chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Inappropriate schedule of product administration, Limb discomfort, Nervousness
Clinical narrative: shaky; my arm is very sore; off label use; Inappropriate schedule of vaccine administered; chills; fever of 100.4 degrees Fahrenheit; extreme pain from mid-elbow to wrist; cannot lift arm beyond 45 degrees; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore) and OFF LABEL USE (off label use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021F21A, 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APREMILAST (OTEZLA) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced LIMB DISCOMFORT (cannot lift arm beyond 45 degrees). On 29-Aug-2021, the patient experienced PAIN (extreme pain from mid-elbow to wrist). On 30-Aug-2021, the patient experienced PYREXIA (fever of 100.4 degrees Fahrenheit). On an unknown date, the patient experienced NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), OFF LABEL USE (off label use), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (chills). At the time of the report, LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), CHILLS (chills) and PYREXIA (fever of 100.4 degrees Fahrenheit) outcome was unknown and OFF LABEL USE (off label use) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Body temperature: 100.4 °F (abnormal) 100.4.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow-up received on 30-AUG-2021 : Updated events
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pyrexia, Vaccination site pain
Clinical narrative: shaky; my arm is very sore; off label use; Inappropriate schedule of vaccine administered; chills; fever of 100.4 degrees Fahrenheit; extreme pain from mid-elbow to wrist; cannot lift arm beyond 45 degrees; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore) and OFF LABEL USE (off label use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021F21A, 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APREMILAST (OTEZLA) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced LIMB DISCOMFORT (cannot lift arm beyond 45 degrees). On 29-Aug-2021, the patient experienced PAIN (extreme pain from mid-elbow to wrist). On 30-Aug-2021, the patient experienced PYREXIA (fever of 100.4 degrees Fahrenheit). On an unknown date, the patient experienced NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), OFF LABEL USE (off label use), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (chills). At the time of the report, LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), CHILLS (chills) and PYREXIA (fever of 100.4 degrees Fahrenheit) outcome was unknown and OFF LABEL USE (off label use) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Body temperature: 100.4 °F (abnormal) 100.4.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow-up received on 30-AUG-2021 : Updated events
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Eye pain, Headache, Illness, Migraine
Clinical narrative: very sick; most of my eye pain is on the side that I got the injection; ear infection; migraine; high fevers; pretty bad headache, back of my head hurt; nausea; my head was about to blow up; I was so nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine) and HEADACHE (my head was about to blow up) in a 64-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 Immunocompromised. Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced HEADACHE (my head was about to blow up) and NAUSEA (I was so nauseated ). On an unknown date, the patient experienced ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine), PYREXIA (high fevers), HEADACHE (pretty bad headache, back of my head hurt) and NAUSEA (nausea). At the time of the report, ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine), HEADACHE (my head was about to blow up), NAUSEA (I was so nauseated ), PYREXIA (high fevers), HEADACHE (pretty bad headache, back of my head hurt) and NAUSEA (nausea) outcome was unknown.            No Treatment medication was provided. Patient did not have joint pain other than ear and her head.  She also reported, Saturday being her worst day. Patient was using a biologic medication at the time of getting the third dose of Moderna COVID19 Vaccine and kept it on hold since then.   This case was linked to MOD-2021-303370, MOD-2021-303360 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: very sick; most of my eye pain is on the side that I got the injection; ear infection; migraine; high fevers; pretty bad headache, back of my head hurt; nausea; my head was about to blow up; I was so nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine) and HEADACHE (my head was about to blow up) in a 64-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 Immunocompromised. Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced HEADACHE (my head was about to blow up) and NAUSEA (I was so nauseated ). On an unknown date, the patient experienced ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine), PYREXIA (high fevers), HEADACHE (pretty bad headache, back of my head hurt) and NAUSEA (nausea). At the time of the report, ILLNESS (very sick), EYE PAIN (most of my eye pain is on the side that I got the injection), EAR INFECTION (ear infection), MIGRAINE (migraine), HEADACHE (my head was about to blow up), NAUSEA (I was so nauseated ), PYREXIA (high fevers), HEADACHE (pretty bad headache, back of my head hurt) and NAUSEA (nausea) outcome was unknown.            No Treatment medication was provided. Patient did not have joint pain other than ear and her head.  She also reported, Saturday being her worst day. Patient was using a biologic medication at the time of getting the third dose of Moderna COVID19 Vaccine and kept it on hold since then.   This case was linked to MOD-2021-303370, MOD-2021-303360 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine). On 25-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm was sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore for 3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm was sore for 3 days). At the time of the report, MYALGIA (Arm was sore for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Urinary tract infection
Clinical narrative: urinary tract infection; Fever; syncopal episode; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (syncopal episode) in a female patient of an unknown age 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 COVID-19 (I did get exposed to COVID on Monday and Tuesday, and I didn't realize until Wednesday night).    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced SYNCOPE (syncopal episode) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY TRACT INFECTION (urinary tract infection) and PYREXIA (Fever). At the time of the report, SYNCOPE (syncopal episode) and URINARY TRACT INFECTION (urinary tract infection) outcome was unknown and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       it was reported that patient went to the emergency room on Monday 30-Aug-21. patient states that a Covid test was performed but patient has not yet received the results as it was a "send out" test.  No concomitant medication details were provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event of urinary tract infection is assessed as unlikely related to mRNA-1273. No treatment information was mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: follow-up received on 01-SEP-2021, significant information received, new events added, outcome of event updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event of urinary tract infection is assessed as unlikely related to mRNA-1273.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Three female 17 year old  college students vaccinated with Moderna Vaccine first vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not reported.  Three 17 year old college students were vaccinated with Moderna vaccine. It was the first vaccine.  Vaccine given right arm upper deltoid muscle for each patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: No new information- reporter confirmed no more information was available for this case.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Depressed mood, Feeling abnormal, Headache
