-APR-2021 in the Right Arm  (Lot#  040B21A)  No Concomitant medications were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: over 8 weeks since first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 8 weeks since first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 8 weeks since first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 8 weeks since first dose) 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.   No concomitant medication details were provided.  No treatment information was mentioned.  Patient was also stated that she did not have any symptoms after the first dose.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 21May2021 and did not get the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information provided. first dose of the Moderna vaccine on 21May2021 at the same facility, and was scheduled to get the second dose on 28Jun2021 but did not attended the appointment at the time
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A dose of moderna vaccine was administered to a 16 yo; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A dose of moderna vaccine was administered to a 16 yo) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A dose of moderna vaccine was administered to a 16 yo). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A dose of moderna vaccine was administered to a 16 yo) 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.   No treatment information was provided.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: A few days after the first one, I had a swollen lymph node in my neck, swelling went down after a couple days; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (A few days after the first one, I had a swollen lymph node in my neck, swelling went down after a couple days) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (A few days after the first one, I had a swollen lymph node in my neck, swelling went down after a couple days). At the time of the report, LYMPHADENOPATHY (A few days after the first one, I had a swollen lymph node in my neck, swelling went down after a couple days) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-270166 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness of the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of the site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015621A or 0512H) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the site). At the time of the report, VACCINATION SITE PAIN (Soreness of the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were reported by the reporter.   This case was linked to MOD-2021-270210 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue, Tinnitus
Clinical narrative: if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm; Some discomfort with ringing in his ears; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Some discomfort with ringing in his ears), MYALGIA (Arm was sore) and PRODUCT DOSE OMISSION ISSUE (if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included ESTRADIOL and PROGESTERONE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced TINNITUS (Some discomfort with ringing in his ears) and MYALGIA (Arm was sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm). At the time of the report, TINNITUS (Some discomfort with ringing in his ears) had not resolved, MYALGIA (Arm was sore) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (if it was okay to receive the second dose of the vaccine if the first one was administered on 29March2021 on the right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Steroids.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow up received includes non significant information. email has been updated
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MRN496914) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS on 16-Feb-2021. Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), MIRABEGRON, SOLIFENACIN SUCCINATE (VESICARE), HYDROCHLOROTHIAZIDE, CETIRIZINE HYDROCHLORIDE (ZYRTEC R), ATORVASTATIN CALCIUM (LIPITOR), VITAMIN B COMPLEX, CLONAZEPAM, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]), LEVOTHYROXINE SODIUM (SYNTHYROID), ZINC, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), PROBIOTICS NOS, VITAMIN C [ASCORBIC ACID] and CALCIUM for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had the first dose of the Moderna vaccine on 05Mar2021 and has not received the second dose yet) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The second dose of vaccine had not been taken because of his knee surgery on 19-Apr-2021 and surgery had not been scheduled before getting Moderna vaccine. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site getting swelling; injection site getting red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site getting swelling) and VACCINATION SITE ERYTHEMA (injection site getting red) 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 VACCINATION SITE SWELLING (injection site getting swelling) and VACCINATION SITE ERYTHEMA (injection site getting red). At the time of the report, VACCINATION SITE SWELLING (injection site getting swelling) and VACCINATION SITE ERYTHEMA (injection site getting red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not reported. Concomitant medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose > 36 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose > 36 days) 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 15-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose > 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose > 36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: TCR received-NNI
