chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Erythema, Feeling hot, Pain in extremity, Urticaria
Clinical narrative: broke out in hives all over her body; Warm; injection site was itchy; arm was red; arm was sore; felt like she had a bug bite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ARTHROPOD BITE (felt like she had a bug bite), URTICARIA (broke out in hives all over her body), FEELING HOT (Warm) and VACCINATION SITE PRURITUS (injection site was itchy) in a 77-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 reported medical history.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN CALCIUM (LIPITOR) and DENOSUMAB (PROLIA) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ARTHROPOD BITE (felt like she had a bug bite), FEELING HOT (Warm), VACCINATION SITE PRURITUS (injection site was itchy) and ERYTHEMA (arm was red). On 02-Feb-2021, the patient experienced URTICARIA (broke out in hives all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL CHILDRENS) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PRURITUS (injection site was itchy) and ERYTHEMA (arm was red) had resolved, ARTHROPOD BITE (felt like she had a bug bite) and FEELING HOT (Warm) outcome was unknown and URTICARIA (broke out in hives all over her body) had not resolved. Not Provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: broke out in hives all over her body; Warm; injection site was itchy; arm was red; arm was sore; felt like she had a bug bite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ARTHROPOD BITE (felt like she had a bug bite), URTICARIA (broke out in hives all over her body), FEELING HOT (Warm) and VACCINATION SITE PRURITUS (injection site was itchy) in a 77-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 reported medical history.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN CALCIUM (LIPITOR) and DENOSUMAB (PROLIA) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ARTHROPOD BITE (felt like she had a bug bite), FEELING HOT (Warm), VACCINATION SITE PRURITUS (injection site was itchy) and ERYTHEMA (arm was red). On 02-Feb-2021, the patient experienced URTICARIA (broke out in hives all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL CHILDRENS) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE PRURITUS (injection site was itchy) and ERYTHEMA (arm was red) had resolved, ARTHROPOD BITE (felt like she had a bug bite) and FEELING HOT (Warm) outcome was unknown and URTICARIA (broke out in hives all over her body) had not resolved. Not Provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Palpitations, Periorbital swelling, Vaccination site pain
Clinical narrative: heart was racing i just felt like I was going to die; both eyes were really puffy; had a sore throat; pain in deltoid muscle; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart was racing i just felt like I was going to die), PERIORBITAL SWELLING (both eyes were really puffy), OROPHARYNGEAL PAIN (had a sore throat) and VACCINATION SITE PAIN (pain in deltoid muscle) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Diabetes.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain in deltoid muscle). On an unknown date, the patient experienced PALPITATIONS (heart was racing i just felt like I was going to die), PERIORBITAL SWELLING (both eyes were really puffy) and OROPHARYNGEAL PAIN (had a sore throat). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and EMERGEN C for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart was racing i just felt like I was going to die), PERIORBITAL SWELLING (both eyes were really puffy), OROPHARYNGEAL PAIN (had a sore throat) and VACCINATION SITE PAIN (pain in deltoid muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment also included an unspecified antihistamine. Reportedly, the patient was feeling better after treatment medications.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Major narrative update: treatment information correction. On 21-Jul-2021: Follow-up received 21-Jul-2021 included no new information.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Product dose omission issue, Swelling face
Clinical narrative: Allergic reaction; cheek on the right side of his face was swollen like a golf ball; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (cheek on the right side of his face was swollen like a golf ball), HYPERSENSITIVITY (Allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 SWELLING FACE (cheek on the right side of his face was swollen like a golf ball). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, SWELLING FACE (cheek on the right side of his face was swollen like a golf ball) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant medication was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Additional events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspepsia, Erythema, Peripheral swelling, Taste disorder
