chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling of body temperature change
Clinical narrative: burning, icy hot feeling in my arms, chest, stomach, back, neck, and head; burning like a sunburn; icy hot; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning like a sunburn), FEELING OF BODY TEMPERATURE CHANGE (icy hot) and FEELING OF BODY TEMPERATURE CHANGE (burning, icy hot feeling in my arms, chest, stomach, back, neck, and head) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.".  Concomitant products included PROPYLTHIOURACIL and Prenatal Vitamin/Multivitamin for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced BURNING SENSATION (burning like a sunburn) and FEELING OF BODY TEMPERATURE CHANGE (icy hot). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (burning, icy hot feeling in my arms, chest, stomach, back, neck, and head). The patient was treated with HYDROXYZINE HYDROCHLORIDE for Adverse event, at a dose of 1.25 mg. At the time of the report, BURNING SENSATION (burning like a sunburn), FEELING OF BODY TEMPERATURE CHANGE (icy hot) and FEELING OF BODY TEMPERATURE CHANGE (burning, icy hot feeling in my arms, chest, stomach, back, neck, and head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient is 27 weeks pregnant and received her first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is 27 weeks pregnant and received her first dose of the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Oct-2020 and the estimated date of delivery was 18-Jul-2021. On 15-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is 27 weeks pregnant and received her first dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 15-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is 27 weeks pregnant and received her first dose of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient wanting to receive second shot 45 days after first shot; 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 PRODUCT DOSE OMISSION ISSUE (patient wanting to receive second shot 45 days after first 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient wanting to receive second shot 45 days after first shot). On 04-Mar-2021, PRODUCT DOSE OMISSION ISSUE (patient wanting to receive second shot 45 days after first shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment details were provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: test positive with COVID-19 Virus; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (test positive with COVID-19 Virus) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (test positive with COVID-19 Virus). At the time of the report, SARS-COV-2 TEST POSITIVE (test positive with COVID-19 Virus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Rhinorrhoea
Clinical narrative: Runny Nose; Feels Run Down; Body Aches; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny Nose), CHILLS (Chills), FATIGUE (Feels Run Down) and MYALGIA (Body Aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Arthritis.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body Aches). On 22-Apr-2021, the patient experienced RHINORRHOEA (Runny Nose) and FATIGUE (Feels Run Down). On 11-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, RHINORRHOEA (Runny Nose), FATIGUE (Feels Run Down) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information included Advil tablets by mouth.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Muscle spasms
Clinical narrative: Bad cramps in the leg; Felt like legs are going to give out beneath her; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Bad cramps in the leg), ASTHENIA (Felt like legs are going to give out beneath her) and FATIGUE (Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes.    On 20-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 MUSCLE SPASMS (Bad cramps in the leg), ASTHENIA (Felt like legs are going to give out beneath her) and FATIGUE (Fatigue). At the time of the report, MUSCLE SPASMS (Bad cramps in the leg), ASTHENIA (Felt like legs are going to give out beneath her) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site dysaesthesia
Clinical narrative: second dose was scheduled for mora than 42 days after the first.; slight discomfort at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DYSAESTHESIA (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was scheduled for mora than 42 days after the first.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE DYSAESTHESIA (slight discomfort at the injection site). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was scheduled for mora than 42 days after the first.). On 12-Mar-2021, VACCINATION SITE DYSAESTHESIA (slight discomfort at the injection site) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was scheduled for mora than 42 days after the first.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was enquired by the reporter that since more than 42 days has passed, she should start the series again or only receive the second dose No concomitant medication reported   No treatment medication reported  The case is cross linked to MOD21-080188   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: First dose date updated
