chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Vaccination site pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (fatigue) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-073354, MOD-2021-073354 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient administered dose before recommended scheduled vaccine date; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, 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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered dose before recommended scheduled vaccine date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received and does not contain any new information.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Myalgia, Swelling
Clinical narrative: redness at the injection site; soreness at the injection site; swelling at the injection site; soreness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site), INJECTION SITE SWELLING (swelling at the injection site), MYALGIA (soreness) and SWELLING (swelling) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus non-insulin-dependent, Blood pressure high and Inflammation. Concomitant products included PREDNISONE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (soreness) and SWELLING (swelling). On 16-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site). On 18-Feb-2021, MYALGIA (soreness) and SWELLING (swelling) had resolved. On 19-Mar-2021, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE DISCOMFORT (soreness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: follow up received includes Patient medical history, concomitant medication, events updated.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain after getting their first dose of the Moderna covid19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after getting their first dose of the Moderna covid19) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0331521a) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia, Blood pressure and Diabetic. Concomitant products included ATORVASTATIN, LISINOPRIL and EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) for an unknown indication.    On 10-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced PAIN IN EXTREMITY (Arm pain after getting their first dose of the Moderna covid19). At the time of the report, PAIN IN EXTREMITY (Arm pain after getting their first dose of the Moderna covid19) 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 medication was not reported.  Reporter mentioned that patient stopped taking concomitant medications five days prior to vaccination and didn't specified the motive for this decision.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up received on 11-JUL-2021 is not significant. Event verbatim is changed but the PT term remains the same.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hyperhidrosis
Clinical narrative: sweating overnight; Chills; arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Drug allergy (Allergic to neomycin). Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and LEVALBUTEROL [LEVOSALBUTAMOL] for Asthma.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia). On 18-Mar-2021, HYPERHIDROSIS (sweating overnight), CHILLS (Chills) and ARTHRALGIA (arthralgia) had resolved.            Concomitant included vitamins was noted. No treatment information was provided by the reporter.   This case was linked to MOD-2021-022028 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Blister
Clinical narrative: Blisters; three different adverse effects; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters) and ADVERSE REACTION (three different adverse effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol (has not taken medication for it). Concomitant products included VITAMIN D NOS for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, 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 experienced BLISTER (Blisters) and ADVERSE REACTION (three different adverse effects). The patient was treated with GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, BLISTER (Blisters) and ADVERSE REACTION (three different adverse effects) outcome was unknown.            Concomitant medications also included Vitamin D deficiency medications and pain medications. Other Treatment information includes Neosporin and it dissipated for first incidence , Lysol wipes, A1 bleach on skin.  Patient have had three different adverse effects on body and was now dealing with the third.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU-Event provided On 14-Aug-2021: FU added:events images On 14-Aug-2021: Follow-up 5 received event images. On 18-Aug-2021: NNI FU: no new information On 20-Aug-2021: Follow up received and contains no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite
Clinical narrative: 2 insect looking bites on buttocks; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD BITE (2 insect looking bites on buttocks) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METHOTREXATE, FOLIC ACID, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and TRIAMCINOLONE for an unknown indication.    On 04-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 ARTHROPOD BITE (2 insect looking bites on buttocks). At the time of the report, ARTHROPOD BITE (2 insect looking bites on buttocks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant medications were Benadryl Gel and triamcinolone cream.  No treatment medication was provided Patient stated that she had 2 insect looking bites on the back of her buttocks that went away after taking an antihistamine. Patient stated that she completed the form but don't know how to return it via email. Patient printed it out and copied it if you can send an actual address to mail it.   This case was linked to MOD-2021-254162 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Aug-2021: Non significant follow up received and does not contain any new information
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received first dose) 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 medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-254000 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant information Appended. 2nd dose details provided .
