chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046c21a) 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 EXPIRED PRODUCT ADMINISTERED (A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A facility has been using a batch with lot #046c21a for 6 weeks now and the batch had expired on the Nov 06, 2021) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Heart disease, unspecified (Heart disease), Cholesterosis (Cholesterol) and Blood pressure high (Blood pressure). Concomitant products included LISINOPRIL for Blood pressure high, ROSUVASTATIN for Cholesterolosis NOS, INSULIN, EMPAGLIFLOZIN (JARDIANCE) and METFORMIN for Diabetes, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disease, unspecified.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The storage condition of the vial at the time of the excursion was refrigerated. Maximum or minimum temperatures reached in by the vial was in between 2-8 Celsius degrees. Excursion duration was almost 24 to 30 hours and one vial of vaccine was impacted. Treatment medication was not provided by the reporter.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, International normalised ratio decreased
Clinical narrative: blood coumadin numbers dropped from  2.2 to 1.7; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO DECREASED (blood coumadin numbers dropped from  2.2 to 1.7) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 004M20A) for COVID-19 vaccination.     Concomitant products included WARFARIN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INTERNATIONAL NORMALISED RATIO DECREASED (blood coumadin numbers dropped from  2.2 to 1.7). At the time of the report, INTERNATIONAL NORMALISED RATIO DECREASED (blood coumadin numbers dropped from  2.2 to 1.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, International normalised ratio (2.0-3.0): 1.7 (Low) Level dropped from 2.2 to 1.7.         Patient was taking Warfarin and his blood coumadin level was supposed to be at 2.0-3.0. After the second dose of the Moderna vaccine, his levels dropped from 2.2 to 1.7. No treatment information were given.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Plantar fasciitis
Clinical narrative: bad heel pain; Around June, they both got plantar fasciitis on the left foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (bad heel pain) and PLANTAR FASCIITIS (Around June, they both got plantar fasciitis on the left foot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-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 PAIN IN EXTREMITY (bad heel pain) and PLANTAR FASCIITIS (Around June, they both got plantar fasciitis on the left foot). At the time of the report, PAIN IN EXTREMITY (bad heel pain) and PLANTAR FASCIITIS (Around June, they both got plantar fasciitis on the left foot) outcome was unknown.            No concomitant medication information provided. On 28-Nov-2021, the patient received booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form (batch number- 034F21A) and the patient was fine. No treatment medication information provided.   This case was linked to MOD-2021-408563 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure to SARS-CoV-2, Headache, Hypersensitivity, Illness
Clinical narrative: Allergies; Really bad body aches; Sick; Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID; Diarrhea; Low grade fever; Really bad headache/headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and PYREXIA (Low grade fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MAGNESIUM CITRATE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Low grade fever) and HEADACHE (Really bad headache/headache). On an unknown date, the patient experienced ILLNESS (Sick), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and EXPOSURE TO SARS-COV-2 (Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and EXPOSURE TO SARS-COV-2 (Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID) outcome was unknown and DIARRHOEA (Diarrhea), PYREXIA (Low grade fever) and HEADACHE (Really bad headache/headache) had not resolved.            No concomitant medications reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Allergies; Really bad body aches; Sick; Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID; Diarrhea; Low grade fever; Really bad headache/headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), DIARRHOEA (Diarrhea), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and PYREXIA (Low grade fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 17B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MAGNESIUM CITRATE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Low grade fever) and HEADACHE (Really bad headache/headache). On an unknown date, the patient experienced ILLNESS (Sick), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and EXPOSURE TO SARS-COV-2 (Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), HYPERSENSITIVITY (Allergies), MYALGIA (Really bad body aches) and EXPOSURE TO SARS-COV-2 (Caller has been exposed to another person that tested positive for COVID/she does not know if her symptoms are COVID) outcome was unknown and DIARRHOEA (Diarrhea), PYREXIA (Low grade fever) and HEADACHE (Really bad headache/headache) had not resolved.            No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes after booster shot; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes after booster 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes after booster shot). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes after booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Illness, Nausea, Pyrexia