Clinical narrative: arm was sore; arm was swollen; arm was red; able to taste it (the shot); bad indigestion; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (arm was sore), PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), TASTE DISORDER (able to taste it (the shot)) and DYSPEPSIA (bad indigestion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced ARTHRALGIA (arm was sore), PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red), TASTE DISORDER (able to taste it (the shot)) and DYSPEPSIA (bad indigestion). On 24-Jan-2021, TASTE DISORDER (able to taste it (the shot)) had resolved. On 27-Jan-2021, ARTHRALGIA (arm was sore), PERIPHERAL SWELLING (arm was swollen), ERYTHEMA (arm was red) and DYSPEPSIA (bad indigestion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: fever; pink; 3x5 patch around the injection site; warm on injection site; itchiness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm on injection site), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (pink), VACCINATION SITE RASH (3x5 patch around the injection site) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm on injection site), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE RASH (3x5 patch around the injection site). On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (pink). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) at an unspecified dose and frequency and VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm on injection site), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE RASH (3x5 patch around the injection site) had not resolved and PYREXIA (fever) outcome was unknown.        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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Diarrhoea, Dyspnoea
Clinical narrative: feels week; diarrhea; 215 over 90 somethings blood pressure; Heart beat racing; itching on the inside; hands red; labor breathing; nightmares; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart beat racing, blood pressure increased, itching on the inside, hands red, labor breathing, nightmares, diarrhea and feeling weak.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 22021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041620A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, immediately after the injection, the patient began to experience her heart beat racing, blood pressure reading of 215/90 , itching on the inside, hands red, labor breathing, and nightmares. On 16 Jan 2021, the patient experienced diarrhea.  On 01 Feb 2021, the patient reported feeling weak.Treatment included vitamin C and vitamin D.   Action taken with mRNA-1273 in response to the events was not reported  The outcome of events, heart beat racing, blood pressure increased, itching on the inside, hands red, labor breathing, nightmares, diarrhea, and feeling weak 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nightmare, Palpitations, Pruritus
Clinical narrative: feels week; diarrhea; 215 over 90 somethings blood pressure; Heart beat racing; itching on the inside; hands red; labor breathing; nightmares; A spontaneous report was received from a consumer concerning a 76-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart beat racing, blood pressure increased, itching on the inside, hands red, labor breathing, nightmares, diarrhea and feeling weak.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 22021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041620A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, immediately after the injection, the patient began to experience her heart beat racing, blood pressure reading of 215/90 , itching on the inside, hands red, labor breathing, and nightmares. On 16 Jan 2021, the patient experienced diarrhea.  On 01 Feb 2021, the patient reported feeling weak.Treatment included vitamin C and vitamin D.   Action taken with mRNA-1273 in response to the events was not reported  The outcome of events, heart beat racing, blood pressure increased, itching on the inside, hands red, labor breathing, nightmares, diarrhea, and feeling weak 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: a little red; it itches a lot; a little swollen; a soreness; a soreness; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MYALGIA (a soreness), VACCINATION SITE ERYTHEMA (a little red), VACCINATION SITE PRURITUS (it itches a lot), VACCINATION SITE SWELLING (a little swollen) and the second episode of MYALGIA (a soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM (XANAX), ZOLPIDEM and ALPRAZOLAM for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced the first episode of MYALGIA (a soreness) and the second episode of MYALGIA (a soreness). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a little red), VACCINATION SITE PRURITUS (it itches a lot) and VACCINATION SITE SWELLING (a little swollen). At the time of the report, VACCINATION SITE ERYTHEMA (a little red), VACCINATION SITE PRURITUS (it itches a lot), VACCINATION SITE SWELLING (a little swollen) and the last episode of MYALGIA (a soreness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on arms and legs) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced URTICARIA (Hives on arms and legs). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 15-Jan-2021, URTICARIA (Hives on arms and legs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants were not reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; CHILLS; fever; joint pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (CHILLS), PYREXIA (fever), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021 at 2:00 AM, the patient experienced PAIN (body aches), CHILLS (CHILLS), PYREXIA (fever), ARTHRALGIA (joint pain) and HEADACHE (headache). At the time of the report, PAIN (body aches), CHILLS (CHILLS), PYREXIA (fever), ARTHRALGIA (joint pain) and HEADACHE (headache) had not resolved.            No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), SWELLING (Swelling 4.5cm x 4cm), SWELLING (swelling 5.5cm x 4cm), VACCINATION SITE PRURITUS (very itchy) and VACCINATION SITE INDURATION (Hard) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), SWELLING (Swelling 4.5cm x 4cm) and VACCINATION SITE INDURATION (Hard). On 01-Feb-2021, the patient experienced SWELLING (swelling 5.5cm x 4cm) and VACCINATION SITE PRURITUS (very itchy). The patient was treated with CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch), SWELLING (Swelling 4.5cm x 4cm), SWELLING (swelling 5.5cm x 4cm), VACCINATION SITE PRURITUS (very itchy), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE ERYTHEMA (redness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Confusional state, Dyspnoea, Fatigue, Headache
