chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Malaise, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat; Sores in mouth; lymph nodes hurts; Head ache/bad headache; sore arm; felt little off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (felt little off), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (Sores in mouth) and LYMPH NODE PAIN (lymph nodes hurts) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (felt little off) and HEADACHE (Head ache/bad headache). On 03-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), STOMATITIS (Sores in mouth) and LYMPH NODE PAIN (lymph nodes hurts). On 19-Feb-2021, PAIN IN EXTREMITY (sore arm), MALAISE (felt little off) and HEADACHE (Head ache/bad headache) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), STOMATITIS (Sores in mouth) and LYMPH NODE PAIN (lymph nodes hurts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.   This case was linked to MOD-2021-170199 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR- updated event information
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: sore throat; Sores in mouth; lymph nodes hurts; Head ache/bad headache; sore arm; felt little off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (felt little off), OROPHARYNGEAL PAIN (sore throat), STOMATITIS (Sores in mouth) and LYMPH NODE PAIN (lymph nodes hurts) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (felt little off) and HEADACHE (Head ache/bad headache). On 03-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), STOMATITIS (Sores in mouth) and LYMPH NODE PAIN (lymph nodes hurts). On 19-Feb-2021, PAIN IN EXTREMITY (sore arm), MALAISE (felt little off) and HEADACHE (Head ache/bad headache) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), STOMATITIS (Sores in mouth) and LYMPH NODE PAIN (lymph nodes hurts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  information was  provided. No Treatment information was  provided.   This case was linked to MOD-2021-170199 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR- updated event information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Sweating; Sore arm; 100.8 degree F fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Sore arm), PYREXIA (100.8 degree F fever) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Sore arm), PYREXIA (100.8 degree F fever) and CHILLS (Chills). At the time of the report, HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Sore arm), PYREXIA (100.8 degree F fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 100.8 degree f High.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Headache, Hot flush, Neck pain, Pain
Clinical narrative: hot flushes; Problem in her neck, L side; sore; no voice during 1 hour and half; small fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flushes), NECK PAIN (Problem in her neck, L side), PAIN (sore), APHONIA (no voice during 1 hour and half) and PYREXIA (small fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and LEVOTHYROXINE for an unknown indication.    On 25-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 HOT FLUSH (hot flushes), NECK PAIN (Problem in her neck, L side), PAIN (sore), APHONIA (no voice during 1 hour and half), PYREXIA (small fever) and HEADACHE (headache). At the time of the report, HOT FLUSH (hot flushes), NECK PAIN (Problem in her neck, L side), PAIN (sore), APHONIA (no voice during 1 hour and half), PYREXIA (small fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: hot flushes; Problem in her neck, L side; sore; no voice during 1 hour and half; small fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flushes), NECK PAIN (Problem in her neck, L side), PAIN (sore), APHONIA (no voice during 1 hour and half) and PYREXIA (small fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and LEVOTHYROXINE for an unknown indication.    On 25-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 HOT FLUSH (hot flushes), NECK PAIN (Problem in her neck, L side), PAIN (sore), APHONIA (no voice during 1 hour and half), PYREXIA (small fever) and HEADACHE (headache). At the time of the report, HOT FLUSH (hot flushes), NECK PAIN (Problem in her neck, L side), PAIN (sore), APHONIA (no voice during 1 hour and half), PYREXIA (small fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: Vomited; Lost 10 pounds of weight; Could not sleep for 3 days; nausea; fatigue; Arm around the injection site was red; Arm around the injection site was swollen; chills; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 10 pounds of weight), INSOMNIA (Could not sleep for 3 days), VOMITING (Vomited), VACCINATION SITE ERYTHEMA (Arm around the injection site was red) and VACCINATION SITE SWELLING (Arm around the injection site was swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm around the injection site was red), VACCINATION SITE SWELLING (Arm around the injection site was swollen), CHILLS (chills) and HEADACHE (Terrible headache). On 25-Feb-2021, the patient experienced INSOMNIA (Could not sleep for 3 days), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 10 pounds of weight) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (Lost 10 pounds of weight), INSOMNIA (Could not sleep for 3 days), VOMITING (Vomited), VACCINATION SITE ERYTHEMA (Arm around the injection site was red), VACCINATION SITE SWELLING (Arm around the injection site was swollen), CHILLS (chills), HEADACHE (Terrible headache), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non significant FU
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vomiting, Weight decreased
Clinical narrative: Vomited; Lost 10 pounds of weight; Could not sleep for 3 days; nausea; fatigue; Arm around the injection site was red; Arm around the injection site was swollen; chills; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 10 pounds of weight), INSOMNIA (Could not sleep for 3 days), VOMITING (Vomited), VACCINATION SITE ERYTHEMA (Arm around the injection site was red) and VACCINATION SITE SWELLING (Arm around the injection site was swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm around the injection site was red), VACCINATION SITE SWELLING (Arm around the injection site was swollen), CHILLS (chills) and HEADACHE (Terrible headache). On 25-Feb-2021, the patient experienced INSOMNIA (Could not sleep for 3 days), NAUSEA (nausea) and FATIGUE (fatigue). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 10 pounds of weight) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, WEIGHT DECREASED (Lost 10 pounds of weight), INSOMNIA (Could not sleep for 3 days), VOMITING (Vomited), VACCINATION SITE ERYTHEMA (Arm around the injection site was red), VACCINATION SITE SWELLING (Arm around the injection site was swollen), CHILLS (chills), HEADACHE (Terrible headache), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non significant FU
