chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Hard time breathing; Scrape got all swelled up; Swelling all over; Scrape turned red; Muscle soreness; Joint soreness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing), INFLAMMATION OF WOUND (Scrape got all swelled up), SWELLING (Swelling all over), ERYTHEMA (Scrape turned red) and MYALGIA (Muscle soreness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cut wound (6 inches long scrape on the hand.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (Hard time breathing), INFLAMMATION OF WOUND (Scrape got all swelled up), SWELLING (Swelling all over), ERYTHEMA (Scrape turned red), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint soreness). At the time of the report, DYSPNOEA (Hard time breathing), SWELLING (Swelling all over), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint soreness) was resolving and INFLAMMATION OF WOUND (Scrape got all swelled up) and ERYTHEMA (Scrape turned red) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: A mild cough; Low fever; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (A mild cough), SARS-COV-2 TEST POSITIVE (Tested positive for Covid) and PYREXIA (Low fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). On an unknown date, the patient experienced COUGH (A mild cough) and PYREXIA (Low fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (A mild cough), SARS-COV-2 TEST POSITIVE (Tested positive for Covid) and PYREXIA (Low fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Illness
Clinical narrative: Feeling so sick, ¨like if i had Covid again¨; Pain in every joint of her body, including her toes; Head is pounding; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Feeling so sick, ¨like if i had Covid again¨), ARTHRALGIA (Pain in every joint of her body, including her toes) and HEADACHE (Head is pounding) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ILLNESS (Feeling so sick, ¨like if i had Covid again¨), ARTHRALGIA (Pain in every joint of her body, including her toes) and HEADACHE (Head is pounding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Feeling so sick, ¨like if i had Covid again¨), ARTHRALGIA (Pain in every joint of her body, including her toes) and HEADACHE (Head is pounding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included blood pressure medication.   Patient took a pain pill along with Tylenol as treatment for the events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of vaccines that may have undergone temperature excursion; Administration of vaccines that may have undergone temperature excursion; 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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccines that may have undergone temperature excursion) and PRODUCT STORAGE ERROR (Administration of vaccines that may have undergone temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccines that may have undergone temperature excursion) and PRODUCT STORAGE ERROR (Administration of vaccines that may have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccines that may have undergone temperature excursion) and PRODUCT STORAGE ERROR (Administration of vaccines that may have undergone temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.   No treatment details were provided.; Reporter's Comments: This report refers to a case of temperature excursion       ( 37 days in refrigerator) and in appropriate storage of product with no associated AEs
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash that is growing; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that is growing) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced RASH (Rash that is growing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash that is growing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: tinnitus and tingling of the ears; tinnitus and tingling of the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus and tingling of the ears) and PARAESTHESIA (tinnitus and tingling of the ears) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-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 TINNITUS (tinnitus and tingling of the ears) and PARAESTHESIA (tinnitus and tingling of the ears). At the time of the report, TINNITUS (tinnitus and tingling of the ears) and PARAESTHESIA (tinnitus and tingling of the ears) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Non significant Follow up received on 20-May-2021. Email address was updated On 08-Jul-2021: non significant followup On 09-Jul-2021: Non significant Follow up  received on 09 Jul 2021 - phone number was updated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure during pregnancy, Scratch, Vaccination site rash