Clinical narrative: slight runny nose; feel little down for about 3 or 4 days; not feeling good; head ache; chills; 99.1°F fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (slight runny nose), DEPRESSED MOOD (feel little down for about 3 or 4 days), FEELING ABNORMAL (not feeling good), HEADACHE (head ache) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004621A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (slight runny nose), DEPRESSED MOOD (feel little down for about 3 or 4 days), FEELING ABNORMAL (not feeling good), HEADACHE (head ache), CHILLS (chills) and PYREXIA (99.1°F fever). At the time of the report, RHINORRHOEA (slight runny nose), DEPRESSED MOOD (feel little down for about 3 or 4 days), FEELING ABNORMAL (not feeling good), HEADACHE (head ache), CHILLS (chills) and PYREXIA (99.1°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (High) 99.1°F fever.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: slight runny nose; feel little down for about 3 or 4 days; not feeling good; head ache; chills; 99.1°F fever; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (slight runny nose), DEPRESSED MOOD (feel little down for about 3 or 4 days), FEELING ABNORMAL (not feeling good), HEADACHE (head ache) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004621A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (slight runny nose), DEPRESSED MOOD (feel little down for about 3 or 4 days), FEELING ABNORMAL (not feeling good), HEADACHE (head ache), CHILLS (chills) and PYREXIA (99.1°F fever). At the time of the report, RHINORRHOEA (slight runny nose), DEPRESSED MOOD (feel little down for about 3 or 4 days), FEELING ABNORMAL (not feeling good), HEADACHE (head ache), CHILLS (chills) and PYREXIA (99.1°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (High) 99.1°F fever.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: started to experience itching around 12:00 AM that evening; red rash from the point of injection to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Immunocompromised.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow) outcome was unknown.            The patient received her 3rd dose around 4:00 PM, she then started to experience itching around 12:00 AM that evening. The next morning she had a red rash extending from the injection site to her elbow  No Concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received on 01-SEP-2021 and does not contain any new information On 01-Sep-2021: TCR received on 01-SEP-2021 and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID/ Felt very sick; Lack of drug effect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Breakthrough COVID/ Felt very sick) and DRUG INEFFECTIVE (Lack of drug effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Adrenal insufficiency (Adrenal fatigue with a very low cortisol level).   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Breakthrough COVID/ Felt very sick) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Breakthrough COVID/ Felt very sick) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment drugs were not provided. The patient's age was estimated to be 45 years.  On an unknown date, about a month ago, the patient experienced breakthrough COVID and felt very sick. The patient want to get a third or booster dose of the vaccine.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Drug Ineffective mRNA-1273, lot # unknown  with COVID-19 as associated AE. Based on the available information and based on the infectious nature of the condition, the event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: grater than 35 days between Moderna Covid-19 vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (grater than 35 days between Moderna Covid-19 vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX in 2021.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (grater than 35 days between Moderna Covid-19 vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (grater than 35 days between Moderna Covid-19 vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Minimal amount of left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minimal amount of left arm soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Psoriatic arthritis. Concomitant products included CERTOLIZUMAB PEGOL (CIMZIA) for Psoriatic arthritis.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Minimal amount of left arm soreness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Minimal amount of left arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 antibody test: negative (Negative) Negative test results for COVID antibodies 6 weeks after having 2nd dose..   The patient was taking quite a few concomitant medications but did not list them out.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021 at 10:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose). On 28-Aug-2021, EXPIRED PRODUCT ADMINISTERED (gave a patient his 3rd Moderna Covid-19 Vaccine dose on 28 Aug2021 from a vial with an expiration date of 26Aug2021/Expired Vaccine dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was provided.  No Treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Patient weight, race and ethnicity was updated. information about rout of administration and anatomical location was updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Metamorphopsia, Visual impairment
Clinical narrative: Distorted vision; felt like she was looking through glass,every time she moved it would trigger it again; headaches; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Distorted vision), VISUAL IMPAIRMENT (felt like she was looking through glass,every time she moved it would trigger it again) and HEADACHE (headaches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-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 METAMORPHOPSIA (Distorted vision), VISUAL IMPAIRMENT (felt like she was looking through glass,every time she moved it would trigger it again) and HEADACHE (headaches). At the time of the report, METAMORPHOPSIA (Distorted vision), VISUAL IMPAIRMENT (felt like she was looking through glass,every time she moved it would trigger it again) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported by reporter Treatment information was not provided by reporter
