chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Sinusitis, Thirst, Tremor
Clinical narrative: Itching under arm and neck; Deathly sick; Felt like needles in her arm and legs; Dry throat; Thirsty; Memory became horrible/"can't think of words"; Lips peeling off; Leg shake; Asthma; Sinus problem; Difficult in walk; Left arm Pain; Headache; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat) and THIRST (Thirsty) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Thyroidectomy (14 years back). Concurrent medical conditions included Asthma (On and off) and Food allergy (Sugar). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CLORAZEPATE DIPOTASSIUM (TRANXENE) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), PAIN IN EXTREMITY (Left arm Pain), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and PARAESTHESIA (Felt like needles in her arm and legs) and PAIN IN EXTREMITY (Left arm Pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Normal. On an unknown date, X-ray: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Steroids
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Itching under arm and neck; Deathly sick; Felt like needles in her arm and legs; Dry throat; Thirsty; Memory became horrible/"can't think of words"; Lips peeling off; Leg shake; Asthma; Sinus problem; Difficult in walk; Left arm Pain; Headache; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat) and THIRST (Thirsty) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Thyroidectomy (14 years back). Concurrent medical conditions included Asthma (On and off) and Food allergy (Sugar). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CLORAZEPATE DIPOTASSIUM (TRANXENE) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), PARAESTHESIA (Felt like needles in her arm and legs), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), PAIN IN EXTREMITY (Left arm Pain), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, PRURITUS (Itching under arm and neck), ILLNESS (Deathly sick), DRY THROAT (Dry throat), THIRST (Thirsty), MEMORY IMPAIRMENT (Memory became horrible/"can't think of words"), LIP DRY (Lips peeling off), TREMOR (Leg shake), ASTHMA (Asthma), SINUSITIS (Sinus problem), GAIT DISTURBANCE (Difficult in walk), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and PARAESTHESIA (Felt like needles in her arm and legs) and PAIN IN EXTREMITY (Left arm Pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: Normal. On an unknown date, X-ray: Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Steroids
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Nasopharyngitis, Pain in extremity, Product dose omission issue, Rhinorrhoea
Clinical narrative: may have already missed the second dose appointment; Right arm sore; Cold; bad sinus of her nose; having a nasal drip, described as her nose is running; symptoms due to pollen; possible soreness when the arm is pressed or rubbed; dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm), PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), PAIN IN EXTREMITY (Right arm sore), NASOPHARYNGITIS (Cold) and SINUS DISORDER (bad sinus of her nose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), PAIN IN EXTREMITY (Right arm sore), NASOPHARYNGITIS (Cold), SINUS DISORDER (bad sinus of her nose), RHINORRHOEA (having a nasal drip, described as her nose is running), SEASONAL ALLERGY (symptoms due to pollen) and VACCINATION SITE PAIN (possible soreness when the arm is pressed or rubbed). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm), PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), NASOPHARYNGITIS (Cold), SINUS DISORDER (bad sinus of her nose), RHINORRHOEA (having a nasal drip, described as her nose is running), SEASONAL ALLERGY (symptoms due to pollen) and VACCINATION SITE PAIN (possible soreness when the arm is pressed or rubbed) outcome was unknown and PAIN IN EXTREMITY (Right arm sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. The patient states that she used alcohol on the arm for the symptom and was not laying on her right side because of the symptom. She also reports that she has not treated the nasal drip, except by blowing her runny nose. The patient states that she needed assistance in rescheduling her second appointment, as she does not know the exact date for which it was scheduled.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy, Sinus disorder, Vaccination site pain
Clinical narrative: may have already missed the second dose appointment; Right arm sore; Cold; bad sinus of her nose; having a nasal drip, described as her nose is running; symptoms due to pollen; possible soreness when the arm is pressed or rubbed; dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm), PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), PAIN IN EXTREMITY (Right arm sore), NASOPHARYNGITIS (Cold) and SINUS DISORDER (bad sinus of her nose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), PAIN IN EXTREMITY (Right arm sore), NASOPHARYNGITIS (Cold), SINUS DISORDER (bad sinus of her nose), RHINORRHOEA (having a nasal drip, described as her nose is running), SEASONAL ALLERGY (symptoms due to pollen) and VACCINATION SITE PAIN (possible soreness when the arm is pressed or rubbed). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (dose was injected as described by the patient, describing the injection's location as the shoulder,the shoulder blade at the neck, and the right arm), PRODUCT DOSE OMISSION ISSUE (may have already missed the second dose appointment), NASOPHARYNGITIS (Cold), SINUS DISORDER (bad sinus of her nose), RHINORRHOEA (having a nasal drip, described as her nose is running), SEASONAL ALLERGY (symptoms due to pollen) and VACCINATION SITE PAIN (possible soreness when the arm is pressed or rubbed) outcome was unknown and PAIN IN EXTREMITY (Right arm sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. The patient states that she used alcohol on the arm for the symptom and was not laying on her right side because of the symptom. She also reports that she has not treated the nasal drip, except by blowing her runny nose. The patient states that she needed assistance in rescheduling her second appointment, as she does not know the exact date for which it was scheduled.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Illness, Myalgia, Somnolence
