chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15-year old patient received the 1st dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received the 1st dose of the Moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received the 1st dose of the Moderna vaccine). On 16-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received the 1st dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received included no new significant information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: The patient became scared about getting the second dose due to the media and never received her second administration of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (The patient became scared about getting the second dose due to the media and never received her second administration of the vaccine) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (She does have a history of heart problems, recently visited her cardiologist). Concomitant products included CARVEDILOL, PRAVASTATIN, EZETIMIBE, SPIRONOLACTONE, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (The patient became scared about getting the second dose due to the media and never received her second administration of the vaccine). On 24-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (The patient became scared about getting the second dose due to the media and never received her second administration of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she did not had any side effects following the vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Tongue ulceration
Clinical narrative: Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches; First vaccine was given beyond the 6 hour expiration.; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches) and EXPIRED PRODUCT ADMINISTERED (First vaccine was given beyond the 6 hour expiration.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced TONGUE ULCERATION (Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches) and EXPIRED PRODUCT ADMINISTERED (First vaccine was given beyond the 6 hour expiration.). The patient was treated with CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date for Tongue ulceration, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Tongue ulceration, at a dose of 1 dosage form and TRIAMCINOLONE (oral) ongoing from 16-Jul-2021 for Mouth ulcer, at a dose of 1 dosage form. In February 2021, EXPIRED PRODUCT ADMINISTERED (First vaccine was given beyond the 6 hour expiration.) had resolved. At the time of the report, TONGUE ULCERATION (Ulcer looking Appearance on her Tongue/ Recurrent Dark Red Patches/ Recurrent White Patches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products were not provided.  The ulcer or patches come and go, on different locations on the tongue,  and sometimes they are dark red and sometimes white.   This case was linked to MOD-2021-259033.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: got my period 15 days late; flow was all  is it affected by COVID-19 vaccine because is happened first time; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (got my period 15 days late) and MENSTRUAL DISORDER (flow was all  is it affected by COVID-19 vaccine because is happened first time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION DELAYED (got my period 15 days late) and MENSTRUAL DISORDER (flow was all  is it affected by COVID-19 vaccine because is happened first time). At the time of the report, MENSTRUATION DELAYED (got my period 15 days late) and MENSTRUAL DISORDER (flow was all  is it affected by COVID-19 vaccine because is happened first time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: little additional tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little additional tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin allergy), Drug allergy (Cortisone allergy) and Hypothyroidism (Low Thyroid). Concomitant products included LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [VITAMINS NOS], GLUCOSAMINE, FISH OIL and ZINC for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (little additional tiredness). At the time of the report, FATIGUE (little additional tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy ) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 an unknown date, the patient experienced DIZZINESS (Dizzy ). At the time of the report, DIZZINESS (Dizzy ) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Toothache
Clinical narrative: my teeth even hurts; arm very sour; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (my teeth even hurts), PAIN IN EXTREMITY (arm very sour), HEADACHE (headaches) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (my teeth even hurts), PAIN IN EXTREMITY (arm very sour), HEADACHE (headaches) and CHILLS (chills). At the time of the report, TOOTHACHE (my teeth even hurts), PAIN IN EXTREMITY (arm very sour), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Large red welt where the vaccine was administered.  It's getting larger each day.; 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 VACCINATION SITE URTICARIA (Large red welt where the vaccine was administered.  It's getting larger each day.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Large red welt where the vaccine was administered.  It's getting larger each day.). At the time of the report, VACCINATION SITE URTICARIA (Large red welt where the vaccine was administered.  It's getting larger each day.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Peripheral swelling
Clinical narrative: Arm is very very swollen (size of golf ball); First dose was Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is very very swollen (size of golf ball)) and INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is very very swollen (size of golf ball)) and INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer). At the time of the report, PERIPHERAL SWELLING (Arm is very very swollen (size of golf ball)) and INTERCHANGE OF VACCINE PRODUCTS (First dose was Pfizer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: weakness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and HEADACHE (Headaches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054c21a) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, the patient experienced ASTHENIA (weakness) and HEADACHE (Headaches). At the time of the report, ASTHENIA (weakness) outcome was unknown and HEADACHE (Headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia, Tongue ulceration