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: chills; headache that hurt so bad; body ache; fever of 100.9'F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache that hurt so bad), MYALGIA (body ache) and PYREXIA (fever of 100.9'F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Liver enlargement, Hashimoto's disease and Fibromyalgia. Concomitant products included ATORVASTATIN for Cholesterol, GABAPENTIN, MELOXICAM and LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (chills), HEADACHE (headache that hurt so bad), MYALGIA (body ache) and PYREXIA (fever of 100.9'F). At the time of the report, CHILLS (chills), HEADACHE (headache that hurt so bad), MYALGIA (body ache) and PYREXIA (fever of 100.9'F) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment products - Patient took 1 Tylenol extra strength even though she was not supposed to due to enlarged liver. Patient also stated to have bodyache and fever of 100.9'F which went down to 99.8'F 6 hours later after taking Tylenol
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: there was a big red, hot spot on the arm of the injection; red hot spot began to hurt and itch; red hot spot began to hurt and itch; headache; chills the progresses to shaking; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (there was a big red, hot spot on the arm of the injection), VACCINATION SITE PAIN (red hot spot began to hurt and itch), VACCINATION SITE PRURITUS (red hot spot began to hurt and itch), HEADACHE (headache) and CHILLS (chills the progresses to shaking) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Flu vaccination.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (there was a big red, hot spot on the arm of the injection), VACCINATION SITE PAIN (red hot spot began to hurt and itch), VACCINATION SITE PRURITUS (red hot spot began to hurt and itch), HEADACHE (headache) and CHILLS (chills the progresses to shaking). The patient was treated with IBUPROFEN for Symptomatic treatment, at a dose of 600 mg. At the time of the report, VACCINATION SITE ERYTHEMA (there was a big red, hot spot on the arm of the injection), VACCINATION SITE PAIN (red hot spot began to hurt and itch), VACCINATION SITE PRURITUS (red hot spot began to hurt and itch), HEADACHE (headache) and CHILLS (chills the progresses to shaking) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications was not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: left arm is sore; it's warm and itching; it's warm and itching; arm was swollen and red; arm was swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE WARMTH (it's warm and itching), VACCINATION SITE PRURITUS (it's warm and itching), VACCINATION SITE SWELLING (arm was swollen and red) and VACCINATION SITE ERYTHEMA (arm was swollen and red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE WARMTH (it's warm and itching), VACCINATION SITE PRURITUS (it's warm and itching), VACCINATION SITE SWELLING (arm was swollen and red) and VACCINATION SITE ERYTHEMA (arm was swollen and red). At the time of the report, PAIN IN EXTREMITY (left arm is sore), VACCINATION SITE WARMTH (it's warm and itching), VACCINATION SITE PRURITUS (it's warm and itching), VACCINATION SITE SWELLING (arm was swollen and red) and VACCINATION SITE ERYTHEMA (arm was swollen and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip is swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip is swelling) 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.    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 LIP SWELLING (Lip is swelling). At the time of the report, LIP SWELLING (Lip is swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was given.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: underage dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (underage dose) had resolved. Not Provided      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.   This case was linked to MOD21-080616 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache, Vaccination site pain
Clinical narrative: sinus headache; arm is a little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (arm is a little bit sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 22-Apr-2021, the patient experienced SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (arm is a little bit sore). At the time of the report, SINUS HEADACHE (sinus headache) and VACCINATION SITE PAIN (arm is a little bit sore) outcome was unknown. Not Provided          Patient stated, that patient did not make a report. Patient  did not have a sore arm or sinus headache No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant TCR received. Event details were updated.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Fatigue, Headache
Clinical narrative: can't wake up; Blurry vision; ear ringing; feet hurt; Pain; redness; Hardness; tired; body aches; nausea; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt) and PAIN (Pain) 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.     The patient's past medical history included No adverse event.    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 ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills). At the time of the report, ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-086085 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Tinnitus, Vaccination site induration