Clinical narrative: Very sick after 2nd dose; Slept for 2 days after 2nd dose; Arm red after 2nd dose; Horrible body pain after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick after 2nd dose), SOMNOLENCE (Slept for 2 days after 2nd dose), ERYTHEMA (Arm red after 2nd dose) and MYALGIA (Horrible body pain after 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 23-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick after 2nd dose), SOMNOLENCE (Slept for 2 days after 2nd dose), ERYTHEMA (Arm red after 2nd dose) and MYALGIA (Horrible body pain after 2nd dose). At the time of the report, ILLNESS (Very sick after 2nd dose), SOMNOLENCE (Slept for 2 days after 2nd dose), ERYTHEMA (Arm red after 2nd dose) and MYALGIA (Horrible body pain after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  .   This case was linked to US-MODERNATX, INC.-MOD-2021-026375 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on  01JUN-2021 contains non-significant information.added the email address; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026375:1st dose
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: threw up three times; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up three times) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (threw up three times). At the time of the report, VOMITING (threw up three times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided Treatment medication was not provided
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Patient reported that her body did not build antibodies after receiving the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Patient reported that her body did not build antibodies after receiving the vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Patient reported that her body did not build antibodies after receiving the vaccine). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Patient reported that her body did not build antibodies after receiving the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment product details not provided.  Concomitant product details not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Had sore arm; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MYALGIA (Had sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 14-Apr-2021, the patient experienced MYALGIA (Had sore arm). On 16-Apr-2021, MYALGIA (Had sore arm) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-054491 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054491:pregnancy
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Somnolence, Swelling, Vaccination site pain
Clinical narrative: falling asleep at work; swelling; hurt to blink; pain in his left arm; super tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (falling asleep at work), SWELLING (swelling), EYE PAIN (hurt to blink), VACCINATION SITE PAIN (pain in his left arm) and FATIGUE (super tired) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced SOMNOLENCE (falling asleep at work), SWELLING (swelling), EYE PAIN (hurt to blink), VACCINATION SITE PAIN (pain in his left arm) and FATIGUE (super tired). At the time of the report, SOMNOLENCE (falling asleep at work), SWELLING (swelling), EYE PAIN (hurt to blink), VACCINATION SITE PAIN (pain in his left arm) and FATIGUE (super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The patient used ice pack to help with the symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: lymph nodes are swollen; radiates to her elbows on both sides; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes are swollen) and PAIN (radiates to her elbows on both sides) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes are swollen) and PAIN (radiates to her elbows on both sides). At the time of the report, LYMPHADENOPATHY (lymph nodes are swollen) and PAIN (radiates to her elbows on both sides) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: dizziness; tiredness; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tiredness) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (tiredness) and CHILLS (chills). On 24-Mar-2021, DIZZINESS (dizziness), FATIGUE (tiredness) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No Treatment Medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-086271 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086271:2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: worst headache ever experienced; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (worst headache ever experienced) 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 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 HEADACHE (worst headache ever experienced). At the time of the report, HEADACHE (worst headache ever experienced) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information were not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left injection arm soreness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (left injection arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (left injection arm soreness). At the time of the report, VACCINATION SITE PAIN (left injection arm soreness) 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.   This case was linked to MOD-2021-086280 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: lump underneath her left underarm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (lump underneath her left underarm) in a 47-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. Concomitant products included VENLAFAXINE, HYDROCHLOROTHIAZIDE, HYDROXYZINE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced SKIN MASS (lump underneath her left underarm). At the time of the report, SKIN MASS (lump underneath her left underarm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow document contains no new information