Clinical narrative: Ulcer or Patches come and go, on different locations on the Tongue; Chills After Second Shot; Fever (Unknown Fahrenheit) After Second Shot; Second dose administered more than a month after the First; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Ulcer or Patches come and go, on different locations on the Tongue), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than a month after the First), CHILLS (Chills After Second Shot) and PYREXIA (Fever (Unknown Fahrenheit) After Second Shot) in a 27-year-old female patient 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 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. In February 2021, the patient experienced TONGUE ULCERATION (Ulcer or Patches come and go, on different locations on the Tongue) and CHILLS (Chills After Second Shot). In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than a month after the First) and PYREXIA (Fever (Unknown Fahrenheit) After Second Shot). The patient was treated with CALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETICONE (MYLANTA [CALCIUM CARBONATE;MAGNESIUM HYDROXIDE;SIMETICONE]) (oral) for Mouth ulcer, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Mouth ulcer, at an unspecified dose and frequency and TRIAMCINOLONE for Mouth ulcer, at an unspecified dose and frequency. In February 2021, CHILLS (Chills After Second Shot) had resolved. In 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered more than a month after the First) and PYREXIA (Fever (Unknown Fahrenheit) After Second Shot) had resolved. At the time of the report, TONGUE ULCERATION (Ulcer or Patches come and go, on different locations on the Tongue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient reported that she experienced Tongue ulceration.   This case was linked to MOD-2021-259009 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Additional information received with no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Nodule, Swelling
Clinical narrative: swelling; nodule; wrist pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), NODULE (nodule) and ARTHRALGIA (wrist pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling), NODULE (nodule) and ARTHRALGIA (wrist pain). At the time of the report, SWELLING (swelling), NODULE (nodule) and ARTHRALGIA (wrist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Unevaluable event; 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 UNEVALUABLE EVENT (Unevaluable event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, UNEVALUABLE EVENT (Unevaluable event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter.  Treatment medication use information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste after taking the second shot of the vaccine; 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 AGEUSIA (loss of taste after taking the second shot of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste after taking the second shot of the vaccine). At the time of the report, AGEUSIA (loss of taste after taking the second shot of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Tongue ulceration
Clinical narrative: Patchy Ulcers on the Tongue after vaccination; 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 TONGUE ULCERATION (Patchy Ulcers on the Tongue after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONGUE ULCERATION (Patchy Ulcers on the Tongue after vaccination). At the time of the report, TONGUE ULCERATION (Patchy Ulcers on the Tongue after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non-Significant Follow-up
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Poor quality sleep, Vaccination site pain
Clinical narrative: Not feeling good today; Is uncomfortable; Arm was really sore at the injection site; Did not sleep well; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Did not sleep well), FEELING ABNORMAL (Not feeling good today), DISCOMFORT (Is uncomfortable) and VACCINATION SITE PAIN (Arm was really sore at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (3 stems after heart surgery.) in 2017. Concurrent medical conditions included Diabetic (Diabetic from 37 years now.). Concomitant products included METFORMIN, INSULIN, INSULIN DEGLUDEC (TRESIBA), INSULIN ASPART (NOVOLOG) and LIRAGLUTIDE (VICTOZA) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced POOR QUALITY SLEEP (Did not sleep well) and VACCINATION SITE PAIN (Arm was really sore at the injection site). On 16-Jul-2021, the patient experienced FEELING ABNORMAL (Not feeling good today) and DISCOMFORT (Is uncomfortable). At the time of the report, POOR QUALITY SLEEP (Did not sleep well), FEELING ABNORMAL (Not feeling good today), DISCOMFORT (Is uncomfortable) and VACCINATION SITE PAIN (Arm was really sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event, included blood thinners.  Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Vaccination complication
Clinical narrative: All side effects; Chest pain; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (All side effects), CHEST PAIN (Chest pain) and PAIN IN EXTREMITY (sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A and 026D21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Patient Allergic to Penicillin), Drug allergy (Patient Allergic to Topamax), Drug allergy (Patient Allergic to Benadryl), Drug allergy (Patient Allergic to Capazine) and Drug allergy (Patient Allergic to Regulin). Concomitant products included VITAMINS NOS for an unknown indication.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jul-2021, the patient experienced CHEST PAIN (Chest pain) and PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced VACCINATION COMPLICATION (All side effects). At the time of the report, VACCINATION COMPLICATION (All side effects), CHEST PAIN (Chest pain) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No Treatment medication was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Follow up document received on 19 JUL 2021 Added adverse event
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Dyspnoea, Fatigue
Clinical narrative: Difficulty breathing; Extreme fatigue; Cough; No sense of taste; No sense of  smell; Headaches every 4 to 5 hours.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), FATIGUE (Extreme fatigue), COUGH (Cough), AGEUSIA (No sense of taste) and ANOSMIA (No sense of  smell) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Extreme fatigue), COUGH (Cough), AGEUSIA (No sense of taste), ANOSMIA (No sense of  smell) and HEADACHE (Headaches every 4 to 5 hours.). At the time of the report, DYSPNOEA (Difficulty breathing), FATIGUE (Extreme fatigue), COUGH (Cough), AGEUSIA (No sense of taste), ANOSMIA (No sense of  smell) and HEADACHE (Headaches every 4 to 5 hours.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Difficulty breathing; Extreme fatigue; Cough; No sense of taste; No sense of  smell; Headaches every 4 to 5 hours.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), FATIGUE (Extreme fatigue), COUGH (Cough), AGEUSIA (No sense of taste) and ANOSMIA (No sense of  smell) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), FATIGUE (Extreme fatigue), COUGH (Cough), AGEUSIA (No sense of taste), ANOSMIA (No sense of  smell) and HEADACHE (Headaches every 4 to 5 hours.). At the time of the report, DYSPNOEA (Difficulty breathing), FATIGUE (Extreme fatigue), COUGH (Cough), AGEUSIA (No sense of taste), ANOSMIA (No sense of  smell) and HEADACHE (Headaches every 4 to 5 hours.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Feeding disorder, Feeling hot, Headache
Clinical narrative: Coldness in hands and feet; a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head; Headache; Nausea; Coughing; prevented her to drink or eat; experienced fever like symptoms; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea) and COUGH (Coughing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Asthma (Occasional requires an inhaler).    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea), COUGH (Coughing), FEEDING DISORDER (prevented her to drink or eat) and PYREXIA (experienced fever like symptoms). At the time of the report, PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea), COUGH (Coughing), FEEDING DISORDER (prevented her to drink or eat) and PYREXIA (experienced fever like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.6f normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include inhaler for asthma.  No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non-significant follow-up