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vaccination site rash
Clinical narrative: Dizziness; Allergic red rash at the injection site/the rash is not itchy and painful; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) and PYREXIA (Little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 031B21A) for COVID-19 vaccination.     Patient medical history was not reported.  Concomitant products included FISH OIL for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (Dizziness), VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) and PYREXIA (Little fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness) and PYREXIA (Little fever) outcome was unknown and VACCINATION SITE RASH (Allergic red rash at the injection site/the rash is not itchy and painful) was resolving.            Patient reported that on the same day of the second vaccination, she developed fever and dizziness. Two to three hours after the second shot she noticed an allergic red rash at the injection site. The following day on 12-MAY-2021 she visited Urgent Care who advised to wait for two days and the rash would disappear by itself. Patient took Ibuprofen for the symptoms. The rash was persisting and the patient was quoted, "I want a clean hand. " The rash was not itchy nor painful. The concern was if the symptoms were normal adverse reactions after receiving the Moderna vaccine and what she should do since the rash was persisting.    This case was linked to MOD-2021-133429 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: The nurse inadvertently administered 1ml instead of 0.5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml). On 27-Apr-2021, ACCIDENTAL OVERDOSE (The nurse inadvertently administered 1ml instead of 0.5ml) 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 treatment medication was provided.   This case was linked to MOD-2021-092554, MOD-2021-092190 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Colonoscopy, Diarrhoea, Fatigue, Stool analysis
Clinical narrative: Lymphocytic colitis; severe diarrhea; Tiredness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COLITIS MICROSCOPIC (Lymphocytic colitis) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Augmentin). Concomitant products included MULTIVITAMIN [VITAMINS NOS], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 22-May-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced DIARRHEA (severe diarrhea) and FATIGUE (Tiredness). On 28-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLITIS MICROSCOPIC (Lymphocytic colitis) (seriousness criterion medically significant). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date at an unspecified dose and frequency and BUDESONIDE for Adverse event, at a dose of two weeks. At the time of the report, COLITIS MICROSCOPIC (Lymphocytic colitis) and DIARRHEA (severe diarrhea) had not resolved and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Stool analysis: normal (normal) no infection. On 28-Jul-2021, Colonoscopy: abnormal (abnormal) Lymphocytic colitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Updated  reporter information, patient demographics, Added medical history, Lab data, updated,concomitant ,Vaccination facility information, Event onset date; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Atrophy, Fatigue, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms; pain like pins and needles poking all over; Tightening between the ball and heel of her left foot; atrophy in feet; Mild headache; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot), ATROPHY (atrophy in feet) and HEADACHE (Mild headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was reported.  Concomitant products included MAGNESIUM for Muscle disorder NOS, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, VITAMIN B1 NOS (B COMPLEX [NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS]) for Nerve injury, MULTIVITAMIN [VITAMINS NOS], RETINOL (VITAMIN-A), ASCORBIC ACID (VITAMIN-C), VITAMIN B NOS, VITAMIN E NOS (VITAMIIN E), ZINC, MILK OF MAGNESIA and VITAMIN D NOS for an unknown indication.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced HEADACHE (Mild headache) and FATIGUE (Extremely tired). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) and ATROPHY (atrophy in feet). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at a dose of 100 mg; GABAPENTIN at a dose of 100 mg; MAGNESIUM SULFATE (EPSOM SALT) for Adverse event, at an unspecified dose and frequency and Physical therapy (Exercises on own) for Hypoaesthesia. At the time of the report, HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), ATROPHY (atrophy in feet), HEADACHE (Mild headache) and FATIGUE (Extremely tired) had not resolved and PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added treatment medications Aspirin & Gabapentin and new events. On 02-Aug-2021: Added New event atrophy in feet and concomitant medications On 13-Aug-2021: Significant TCR received. case updated to not recovered/Not resolved
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms; pain like pins and needles poking all over; Tightening between the ball and heel of her left foot; atrophy in feet; Mild headache; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot), ATROPHY (atrophy in feet) and HEADACHE (Mild headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was reported.  Concomitant products included MAGNESIUM for Muscle disorder NOS, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, VITAMIN B1 NOS (B COMPLEX [NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS]) for Nerve injury, MULTIVITAMIN [VITAMINS NOS], RETINOL (VITAMIN-A), ASCORBIC ACID (VITAMIN-C), VITAMIN B NOS, VITAMIN E NOS (VITAMIIN E), ZINC, MILK OF MAGNESIA and VITAMIN D NOS for an unknown indication.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced HEADACHE (Mild headache) and FATIGUE (Extremely tired). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) and ATROPHY (atrophy in feet). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at a dose of 100 mg; GABAPENTIN at a dose of 100 mg; MAGNESIUM SULFATE (EPSOM SALT) for Adverse event, at an unspecified dose and frequency and Physical therapy (Exercises on own) for Hypoaesthesia. At the time of the report, HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), ATROPHY (atrophy in feet), HEADACHE (Mild headache) and FATIGUE (Extremely tired) had not resolved and PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added treatment medications Aspirin & Gabapentin and new events. On 02-Aug-2021: Added New event atrophy in feet and concomitant medications On 13-Aug-2021: Significant TCR received. case updated to not recovered/Not resolved