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hypersensitivity, Pain in extremity, Pruritus, Rash
Clinical narrative: allergy; itching / pruritus; hives / urticaria; She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon; she experienced a Red Blotchy Rash all over her body; Diarrhea; She is Very Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy) and HYPERSENSITIVITY (allergy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: EMGALITY [GALCANEZUMAB GNLM] on 15-Apr-2021. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy-Red splotchy and itchy). Concomitant products included ONE A DAY WOMEN'S, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ESTRADIOL from 15-Jul-2020 to an unknown date and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy), PRURITUS (itching / pruritus) and URTICARIA (hives / urticaria). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Apr-2021 at an unspecified dose and frequency. On 22-Apr-2021, PRURITUS (itching / pruritus) and URTICARIA (hives / urticaria) had resolved. At the time of the report, PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy) and HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics were updated includes patient height, weight, ethnic group was updated. Updated the allergic drug describe reaction includes Red spot itchy was added. Historical vaccine were added. Added Emgality with the start date of vaccineAdded concomitant medication. Added Zyrtec, women a day, estradiol with the start dat and Vitamin C was added. Added outcome of event.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urticaria
Clinical narrative: allergy; itching / pruritus; hives / urticaria; She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon; she experienced a Red Blotchy Rash all over her body; Diarrhea; She is Very Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy) and HYPERSENSITIVITY (allergy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: EMGALITY [GALCANEZUMAB GNLM] on 15-Apr-2021. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy-Red splotchy and itchy). Concomitant products included ONE A DAY WOMEN'S, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ESTRADIOL from 15-Jul-2020 to an unknown date and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy), PRURITUS (itching / pruritus) and URTICARIA (hives / urticaria). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Apr-2021 at an unspecified dose and frequency. On 22-Apr-2021, PRURITUS (itching / pruritus) and URTICARIA (hives / urticaria) had resolved. At the time of the report, PAIN IN EXTREMITY (She experienced Shooting Pain in the Left Arm from Elbow toWrist, and Left Shoulder-blade to Collar bon), RASH (she experienced a Red Blotchy Rash all over her body), DIARRHOEA (Diarrhea), SOMNOLENCE (She is Very Sleepy) and HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics were updated includes patient height, weight, ethnic group was updated. Updated the allergic drug describe reaction includes Red spot itchy was added. Historical vaccine were added. Added Emgality with the start date of vaccineAdded concomitant medication. Added Zyrtec, women a day, estradiol with the start dat and Vitamin C was added. Added outcome of event.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive
Clinical narrative: Positive COVID-19 Serology test; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID-19 Serology test) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID-19 Serology test). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID-19 Serology test) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Mixed series vaccines (First Pfizer, second Moderna); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Mixed series vaccines (First Pfizer, second Moderna)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Mixed series vaccines (First Pfizer, second Moderna)). At the time of the report, WRONG PRODUCT ADMINISTERED (Mixed series vaccines (First Pfizer, second Moderna)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms; fever night at 103 Deg; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever night at 103 Deg) and MYALGIA (Body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever night at 103 Deg) and MYALGIA (Body ache). The patient was treated with PARACETAMOL at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever night at 103 Deg) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: arm became swollen and red, it's also warm; arm became swollen and red, it's also warm; arm became swollen and red, it's also warm; arm was really sore to the extent it hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm became swollen and red, it's also warm), VACCINATION SITE WARMTH (arm became swollen and red, it's also warm), VACCINATION SITE ERYTHEMA (arm became swollen and red, it's also warm) and VACCINATION SITE PAIN (arm was really sore to the extent it hurt) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (arm was really sore to the extent it hurt). On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became swollen and red, it's also warm). On an unknown date, the patient experienced PERIPHERAL SWELLING (arm became swollen and red, it's also warm) and VACCINATION SITE WARMTH (arm became swollen and red, it's also warm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, VACCINATION SITE PAIN (arm was really sore to the extent it hurt) had resolved. At the time of the report, PERIPHERAL SWELLING (arm became swollen and red, it's also warm), VACCINATION SITE WARMTH (arm became swollen and red, it's also warm) and VACCINATION SITE ERYTHEMA (arm became swollen and red, it's also warm) outcome was unknown.            No concomitant medication details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received and contains No New inforrmation; 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: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Stress