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: a little bit of swelling on her bottom lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (a little bit of swelling on her bottom lip) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 016M20A and 088B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (She states that she's a highly allergic person.). Concomitant products included FAMOTIDINE, MONTELUKAST SODIUM (SINGULAIR) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY NIGHTTIME) for Allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-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 LIP SWELLING (a little bit of swelling on her bottom lip). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10-20mg , qd; DEXAMETHASONE (oral) at an unspecified dose and frequency and FAMOTIDINE (oral) at a dose of 40 mg. At the time of the report, LIP SWELLING (a little bit of swelling on her bottom lip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-302461 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Non significant follow-up received on 3 sep 2021 include no new information. On 09-Sep-2021: Non significant follow up received on o9 SEP 2021 contains no new information
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Coronavirus infection, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Contracted coronavirus 2 weeks ago; felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away; first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of CORONAVIRUS INFECTION (Contracted coronavirus 2 weeks ago), INTERCHANGE OF VACCINE PRODUCTS (first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine) and CHILLS (felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine). On an unknown date, the patient experienced CORONAVIRUS INFECTION (Contracted coronavirus 2 weeks ago) and CHILLS (felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away). On 30-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose of the Moderna COVID-19 vaccine second dose patient received Pfizer vaccine) had resolved. At the time of the report, CORONAVIRUS INFECTION (Contracted coronavirus 2 weeks ago) outcome was unknown and CHILLS (felt like he fell in big tub of ice/ chills for 5-10 mins/ chills came out of nowhere, went fast away) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) Covid-19 Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant Follow-up Received on 01-Sept-2021. Co-suspect Pfizer was added. Two Events- Corona Virus infection and Chills were added.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have had friends and family that had " nasty" side effects from the second shot .; 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 (I have had friends and family that had " nasty" side effects from the second shot .) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 VACCINATION COMPLICATION (I have had friends and family that had " nasty" side effects from the second shot .). At the time of the report, VACCINATION COMPLICATION (I have had friends and family that had " nasty" side effects from the second shot .) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment product information was not provided.  Concomitant product use was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Neoplasm
Clinical narrative: lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.; This spontaneous case was reported by an other health care professional and describes the occurrence of NEOPLASM (lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced NEOPLASM (lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.). The patient was treated with Surgery for Neoplasm. At the time of the report, NEOPLASM (lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: abnormal (abnormal) showed it was not a cyst.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was stated that a few days before 26-Aug-2021 patient noticed a lump. The patient went to an urgent care who said they were not sure what this lump was and to keep an eye on it. patient saw an ENT for this lump. The lump was removed and sent to a pathologist, who forwarded it to a specialist. They have not been able to identify the type of tumor.  The patient was a very healthy athlete and has not had any issues like this in the past. He has not taken any medications or treatments.  Concomitant medications was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Headache, Myalgia, Pyrexia
Clinical narrative: Acky Bones; temperature of 103.4; body ackes; mass headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Acky Bones), PYREXIA (temperature of 103.4), MYALGIA (body ackes) and HEADACHE (mass headache) 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 BONE PAIN (Acky Bones), PYREXIA (temperature of 103.4), MYALGIA (body ackes) and HEADACHE (mass headache). At the time of the report, BONE PAIN (Acky Bones), PYREXIA (temperature of 103.4), MYALGIA (body ackes) and HEADACHE (mass headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.4 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.  The patient also stated he/she Felt like got run over by a Truck.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: follow up received contains significant information-Event added like Acky Bones. On 02-Sep-2021: Follow-up received contains NNI
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: Weakness; Mild fever after second dose; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PYREXIA (Mild fever after second dose) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PYREXIA (Mild fever after second dose) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weakness), PYREXIA (Mild fever after second dose) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: permanent a-fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (permanent a-fib) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cardiac ablation (in 2015).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (permanent a-fib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (permanent a-fib) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Electrocardiogram: permanent a-fib (abnormal) permanent a-fib.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  The patient had medical history of an ablation in 2015. Then he had no more a-fib until the second Moderna vaccine. On 05-Feb-2021, his heart started to dance around in his chest. It would go very slow, then it would take off like a motor boat and go extremely fast. It took him about 4 hours of different techniques to get this under control. His cardiologist took an EKG in Jul-2021 and said you're in permanent a-fib. They did a cardioversion a couple of weeks ago.  The patient reports having a cardioversion in Aug-2021.  No treatment medication details was reported.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event (atrial fibrillation), a causal relationship cannot be excluded. However, as per the reported information, the medical history of ablation (probably indicates pre-existing atrial fibrillation in this patient) and is a confounder for the occurrence of the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (atrial fibrillation), a causal relationship cannot be excluded. However, as per the reported information, the medical history of ablation (probably indicates pre-existing atrial fibrillation in this patient) and is a confounder for the occurrence of the event.