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: Vaccinated in incorrect site; Red mark on site of injection; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinated in incorrect site) and VACCINATION SITE ERYTHEMA (Red mark on site of injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. no provided) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinated in incorrect site) and VACCINATION SITE ERYTHEMA (Red mark on site of injection). On 01-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinated in incorrect site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red mark on site of injection) 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.   No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site erythema, a causal relationship cannot be excluded. Very limited information regarding this event: inappropriate route of vaccination, has been provided at this time. Further information has been requested.; 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 of vaccination site erythema, a causal relationship cannot be excluded. Very limited information regarding this event: inappropriate route of vaccination, has been provided at this time. Further information has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: sore left arm; it hurts a little bit down the injection site, like in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) and VACCINATION SITE PAIN (it hurts a little bit down the injection site, like in the muscle) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore left arm) and VACCINATION SITE PAIN (it hurts a little bit down the injection site, like in the muscle). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm) and VACCINATION SITE PAIN (it hurts a little bit down the injection site, like in the muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking unspecified medications for blood pressure and blood thinning.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Vaccination complication
Clinical narrative: stomach/intestinal issues; headache; very miserable; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach/intestinal issues), HEADACHE (headache) and VACCINATION COMPLICATION (very miserable) 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 16-Feb-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 an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach/intestinal issues), HEADACHE (headache) and VACCINATION COMPLICATION (very miserable). At the time of the report, ABDOMINAL DISCOMFORT (stomach/intestinal issues), HEADACHE (headache) and VACCINATION COMPLICATION (very miserable) outcome was unknown.            In this case no information about concomitant medications and treatment medications.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash macular, Urticaria
Clinical narrative: Arm became blotchy; Red; Hives which has gone to her face, chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Arm became blotchy), ERYTHEMA (Red) and URTICARIA (Hives which has gone to her face, chest and neck) 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 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced RASH MACULAR (Arm became blotchy), ERYTHEMA (Red) and URTICARIA (Hives which has gone to her face, chest and neck). At the time of the report, RASH MACULAR (Arm became blotchy), ERYTHEMA (Red) and URTICARIA (Hives which has gone to her face, chest and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Cough, Headache, Pyrexia
Clinical narrative: I'm having a flare up of asthma; It was well controlled before and Sunday afternoon, started coughing, Monday a little more, yesterday all day, and during the night.; 12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache; 12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache; 12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (I'm having a flare up of asthma), COUGH (It was well controlled before and Sunday afternoon, started coughing, Monday a little more, yesterday all day, and during the night.), CHILLS (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache), PYREXIA (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache) and HEADACHE (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma since an unknown date. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), Albuterol inhaler, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), OMEPRAZOLE, Cholesterol medication and ALLERGENS, HOUSE DUST & MITE (ODACTRA) for an unknown indication.    On 28-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 ASTHMA (I'm having a flare up of asthma), COUGH (It was well controlled before and Sunday afternoon, started coughing, Monday a little more, yesterday all day, and during the night.), CHILLS (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache), PYREXIA (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache) and HEADACHE (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache). At the time of the report, ASTHMA (I'm having a flare up of asthma), COUGH (It was well controlled before and Sunday afternoon, started coughing, Monday a little more, yesterday all day, and during the night.), CHILLS (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache), PYREXIA (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache) and HEADACHE (12 hours after vaccination, hit hard with the chills, fever of 101.7, and headache) 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.   Treatment drugs include Stronger inhaler is being prescribed by allergist. Other Concomitant medications include Cholesterol Medication.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Bone pain, Headache, Pain in extremity
