chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: migraines; arm of injection warm; arm of injection hard; arm of injection itchy; arm of injection red; Chills; tired; low grade temp 100.6F; slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), VACCINATION SITE WARMTH (arm of injection warm), VACCINATION SITE INDURATION (arm of injection hard), VACCINATION SITE PRURITUS (arm of injection itchy) and VACCINATION SITE ERYTHEMA (arm of injection red) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included GERD. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced MIGRAINE (migraines), VACCINATION SITE WARMTH (arm of injection warm), VACCINATION SITE INDURATION (arm of injection hard), VACCINATION SITE PRURITUS (arm of injection itchy), VACCINATION SITE ERYTHEMA (arm of injection red), CHILLS (Chills), FATIGUE (tired), PYREXIA (low grade temp 100.6F) and NAUSEA (slight nausea). The patient was treated with ACETAMINOPHEN for Migraine, at an unspecified dose and frequency. On 09-May-2021, MIGRAINE (migraines), CHILLS (Chills), FATIGUE (tired), PYREXIA (low grade temp 100.6F) and NAUSEA (slight nausea) had resolved. At the time of the report, VACCINATION SITE WARMTH (arm of injection warm), VACCINATION SITE INDURATION (arm of injection hard), VACCINATION SITE PRURITUS (arm of injection itchy) and VACCINATION SITE ERYTHEMA (arm of injection red) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Body temperature: 100.6 (High) low grade temp 100.6F.         Concomitant included vitamins and two medications for GERD ( unspecified)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: sore to the touch; Dark spot at the injection site,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Dark spot at the injection site,) and VACCINATION SITE PAIN (sore to the touch) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Dark spot at the injection site,). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore to the touch). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-116362 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy after 1st dose of Moderna COVID 19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Mar-2021 and the estimated date of delivery was 16-Dec-2021. On 03-May-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy after 1st dose of Moderna COVID 19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy. On 03-May-2021, EXPOSURE DURING PREGNANCY (Pregnancy after 1st dose of Moderna COVID 19 vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Pregnancy test: positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details were reported. No treatment medication details was reported.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: plaque psoriasis flare up on torso with Skyrizi; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (plaque psoriasis flare up on torso with Skyrizi) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (plaque psoriasis flare up on torso with Skyrizi). At the time of the report, PSORIASIS (plaque psoriasis flare up on torso with Skyrizi) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported   This case was linked to MOD-2021-116356 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive COVID test after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID test after receiving vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLLAGEN for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID test after receiving vaccine). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; VITAMINS NOS (MULTIVITAMINUM) at an unspecified dose and frequency; MELATONIN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID test after receiving vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, COVID-19: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Vitamin C, Multivitamin, Melatonin, Aspirin   This case was linked to MOD21-088505, US-MODERNATX, INC.-MOD-2021-116365 (E2B Linked Report).; Sender's Comments:  MOD21-088505: US-MODERNATX, INC.-MOD-2021-116365:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive COVID test after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive COVID test after vaccination) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive COVID test after vaccination). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; MULTIVITAMIN [VITAMINS NOS] at an unspecified dose and frequency; MELATONIN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (positive COVID test after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-116363 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116363:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Deviation from the recommended dosing interval; Patient contracted COVID-19 after the first vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from the recommended dosing interval) and SARS-COV-2 TEST POSITIVE (Patient contracted COVID-19 after the first vaccination) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from the recommended dosing interval) and SARS-COV-2 TEST POSITIVE (Patient contracted COVID-19 after the first vaccination). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from the recommended dosing interval) had resolved and SARS-COV-2 TEST POSITIVE (Patient contracted COVID-19 after the first vaccination) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid after getting 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid after getting 2nd dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 SARS-COV-2 TEST POSITIVE (tested positive for Covid after getting 2nd dose). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid after getting 2nd dose) outcome was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: sore arm,aches; tiredness; pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm,aches), FATIGUE (tiredness) and PAIN (pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS) and Thyroid medication for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FATIGUE (tiredness) and PAIN (pain). On an unknown date, the patient experienced MYALGIA (sore arm,aches). On 27-Apr-2021, FATIGUE (tiredness) and PAIN (pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Night sweats, Rash