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm after second dose; Tiredness after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after second dose) and FATIGUE (Tiredness after second dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after second dose) and FATIGUE (Tiredness after second dose). On 06-May-2021, PAIN IN EXTREMITY (Sore arm after second dose) and FATIGUE (Tiredness after second dose) had resolved.            No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-100575 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up received and contains
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), AMLODIPINE, LEVOTHYROXINE, MIRTAZAPINE, MONTELUKAST, DRONEDARONE, ROSUVASTATIN, FUROSEMIDE, VALSARTAN and PARICALCITOL for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (severe headache). The patient was treated with RIMEGEPANT at an unspecified dose and frequency; MOXIFLOXACIN at an unspecified dose and frequency; METHYLPREDNISOLONE at an unspecified dose and frequency and PROPRANOLOL at an unspecified dose and frequency. At the time of the report, HEADACHE (severe headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The PCP gave the patient 2 medicines, they didn't help (Nurtec ODT (rimegepant) and Moxifloxacin). The neurologist gave her 2 medicines, methylprednisolone and propranolol, the latter she was still taking, but she felt the same.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) 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.   The reporter states the patient received a dose of the Moderna COVID-19 Vaccine that expired on 25 July 2021.  No concomitant medication were reported.  No treatment medication was reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on 25-JUL-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Palpitations, Peripheral swelling, Vaccination site pain
Clinical narrative: Several days after receiving 1st dose, at night her heart was really racing / heart palpitation; She had cough.; She had swelling in her feet.; Her left arm was really sore for 1 week; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Several days after receiving 1st dose, at night her heart was really racing / heart palpitation), COUGH (She had cough.), PERIPHERAL SWELLING (She had swelling in her feet.) and VACCINATION SITE PAIN (Her left arm was really sore for 1 week) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CYANOCOBALAMIN (VITAMIN B-12) for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Several days after receiving 1st dose, at night her heart was really racing / heart palpitation), COUGH (She had cough.), PERIPHERAL SWELLING (She had swelling in her feet.) and VACCINATION SITE PAIN (Her left arm was really sore for 1 week). At the time of the report, PALPITATIONS (Several days after receiving 1st dose, at night her heart was really racing / heart palpitation), COUGH (She had cough.), PERIPHERAL SWELLING (She had swelling in her feet.) and VACCINATION SITE PAIN (Her left arm was really sore for 1 week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's additional concomitant medications included other supplements. It was reported that the patient had fast heart beats.  No treatment information was provided by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: swollen lymph node again, not as big as first time but its still there, going away very slowly; I have felt very tired, fatigued, felt like I worked all day even though I had not worked; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node again, not as big as first time but its still there, going away very slowly) and FATIGUE (I have felt very tired, fatigued, felt like I worked all day even though I had not worked) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 LYMPHADENOPATHY (swollen lymph node again, not as big as first time but its still there, going away very slowly) and FATIGUE (I have felt very tired, fatigued, felt like I worked all day even though I had not worked). At the time of the report, LYMPHADENOPATHY (swollen lymph node again, not as big as first time but its still there, going away very slowly) was resolving and FATIGUE (I have felt very tired, fatigued, felt like I worked all day even though I had not worked) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was not applicable.   This case was linked to MOD-2021-270094 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dyspnoea, Dysuria, Fatigue, Fluid retention