Clinical narrative: pain in the back; pain in the bones; Still in bed; Pain in the arm of the injection; Could not touch the arm; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in the back), BONE PAIN (pain in the bones), ASTHENIA (Still in bed), PAIN IN EXTREMITY (Pain in the arm of the injection) and VACCINATION SITE DISCOMFORT (Could not touch the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced BACK PAIN (pain in the back), BONE PAIN (pain in the bones), ASTHENIA (Still in bed), PAIN IN EXTREMITY (Pain in the arm of the injection), VACCINATION SITE DISCOMFORT (Could not touch the arm) and HEADACHE (Severe headache). On 02-Mar-2021, PAIN IN EXTREMITY (Pain in the arm of the injection), VACCINATION SITE DISCOMFORT (Could not touch the arm) and HEADACHE (Severe headache) had resolved. At the time of the report, BACK PAIN (pain in the back), BONE PAIN (pain in the bones) and ASTHENIA (Still in bed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included high blood pressure medications and diabetes medications. No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: pain in the back; pain in the bones; Still in bed; Pain in the arm of the injection; Could not touch the arm; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in the back), BONE PAIN (pain in the bones), ASTHENIA (Still in bed), PAIN IN EXTREMITY (Pain in the arm of the injection) and VACCINATION SITE DISCOMFORT (Could not touch the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced BACK PAIN (pain in the back), BONE PAIN (pain in the bones), ASTHENIA (Still in bed), PAIN IN EXTREMITY (Pain in the arm of the injection), VACCINATION SITE DISCOMFORT (Could not touch the arm) and HEADACHE (Severe headache). On 02-Mar-2021, PAIN IN EXTREMITY (Pain in the arm of the injection), VACCINATION SITE DISCOMFORT (Could not touch the arm) and HEADACHE (Severe headache) had resolved. At the time of the report, BACK PAIN (pain in the back), BONE PAIN (pain in the bones) and ASTHENIA (Still in bed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included high blood pressure medications and diabetes medications. No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache
Clinical narrative: Headache; Felt cold and hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot). On 12-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt cold and hot) and HEADACHE (Headache) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-006025 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-006025:
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) 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.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Anxiety, Blood pressure abnormal and Cholesterol.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly, patient was taking medications for her depression, anxiety, blood pressure and cholesterol.  No treatment related information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Pinkness at the injection site; Bump at the injection site; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pinkness at the injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (Pinkness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site). On 24-Feb-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Pinkness at the injection site) and VACCINATION SITE SWELLING (Bump at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: soreness in his arm; pain happens when he tries to lift his arms above shoulder level; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) and PAIN (pain happens when he tries to lift his arms above shoulder level) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included POTASSIUM CHLORIDE, LISINOPRIL, CHLORTHALIDONE and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm) and PAIN (pain happens when he tries to lift his arms above shoulder level). At the time of the report, PAIN IN EXTREMITY (soreness in his arm) and PAIN (pain happens when he tries to lift his arms above shoulder level) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information was reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Joint swelling, Pain, Pruritus, Rash
Clinical narrative: itchy; hand was really swollen from thumb to wrist; rash from the waist to under the breast and the sides; it felt like stings; my eyes kind of got a little bit hard to focus; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PAIN (it felt like stings), DISTURBANCE IN ATTENTION (my eyes kind of got a little bit hard to focus), JOINT SWELLING (hand was really swollen from thumb to wrist) and RASH (rash from the waist to under the breast and the sides) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to allopathic drugs. Concomitant products included CLOPIDOGREL, EZETIMIBE, METOPROLOL and AMLODIPINE for an unknown indication.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (it felt like stings) and DISTURBANCE IN ATTENTION (my eyes kind of got a little bit hard to focus). On 09-Feb-2021, the patient experienced PRURITUS (itchy), JOINT SWELLING (hand was really swollen from thumb to wrist) and RASH (rash from the waist to under the breast and the sides). At the time of the report, PRURITUS (itchy), PAIN (it felt like stings), DISTURBANCE IN ATTENTION (my eyes kind of got a little bit hard to focus), JOINT SWELLING (hand was really swollen from thumb to wrist) and RASH (rash from the waist to under the breast and the sides) 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 treatment information provided by Reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Insomnia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site is now a little swollen and itching so bad that she could not sleep; injection site is now a little swollen and itching so bad that she could not sleep; injection site is now a little swollen and itching so bad that she could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (injection site is now a little swollen and itching so bad that she could not sleep), VACCINATION SITE PRURITUS (injection site is now a little swollen and itching so bad that she could not sleep) and VACCINATION SITE SWELLING (injection site is now a little swollen and itching so bad that she could not sleep) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INSOMNIA (injection site is now a little swollen and itching so bad that she could not sleep), VACCINATION SITE PRURITUS (injection site is now a little swollen and itching so bad that she could not sleep) and VACCINATION SITE SWELLING (injection site is now a little swollen and itching so bad that she could not sleep). At the time of the report, INSOMNIA (injection site is now a little swollen and itching so bad that she could not sleep), VACCINATION SITE PRURITUS (injection site is now a little swollen and itching so bad that she could not sleep) and VACCINATION SITE SWELLING (injection site is now a little swollen and itching so bad that she could not sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) Blood pressure spiked..         The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Telephone contact report was received as an initial additional document on 25-MAY-2021. Patient stated she does not have email or fax to do follow up. It contains non significant information.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Headache, Heart rate