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Fatigue, SARS-CoV-2 test, Sinoscopy
Clinical narrative: cough still like covid mucous in bronchial tubes; cough still like covid mucous in bronchial tubes; Tired than ususal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 041B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Drug allergy (allergy to oxysporein drugs in antibiotic), Anaphylaxis (Full blown anaphylaxis on tablet) since June 2012, Autoimmune thyroid disorder since 15-Jun-2014, Arthritis and Hypertension. Concomitant products included HYDROXYCHLOROQUINE from 04-Sep-2019 to an unknown date and DULOXETINE from 19-Jun-2019 to an unknown date for Arthritis, LISINOPRIL for Blood pressure management, LIOTHYRONINE for Hypothyroidism, LEVOTHYROXINE for Thyroid activity decreased, PARACETAMOL (TYLENOL) and VIT D [VITAMIN D NOS] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-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 COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal). The patient was treated with IPRATROPIUM BROMIDE at a dose of nasal solution. At the time of the report, COUGH (cough still like covid mucous in bronchial tubes), BRONCHITIS (cough still like covid mucous in bronchial tubes) and FATIGUE (Tired than ususal) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, SARS-CoV-2 test:. On an unknown date, Sinoscopy: normal (normal) right sinus examined with scope- looked ok.         This case was linked to MOD-2021-053063 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia, Product dose omission issue, Pyrexia
Clinical narrative: My right foot felt like it was asleep; Tingling in her right leg; rash on her right leg; More than 35 days since the patient received her first Moderna Covid-19 vaccine; Tinnitus; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), TINNITUS (Tinnitus), PARAESTHESIA (Tingling in her right leg) and RASH (rash on her right leg) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 22-Apr-2021, the patient experienced TINNITUS (Tinnitus). On 23-Apr-2021, the patient experienced PARAESTHESIA (Tingling in her right leg), RASH (rash on her right leg) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since the patient received her first Moderna Covid-19 vaccine). On an unknown date, the patient experienced HYPOAESTHESIA (My right foot felt like it was asleep). At the time of the report, PYREXIA (Fever), CHILLS (Chills), TINNITUS (Tinnitus), PARAESTHESIA (Tingling in her right leg), RASH (rash on her right leg), PRODUCT DOSE OMISSION ISSUE (More than 35 days since the patient received her first Moderna Covid-19 vaccine) and HYPOAESTHESIA (My right foot felt like it was asleep) 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 drugs included no concomitant drugs included
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tinnitus
Clinical narrative: My right foot felt like it was asleep; Tingling in her right leg; rash on her right leg; More than 35 days since the patient received her first Moderna Covid-19 vaccine; Tinnitus; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), TINNITUS (Tinnitus), PARAESTHESIA (Tingling in her right leg) and RASH (rash on her right leg) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 22-Apr-2021, the patient experienced TINNITUS (Tinnitus). On 23-Apr-2021, the patient experienced PARAESTHESIA (Tingling in her right leg), RASH (rash on her right leg) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since the patient received her first Moderna Covid-19 vaccine). On an unknown date, the patient experienced HYPOAESTHESIA (My right foot felt like it was asleep). At the time of the report, PYREXIA (Fever), CHILLS (Chills), TINNITUS (Tinnitus), PARAESTHESIA (Tingling in her right leg), RASH (rash on her right leg), PRODUCT DOSE OMISSION ISSUE (More than 35 days since the patient received her first Moderna Covid-19 vaccine) and HYPOAESTHESIA (My right foot felt like it was asleep) 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 drugs included no concomitant drugs included
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 36 days since got the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days since got the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose on day 34 of refrigeration, 4 days over use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose on day 34 of refrigeration, 4 days over use by date) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Additional information received included that the vials were stored in liquid state for 34 days from 3C to 5C and only exposed to 70F for 30 minutes during administration. Upon visual inspection, the vaccine looked normal.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received on 15-Jul-2021 and included reporter details, suspect vaccine details and updated to events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARAFFIN (VASELINE INTENSIVE CARE [PARAFFIN]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-017966 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received on 12-Jul-2021 and updated outcome of the event as resolved.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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 were not provided concomitant drugs were not provided   This case was linked to MOD-2021-067524, MOD-2021-221042, MOD-2021-257250 (Patient Link).