Clinical narrative: can't wake up; Blurry vision; ear ringing; feet hurt; Pain; redness; Hardness; tired; body aches; nausea; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt) and PAIN (Pain) 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.     The patient's past medical history included No adverse event.    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 ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills). At the time of the report, ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-086085 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: can't wake up; Blurry vision; ear ringing; feet hurt; Pain; redness; Hardness; tired; body aches; nausea; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt) and PAIN (Pain) 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.     The patient's past medical history included No adverse event.    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 ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills). At the time of the report, ASTHENIA (can't wake up), VISION BLURRED (Blurry vision), TINNITUS (ear ringing), PAIN (feet hurt), PAIN (Pain), ERYTHEMA (redness), VACCINATION SITE INDURATION (Hardness), FATIGUE (tired), MYALGIA (body aches), NAUSEA (nausea), HEADACHE (headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-086085 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Chills; Fatigued; Arm red, swollen and feverish at the injection site; Arm red, swollen and feverish at the injection site; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Arm red, swollen and feverish at the injection site), VACCINATION SITE SWELLING (Arm red, swollen and feverish at the injection site) and PYREXIA (Feverish) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigued), VACCINATION SITE ERYTHEMA (Arm red, swollen and feverish at the injection site), VACCINATION SITE SWELLING (Arm red, swollen and feverish at the injection site) and PYREXIA (Feverish). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 18-Apr-2021, CHILLS (Chills) and FATIGUE (Fatigued) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Arm red, swollen and feverish at the injection site), VACCINATION SITE SWELLING (Arm red, swollen and feverish at the injection site) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID-19 after dose 1; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (diagnosed with COVID-19 after dose 1) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced COVID-19 (diagnosed with COVID-19 after dose 1). At the time of the report, COVID-19 (diagnosed with COVID-19 after dose 1) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.Treatment medication was not provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Oxygen saturation, Pyrexia, Sluggishness, Tachycardia
Clinical narrative: heart rate shot up; was getting sluggish; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate shot up), SLUGGISHNESS (was getting sluggish) and PYREXIA (Fever) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke on 30-Mar-2021. Concurrent medical conditions included Polycythemia. Concomitant products included IBUPROFEN for Hip fracture, SIMVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN), LISINOPRIL and METOPROLOL for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TACHYCARDIA (heart rate shot up), SLUGGISHNESS (was getting sluggish) and PYREXIA (Fever). At the time of the report, TACHYCARDIA (heart rate shot up), SLUGGISHNESS (was getting sluggish) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Heart rate: (High) increased. On 21-Apr-2021, Oxygen saturation: (abnormal) oxygen level was bumping up and down.         The reporter mentioned that the patient was in ER for 12 hours. They ran every test they can to make sure he didn't have UTI that was causing the fever. The ER is attributing the fever to the shot.  Concomitant medication also included clot busters.  No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-086386, US-MODERNATX, INC.-MOD-2021-086668 (Linked Report). This case was linked to MOD-2021-086137 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086386:case for dose 1 US-MODERNATX, INC.-MOD-2021-086668:case for dose 2
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm; Night sweats worse at night; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), NIGHT SWEATS (Night sweats worse at night) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), NIGHT SWEATS (Night sweats worse at night) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in arm), NIGHT SWEATS (Night sweats worse at night) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-086114, US-MODERNATX, INC.-MOD-2021-085994, US-MODERNATX, INC.-MOD-2021-086095 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086114:Case for dose 1 US-MODERNATX, INC.-MOD-2021-085994:Case for husband US-MODERNATX, INC.-MOD-2021-086095:Case for husband
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal
Clinical narrative: diarrhea; little warning on when it is going to occur; diarrhea for over 72 hours; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FEELING ABNORMAL (little warning on when it is going to occur) and DIARRHOEA (diarrhea for over 72 hours) in a 64-year-old male patient 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 DIARRHOEA (diarrhea), FEELING ABNORMAL (little warning on when it is going to occur) and DIARRHOEA (diarrhea for over 72 hours). At the time of the report, DIARRHOEA (diarrhea), FEELING ABNORMAL (little warning on when it is going to occur) and DIARRHOEA (diarrhea for over 72 hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: upper muscles in my left arm are in intermittent spasms.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (upper muscles in my left arm are in intermittent spasms.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002CIA) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MUSCLE SPASMS (upper muscles in my left arm are in intermittent spasms.). At the time of the report, MUSCLE SPASMS (upper muscles in my left arm are in intermittent spasms.