Clinical narrative: stomach cramps; confusion; fatigued; little headache; difficulty breathing; vision issues; cloudy and fogginess; vomiting; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of   in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Lupus syndrome and COPD. Concomitant products included SALBUTAMOL SULFATE (INHALERIN), ALPRAZOLAM (XANAX), LISINOPRIL and EZETIMIBE (ZETIA) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency; OXYGEN ongoing since an unknown date at an unspecified dose and frequency and MORPHINE ongoing since an unknown date at an unspecified dose and frequency.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: stomach cramps; confusion; fatigued; little headache; difficulty breathing; vision issues; cloudy and fogginess; vomiting; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of   in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Lupus syndrome and COPD. Concomitant products included SALBUTAMOL SULFATE (INHALERIN), ALPRAZOLAM (XANAX), LISINOPRIL and EZETIMIBE (ZETIA) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency; OXYGEN ongoing since an unknown date at an unspecified dose and frequency and MORPHINE ongoing since an unknown date at an unspecified dose and frequency.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Retinal migraine, Vaccination site pain, Visual impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RETINAL MIGRAINE (Macular Migraine, usual ocular migraine in the opposite eye), VISUAL IMPAIRMENT (Jazzed Sphere in right eye/Jazzed Sphere in left eye), VACCINATION SITE PAIN (Arm soreness), FATIGUE (Very Fatigued,tired,) and HEADACHE (slight headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included Retinal migraine (for over 30 years). Concurrent medical conditions included Blood pressure high (Higher blood pressure than normal). Concomitant products included LANSOPRAZOLE for Hiatal hernia, HYDROCHLOROTHIAZIDE for Hypertension. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced RETINAL MIGRAINE (Macular Migraine,usual ocular migraine in the opposite eye), FATIGUE (Very Fatigued,tired,) and HEADACHE (slight headache). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Jazzed Sphere in right eye/Jazzed Sphere in left eye) and VACCINATION SITE PAIN (Arm soreness). On 27-Jan-2021, RETINAL MIGRAINE (Macular Migraine,usual ocular migraine in the opposite eye) had resolved. On 28-Jan-2021, FATIGUE (Very Fatigued,tired,) and HEADACHE (slight headache) had resolved. At the time of the report, VISUAL IMPAIRMENT (Jazzed Sphere in right eye/Jazzed Sphere in left eye) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported that although she had ocular migraine for over 30 years, the vaccination triggered the symptoms and also affected the opposite eye, which was different from the eye which usually got affected. No treatment medications were reported. This case was linked to MOD-2021-224742, MOD-2021-224742. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up was received on 14-JUN-2021. Second dose details were added; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site irritation
Clinical narrative: Bruise at the injection site; Irritation at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE IRRITATION (Irritation at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE IRRITATION (Irritation at injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise at the injection site) and VACCINATION SITE IRRITATION (Irritation at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.  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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up received updates event outcome.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash across trunk and limbs; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Rash across trunk and limbs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa drugs), Hypertension since 2014 and Hypothyroidism since 2014. Concomitant products included LOSARTAN, HYDRALAZINE and DILTIAZEM for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 25-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the patient experienced URTICARIA (Hives) and RASH (Rash across trunk and limbs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 50 mg. On 30-Jan-2021, URTICARIA (Hives) and RASH (Rash across trunk and limbs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21JUN2021, added patient's demographics, medical history and concomitant medications.