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity
Clinical narrative: Sore arm; Intentional administration of vaccine to patient <18 yrs of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Intentional administration of vaccine to patient <18 yrs of age) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02b21a and 043b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-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 PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Intentional administration of vaccine to patient <18 yrs of age). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and OFF LABEL USE (Intentional administration of vaccine to patient <18 yrs of age) 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 was provided. No treatment medication was provided. Patient race is black.   This case was linked to MOD-2021-067524, MOD-2021-221042, MOD-2021-257236 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Back pain, Gait disturbance, Insomnia
Clinical narrative: leg pain and hand pain; back pain; vertigo; difficulty walking; difficulty sleeping; arthritis gotten worse; hip pain and knee pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking) and INSOMNIA (difficulty sleeping) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle fracture and Arthritis.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking), INSOMNIA (difficulty sleeping), ARTHRITIS (arthritis gotten worse) and ARTHRALGIA (hip pain and knee pain). At the time of the report, PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking), INSOMNIA (difficulty sleeping), ARTHRITIS (arthritis gotten worse) and ARTHRALGIA (hip pain and knee pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   This case was linked to MOD-2021-257873.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non significant follow-up. On 14-Aug-2021: Follow-up information contains action taken update from  Unknown to No change.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vertigo
Clinical narrative: leg pain and hand pain; back pain; vertigo; difficulty walking; difficulty sleeping; arthritis gotten worse; hip pain and knee pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking) and INSOMNIA (difficulty sleeping) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle fracture and Arthritis.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking), INSOMNIA (difficulty sleeping), ARTHRITIS (arthritis gotten worse) and ARTHRALGIA (hip pain and knee pain). At the time of the report, PAIN IN EXTREMITY (leg pain and hand pain), BACK PAIN (back pain), VERTIGO (vertigo), GAIT DISTURBANCE (difficulty walking), INSOMNIA (difficulty sleeping), ARTHRITIS (arthritis gotten worse) and ARTHRALGIA (hip pain and knee pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   This case was linked to MOD-2021-257873.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non significant follow-up. On 14-Aug-2021: Follow-up information contains action taken update from  Unknown to No change.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-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 PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.            No concomitant medication was reported No treatment medication was provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Muscle spasms, Myalgia, Pain
Clinical narrative: Pain; Cramping really bad by her femur; Leg problems; Pain in left arm upper deltoid muscle still but sporadic; Pain that moves around the femur bone and knee concerned it could be a clot/pain moves down to her upper knee/pain moves down to her ankle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), MUSCLE SPASMS (Cramping really bad by her femur), LIMB DISCOMFORT (Leg problems), MYALGIA (Pain in left arm upper deltoid muscle still but sporadic) and ARTHRALGIA (Pain that moves around the femur bone and knee concerned it could be a clot/pain moves down to her upper knee/pain moves down to her ankle) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-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 PAIN (Pain), MUSCLE SPASMS (Cramping really bad by her femur), LIMB DISCOMFORT (Leg problems), MYALGIA (Pain in left arm upper deltoid muscle still but sporadic) and ARTHRALGIA (Pain that moves around the femur bone and knee concerned it could be a clot/pain moves down to her upper knee/pain moves down to her ankle). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Pain) had not resolved and MUSCLE SPASMS (Cramping really bad by her femur), LIMB DISCOMFORT (Leg problems), MYALGIA (Pain in left arm upper deltoid muscle still but sporadic) and ARTHRALGIA (Pain that moves around the femur bone and knee concerned it could be a clot/pain moves down to her upper knee/pain moves down to her ankle) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-257802 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Additional information was received on 04 Aug 2021 and new events added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Blood test, Chest pain, Colonoscopy, Dizziness
Clinical narrative: all COVID symptoms; shortness of breath; chest pain; taste very little; feeling of  light headedness upon bending; hardly can walk; body aches  all over; headache 24X7; extremely  tired; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (all COVID symptoms), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), AGEUSIA (taste very little) and DIZZINESS (feeling of  light headedness upon bending) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), AGEUSIA (taste very little), DIZZINESS (feeling of  light headedness upon bending), GAIT DISTURBANCE (hardly can walk), MYALGIA (body aches  all over), HEADACHE (headache 24X7) and FATIGUE (extremely  tired). On an unknown date, the patient experienced SUSPECTED COVID-19 (all COVID symptoms). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of once or twice  a week. At the time of the report, SUSPECTED COVID-19 (all COVID symptoms), DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), AGEUSIA (taste very little), DIZZINESS (feeling of  light headedness upon bending), GAIT DISTURBANCE (hardly can walk), MYALGIA (body aches  all over), HEADACHE (headache 24X7) and FATIGUE (extremely  tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) normal. In 2021, Colonoscopy: normal (normal) Normal. In 2021, Electrocardiogram: normal (normal) normal. In 2021, SARS-CoV-2 test: negative (Negative) negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included a cholesterol medicine and few other medications; names were not reported.  Treatment includes inhaler to be used every 8 hours for shortness of breath..   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non significant follow up. Source document (with no new information ) attached