Clinical narrative: stressed; wanted to sleep; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (stressed) and SLEEP DISORDER (wanted to sleep) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prediabetes and Blood clot in urine. Concomitant products included METFORMIN and RIVAROXABAN (XARELTO) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced STRESS (stressed) and SLEEP DISORDER (wanted to sleep). At the time of the report, STRESS (stressed) and SLEEP DISORDER (wanted to sleep) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received. Suspect product start month and first dose events, events outcome as resolved were added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Headache, Pain, Vaccination site pain
Clinical narrative: body aches; head aches; sting on the hand's veins; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (head aches) and VACCINATION SITE PAIN (sting on the hand's veins) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and Hypercholesterolemia.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), HEADACHE (head aches) and VACCINATION SITE PAIN (sting on the hand's veins). The patient was treated with NAPROXEN at a dose of 500 milligram. At the time of the report, PAIN (body aches), HEADACHE (head aches) and VACCINATION SITE PAIN (sting on the hand's veins) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: super high (High) super high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Off label use, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: dry cough; cold; fever; second dose was rescheduled outside the window; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Contracted COVID), COUGH (dry cough), NASOPHARYNGITIS (cold), PYREXIA (fever) and OFF LABEL USE (second dose was rescheduled outside the window) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Contracted COVID). On an unknown date, the patient experienced COUGH (dry cough), NASOPHARYNGITIS (cold), PYREXIA (fever) and OFF LABEL USE (second dose was rescheduled outside the window). At the time of the report, SARS-COV-2 TEST POSITIVE (Contracted COVID), COUGH (dry cough), NASOPHARYNGITIS (cold) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: chills; fatigue; injection arm soreness/right arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (injection arm soreness/right arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (injection arm soreness/right arm). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (injection arm soreness/right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  The patient took Advil to relieve the symptoms.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-086253 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: headaches; dizziness; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for Thyroiditis.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nauseous). At the time of the report, HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nauseous) outcome was unknown. Not Provided        The action takren with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Treatment products included Tylenol and advil.   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: dizziness at work; experiencing symptoms the next day including swelling; redness at injection site; pain a little bit (not that much) at injection site; feeling nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness at work), VACCINATION SITE SWELLING (experiencing symptoms the next day including swelling), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain a little bit (not that much) at injection site) and NAUSEA (feeling nauseous) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (dizziness at work), VACCINATION SITE SWELLING (experiencing symptoms the next day including swelling), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PAIN (pain a little bit (not that much) at injection site) and NAUSEA (feeling nauseous). The patient was treated with IBUPROFEN at a dose of 1 dosage form once. On 16-Apr-2021, DIZZINESS (dizziness at work), VACCINATION SITE PAIN (pain a little bit (not that much) at injection site) and NAUSEA (feeling nauseous) had resolved. At the time of the report, VACCINATION SITE SWELLING (experiencing symptoms the next day including swelling) and VACCINATION SITE ERYTHEMA (redness at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. It was reported that patient took Ibuprofen prior to receiving the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Outcome of the events Redness at the injection site,Swelling at injection site were changed from Unknown to recovering
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site discomfort
Clinical narrative: slight discomfort at the injection site; second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOMFORT (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose). At the time of the report, VACCINATION SITE DISCOMFORT (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported     Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up document received on 23-04-2021 contains No New Information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sore arm in the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm in the injection site arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm in the injection site arm). At the time of the report, INJECTION SITE PAIN (sore arm in the injection site arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-086345 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose administered to 17 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old). On 21-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 17 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Initial additional. Reporter reported no adverse reaction.