Clinical narrative: diarrhea; Scratch; Vaccination site rash; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), DIARRHOEA (diarrhea), SCRATCH (Scratch) and VACCINATION SITE RASH (Vaccination site rash) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (28th Week of Pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jun-2021. On 05-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 05-Apr-2021 at 7:00 PM, the patient experienced DIARRHOEA (diarrhea), SCRATCH (Scratch) and VACCINATION SITE RASH (Vaccination site rash). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and DIARRHOEA (diarrhea), SCRATCH (Scratch) and VACCINATION SITE RASH (Vaccination site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not take any treatment for the event. Events.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: First dose in January and a week later she got COVID; 91 days since the first shot; It has been 91 days since the first shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (First dose in January and a week later she got COVID; 91 days since the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been 91 days since the first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (First dose in January and a week later she got COVID; 91 days since the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been 91 days since the first shot). At the time of the report, COVID-19 (First dose in January and a week later she got COVID; 91 days since the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been 91 days since the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Joint swelling, Pruritus, Urticaria
Clinical narrative: Intense itching in hands; Red hives in hands; Allergic reaction; Urticaria in hands; Wrist was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Intense itching in hands), ERYTHEMA (Red hives in hands), HYPERSENSITIVITY (Allergic reaction), URTICARIA (Urticaria in hands) and JOINT SWELLING (Wrist was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FENOFIBRATE for Hyperlipidemia, TRIGLYCERIDES for an unknown indication.    On 05-Apr-2021 at 12:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (Intense itching in hands), ERYTHEMA (Red hives in hands), HYPERSENSITIVITY (Allergic reaction), URTICARIA (Urticaria in hands) and JOINT SWELLING (Wrist was swollen). At the time of the report, PRURITUS (Intense itching in hands), ERYTHEMA (Red hives in hands), HYPERSENSITIVITY (Allergic reaction), URTICARIA (Urticaria in hands) and JOINT SWELLING (Wrist was swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: High Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (High Fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia. Concomitant products included IRON and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for Anemia.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FATIGUE (High Fatigue). At the time of the report, FATIGUE (High Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Injection site bruising, Injection site irritation, Vaccination site swelling
Clinical narrative: Injection site irritation; injection site bruising; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site irritation), INJECTION SITE BRUISING (injection site bruising) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    The patient's past medical history included Hidradenitis (Hidradenitis suppurativa outbreak on right side of groin area.) and Hysterectomy (Outpatient surgery and recovered) in February 2021. Concurrent medical conditions included Arthritis since 2016 and Alcohol use (A couple of glasses of wine a week). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (esophageal), BUPROPION for Anxiety and Depression, POTASSIUM CHLORIDE, LISINOPRIL, FUROSEMIDE SODIUM (LASIX [FUROSEMIDE SODIUM]), LABETALOL, HYDROCHLOROTHIAZIDE and ROSUVASTATIN CALCIUM (CRESTOR) for Blood pressure high, HYOSCYAMINE for Irritable bowel syndrome.   In July 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). On an unknown date, the patient experienced INJECTION SITE IRRITATION (Injection site irritation) and INJECTION SITE BRUISING (injection site bruising). At the time of the report, INJECTION SITE IRRITATION (Injection site irritation) and INJECTION SITE BRUISING (injection site bruising) was resolving and VACCINATION SITE SWELLING (Vaccination site swelling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Biopsy: negative (Negative) Negative. On 04-Mar-2021, Blood test: unknown (normal) No value reporter.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Hypersensitivity, Illness, Periarthritis, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE, ILLNESS, PERIARTHRITIS, and HYPERSENSITIVITY in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE and ILLNESS. On an unknown date, the patient experienced PERIARTHRITIS and HYPERSENSITIVITY. At the time of the report, PRODUCT DOSE OMISSION ISSUE, ILLNESS, PERIARTHRITIS, and HYPERSENSITIVITY outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 200 (High).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on 26-JUN-2021. No New Information On 27-Jun-2021: Follow up received on 27 Jun 2021, no new information updated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: headache; arm pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (arm pain) and FATIGUE (fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (arm pain) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency; HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (arm pain) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years old patient received the first shot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old patient received the first shot of the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old patient received the first shot of the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old patient received the first shot of the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments..
