chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm  soreness; Fever; Chills; Headache; Nausea; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (Left arm  soreness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Pruritus, Rash, Somnolence
Clinical narrative: tired all day; itchy; About 4 min high, and a couple of inches across; pulse was high; I was very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I was very sleepy), PRURITUS (itchy), RASH (About 4 min high, and a couple of inches across), HEART RATE INCREASED (pulse was high) and FATIGUE (tired all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included CALCIUM for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced SOMNOLENCE (I was very sleepy). On 03-Mar-2021, the patient experienced PRURITUS (itchy), RASH (About 4 min high, and a couple of inches across) and HEART RATE INCREASED (pulse was high). On 05-Mar-2021, the patient experienced FATIGUE (tired all day). On 02-Mar-2021, SOMNOLENCE (I was very sleepy) had resolved. On 07-Mar-2021, FATIGUE (tired all day) had resolved. At the time of the report, PRURITUS (itchy) outcome was unknown, RASH (About 4 min high, and a couple of inches across) was resolving and HEART RATE INCREASED (pulse was high) had resolved.            Concomitant medications also included vitamins. Treatment details included Antihistamine pill the first night of the rash.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow-up received-New events are added.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in the armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Swelling in the armpit). At the time of the report, LYMPHADENOPATHY (Swelling in the armpit) had not resolved.     No concomitant medications were reported.  Treatment details was not provided.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: proportion of the dose administered could be estimated as about half; vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (proportion of the dose administered could be estimated as about half) and DEVICE CONNECTION ISSUE (vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030L30A) for COVID-19 vaccination.     Concurrent medical conditions included GERD (No Historical Condition reported) since 01-Jan-2016. Concomitant products included OMEPRAZOLE from 01-Jan-2016 to an unknown date for GERD.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced UNDERDOSE (proportion of the dose administered could be estimated as about half) and DEVICE CONNECTION ISSUE (vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing). On 17-Mar-2021, UNDERDOSE (proportion of the dose administered could be estimated as about half) and DEVICE CONNECTION ISSUE (vaccine flowed 3 or 4 inches quickly down my arm and the over the finger holding my clothing) had resolved.            Patient stated she was 70 years old with no comorbidities.  Patient reported no allergies.  Patient stated the second vaccination dose was administered by a non-medical staff (office manager).  There was no physician at the vaccination site; however, a nurse practitioner who was in charge "did not know if it was a problem or not but, either way, another shot was impossible because I would go into shock."    Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up included patient age, weight, height, medical history and  concomitant medication information added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Exposure during pregnancy, Glucose tolerance test, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of Vaccine exposure during pregnancy in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional), Nicotine abuse in 2017, Childhood asthma, Eosinophilia, and Pregnancy on 09-Oct-2018. Concurrent medical conditions included Acid reflux. Concomitant products included FAMOTIDINE for Acid reflux, PRENATAL VITAMINS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced Vaccine exposure during pregnancy. On 30-Dec-2020, Vaccine exposure during pregnancy had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2020, Pregnancy test: positive. On an unknown date, Amniocentesis: normal. On an unknown date, Glucose tolerance test: normal. On an unknown date, Ultrasound scan: normal.         The date of positive pregnancy test was 28-Jul-2020. The patient has an established prenatal care. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Internal review on 28-Jul-2021 resulted in updates to the pregnancy information.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Dizziness, Feeling cold
Clinical narrative: out came breakfast out of both ends; every part of body ached from head to toe; dizzy; horrible horrible pain; freezing, could not get warm; fingers red and swollen; feverish; fever for a few hours; out came breakfast out of both ends; kept vomitting; shivering like crazy; left arm was hurting so bad; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain) and FEELING COLD (freezing, could not get warm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Mar-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain), FEELING COLD (freezing, could not get warm), PERIPHERAL SWELLING (fingers red and swollen), PYREXIA (feverish), PYREXIA (fever for a few hours), VOMITING (out came breakfast out of both ends), VOMITING (kept vomitting), CHILLS (shivering like crazy) and INJECTION SITE PAIN (left arm was hurting so bad). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain), FEELING COLD (freezing, could not get warm), PERIPHERAL SWELLING (fingers red and swollen), PYREXIA (feverish), PYREXIA (fever for a few hours), VOMITING (out came breakfast out of both ends), VOMITING (kept vomitting), CHILLS (shivering like crazy) and INJECTION SITE PAIN (left arm was hurting so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: high (High) High 101.7 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: out came breakfast out of both ends; every part of body ached from head to toe; dizzy; horrible horrible pain; freezing, could not get warm; fingers red and swollen; feverish; fever for a few hours; out came breakfast out of both ends; kept vomitting; shivering like crazy; left arm was hurting so bad; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain) and FEELING COLD (freezing, could not get warm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Mar-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain), FEELING COLD (freezing, could not get warm), PERIPHERAL SWELLING (fingers red and swollen), PYREXIA (feverish), PYREXIA (fever for a few hours), VOMITING (out came breakfast out of both ends), VOMITING (kept vomitting), CHILLS (shivering like crazy) and INJECTION SITE PAIN (left arm was hurting so bad). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DIARRHOEA (out came breakfast out of both ends), PAIN (every part of body ached from head to toe), DIZZINESS (dizzy), PAIN (horrible horrible pain), FEELING COLD (freezing, could not get warm), PERIPHERAL SWELLING (fingers red and swollen), PYREXIA (feverish), PYREXIA (fever for a few hours), VOMITING (out came breakfast out of both ends), VOMITING (kept vomitting), CHILLS (shivering like crazy) and INJECTION SITE PAIN (left arm was hurting so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: high (High) High 101.7 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site area is very itchy; Nausea; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE PRURITUS (Injection site area is very itchy) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Dairy intolerance, Egg allergy, Allergy to grains (Wheat), Food allergy (beef,xanthan gums, guar gums (thickeners)), Anesthesia general, Allergy to antibiotic (Levaquin), Drug allergy (all aspirin family), Drug allergy (Valtrex), Drug allergy (Lamisil), Drug allergy (Mortin), Drug allergy (Advil), Drug allergy (Vanceril), Drug allergy (Xloft) and Drug allergy (Prednizone). Concomitant products included BETA CAROTENE, BIOTIN, UBIDECARENONE (COQ10 [UBIDECARENONE]), GLUCOSAMINE & CHONDORITIN, MULTIVITAMIN [VITAMINS NOS], LUTEIN [XANTOFYL], VITAMIN B12 [VITAMIN B12 NOS], ASCORBIC ACID (VIT-C), VITAMIN D3 and VITAMIN E NOS for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm) and NAUSEA (Nausea). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site area is very itchy). At the time of the report, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE PRURITUS (Injection site area is very itchy) and NAUSEA (Nausea) had resolved.            Other concomitant medication included blilberry.  No treatment was received by patient.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non significant follow-up information received on  24-May-2021 contains reporters address and email ID On 04-Aug-2021: Patient demographics added, allergies updated. Suspect dose information, event outcome  and Concomitants updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Sensitive skin, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: It's warm and red; Not majorly sore but I'm starting to feel something again that I haven't felt; Feeling itchy in that spot (at injection site); After scratching, area is red and it's been getting bigger; Arm got a little sore and sensitive to touch; Arm got a little sore and sensitive to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch), SENSITIVE SKIN (Arm got a little sore and sensitive to touch), VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt) and VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch) and SENSITIVE SKIN (Arm got a little sore and sensitive to touch). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt), VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) and VACCINATION SITE ERYTHEMA (After scratching, area is red and it's been getting bigger). On 10-Mar-2021, PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch) and SENSITIVE SKIN (Arm got a little sore and sensitive to touch) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt), VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) and VACCINATION SITE ERYTHEMA (After scratching, area is red and it's been getting bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: It's warm and red; Not majorly sore but I'm starting to feel something again that I haven't felt; Feeling itchy in that spot (at injection site); After scratching, area is red and it's been getting bigger; Arm got a little sore and sensitive to touch; Arm got a little sore and sensitive to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch), SENSITIVE SKIN (Arm got a little sore and sensitive to touch), VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt) and VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch) and SENSITIVE SKIN (Arm got a little sore and sensitive to touch). On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt), VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) and VACCINATION SITE ERYTHEMA (After scratching, area is red and it's been getting bigger). On 10-Mar-2021, PAIN IN EXTREMITY (Arm got a little sore and sensitive to touch) and SENSITIVE SKIN (Arm got a little sore and sensitive to touch) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's warm and red), MALAISE (Not majorly sore but I'm starting to feel something again that I haven't felt), VACCINATION SITE PRURITUS (Feeling itchy in that spot (at injection site)) and VACCINATION SITE ERYTHEMA (After scratching, area is red and it's been getting bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Stiff neck from chin bone to shoulder; Tenderness where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck from chin bone to shoulder) and VACCINATION SITE PAIN (Tenderness where she got the shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck from chin bone to shoulder) and VACCINATION SITE PAIN (Tenderness where she got the shot). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck from chin bone to shoulder) and VACCINATION SITE PAIN (Tenderness where she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Pain in the arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and RASH (Rash) 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.  Treatment information was not provided.   This case was linked to MOD-2021-049631 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Body temperature, Dizziness, Feeling abnormal, Malaise