Clinical narrative: I had full blown diarrhea.; mild diarrhea; nausea.; I had extreme fatigue; fever of 100.6F; I became violently ill; Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter; it was hard; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I became violently ill), DIARRHOEA (mild diarrhea), DIARRHOEA (I had full blown diarrhea.), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 14-Aug-2021 to 19-Aug-2021.    On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced ILLNESS (I became violently ill), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard). On 08-Dec-2021, the patient experienced DIARRHOEA (mild diarrhea), NAUSEA (nausea.), FATIGUE (I had extreme fatigue) and PYREXIA (fever of 100.6F). On 09-Dec-2021, the patient experienced DIARRHOEA (I had full blown diarrhea.). On 10-Dec-2021, ILLNESS (I became violently ill), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard) had resolved. At the time of the report, DIARRHOEA (mild diarrhea), DIARRHOEA (I had full blown diarrhea.), NAUSEA (nausea.), FATIGUE (I had extreme fatigue) and PYREXIA (fever of 100.6F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Patient received Regeneron monoclonal treatment. On 8-Dec-2021 patient reported 21days due for second dose.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: I had full blown diarrhea.; mild diarrhea; nausea.; I had extreme fatigue; fever of 100.6F; I became violently ill; Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter; it was hard; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I became violently ill), DIARRHOEA (mild diarrhea), DIARRHOEA (I had full blown diarrhea.), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 14-Aug-2021 to 19-Aug-2021.    On 07-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced ILLNESS (I became violently ill), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard). On 08-Dec-2021, the patient experienced DIARRHOEA (mild diarrhea), NAUSEA (nausea.), FATIGUE (I had extreme fatigue) and PYREXIA (fever of 100.6F). On 09-Dec-2021, the patient experienced DIARRHOEA (I had full blown diarrhea.). On 10-Dec-2021, ILLNESS (I became violently ill), VACCINATION SITE SWELLING (Within 4 hrs, my arm became swollen/The swelling was about a 4 inch diameter) and VACCINATION SITE INDURATION (it was hard) had resolved. At the time of the report, DIARRHOEA (mild diarrhea), DIARRHOEA (I had full blown diarrhea.), NAUSEA (nausea.), FATIGUE (I had extreme fatigue) and PYREXIA (fever of 100.6F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Patient received Regeneron monoclonal treatment. On 8-Dec-2021 patient reported 21days due for second dose.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder
Clinical narrative: experiencing a flash before his eyes, a clear film formed in front of his eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISORDER (experiencing a flash before his eyes, a clear film formed in front of his eyes) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 002A21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE DISORDER (experiencing a flash before his eyes, a clear film formed in front of his eyes). At the time of the report, EYE DISORDER (experiencing a flash before his eyes, a clear film formed in front of his eyes) had resolved.            No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-057671 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Wrong technique in device usage process
Clinical narrative: My wife is having side effects after the booster dose; Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My wife is having side effects after the booster dose) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My wife is having side effects after the booster dose) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the dose). At the time of the report, VACCINATION COMPLICATION (My wife is having side effects after the booster dose) outcome was unknown and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the dose) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the pharmacy used a jet injection for giving the vaccine instead of typical syringe.   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Nausea, Vomiting
Clinical narrative: started experiencing headaches, nausea, and vomiting; started experiencing headaches, nausea, and vomiting; started experiencing headaches, nausea, and vomiting; Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (started experiencing headaches, nausea, and vomiting), NAUSEA (started experiencing headaches, nausea, and vomiting), VOMITING (started experiencing headaches, nausea, and vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (The IM injection was given into the right arm with lot number EL9263.) on 20-Jan-2021 and Pfizer (The IM injection was given into the right arm with lot number EN2601.) on 12-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021). On 10-Dec-2021, the patient experienced HEADACHE (started experiencing headaches, nausea, and vomiting), NAUSEA (started experiencing headaches, nausea, and vomiting) and VOMITING (started experiencing headaches, nausea, and vomiting). On 09-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Husband reported his wife received the MODRNA booster dose on 09-Dec-2021/first PFIZER dose on 20-Jan-2021/ second PFIZER dose on 12-Feb-2021) had resolved. At the time of the report, HEADACHE (started experiencing headaches, nausea, and vomiting), NAUSEA (started experiencing headaches, nausea, and vomiting) and VOMITING (started experiencing headaches, nausea, and vomiting) outcome was unknown.            