Clinical narrative: night sweats; slight rash on face like acne; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats), RASH (slight rash on face like acne) and HEADACHE (slight headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced NIGHT SWEATS (night sweats), RASH (slight rash on face like acne) and HEADACHE (slight headache). On 02-Apr-2021, RASH (slight rash on face like acne) and HEADACHE (slight headache) had resolved. At the time of the report, NIGHT SWEATS (night sweats) 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.   This case was linked to MOD-2021-116382 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: headache is persisting; headache is constant; fever (104 Fahrenheit)/Rechecked his temperature/100.6 Fahrenheit; chills; tiredness; pain; aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PAIN IN EXTREMITY (aches), HEADACHE (headache is persisting), ARTHRALGIA (sore arm) and FATIGUE (tiredness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ARTHRALGIA (sore arm). On 06-May-2021, the patient experienced PAIN (pain), PAIN IN EXTREMITY (aches), FATIGUE (tiredness) and CHILLS (chills). On 07-May-2021, the patient experienced PYREXIA (fever (104 Fahrenheit)/Rechecked his temperature/100.6 Fahrenheit). On an unknown date, the patient experienced HEADACHE (headache is persisting) and HEADACHE (headache is constant). At the time of the report, PAIN (pain), PAIN IN EXTREMITY (aches), HEADACHE (headache is persisting), ARTHRALGIA (sore arm), FATIGUE (tiredness), PYREXIA (fever (104 Fahrenheit)/Rechecked his temperature/100.6 Fahrenheit), CHILLS (chills) and HEADACHE (headache is constant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include Tylenol 2 dose of 350 mg for fever Rubbed down with alcohol.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: headache is persisting; headache is constant; fever (104 Fahrenheit)/Rechecked his temperature/100.6 Fahrenheit; chills; tiredness; pain; aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), PAIN IN EXTREMITY (aches), HEADACHE (headache is persisting), ARTHRALGIA (sore arm) and FATIGUE (tiredness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ARTHRALGIA (sore arm). On 06-May-2021, the patient experienced PAIN (pain), PAIN IN EXTREMITY (aches), FATIGUE (tiredness) and CHILLS (chills). On 07-May-2021, the patient experienced PYREXIA (fever (104 Fahrenheit)/Rechecked his temperature/100.6 Fahrenheit). On an unknown date, the patient experienced HEADACHE (headache is persisting) and HEADACHE (headache is constant). At the time of the report, PAIN (pain), PAIN IN EXTREMITY (aches), HEADACHE (headache is persisting), ARTHRALGIA (sore arm), FATIGUE (tiredness), PYREXIA (fever (104 Fahrenheit)/Rechecked his temperature/100.6 Fahrenheit), CHILLS (chills) and HEADACHE (headache is constant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include Tylenol 2 dose of 350 mg for fever Rubbed down with alcohol.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Type IV hypersensitivity reaction
Clinical narrative: ¨i am sick , i Was Diagnosed with COVID¨; ¨i am sick , i Was Diagnosed with COVID¨; Lack of efficacy; Delayed reaction; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (¨i am sick , i Was Diagnosed with COVID¨), COVID-19 (¨i am sick , i Was Diagnosed with COVID¨), TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction) and DRUG INEFFECTIVE (Lack of efficacy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037U20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction). On 10-May-2021, the patient experienced ILLNESS (¨i am sick , i Was Diagnosed with COVID¨), COVID-19 (¨i am sick , i Was Diagnosed with COVID¨) and DRUG INEFFECTIVE (Lack of efficacy). On 10-May-2021, DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown. At the time of the report, ILLNESS (¨i am sick , i Was Diagnosed with COVID¨), COVID-19 (¨i am sick , i Was Diagnosed with COVID¨) and TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.  The event of drug ineffective is assessed as possible. Based on the current available information and temporal association between the use of the product and the start date of the event of Type IV hypersensitivity reaction, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Upon internal review on 14 Jul 2021, an event (lack of efficacy) was added at Moderna's request.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.  The event of drug ineffective is assessed as possible. Based on the current available information and temporal association between the use of the product and the start date of the event of Type IV hypersensitivity reaction, a causal relationship cannot be excluded.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout flare up after 1st dose of Moderna COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flare up after 1st dose of Moderna COVID 19 vaccine) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Gout.    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 GOUT (Gout flare up after 1st dose of Moderna COVID 19 vaccine). At the time of the report, GOUT (Gout flare up after 1st dose of Moderna COVID 19 vaccine) outcome was unknown. 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.   Concomitant Colchicine
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Chills, Influenza, Pain in extremity, Pyrexia