Clinical narrative: adverse reaction to Moderna vaccine; felt very heavy; felt very dizzy; Covid arm for 2 days; feel light headed even when I was in shower; felt ill for about a week; fever was 102degF; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days) and DIZZINESS (feel light headed even when I was in shower) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days), DIZZINESS (feel light headed even when I was in shower), MALAISE (felt ill for about a week) and PYREXIA (fever was 102degF). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days), DIZZINESS (feel light headed even when I was in shower), MALAISE (felt ill for about a week) and PYREXIA (fever was 102degF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Lots of fluid and Gatorade   This case was linked to US-MODERNATX, INC.-MOD-2021-049707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049707:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site reaction
Clinical narrative: adverse reaction to Moderna vaccine; felt very heavy; felt very dizzy; Covid arm for 2 days; feel light headed even when I was in shower; felt ill for about a week; fever was 102degF; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days) and DIZZINESS (feel light headed even when I was in shower) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days), DIZZINESS (feel light headed even when I was in shower), MALAISE (felt ill for about a week) and PYREXIA (fever was 102degF). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ADVERSE DRUG REACTION (adverse reaction to Moderna vaccine), FEELING ABNORMAL (felt very heavy), DIZZINESS (felt very dizzy), VACCINATION SITE REACTION (Covid arm for 2 days), DIZZINESS (feel light headed even when I was in shower), MALAISE (felt ill for about a week) and PYREXIA (fever was 102degF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Lots of fluid and Gatorade   This case was linked to US-MODERNATX, INC.-MOD-2021-049707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049707:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Myalgia, Pyrexia
Clinical narrative: warm; fever 101.5; fatigue; achiness all over the body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warm), PYREXIA (fever 101.5), FATIGUE (fatigue) and MYALGIA (achiness all over the body) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING HOT (warm), PYREXIA (fever 101.5), FATIGUE (fatigue) and MYALGIA (achiness all over the body). At the time of the report, FEELING HOT (warm), PYREXIA (fever 101.5), FATIGUE (fatigue) and MYALGIA (achiness all over the body) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness
Clinical narrative: Diarrhea; Dizziness; weakness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (weakness) and DIARRHOEA (Diarrhea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included AMLODIPINE for Blood pressure high, ATORVASTATIN for Cholesterol, IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (weakness). On 12-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (weakness) outcome was unknown and DIARRHOEA (Diarrhea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated he takes Advil when he has a headache and drinks lots of water.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: Itching at the injection site that seems to worsen during the night time; Intense arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense arm pain) and VACCINATION SITE PRURITUS (Itching at the injection site that seems to worsen during the night time) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) 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 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Intense arm pain). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site that seems to worsen during the night time). At the time of the report, PAIN IN EXTREMITY (Intense arm pain) and VACCINATION SITE PRURITUS (Itching at the injection site that seems to worsen during the night time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Myalgia, Pain in extremity
Clinical narrative: Pain in the arm; lost taste; Starting to get rash again; High fever - 102 F; Body aches; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), AGEUSIA (lost taste), RASH (Starting to get rash again), PYREXIA (High fever - 102 F) and MYALGIA (Body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced AGEUSIA (lost taste), RASH (Starting to get rash again), PYREXIA (High fever - 102 F), MYALGIA (Body aches) and CHILLS (Chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), AGEUSIA (lost taste), RASH (Starting to get rash again), PYREXIA (High fever - 102 F), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 102 High.         No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-049606.   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Pain in the arm; lost taste; Starting to get rash again; High fever - 102 F; Body aches; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), AGEUSIA (lost taste), RASH (Starting to get rash again), PYREXIA (High fever - 102 F) and MYALGIA (Body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced AGEUSIA (lost taste), RASH (Starting to get rash again), PYREXIA (High fever - 102 F), MYALGIA (Body aches) and CHILLS (Chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), AGEUSIA (lost taste), RASH (Starting to get rash again), PYREXIA (High fever - 102 F), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 102 High.         No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-049606.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain
Clinical narrative: weakness; like when you're really hungry and your stomach growls a little bit, that's what's happening in their chest; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and CHEST PAIN (like when you're really hungry and your stomach growls a little bit, that's what's happening in their chest) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced CHEST PAIN (like when you're really hungry and your stomach growls a little bit, that's what's happening in their chest). On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, ASTHENIA (weakness) and CHEST PAIN (like when you're really hungry and your stomach growls a little bit, that's what's happening in their chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information as not reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Pain, Rhinorrhoea, Throat irritation