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: small patch very itchy; 1 week later has a small patch very itchy and red, it still itching and growing on size; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (small patch very itchy) and VACCINATION SITE ERYTHEMA (1 week later has a small patch very itchy and red, it still itching and growing on size) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included  (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (small patch very itchy) and VACCINATION SITE ERYTHEMA (1 week later has a small patch very itchy and red, it still itching and growing on size). At the time of the report, VACCINATION SITE PRURITUS (small patch very itchy) and VACCINATION SITE ERYTHEMA (1 week later has a small patch very itchy and red, it still itching and growing on size) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain). On 25-Jan-2021, VACCINATION SITE PAIN (Arm Pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: Arm is red; Arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm is red) and SWELLING (Arm is swollen) 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 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ERYTHEMA (Arm is red) and SWELLING (Arm is swollen). At the time of the report, ERYTHEMA (Arm is red) and SWELLING (Arm is swollen) had not resolved.            No concomitant medications provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Vaccination site pain
Clinical narrative: really bad chills; nausea; my arm was sore at the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (really bad chills), NAUSEA (nausea) and VACCINATION SITE PAIN (my arm was sore at the injection site.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (really bad chills), NAUSEA (nausea) and VACCINATION SITE PAIN (my arm was sore at the injection site.). At the time of the report, CHILLS (really bad chills), NAUSEA (nausea) and VACCINATION SITE PAIN (my arm was sore at the injection site.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Dizziness, Fatigue, Feeling cold, Feeling hot
Clinical narrative: arthritis flared up; rash; headache; muscle pain; dizzy; tired; cold; warm; ringing in her left ear; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis flared up), FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear) and LETHARGY (lethargic) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus since 03-Feb-2021, Rash since 03-Feb-2021, Headache since 03-Feb-2021, Muscle pain since 03-Feb-2021, Dizzy since 03-Feb-2021 and Arthritis.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear), LETHARGY (lethargic), MYALGIA (muscle pain), DIZZINESS (dizzy) and FATIGUE (tired). On 28-Jan-2021, the patient experienced ARTHRITIS (arthritis flared up), RASH (rash) and HEADACHE (headache). On 28-Jan-2021, ARTHRITIS (arthritis flared up), FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear) and HEADACHE (headache) had resolved. On 30-Jan-2021, MYALGIA (muscle pain) had resolved. On 01-Feb-2021, RASH (rash) had resolved. At the time of the report, LETHARGY (lethargic), DIZZINESS (dizzy) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Rash, Tinnitus
Clinical narrative: arthritis flared up; rash; headache; muscle pain; dizzy; tired; cold; warm; ringing in her left ear; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (arthritis flared up), FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear) and LETHARGY (lethargic) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus since 03-Feb-2021, Rash since 03-Feb-2021, Headache since 03-Feb-2021, Muscle pain since 03-Feb-2021, Dizzy since 03-Feb-2021 and Arthritis.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear), LETHARGY (lethargic), MYALGIA (muscle pain), DIZZINESS (dizzy) and FATIGUE (tired). On 28-Jan-2021, the patient experienced ARTHRITIS (arthritis flared up), RASH (rash) and HEADACHE (headache). On 28-Jan-2021, ARTHRITIS (arthritis flared up), FEELING COLD (cold), FEELING HOT (warm), TINNITUS (ringing in her left ear) and HEADACHE (headache) had resolved. On 30-Jan-2021, MYALGIA (muscle pain) had resolved. On 01-Feb-2021, RASH (rash) had resolved. At the time of the report, LETHARGY (lethargic), DIZZINESS (dizzy) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bug bite looking reactions on elbow, hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Bug bite looking reactions on elbow, hands and feet) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Bug bite looking reactions on elbow, hands and feet). At the time of the report, RASH (Bug bite looking reactions on elbow, hands and feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Ultrasound scan, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: rash started to lighten up and developed a dark red line around rash; arm was sore where she received the shot; soft lump an inch away from injection site; rash on arm at injection site 4 inches long; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (soft lump an inch away from injection site), VACCINATION SITE RASH (rash on arm at injection site 4 inches long), VACCINATION SITE ERYTHEMA (rash started to lighten up and developed a dark red line around rash) and VACCINATION SITE PAIN (arm was sore where she received the shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LD00A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Jan-2021, the patient experienced VACCINATION SITE MASS (soft lump an inch away from injection site), VACCINATION SITE RASH (rash on arm at injection site 4 inches long) and VACCINATION SITE PAIN (arm was sore where she received the shot). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (rash started to lighten up and developed a dark red line around rash). On 01-Feb-2021, VACCINATION SITE ERYTHEMA (rash started to lighten up and developed a dark red line around rash) had resolved. At the time of the report, VACCINATION SITE MASS (soft lump an inch away from injection site) and VACCINATION SITE RASH (rash on arm at injection site 4 inches long) had not resolved and VACCINATION SITE PAIN (arm was sore where she received the shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided.  On the second day her arm was sore where she received the shot. Then she got a red rash on arm at injection site 4 inches long. Concerned that two days after rash, she developed a soft lump an inch away from injection site. Over a couple of weeks, starting yesterday the rash started to lighten up and developed a dark red line around rash. The dark red line went away yesterday, but the rash is back and lump still there.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash started to lighten up and developed a dark red line around rash; arm was sore where she received the shot; soft lump an inch away from injection site; rash on arm at injection site 4 inches long; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (soft lump an inch away from injection site), VACCINATION SITE RASH (rash on arm at injection site 4 inches long), VACCINATION SITE ERYTHEMA (rash started to lighten up and developed a dark red line around rash) and VACCINATION SITE PAIN (arm was sore where she received the shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012LD00A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 20-Jan-2021, the patient experienced VACCINATION SITE MASS (soft lump an inch away from injection site), VACCINATION SITE RASH (rash on arm at injection site 4 inches long) and VACCINATION SITE PAIN (arm was sore where she received the shot). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (rash started to lighten up and developed a dark red line around rash). On 01-Feb-2021, VACCINATION SITE ERYTHEMA (rash started to lighten up and developed a dark red line around rash) had resolved. At the time of the report, VACCINATION SITE MASS (soft lump an inch away from injection site) and VACCINATION SITE RASH (rash on arm at injection site 4 inches long) had not resolved and VACCINATION SITE PAIN (arm was sore where she received the shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided.  On the second day her arm was sore where she received the shot. Then she got a red rash on arm at injection site 4 inches long. Concerned that two days after rash, she developed a soft lump an inch away from injection site. Over a couple of weeks, starting yesterday the rash started to lighten up and developed a dark red line around rash. The dark red line went away yesterday, but the rash is back and lump still there.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Same round redness spot; Little bit of swelling under the spot; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), INJECTION SITE ERYTHEMA (Same round redness spot) and INJECTION SITE SWELLING (Little bit of swelling under the spot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced ERYTHEMA (Redness) and SWELLING (Swelling). On 01-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Same round redness spot) and INJECTION SITE SWELLING (Little bit of swelling under the spot). On 23-Jan-2021, ERYTHEMA (Redness) and SWELLING (Swelling) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Same round redness spot) and INJECTION SITE SWELLING (Little bit of swelling under the spot) 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.  Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased
Clinical narrative: elevated ALT/ALT increased more; This spontaneous case was reported by a consumer and describes the occurrence of ALANINE AMINOTRANSFERASE INCREASED (elevated ALT/ALT increased more) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ALANINE AMINOTRANSFERASE INCREASED (elevated ALT/ALT increased more). At the time of the report, ALANINE AMINOTRANSFERASE INCREASED (elevated ALT/ALT increased more) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Alanine aminotransferase: elevated (High) elevated. On 28-Jan-2021, Alanine aminotransferase: increased more (High) increased more.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment information was provided.  On 13Jan2021 had blood work with elevated ALT. On 28Jan2021 same blood work was repeated and ALT increased more.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) 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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Fatigue, Headache, Nausea
Clinical narrative: diarrhea; heartburn; stool is liquid, had mucus and is yellow; fatigue; headache; nausea; pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DYSPEPSIA (heartburn), DIARRHOEA (stool is liquid, had mucus and is yellow), PAIN (pain) and FATIGUE (fatigue) in a 65-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 31-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 PAIN (pain). On 02-Feb-2021, the patient experienced DIARRHOEA (diarrhea), DYSPEPSIA (heartburn), DIARRHOEA (stool is liquid, had mucus and is yellow), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), DYSPEPSIA (heartburn), DIARRHOEA (stool is liquid, had mucus and is yellow), PAIN (pain), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.