Clinical narrative: thought she had the flu; fever; chills; arm sore; Lump on left arm/very painful lump under the armpit/lump under the armpit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), AXILLARY MASS (Lump on left arm/very painful lump under the armpit/lump under the armpit), INFLUENZA (thought she had the flu), PYREXIA (fever) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022-B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (arm sore) and AXILLARY MASS (Lump on left arm/very painful lump under the armpit/lump under the armpit). On 08-May-2021, the patient experienced INFLUENZA (thought she had the flu), PYREXIA (fever) and CHILLS (chills). On 09-May-2021, INFLUENZA (thought she had the flu), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN IN EXTREMITY (arm sore) and AXILLARY MASS (Lump on left arm/very painful lump under the armpit/lump under the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication  include anxiety medication. Treatment medication include Ibuprofen .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007Bz1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), AZITHROMYCIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), OMEGA-3-ACID ETHYL ESTER, IBUPROFEN, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA HANDIHALER), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT FORTE TURBUHALER) and TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication.    On 25-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 LYMPH NODE PAIN (Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection). At the time of the report, LYMPH NODE PAIN (Swollen and tender Lymph nodes causing difficulty sleeping on the same side as the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: patient is only 17 years old; Arm soreness for 1 day; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 17 years old) and PAIN IN EXTREMITY (Arm soreness for 1 day) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Crabs, shrimp).   On 06-May-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 17 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness for 1 day). On 06-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is only 17 years old) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness for 1 day) had resolved. 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 09-Jun-2021: Added other relevant history. Added new event-pain in extremity. Added second dose details of a patient. Updated reporter information and patient details. Updated the time of first dose. Updated action taken in products tab and product-event details.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine; "patient felt horrible"; Fever; Chills; Nausea; Diarrhea; tired; Rash; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Hypertension.    On 20-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 COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), FATIGUE (tired) and RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), FATIGUE (tired) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash
Clinical narrative: tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine; "patient felt horrible"; Fever; Chills; Nausea; Diarrhea; tired; Rash; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Hypertension.    On 20-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 COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), FATIGUE (tired) and RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid Infection after receiving the 1st dose of Moderna vaccine), FEELING ABNORMAL ("patient felt horrible"), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIARRHOEA (Diarrhea), FATIGUE (tired) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, SARS-CoV-2 antibody test positive, Somnolence
Clinical narrative: RT-PCR positive for covid; Tiredness; drowsiness; congestion; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), SOMNOLENCE (drowsiness), NASAL CONGESTION (congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (RT-PCR positive for covid) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) 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) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (Tiredness), SOMNOLENCE (drowsiness) and NASAL CONGESTION (congestion). On 24-Apr-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (RT-PCR positive for covid). At the time of the report, FATIGUE (Tiredness), SOMNOLENCE (drowsiness), NASAL CONGESTION (congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (RT-PCR positive for covid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 PAIN IN EXTREMITY (Sore arm). On 16-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.    This case was linked to MOD21-088435, US-MODERNATX, INC.-MOD-2021-116485 (E2B Linked Report).; Sender's Comments:  MOD21-088435:wife's case US-MODERNATX, INC.-MOD-2021-116485:wife's case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Illness, Myalgia, Nasopharyngitis
Clinical narrative: sensitive to medication; CHILLS; muscle pain; sick with a bad cold; sick with a bad cold; cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with a bad cold), NASOPHARYNGITIS (sick with a bad cold), COUGH (cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered), SENSITISATION (sensitive to medication) and CHILLS (CHILLS) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ILLNESS (sick with a bad cold), NASOPHARYNGITIS (sick with a bad cold) and COUGH (cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered). On an unknown date, the patient experienced SENSITISATION (sensitive to medication), CHILLS (CHILLS) and MYALGIA (muscle pain). At the time of the report, ILLNESS (sick with a bad cold), NASOPHARYNGITIS (sick with a bad cold), COUGH (cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered), SENSITISATION (sensitive to medication), CHILLS (CHILLS) and MYALGIA (muscle pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-052120 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Patient route of administration was updated as unknown
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitisation