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Sinus pain
Clinical narrative: Pain in sinuses and temples; Sore arm at injection site; Headache; Headache in back of head; Fever; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN, PYREXIA, CHILLS, MYALGIA, and VACCINATION SITE PAIN in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No allergies were reported.  Patient has never been diagnosed with COVID-19.  Concurrent medical conditions included Psoriatic arthritis since 04-Jan-2012, Cholesterol and Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure, CRESTOR for Cholesterol.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced Fever. 01-Apr-2021, the patient experienced CHILLS and MYALGIA. On an unknown date, the patient experienced SINUS PAIN, VACCINATION SITE PAIN, HEADACHE, and HEADACHE. The patient was treated with IBUPROFEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 02-Apr-2021, PYREXIA, CHILLS, and MYALGIA had resolved. At the time of the report, SINUS PAIN, VACCINATION SITE PAIN, HEADACHE, and HEADACHE had resolved.            Most recent FOLLOW-UP information incorporated above On 24-May-2021: No specific follow-up information recorded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in sinuses and temples; Sore arm at injection site; Headache; Headache in back of head; Fever; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS PAIN, PYREXIA, CHILLS, MYALGIA, and VACCINATION SITE PAIN in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No allergies were reported.  Patient has never been diagnosed with COVID-19.  Concurrent medical conditions included Psoriatic arthritis since 04-Jan-2012, Cholesterol and Blood pressure abnormal. Concomitant products included LISINOPRIL for Blood pressure, CRESTOR for Cholesterol.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced Fever. 01-Apr-2021, the patient experienced CHILLS and MYALGIA. On an unknown date, the patient experienced SINUS PAIN, VACCINATION SITE PAIN, HEADACHE, and HEADACHE. The patient was treated with IBUPROFEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 02-Apr-2021, PYREXIA, CHILLS, and MYALGIA had resolved. At the time of the report, SINUS PAIN, VACCINATION SITE PAIN, HEADACHE, and HEADACHE had resolved.            Most recent FOLLOW-UP information incorporated above On 24-May-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient is not feeling well after receiving first dose Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient is not feeling well after receiving first dose Covid-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient is not feeling well after receiving first dose Covid-19 Vaccine). At the time of the report, MALAISE (Patient is not feeling well after receiving first dose Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age
Clinical narrative: 16 years old and received vaccine; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received vaccine) and FATIGUE (Fatigue) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis since 06-Sep-2017, Syncope vasovagal since 30-Oct-2019, Asthma since 07-Apr-2021, Heartburn since 06-Sep-2017, Insomnia since 30-Oct-2019, Food allergy (Cabbage) and Drug allergy (Famotidine). Concomitant products included LORATADINE (LORA [LORATADINE]) from 07-Apr-2021 to an unknown date and FLUTICASONE PROPIONATE (FLUTICASONE [FLUTICASONE PROPIONATE]) from 07-Apr-2021 to an unknown date for Allergy, ALBUTEROL SULFATE from 07-Apr-2021 to an unknown date for Asthma, DICYCLOVERINE HYDROCHLORIDE (BENTYL) from 04-Mar-2020 to an unknown date for Gastritis, LANSOPRAZOLE (PREVACID) from 03-Apr-2021 to an unknown date for Heartburn, MELATONIN from 30-Oct-2019 to an unknown date for Insomnia, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), DICYCLOVERINE HYDROCHLORIDE (BENTO) and ALBUTEROL [SALBUTAMOL] from 07-Apr-2021 to an unknown date for an unknown indication.   On 23-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021 at 7:00 PM, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received vaccine). On 27-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received vaccine) outcome was unknown.            Other vaccine -CRR is reported. Concomitant medication-ORTHO TRI-CYCLEN is reported. No treatment medications were reported.   This case was linked to MOD-2021-222970 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Patient medical history,Concomitant products,Event details are added . Patient information,Patient details and second dose details are updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: itchiness in hands; swelling in hands; pain in hands; redness in hands; hives on arm and stomach; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness in hands), PERIPHERAL SWELLING (swelling in hands), PAIN IN EXTREMITY (pain in hands), ERYTHEMA (redness in hands) and URTICARIA (hives on arm and stomach) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PRURITUS (itchiness in hands), PERIPHERAL SWELLING (swelling in hands), PAIN IN EXTREMITY (pain in hands), ERYTHEMA (redness in hands) and URTICARIA (hives on