Patient has no known food or drug allergies. Concomitant medications include Vitamins. Treatment information was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.; since then the injection site hurts; it hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (since then the injection site hurts; it hurts) and MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (on late September-early October). Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOL [OMEPRAZOLE] for Acid reflux (esophageal).    On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced VACCINATION SITE PAIN (since then the injection site hurts; it hurts). On an unknown date, the patient experienced MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (since then the injection site hurts; it hurts) and MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient thought it was normal for the first day or so, but now it's been 3 weeks. He has the second dose scheduled for 16-Dec-2021. Patient stated he does a lot of physical work and used to some aches to his age, but this is bothering him the most. Patient took Tylenol because if not the pain wakes him up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Influenza like illness, Pain, Rash
Clinical narrative: Inappropriate schedule of vaccine administered; small break out rash in the lower back to the buttcrack area/localized rash.; Chills; Flu-like symptoms; Pains/aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Pains/aches), RASH (small break out rash in the lower back to the buttcrack area/localized rash.), CHILLS (Chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Pfizer (Batch no- EN620A. first shot 14-Mar-2021) on 14-Mar-2021 and Pfizer (Batch no- EP7533 second shot 7-Apr-2021) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), FLECAINIDE, ATORVASTATIN, MULTIVITAMINS [VITAMINS NOS], CALCIUM and BIOTIN for an unknown indication.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Pains/aches) and CHILLS (Chills). On 10-Dec-2021, the patient experienced RASH (small break out rash in the lower back to the buttcrack area/localized rash.). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Pains/aches) and CHILLS (Chills) had resolved. At the time of the report, RASH (small break out rash in the lower back to the buttcrack area/localized rash.) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No treatment reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 031A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NALOXONE, IBUPROFEN, HYDROCHLOROTHIAZIDE and TRAMADOL for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter states it is unknown if patient experiencing any symptoms. The Number of doses/vials: 7 Doses administered from 3 vials. The vial was initially stored in the refrigerator on 07-Dec-2021, it was taken out of freezer and kept into fridge, vial did not undergo any temperature excursions.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Insomnia, Malaise, Migraine
Clinical narrative: Migraines; Severe insomnia again/Sleep difficult; Terrible side effects; Throwing up (repeatedly)/dry heaving; Nauseated, starting throwing up (repeatedly); Full-blown fever; Had the chills (no fever); No appetite since Wednesday; Began to feel achy/I was achy; Not feeling well (nauseated); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult) and DECREASED APPETITE (No appetite since Wednesday) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (2nd dose- experienced severe insomnia) and Pfizer (1st dose- experienced severe insomnia). Past adverse reactions to the above products included Insomnia with Pfizer and Pfizer.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), DECREASED APPETITE (No appetite since Wednesday) and CHILLS (Had the chills (no fever)). On 09-Dec-2021, the patient experienced MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult), VACCINATION SITE REACTION (Terrible side effects), VOMITING (Throwing up (repeatedly)/dry heaving), NAUSEA (Nauseated, starting throwing up (repeatedly)) and PYREXIA (Full-blown fever). At the time of the report, PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult), DECREASED APPETITE (No appetite since Wednesday), VACCINATION SITE REACTION (Terrible side effects), VOMITING (Throwing up (repeatedly)/dry heaving), NAUSEA (Nauseated, starting throwing up (repeatedly)), PYREXIA (Full-blown fever) and CHILLS (Had the chills (no fever)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that she had to leave work because she was not feeling well (nauseated). Patient also reported that she had terrible side effects for couple of days. She also had migraines and severe insomnia again. She had only 3 hours of sleep since Wednesday. Patient stated that first 2 does were Pfizer and she had severe insomnia after both does and it lasted for 3 months, it was debilitating, and she was really ill.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vaccination site reaction, Vomiting