Clinical narrative: sensitive to medication; CHILLS; muscle pain; sick with a bad cold; sick with a bad cold; cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with a bad cold), NASOPHARYNGITIS (sick with a bad cold), COUGH (cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered), SENSITISATION (sensitive to medication) and CHILLS (CHILLS) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ILLNESS (sick with a bad cold), NASOPHARYNGITIS (sick with a bad cold) and COUGH (cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered). On an unknown date, the patient experienced SENSITISATION (sensitive to medication), CHILLS (CHILLS) and MYALGIA (muscle pain). At the time of the report, ILLNESS (sick with a bad cold), NASOPHARYNGITIS (sick with a bad cold), COUGH (cough that went down to my chest, still had a cough and tickling in my throat, never completely recovered), SENSITISATION (sensitive to medication), CHILLS (CHILLS) and MYALGIA (muscle pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-052120 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Patient route of administration was updated as unknown
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: I felt sleepy; I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I felt sleepy) and FATIGUE (I felt tired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced SOMNOLENCE (I felt sleepy) and FATIGUE (I felt tired). On 07-Apr-2021, SOMNOLENCE (I felt sleepy) and FATIGUE (I felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear pain, Headache, Nausea, Pain in extremity
Clinical narrative: Sore left arm; Right ear stopped up; Ear pain; Loud ringing in ears; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            Concomitant medications was not provided. Treatment medications was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Sore left arm; Right ear stopped up; Ear pain; Loud ringing in ears; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore left arm), EAR CONGESTION (Right ear stopped up), EAR PAIN (Ear pain), TINNITUS (Loud ringing in ears), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            Concomitant medications was not provided. Treatment medications was not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: COVID-19; greater than 35 days between Covid 19 first and second vaccination; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Covid 19 first and second vaccination) and VACCINATION SITE PAIN (sore right injection site arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-May-2021.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Covid 19 first and second vaccination) and VACCINATION SITE PAIN (sore right injection site arm). On 03-May-2021, the patient experienced COVID-19 (COVID-19). On 03-Jun-2021, PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Covid 19 first and second vaccination) had resolved. At the time of the report, COVID-19 (COVID-19) and VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: unknown (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were given by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of extreme fatigue, aches, pyrexia (temperature of 102), dyspnea (shortness of breath) and pain(s) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036A21A) for COVID-19 immunization. No medical history reported. On Apr 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced extreme fatigue, aches, pyrexia (temperature of 102), dyspnea (shortness of breath) and pain(s). At the time of the report, extreme fatigue, aches, pyrexia (temperature of 102), dyspnea (shortness of breath) and pain(s) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb injury
Clinical narrative: Original second shot was supposed to be 29April2021 and had to postpone that one; scraped my arm cleaning up scrap metal enough to draw blood; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Original second shot was supposed to be 29April2021 and had to postpone that one) and LIMB INJURY (scraped my arm cleaning up scrap metal enough to draw blood) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: TETANUS (The patient stated that he got the tetanus shot at pharmacy) on 09-May-2021.    On 01-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Original second shot was supposed to be 29April2021 and had to postpone that one) and LIMB INJURY (scraped my arm cleaning up scrap metal enough to draw blood). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Original second shot was supposed to be 29April2021 and had to postpone that one) and LIMB INJURY (scraped my arm cleaning up scrap metal enough to draw blood) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inflammation, Lip swelling, Swelling face, Throat tightness
Clinical narrative: Full of allergies; Hives from her shoulders to the top/full of hives; Face swelled; Throat closed up; Inflammation; Swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Full of allergies), URTICARIA (Hives from her shoulders to the top/full of hives), SWELLING FACE (Face swelled), THROAT TIGHTNESS (Throat closed up) and INFLAMMATION (Inflammation) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CA1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced HYPERSENSITIVITY (Full of allergies), URTICARIA (Hives from her shoulders to the top/full of hives), SWELLING FACE (Face swelled), THROAT TIGHTNESS (Throat closed up), INFLAMMATION (Inflammation) and LIP SWELLING (Swollen lips). The patient was treated with PREDNISONE for Allergy, at a dose of 10 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) for Allergy, at an unspecified dose and frequency and AMOXICILLIN TRIHYDRATE (AMOXIDIN) for Allergy, at an unspecified dose and frequency. On 09-May-2021, LIP SWELLING (Swollen lips) had resolved. At the time of the report, HYPERSENSITIVITY (Full of allergies), URTICARIA (Hives from her shoulders to the top/full of hives), SWELLING FACE (Face swelled), THROAT TIGHTNESS (Throat closed up) and INFLAMMATION (Inflammation) 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.   The patient had picket at the pharmacy and injections at the hospital   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Document received and does not contain any new information