Clinical narrative: joint pain; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and HEADACHE (slight headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 016N120A) for COVID-19 vaccination.     No medical history was reported and concomitant drugs are provided.  Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), LISINOPRIL, METFORMIN and AMIODARONE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRALGIA (joint pain) and HEADACHE (slight headache). At the time of the report, ARTHRALGIA (joint pain) and HEADACHE (slight headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: (High) 187/86. On an unknown date, Heart rate: 88/90 and 62 beats.         No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Patient denied consent for further follow up.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Illness, Nausea
Clinical narrative: sick; cannot function; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), ASTHENIA (cannot function) and NAUSEA (nausea) in a male 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 ILLNESS (sick), ASTHENIA (cannot function) and NAUSEA (nausea). At the time of the report, ILLNESS (sick), ASTHENIA (cannot function) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: red bump at the injection site; red bump at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (red bump at the injection site), VACCINATION SITE ERYTHEMA (red bump at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE MASS (red bump at the injection site), VACCINATION SITE ERYTHEMA (red bump at the injection site) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE MASS (red bump at the injection site), VACCINATION SITE ERYTHEMA (red bump at the injection site) and VACCINATION SITE PAIN (soreness at the injection site) 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 was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Erythema, Fatigue, Limb discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen) and DISCOMFORT (uncomfortable to touch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 16-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 FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen), DISCOMFORT (uncomfortable to touch), RASH MACULAR (huge red spot), PAIN (painful), PRURITUS (itching), AXILLARY PAIN (under armpit it was painful), TENDERNESS (under armpit tenderness), ERYTHEMA (redness has now spreaded down to her elbow), SKIN EXFOLIATION (skin is pealing off) and LIMB DISCOMFORT (arm it feels like it pulling somethin). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen), DISCOMFORT (uncomfortable to touch), RASH MACULAR (huge red spot), PAIN (painful), PRURITUS (itching), AXILLARY PAIN (under armpit it was painful), TENDERNESS (under armpit tenderness), ERYTHEMA (redness has now spreaded down to her elbow), SKIN EXFOLIATION (skin is pealing off) and LIMB DISCOMFORT (arm it feels like it pulling somethin) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash macular, Skin exfoliation, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen) and DISCOMFORT (uncomfortable to touch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 16-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 FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen), DISCOMFORT (uncomfortable to touch), RASH MACULAR (huge red spot), PAIN (painful), PRURITUS (itching), AXILLARY PAIN (under armpit it was painful), TENDERNESS (under armpit tenderness), ERYTHEMA (redness has now spreaded down to her elbow), SKIN EXFOLIATION (skin is pealing off) and LIMB DISCOMFORT (arm it feels like it pulling somethin). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen), DISCOMFORT (uncomfortable to touch), RASH MACULAR (huge red spot), PAIN (painful), PRURITUS (itching), AXILLARY PAIN (under armpit it was painful), TENDERNESS (under armpit tenderness), ERYTHEMA (redness has now spreaded down to her elbow), SKIN EXFOLIATION (skin is pealing off) and LIMB DISCOMFORT (arm it feels like it pulling somethin) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen) and DISCOMFORT (uncomfortable to touch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 16-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 FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen), DISCOMFORT (uncomfortable to touch), RASH MACULAR (huge red spot), PAIN (painful), PRURITUS (itching), AXILLARY PAIN (under armpit it was painful), TENDERNESS (under armpit tenderness), ERYTHEMA (redness has now spreaded down to her elbow), SKIN EXFOLIATION (skin is pealing off) and LIMB DISCOMFORT (arm it feels like it pulling somethin). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (some fatigue), PAIN (some body ache), VACCINATION SITE ERYTHEMA (injection site became red), SWELLING (swollen), DISCOMFORT (uncomfortable to touch), RASH MACULAR (huge red spot), PAIN (painful), PRURITUS (itching), AXILLARY PAIN (under armpit it was painful), TENDERNESS (under armpit tenderness), ERYTHEMA (redness has now spreaded down to her elbow), SKIN EXFOLIATION (skin is pealing off) and LIMB DISCOMFORT (arm it feels like it pulling somethin) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Headache, Myalgia, Vertigo, Vomiting
Clinical narrative: Vertigo; Dehydration; Vomiting/ throwning up so much; Body aches; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo), DEHYDRATION (Dehydration), VOMITING (Vomiting/ throwning up so much), MYALGIA (Body aches) and HEADACHE (Headaches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Addison's disease.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), DEHYDRATION (Dehydration), VOMITING (Vomiting/ throwning up so much), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, VERTIGO (Vertigo), DEHYDRATION (Dehydration), VOMITING (Vomiting/ throwning up so much), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   treatment information provided was Fluids were given No relevant concomitant medications reported.