Clinical narrative: Migraines; Severe insomnia again/Sleep difficult; Terrible side effects; Throwing up (repeatedly)/dry heaving; Nauseated, starting throwing up (repeatedly); Full-blown fever; Had the chills (no fever); No appetite since Wednesday; Began to feel achy/I was achy; Not feeling well (nauseated); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult) and DECREASED APPETITE (No appetite since Wednesday) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (2nd dose- experienced severe insomnia) and Pfizer (1st dose- experienced severe insomnia). Past adverse reactions to the above products included Insomnia with Pfizer and Pfizer.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), DECREASED APPETITE (No appetite since Wednesday) and CHILLS (Had the chills (no fever)). On 09-Dec-2021, the patient experienced MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult), VACCINATION SITE REACTION (Terrible side effects), VOMITING (Throwing up (repeatedly)/dry heaving), NAUSEA (Nauseated, starting throwing up (repeatedly)) and PYREXIA (Full-blown fever). At the time of the report, PAIN (Began to feel achy/I was achy), MALAISE (Not feeling well (nauseated)), MIGRAINE (Migraines), INSOMNIA (Severe insomnia again/Sleep difficult), DECREASED APPETITE (No appetite since Wednesday), VACCINATION SITE REACTION (Terrible side effects), VOMITING (Throwing up (repeatedly)/dry heaving), NAUSEA (Nauseated, starting throwing up (repeatedly)), PYREXIA (Full-blown fever) and CHILLS (Had the chills (no fever)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient stated that she had to leave work because she was not feeling well (nauseated). Patient also reported that she had terrible side effects for couple of days. She also had migraines and severe insomnia again. She had only 3 hours of sleep since Wednesday. Patient stated that first 2 does were Pfizer and she had severe insomnia after both does and it lasted for 3 months, it was debilitating, and she was really ill.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Booster dose was given instead of a first dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Booster dose was given instead of a first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Booster dose was given instead of a first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Booster dose was given instead of a first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient was given a booster dose instead of a first dose.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: I had Moderna shot and 2 boosters; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (I had Moderna shot and 2 boosters) 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 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXTRA DOSE ADMINISTERED (I had Moderna shot and 2 boosters). On 20-Sep-2021, EXTRA DOSE ADMINISTERED (I had Moderna shot and 2 boosters) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose three weeks apart from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose three weeks apart from the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose three weeks apart from the first dose). In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose three weeks apart from the first dose) had resolved.            No concomitant medication were provided. No treatment information were given.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Facial asymmetry, Vaccination complication
Clinical narrative: Sudden onset of symptoms; Sudden onset of facial asymmetry, not able to smile properly; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Sudden onset of symptoms) and FACIAL ASYMMETRY (Sudden onset of facial asymmetry, not able to smile properly) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Patient first 2 doses were Pfizer.). Past adverse reactions to the above products included No adverse event with Pfizer.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION COMPLICATION (Sudden onset of symptoms) and FACIAL ASYMMETRY (Sudden onset of facial asymmetry, not able to smile properly). At the time of the report, VACCINATION COMPLICATION (Sudden onset of symptoms) and FACIAL ASYMMETRY (Sudden onset of facial asymmetry, not able to smile properly) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.  A week after the booster shot of Moderna vaccine , she felt sudden onset of symptoms where she was not able to smile properly, she does not know if it was Bell's Palsy.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Magnetic resonance imaging
Clinical narrative: She couldn't walk without holding onto something & couldn't read or watch tv; severe dizziness so bad that she couldn't drive or do anything; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (She couldn't walk without holding onto something & couldn't read or watch tv) and DIZZINESS (severe dizziness so bad that she couldn't drive or do anything) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus and Overweight.   On 12-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced DYSKINESIA (She couldn't walk without holding onto something & couldn't read or watch tv) and DIZZINESS (severe dizziness so bad that she couldn't drive or do anything). At the time of the report, DYSKINESIA (She couldn't walk without holding onto something & couldn't read or watch tv) outcome was unknown and DIZZINESS (severe dizziness so bad that she couldn't drive or do anything) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) negative for benign positional vertigo and MS (MRI was normal).         Concomitant medication of the patient was not reported.   The patient began seeing a neurological specialist who tested her for benign positional vertigo and MS; including an MRI. The dizziness finally went away after 8 months. The events never did affect her strength.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-408514 .