Clinical narrative: Cold-like symptoms; Runny nose; A little bit of a scratchy, itchy throat; Cough; A little bit of soreness; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (Runny nose), THROAT IRRITATION (A little bit of a scratchy, itchy throat), COUGH (Cough) and PAIN (A little bit of soreness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (A little bit of soreness). On 15-Mar-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (Runny nose) and THROAT IRRITATION (A little bit of a scratchy, itchy throat). At the time of the report, NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (Runny nose) and THROAT IRRITATION (A little bit of a scratchy, itchy throat) outcome was unknown, COUGH (Cough) had not resolved and PAIN (A little bit of soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details not provided.  The patient had experienced a little bit of a scratchy, itchy throat, then drainage and then it developed into a cough.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-049659 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, Rash
Clinical narrative: She was sweating like crazy; Fever; Chills; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (She was sweating like crazy), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rash). On 29-Jan-2021, the patient experienced HYPERHIDROSIS (She was sweating like crazy), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (She was sweating like crazy), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This case was linked to MOD-2021-015178 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling jittery, Presyncope, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Felt like I was going to pass out; Jittery; Warm to the touch injection site; Itchy; Red,5-6 cm in size; Pain at site/very very sore to touch only; A spontaneous report was received from other healthcare professional  concerning a 51-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at site/ vaccination site pain, itchy/ vaccination site pruritus, painful/ pain and hot/ vaccination site warmth, red, 5-6 cm in size/ vaccination site erythema, very very sore to touch only, felt like was going to pass out/ loss of consciousness and jittery/ feeling jittery.  The patient's medical history included hypothyroidism.  Concomitant product use was not provided by the reporter.   On 11 Mar 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 002A21A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, patient experienced pain at site, itchy, painful and hot, red, 5-6 cm in size, sore to touch. On 12 Mar 2021, patient felt like was going to pass out a medically significant event and jittery. Treatment details included arnaca cream and neosporin applied to location.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events felt like was going to pass out and jittery was resolved on 13 Mar 2021. The outcome of the events pain at site, itchy, painful and hot, red, 5-6 cm in size, sore to touch was not reported.; Reporter'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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Felt like I was going to pass out; Jittery; Warm to the touch injection site; Itchy; Red,5-6 cm in size; Pain at site/very very sore to touch only; A spontaneous report was received from other healthcare professional  concerning a 51-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at site/ vaccination site pain, itchy/ vaccination site pruritus, painful/ pain and hot/ vaccination site warmth, red, 5-6 cm in size/ vaccination site erythema, very very sore to touch only, felt like was going to pass out/ loss of consciousness and jittery/ feeling jittery.  The patient's medical history included hypothyroidism.  Concomitant product use was not provided by the reporter.   On 11 Mar 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 002A21A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, patient experienced pain at site, itchy, painful and hot, red, 5-6 cm in size, sore to touch. On 12 Mar 2021, patient felt like was going to pass out a medically significant event and jittery. Treatment details included arnaca cream and neosporin applied to location.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events felt like was going to pass out and jittery was resolved on 13 Mar 2021. The outcome of the events pain at site, itchy, painful and hot, red, 5-6 cm in size, sore to touch was not reported.; Reporter'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.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received the COVID-19 vaccine on March 18 following a temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received the COVID-19 vaccine on March 18 following a temperature excursion) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received the COVID-19 vaccine on March 18 following a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received the COVID-19 vaccine on March 18 following a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medications were reported. No treatment related information has been reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 Disease 5-7 days after first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 Disease 5-7 days after first vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Disease 5-7 days after first vaccine). At the time of the report, COVID-19 (COVID-19 Disease 5-7 days after first vaccine) 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in their leg; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in their leg) 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 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 PARAESTHESIA (tingling in their leg). At the time of the report, PARAESTHESIA (tingling in their leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.