Clinical narrative: face was all swollen; eyes were puffy; throat felt swollen; couldn't pee; She could still breath; stomach was swollen; retaining a lot of water after the vaccine.; chronic pain; throat felt thick; strong headache; just really tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSURIA (couldn't pee) and DYSPNOEA (She could still breath) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Flu vaccination (Flu vaccine) and Food allergy (Avocado).    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 SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSURIA (couldn't pee), DYSPNOEA (She could still breath), ABDOMINAL DISTENSION (stomach was swollen), FLUID RETENTION (retaining a lot of water after the vaccine.), PAIN (chronic pain), PHARYNGEAL OEDEMA (throat felt thick), HEADACHE (strong headache) and FATIGUE (just really tired). At the time of the report, SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSPNOEA (She could still breath), FLUID RETENTION (retaining a lot of water after the vaccine.), PAIN (chronic pain), PHARYNGEAL OEDEMA (throat felt thick), HEADACHE (strong headache) and FATIGUE (just really tired) outcome was unknown, DYSURIA (couldn't pee) had resolved and ABDOMINAL DISTENSION (stomach was swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given. Laboratory details given as blood glucose decreased on an unknown date. No treatment information was given
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Periorbital swelling, Pharyngeal oedema, Pharyngeal swelling
Clinical narrative: face was all swollen; eyes were puffy; throat felt swollen; couldn't pee; She could still breath; stomach was swollen; retaining a lot of water after the vaccine.; chronic pain; throat felt thick; strong headache; just really tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSURIA (couldn't pee) and DYSPNOEA (She could still breath) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Flu vaccination (Flu vaccine) and Food allergy (Avocado).    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 SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSURIA (couldn't pee), DYSPNOEA (She could still breath), ABDOMINAL DISTENSION (stomach was swollen), FLUID RETENTION (retaining a lot of water after the vaccine.), PAIN (chronic pain), PHARYNGEAL OEDEMA (throat felt thick), HEADACHE (strong headache) and FATIGUE (just really tired). At the time of the report, SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSPNOEA (She could still breath), FLUID RETENTION (retaining a lot of water after the vaccine.), PAIN (chronic pain), PHARYNGEAL OEDEMA (throat felt thick), HEADACHE (strong headache) and FATIGUE (just really tired) outcome was unknown, DYSURIA (couldn't pee) had resolved and ABDOMINAL DISTENSION (stomach was swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given. Laboratory details given as blood glucose decreased on an unknown date. No treatment information was given
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face was all swollen; eyes were puffy; throat felt swollen; couldn't pee; She could still breath; stomach was swollen; retaining a lot of water after the vaccine.; chronic pain; throat felt thick; strong headache; just really tired; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSURIA (couldn't pee) and DYSPNOEA (She could still breath) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Flu vaccination (Flu vaccine) and Food allergy (Avocado).    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 SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSURIA (couldn't pee), DYSPNOEA (She could still breath), ABDOMINAL DISTENSION (stomach was swollen), FLUID RETENTION (retaining a lot of water after the vaccine.), PAIN (chronic pain), PHARYNGEAL OEDEMA (throat felt thick), HEADACHE (strong headache) and FATIGUE (just really tired). At the time of the report, SWELLING FACE (face was all swollen), PERIORBITAL SWELLING (eyes were puffy), PHARYNGEAL SWELLING (throat felt swollen), DYSPNOEA (She could still breath), FLUID RETENTION (retaining a lot of water after the vaccine.), PAIN (chronic pain), PHARYNGEAL OEDEMA (throat felt thick), HEADACHE (strong headache) and FATIGUE (just really tired) outcome was unknown, DYSURIA (couldn't pee) had resolved and ABDOMINAL DISTENSION (stomach was swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was given. Laboratory details given as blood glucose decreased on an unknown date. No treatment information was given
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, C-reactive protein, Headache, Nausea, White blood cell count
Clinical narrative: Stomach upset; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), HEADACHE (Headache) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Foot surgery (surgery on foot several months earlier). Concurrent medical conditions included White blood cell count (Low white blood count) since 09-Oct-1971, Nerve pain (Chronic nerve pain in foot from accident) since 10-Jun-2014, Thyroid nodule (thyroid issues and nodules) since 2009, Gastritis (acid reflux/gastritis) since 2010, Osteoporosis (Left hip) since 2016, Sulfonamide allergy (Allergies to medications : Sulfa), Drug allergy (macrodantin), Sulfonamide allergy (gantrisin), Allergy to antibiotic (Erythromycin), Allergy to antibiotic (ampicillin), Drug allergy (Chlorhexidine), CRP increased and Allergy (not specified). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), LORATADINE for Allergy, VITAMIN D3 and MAGNESIUM for Bone density abnormal, ATORVASTATIN for CRP increased, TRAMADOL for Chronic pain, VITAMIN C [ASCORBIC ACID] for Immune system disorder (NOS), CALCIUM CITRATE for Osteoporosis, COENZYME Q10 [UBIDECARENONE] for Supplementation therapy.    