arm and stomach). At the time of the report, PRURITUS (itchiness in hands), PERIPHERAL SWELLING (swelling in hands), PAIN IN EXTREMITY (pain in hands), ERYTHEMA (redness in hands) and URTICARIA (hives on arm and stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia, Nausea, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (feeling awful), chills, pyrexia (slight fever), myalgia (severe body ache) and nausea in an 81-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. No medical history reported. On Mar 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (feeling awful), chills, pyrexia (slight fever), myalgia (severe body ache) and nausea. The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, feeling abnormal (feeling awful), chills, pyrexia (slight fever), myalgia (severe body ache) and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Fever of 100.5; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever of 100.5) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical history was reported by the reporter.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NAUSEA (Nausea). On 03-Apr-2021, the patient experienced PYREXIA (Fever of 100.5) and CHILLS (Chills). On 03-Apr-2021, PYREXIA (Fever of 100.5) and CHILLS (Chills) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 27-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 27-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain
Clinical narrative: Could barely walk; All her joints hurt; Felt pain in ever joint; So much pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could barely walk), ARTHRALGIA (All her joints hurt), ARTHRALGIA (Felt pain in ever joint) and PAIN (So much pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced GAIT DISTURBANCE (Could barely walk), ARTHRALGIA (All her joints hurt), ARTHRALGIA (Felt pain in ever joint) and PAIN (So much pain). On 05-Apr-2021, GAIT DISTURBANCE (Could barely walk) had resolved. At the time of the report, ARTHRALGIA (All her joints hurt), ARTHRALGIA (Felt pain in ever joint) and PAIN (So much pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: severe neck pain; left arm hurts when she tries to move it; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe neck pain) and PAIN IN EXTREMITY (left arm hurts when she tries to move it) in a 56-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (severe neck pain) and PAIN IN EXTREMITY (left arm hurts when she tries to move it). At the time of the report, NECK PAIN (severe neck pain) and PAIN IN EXTREMITY (left arm hurts when she tries to move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Food poisoning, Headache
Clinical narrative: headaches; stomach cramps; like if he had food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), FOOD POISONING (like if he had food poisoning) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. In April 2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps) and FOOD POISONING (like if he had food poisoning). On an unknown date, the patient experienced HEADACHE (headaches). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), FOOD POISONING (like if he had food poisoning) and HEADACHE (headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Lip swelling, Peripheral swelling, Swelling of eyelid
Clinical narrative: Swelling of Half of Lower Lip; eyelid swelling; swelling of ears; swelling of palms; This spontaneous case was reported by a health care professional and describes the occurrence of LIP SWELLING (Swelling of Half of Lower Lip), SWELLING OF EYELID (eyelid swelling), EAR SWELLING (swelling of ears) and PERIPHERAL SWELLING (swelling of palms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Idiopathic urticaria. Concomitant products included OMALIZUMAB (XOLAIR), CETIRIZINE HYDROCHLORIDE (CETRIZINE), RANITIDINE, LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Swelling of Half of Lower Lip), SWELLING OF EYELID (eyelid swelling), EAR SWELLING (swelling of ears) and PERIPHERAL SWELLING (swelling of palms). At the time of the report, LIP SWELLING (Swelling of Half of Lower Lip), SWELLING OF EYELID (eyelid swelling), EAR SWELLING (swelling of ears) and PERIPHERAL SWELLING (swelling of palms) 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 treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Fatigue, Pain in extremity
Clinical narrative: Metal Mouth; Fatigue; Chills; sore; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (sore), DYSGEUSIA (Metal Mouth), FATIGUE (Fatigue) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore). On 01-Apr-2021, the patient experienced DYSGEUSIA (Metal Mouth), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore), DYSGEUSIA (Metal Mouth), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product is not provided.  Patient drinking 12 cups of water that day for treating sore.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Eye red; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eye red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced OCULAR HYPERAEMIA (Eye red). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Depression, Myalgia, Pain in extremity