Sex: U
Vaccine: COVID19
Symptoms: Agitation
Clinical narrative: Agitation after both doses of the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of AGITATION (Agitation after both doses of the Moderna COVID-19 vaccine) in an elderly 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGITATION (Agitation after both doses of the Moderna COVID-19 vaccine). At the time of the report, AGITATION (Agitation after both doses of the Moderna COVID-19 vaccine) outcome was unknown.        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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given 2nd dose of Moderna 17 hours after vial was opened; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given 2nd dose of Moderna 17 hours after vial was opened) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, LOSARTAN and TRAZODONE for an unknown indication.    On 31-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given 2nd dose of Moderna 17 hours after vial was opened). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given 2nd dose of Moderna 17 hours after vial was opened) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has not reported any adverse events so far.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Hypersensitivity, Lymphadenopathy, Pharyngeal swelling
Clinical narrative: Throat swelled; An allergic Reaction; Red arm; Hot to touch; Chickenpox scares became inflamed  and red; Rash all over body; Injection site swelled; Lymph nodes in the neck also swelled; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL SWELLING (Throat swelled), HYPERSENSITIVITY (An allergic Reaction), ERYTHEMA (Red arm), BURNING SENSATION (Hot to touch) and VARICELLA (Chickenpox scares became inflamed  and red) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelled), HYPERSENSITIVITY (An allergic Reaction), ERYTHEMA (Red arm), BURNING SENSATION (Hot to touch), VARICELLA (Chickenpox scares became inflamed  and red), RASH (Rash all over body), VACCINATION SITE SWELLING (Injection site swelled), LYMPHADENOPATHY (Lymph nodes in the neck also swelled) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Throat swelled), HYPERSENSITIVITY (An allergic Reaction), ERYTHEMA (Red arm), BURNING SENSATION (Hot to touch), VARICELLA (Chickenpox scares became inflamed  and red), RASH (Rash all over body), VACCINATION SITE SWELLING (Injection site swelled), LYMPHADENOPATHY (Lymph nodes in the neck also swelled) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment also included prescribed steroids. Reporter stated that patient currently taking other medications.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site swelling, Varicella
Clinical narrative: Throat swelled; An allergic Reaction; Red arm; Hot to touch; Chickenpox scares became inflamed  and red; Rash all over body; Injection site swelled; Lymph nodes in the neck also swelled; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL SWELLING (Throat swelled), HYPERSENSITIVITY (An allergic Reaction), ERYTHEMA (Red arm), BURNING SENSATION (Hot to touch) and VARICELLA (Chickenpox scares became inflamed  and red) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelled), HYPERSENSITIVITY (An allergic Reaction), ERYTHEMA (Red arm), BURNING SENSATION (Hot to touch), VARICELLA (Chickenpox scares became inflamed  and red), RASH (Rash all over body), VACCINATION SITE SWELLING (Injection site swelled), LYMPHADENOPATHY (Lymph nodes in the neck also swelled) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Throat swelled), HYPERSENSITIVITY (An allergic Reaction), ERYTHEMA (Red arm), BURNING SENSATION (Hot to touch), VARICELLA (Chickenpox scares became inflamed  and red), RASH (Rash all over body), VACCINATION SITE SWELLING (Injection site swelled), LYMPHADENOPATHY (Lymph nodes in the neck also swelled) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment also included prescribed steroids. Reporter stated that patient currently taking other medications.