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: a little sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (a little sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (a little sick). At the time of the report, ILLNESS (a little sick) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Induration, Peripheral swelling, Skin discolouration
Clinical narrative: normal activity is done, all she doing is eating and sleeping; feels wiped out; had a swollen arm; had a really bad reaction at first; have bruising,visible bruise; one time discolored the whole arm; still hard tissue about 4 inch about 2 and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first) and CONTUSION (have bruising,visible bruise) in an 83-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.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first), CONTUSION (have bruising,visible bruise), SKIN DISCOLOURATION (one time discolored the whole arm) and INDURATION (still hard tissue about 4 inch about 2 and a half inches). At the time of the report, SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first), CONTUSION (have bruising,visible bruise), SKIN DISCOLOURATION (one time discolored the whole arm) and INDURATION (still hard tissue about 4 inch about 2 and a half inches) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination complication
Clinical narrative: normal activity is done, all she doing is eating and sleeping; feels wiped out; had a swollen arm; had a really bad reaction at first; have bruising,visible bruise; one time discolored the whole arm; still hard tissue about 4 inch about 2 and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first) and CONTUSION (have bruising,visible bruise) in an 83-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.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first), CONTUSION (have bruising,visible bruise), SKIN DISCOLOURATION (one time discolored the whole arm) and INDURATION (still hard tissue about 4 inch about 2 and a half inches). At the time of the report, SOMNOLENCE (normal activity is done, all she doing is eating and sleeping), ASTHENIA (feels wiped out), PERIPHERAL SWELLING (had a swollen arm), VACCINATION COMPLICATION (had a really bad reaction at first), CONTUSION (have bruising,visible bruise), SKIN DISCOLOURATION (one time discolored the whole arm) and INDURATION (still hard tissue about 4 inch about 2 and a half inches) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel good on the evening (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel good on the evening (1st dose)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MALAISE (Did not feel good on the evening (1st dose)). At the time of the report, MALAISE (Did not feel good on the evening (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-408482 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received the first dose of the Moderna Covid19 Vaccine, and the second dose of Pfizer Covid19 vaccine as mistake; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received the first dose of the Moderna Covid19 Vaccine, and the second dose of Pfizer Covid19 vaccine as mistake) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer Covid19 vaccine (second dose). Past adverse reactions to the above products included No adverse event with Pfizer Covid19 vaccine.    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 INCORRECT DOSE ADMINISTERED (patient received the first dose of the Moderna Covid19 Vaccine, and the second dose of Pfizer Covid19 vaccine as mistake). At the time of the report, INCORRECT DOSE ADMINISTERED (patient received the first dose of the Moderna Covid19 Vaccine, and the second dose of Pfizer Covid19 vaccine as mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness finally went away after 8 months but came back after her booster; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness finally went away after 8 months but came back after her booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 004M20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus and Overweight.   On 12-Feb-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness finally went away after 8 months but came back after her booster). At the time of the report, DIZZINESS (dizziness finally went away after 8 months but came back after her booster) outcome was unknown.            No Concomitant medications provided.. No treatment medications provided.   This case was linked to MOD-2021-408505 (Patient Link).