Clinical narrative: depression; feeling anguish/ feeling anxiety; felt like crying; fever; body aches; slept all night; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), ANXIETY (feeling anguish/ feeling anxiety) and CRYING (felt like crying) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A-HRSA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included CORTISONE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and MYALGIA (body aches). On 22-Mar-2021, the patient experienced ANXIETY (feeling anguish/ feeling anxiety) and CRYING (felt like crying). On an unknown date, the patient experienced DEPRESSION (depression). The patient was treated with MIRTAZAPINE ongoing since an unknown date for Depression, at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, DEPRESSION (depression) had not resolved and SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), ANXIETY (feeling anguish/ feeling anxiety), CRYING (felt like crying), PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information was provided that patient had got started after when she had got cortisone IV. Patient had took mirtazapine for depression which had affected her sleep   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021 and contains no new information
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: depression; feeling anguish/ feeling anxiety; felt like crying; fever; body aches; slept all night; arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), ANXIETY (feeling anguish/ feeling anxiety) and CRYING (felt like crying) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A-HRSA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression. Concomitant products included CORTISONE for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), PYREXIA (fever) and MYALGIA (body aches). On 22-Mar-2021, the patient experienced ANXIETY (feeling anguish/ feeling anxiety) and CRYING (felt like crying). On an unknown date, the patient experienced DEPRESSION (depression). The patient was treated with MIRTAZAPINE ongoing since an unknown date for Depression, at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, DEPRESSION (depression) had not resolved and SOMNOLENCE (slept all night), PAIN IN EXTREMITY (arm hurt), ANXIETY (feeling anguish/ feeling anxiety), CRYING (felt like crying), PYREXIA (fever) and MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information was provided that patient had got started after when she had got cortisone IV. Patient had took mirtazapine for depression which had affected her sleep   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-May-2021 and contains no new information
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Burning sensation, Diarrhoea, Diplopia, Dysgeusia
Clinical narrative: Double vision; Taste metallic; Felt a hot searing through her veins; Diarrhea; Rash on her arm; Sore arm; headache; fatigue; lymphedema; lost her vocabulary; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema), APHASIA (lost her vocabulary), DIPLOPIA (Double vision), DYSGEUSIA (Taste metallic) and BURNING SENSATION (Felt a hot searing through her veins) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphedema.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced APHASIA (lost her vocabulary). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema), DIPLOPIA (Double vision), DYSGEUSIA (Taste metallic), BURNING SENSATION (Felt a hot searing through her veins), DIARRHOEA (Diarrhea), RASH (Rash on her arm), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, LYMPHOEDEMA (lymphedema), APHASIA (lost her vocabulary), DIPLOPIA (Double vision), DYSGEUSIA (Taste metallic), BURNING SENSATION (Felt a hot searing through her veins), DIARRHOEA (Diarrhea), RASH (Rash on her arm), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphoedema, Pain in extremity, Rash
Clinical narrative: Double vision; Taste metallic; Felt a hot searing through her veins; Diarrhea; Rash on her arm; Sore arm; headache; fatigue; lymphedema; lost her vocabulary; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema), APHASIA (lost her vocabulary), DIPLOPIA (Double vision), DYSGEUSIA (Taste metallic) and BURNING SENSATION (Felt a hot searing through her veins) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphedema.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced APHASIA (lost her vocabulary). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema), DIPLOPIA (Double vision), DYSGEUSIA (Taste metallic), BURNING SENSATION (Felt a hot searing through her veins), DIARRHOEA (Diarrhea), RASH (Rash on her arm), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, LYMPHOEDEMA (lymphedema), APHASIA (lost her vocabulary), DIPLOPIA (Double vision), DYSGEUSIA (Taste metallic), BURNING SENSATION (Felt a hot searing through her veins), DIARRHOEA (Diarrhea), RASH (Rash on her arm), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired 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 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.