On 27-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021 at 9:00 AM, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 29-Jan-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) High CRP level. On an unknown date, White blood cell count: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stomach was upset but he never vomited he could only eat lightly all day like soup ,ginger ,ale and toast.   This case was linked to MOD-2021-253907 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Felt like fireworks in her chest, just bursting; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and CHEST DISCOMFORT (Felt like fireworks in her chest, just bursting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced CHEST DISCOMFORT (Felt like fireworks in her chest, just bursting). At the time of the report, CHEST PAIN (chest pain) and CHEST DISCOMFORT (Felt like fireworks in her chest, just bursting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient  has chest pain that gotten little worse and patient went to VAERS.  No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Fatigue, Headache, Myalgia
Clinical narrative: sleeps all the time; chest pain; pain behind left breast; still has not received the 2nd dose; headaches; low grade fever; tiredness/chronic fatigue; pain all over the body; vomiting; nausea; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeps all the time), CHEST PAIN (chest pain), BREAST PAIN (pain behind left breast), PRODUCT DOSE OMISSION ISSUE (still has not received the 2nd dose) and HEADACHE (headaches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Diverticulitis, Irritable bowel syndrome, Bladder irritability, Chronic fatigue syndrome, Osteoarthritis, Osteoporosis, Glaucoma, GERD, Hiatal hernia and Seasonal asthma (myocardial valve prolapse). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for Seasonal asthma, PREDNISONE, MORPHINE SULFATE, OXYCODONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), DICYCLOMINE [DICYCLOVERINE] and PARACETAMOL (TYLENOL) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleeps all the time), CHEST PAIN (chest pain), BREAST PAIN (pain behind left breast), PRODUCT DOSE OMISSION ISSUE (still has not received the 2nd dose), HEADACHE (headaches), PYREXIA (low grade fever), FATIGUE (tiredness/chronic fatigue), MYALGIA (pain all over the body), VOMITING (vomiting), NAUSEA (nausea) and FATIGUE (exhaustion). At the time of the report, SOMNOLENCE (sleeps all the time), HEADACHE (headaches), FATIGUE (tiredness/chronic fatigue) and MYALGIA (pain all over the body) had not resolved, CHEST PAIN (chest pain), BREAST PAIN (pain behind left breast), PRODUCT DOSE OMISSION ISSUE (still has not received the 2nd dose) and VOMITING (vomiting) had resolved, PYREXIA (low grade fever) and NAUSEA (nausea) outcome was unknown and FATIGUE (exhaustion) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's additional concomitant medication included steroids. The patient had medical history of myocardial valve prolapse.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and added Patient's Other relevant history. Added Concomitant drugs. Added new events and events outcome updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Product dose omission issue, Pyrexia, Somnolence, Vomiting
Clinical narrative: sleeps all the time; chest pain; pain behind left breast; still has not received the 2nd dose; headaches; low grade fever; tiredness/chronic fatigue; pain all over the body; vomiting; nausea; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeps all the time), CHEST PAIN (chest pain), BREAST PAIN (pain behind left breast), PRODUCT DOSE OMISSION ISSUE (still has not received the 2nd dose) and HEADACHE (headaches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Diverticulitis, Irritable bowel syndrome, Bladder irritability, Chronic fatigue syndrome, Osteoarthritis, Osteoporosis, Glaucoma, GERD, Hiatal hernia and Seasonal asthma (myocardial valve prolapse). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and ALBUTEROL [SALBUTAMOL] for Seasonal asthma, PREDNISONE, MORPHINE SULFATE, OXYCODONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), DICYCLOMINE [DICYCLOVERINE] and PARACETAMOL (TYLENOL) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleeps all the time), CHEST PAIN (chest pain), BREAST PAIN (pain behind left breast), PRODUCT DOSE OMISSION ISSUE (still has not received the 2nd dose), HEADACHE (headaches), PYREXIA (low grade fever), FATIGUE (tiredness/chronic fatigue), MYALGIA (pain all over the body), VOMITING (vomiting), NAUSEA (nausea) and FATIGUE (exhaustion). At the time of the report, SOMNOLENCE (sleeps all the time), HEADACHE (headaches), FATIGUE (tiredness/chronic fatigue) and MYALGIA (pain all over the body) had not resolved, CHEST PAIN (chest pain), BREAST PAIN (pain behind left breast), PRODUCT DOSE OMISSION ISSUE (still has not received the 2nd dose) and VOMITING (vomiting) had resolved, PYREXIA (low grade fever) and NAUSEA (nausea) outcome was unknown and FATIGUE (exhaustion) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's additional concomitant medication included steroids. The patient had medical history of myocardial valve prolapse.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and added Patient's Other relevant history. Added Concomitant drugs. Added new events and events outcome updated.