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: NNI FU - No new information provided; 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, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: About 6 family member received their 2nd dose 2 weeks after the 1st dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (About 6 family member received their 2nd dose 2 weeks after the 1st dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (About 6 family member received their 2nd dose 2 weeks after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (About 6 family member received their 2nd dose 2 weeks after the 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: vaccine administration to 17 year old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration to 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration to 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administration to 17 year old) outcome was unknown. Not Provided      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.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease since 2003 and Irritable bowel syndrome since 2003. Concomitant products included CHOLESTYRAMINE for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) had not resolved. Not Provided          Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-086242 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Live follow up received on 25-Jun-2021 date; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086242:cross linked; Dose 1
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site rash (whelp around the injection site looked like a rash), vaccination site pruritus (itchy) and vaccination site swelling (itchy and swollen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036B21A) for COVID-19 immunization. No medical history reported. On Apr 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 22, 2021, patient experienced vaccination site rash (whelp around the injection site looked like a rash), vaccination site pruritus (itchy) and vaccination site swelling (itchy and swollen). At the time of the report, vaccination site rash (whelp around the injection site looked like a rash), vaccination site pruritus (itchy) and vaccination site swelling  (itchy and swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported/provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Pyrexia
Clinical narrative: woke up with her bottom lip swollen; now both lips are swollen; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (woke up with her bottom lip swollen), LIP SWELLING (now both lips are swollen), CHILLS (chills) and PYREXIA (fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). On 22-Apr-2021, the patient experienced LIP SWELLING (woke up with her bottom lip swollen) and LIP SWELLING (now both lips are swollen). At the time of the report, LIP SWELLING (woke up with her bottom lip swollen), LIP SWELLING (now both lips are swollen), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: he has red rash at injection site of 3inch in size; he has red rash at injection site of 3inch in size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (he has red rash at injection site of 3inch in size) and VACCINATION SITE ERYTHEMA (he has red rash at injection site of 3inch in size) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chemotherapy.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE RASH (he has red rash at injection site of 3inch in size) and VACCINATION SITE ERYTHEMA (he has red rash at injection site of 3inch in size). At the time of the report, VACCINATION SITE RASH (he has red rash at injection site of 3inch in size) and VACCINATION SITE ERYTHEMA (he has red rash at injection site of 3inch in size) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dry throat, Fatigue, Full blood count, Gait disturbance
Clinical narrative: Itching under arm and neck; Deathly sick; Felt like needles in her arm and legs; Dry throat; Thirsty; Memory became horrible/"can't think of words"; Lips peeling off; Leg shake; Asthma; Sinus problem; Difficult in walk; Left arm Pain; Headache; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat) and THIRST (Thirsty) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Thyroidectomy (14 years back). Concurrent medical conditions included Asthma (On and off) and Food allergy (Sugar). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CLORAZEPATE DIPOTASSIUM (TRANXENE) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), PAIN IN EXTREMITY (Left arm Pain), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and PARAESTHESIA (Felt like needles in her arm and legs) and PAIN IN EXTREMITY (Left arm Pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Normal. On an unknown date, X-ray: Normal.     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.   Treatment: Steroids
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Lip dry, Memory impairment, Pain in extremity
Clinical narrative: Itching under arm and neck; Deathly sick; Felt like needles in her arm and legs; Dry throat; Thirsty; Memory became horrible/"can't think of words"; Lips peeling off; Leg shake; Asthma; Sinus problem; Difficult in walk; Left arm Pain; Headache; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat) and THIRST (Thirsty) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Thyroidectomy (14 years back). Concurrent medical conditions included Asthma (On and off) and Food allergy (Sugar). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CLORAZEPATE DIPOTASSIUM (TRANXENE) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), PAIN IN EXTREMITY (Left arm Pain), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and PARAESTHESIA (Felt like needles in her arm and legs) and PAIN IN EXTREMITY (Left arm Pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Normal. On an unknown date, X-ray: Normal.     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.   Treatment: Steroids