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral coldness, Pyrexia
Clinical narrative: Coldness in hands and feet; a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head; Headache; Nausea; Coughing; prevented her to drink or eat; experienced fever like symptoms; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea) and COUGH (Coughing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Asthma (Occasional requires an inhaler).    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea), COUGH (Coughing), FEEDING DISORDER (prevented her to drink or eat) and PYREXIA (experienced fever like symptoms). At the time of the report, PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea), COUGH (Coughing), FEEDING DISORDER (prevented her to drink or eat) and PYREXIA (experienced fever like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.6f normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include inhaler for asthma.  No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non-significant follow-up
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Product administration error, Vaccination site pain
Clinical narrative: "not sure if the vaccine was administered properly"; at times fingers go numb; excruciating pain that radiates down left arm; "shoulder problems" and pain of left shoulder; still feel the injection site where the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR ("not sure if the vaccine was administered properly"), HYPOAESTHESIA (at times fingers go numb), PAIN IN EXTREMITY (excruciating pain that radiates down left arm), ARTHRALGIA ("shoulder problems" and pain of left shoulder) and VACCINATION SITE PAIN (still feel the injection site where the vaccine was given) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), MELATONIN and FISH OIL for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR ("not sure if the vaccine was administered properly"), HYPOAESTHESIA (at times fingers go numb), PAIN IN EXTREMITY (excruciating pain that radiates down left arm), ARTHRALGIA ("shoulder problems" and pain of left shoulder) and VACCINATION SITE PAIN (still feel the injection site where the vaccine was given). At the time of the report, PRODUCT ADMINISTRATION ERROR ("not sure if the vaccine was administered properly"), HYPOAESTHESIA (at times fingers go numb), PAIN IN EXTREMITY (excruciating pain that radiates down left arm), ARTHRALGIA ("shoulder problems" and pain of left shoulder) and VACCINATION SITE PAIN (still feel the injection site where the vaccine was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body Aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body Aches). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year old patient received the 1st dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old patient received the 1st dose of the Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history and concomitant drug information was provided by reporter.     On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old patient received the 1st dose of the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year old patient received the 1st dose of the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received contains no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient passed 42 days without second dose; 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 PRODUCT DOSE OMISSION ISSUE (Patient passed 42 days without second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient passed 42 days without second dose). On 16-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient passed 42 days without second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Today I tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Today I tested positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced COVID-19 (Today I tested positive). At the time of the report, COVID-19 (Today I tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medications were not reported. No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: Throat has been full of mucus; This spontaneous case was reported by a patient and describes the occurrence of SECRETION DISCHARGE (Throat has been full of mucus) 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 17-Jun-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 SECRETION DISCHARGE (Throat has been full of mucus). At the time of the report, SECRETION DISCHARGE (Throat has been full of mucus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  Treatment medication were not reported.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-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 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not received her 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose.) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009O21A) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Body temperature: 101 (High) 101 F.     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 was not provided. Treatment medication was not reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Penile swelling, Vaccination site reaction
Clinical narrative: penis is swollen; injection site reaction; This spontaneous case was reported by a consumer and describes the occurrence of PENILE SWELLING (penis is swollen) and VACCINATION SITE REACTION (injection site reaction) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PENILE SWELLING (penis is swollen) and VACCINATION SITE REACTION (injection site reaction). At the time of the report, PENILE SWELLING (penis is swollen) and VACCINATION SITE REACTION (injection site reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea; This spontaneous case was reported by a consumer and describes the occurrence of PITYRIASIS ROSEA (Pityriasis rosea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Skin rash.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PITYRIASIS ROSEA (Pityriasis rosea). At the time of the report, PITYRIASIS ROSEA (Pityriasis rosea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient had skin rash for few months. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Can't taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Can't taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Can't taste). At the time of the report, AGEUSIA (Can't taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. The treatment information was not provided.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hysterectomy, Product dose omission issue
Clinical narrative: missed the second dose; hysterectomy; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HYSTERECTOMY (hysterectomy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included OMEPRAZOLE and VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HYSTERECTOMY (hysterectomy). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) and HYSTERECTOMY (hysterectomy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the second dose of the Moderna COVID-19 Vaccine on it's intramuscular on May 5th, 2021.batch no 013A21A (013AZIA).      No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Live Follow-up information received on 16-JUL-2021 contains non-significant information.