chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Aug-2021. On 11-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.  The patient gestation period was 17 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Pregnancy data clean up
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Blood pressure measurement, Diarrhoea, Erythema, Fatigue
Clinical narrative: Diarrhea; Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip; Hives broke out on blisters; Redness on fingers; Hives broke out with blisters, itching; Tired, wanted to sleep, fatigue again; Really hungry; R hand fingers and palms itching that come and go; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip) and BLISTER (Hives broke out on blisters) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, METOPROLOL, AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go) and FATIGUE (Tired, wanted to sleep, fatigue again). On 16-Mar-2021, the patient experienced PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers) and URTICARIA (Hives broke out with blisters, itching). On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with HYDROCORTISONE (ITCH-X [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency. At the time of the report, HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers), URTICARIA (Hives broke out with blisters, itching) and FATIGUE (Tired, wanted to sleep, fatigue again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: unk (normal) blood pressure stable.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hunger, Pruritus, Urticaria
Clinical narrative: Diarrhea; Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip; Hives broke out on blisters; Redness on fingers; Hives broke out with blisters, itching; Tired, wanted to sleep, fatigue again; Really hungry; R hand fingers and palms itching that come and go; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip) and BLISTER (Hives broke out on blisters) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, METOPROLOL, AMLODIPINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go) and FATIGUE (Tired, wanted to sleep, fatigue again). On 16-Mar-2021, the patient experienced PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers) and URTICARIA (Hives broke out with blisters, itching). On 17-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with HYDROCORTISONE (ITCH-X [HYDROCORTISONE]) for Itching, at an unspecified dose and frequency. At the time of the report, HUNGER (Really hungry), PRURITUS (R hand fingers and palms itching that come and go), DIARRHOEA (Diarrhea), PRURITUS (Itch moved to L hand from the palms to the wrist/itching moved to between knee and hip), BLISTER (Hives broke out on blisters), ERYTHEMA (Redness on fingers), URTICARIA (Hives broke out with blisters, itching) and FATIGUE (Tired, wanted to sleep, fatigue again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: unk (normal) blood pressure stable.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: patient did not show up for her 2nd appointment; administered 1st dose of vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old) and PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21A) 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) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of vaccine to a 17 year old) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient did not show up for her 2nd appointment) 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.   Concomitant medications were not provided. Treatment details were not provided.  patient presented herself for covid vaccination after making an online appointment where she attested that she was 18 years old to make this appointment.  it was discovered that she was actually 17 years old when the informed consent form was scanned for billing purpose. at that point pharmacist called Moderna and spoke to an agent. it is my understanding that CDC did recomend use of moderna for 16-17 year old. and that second dose should be given as off label use. However patient did not show up for her 2nd appointment.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: As reported: patient did not show up for her 2nd appointment.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) 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 (No reported medical history).    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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Nodule, Pain, Pruritus
Clinical narrative: DIscomfort; Felt a lump/ lump was the size of silver dollar; Really itchy and horrible; rash got larger and looked like "measles; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; "Felt it throughout her whole body"; Pain above anklesand Pain to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar) and PRURITUS (Really itchy and horrible) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M(??)A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol high. Concurrent medical conditions included Drug allergy (Naproxen,), Drug allergy (Codeine), Food allergy (Pineapple , Acidic fruits) and Drug allergy (allergic reaction to the Benadryl tablet). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and ATORVASTATIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL ("Felt it throughout her whole body") and PAIN (Pain above anklesand Pain to touch). On 16-Feb-2021, the patient experienced DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), RASH (rash got larger and looked like "measles), VACCINATION SITE RASH (rash, swelling and hurting at injection site), VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), VACCINATION SITE RASH (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site) outcome was unknown and RASH (rash got larger and looked like "measles) and VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-047860 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Added medical history. Treatment drug information is added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: DIscomfort; Felt a lump/ lump was the size of silver dollar; Really itchy and horrible; rash got larger and looked like "measles; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; "Felt it throughout her whole body"; Pain above anklesand Pain to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar) and PRURITUS (Really itchy and horrible) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M(??)A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol high. Concurrent medical conditions included Drug allergy (Naproxen,), Drug allergy (Codeine), Food allergy (Pineapple , Acidic fruits) and Drug allergy (allergic reaction to the Benadryl tablet). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and ATORVASTATIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL ("Felt it throughout her whole body") and PAIN (Pain above anklesand Pain to touch). On 16-Feb-2021, the patient experienced DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), RASH (rash got larger and looked like "measles), VACCINATION SITE RASH (rash, swelling and hurting at injection site), VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), VACCINATION SITE RASH (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site) outcome was unknown and RASH (rash got larger and looked like "measles) and VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-047860 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Added medical history. Treatment drug information is added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Headache
Clinical narrative: Nausea; Fever of 102F; Body aches; Headaches; Vomited; She was really "put down"; Has barely eaten; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever of 102F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), NAUSEA (Nausea), PYREXIA (Fever of 102F), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited) outcome was unknown and PYREXIA (Fever of 102F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: high (High) 102 F.         The action taken with the drug in response to the event(s) was not applicable.   This case was linked to MOD-2021-019543 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Fever of 102F; Body aches; Headaches; Vomited; She was really "put down"; Has barely eaten; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Fever of 102F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills). On 13-Mar-2021, the patient experienced ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), NAUSEA (Nausea), PYREXIA (Fever of 102F), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (She was really "put down"), DECREASED APPETITE (Has barely eaten), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches), HEADACHE (Headaches) and VOMITING (Vomited) outcome was unknown and PYREXIA (Fever of 102F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: high (High) 102 F.         The action taken with the drug in response to the event(s) was not applicable.   This case was linked to MOD-2021-019543 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Incorrect dose administered, Pyrexia
Clinical narrative: Fever; Night time Chills; Received 3 Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 3 Moderna Covid-19 vaccinations), CHILLS (Night time Chills) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 016M20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (Left shoulder and right foot).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Received 3 Moderna Covid-19 vaccinations). On 04-Feb-2021, the patient experienced CHILLS (Night time Chills). On 05-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, INCORRECT DOSE ADMINISTERED (Received 3 Moderna Covid-19 vaccinations), CHILLS (Night time Chills) and PYREXIA (Fever) had resolved. Not Provided          No concomitant medications were provided by the reporter.    Patient reported that his chronically swollen right fingers, left shoulder arthritis, right foot arthritis were all gone and feeling better after second shot of the vaccine. Treatment information was not provided.   This case was linked to MOD-2021-048730 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Additional information received
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AP21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Blood pressure and Cholesterol medications.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Left arm muscle pain; Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm soreness) and MYALGIA (Left arm muscle pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Fall in February 2021. Concurrent medical conditions included Headache (She was having headache since she had a fall a month ago) since February 2021. Concomitant products included PARACETAMOL (TYLENOL) for Headache, ESTRADIOL (ESTROGEN) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm soreness). On 13-Mar-2021, the patient experienced MYALGIA (Left arm muscle pain). On 13-Mar-2021, VACCINATION SITE PAIN (Left arm soreness) had resolved. At the time of the report, MYALGIA (Left arm muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment informations was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Ringing in ears after first shot; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears after first shot) and HEADACHE (very bad headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in ears after first shot) and HEADACHE (very bad headache). At the time of the report, TINNITUS (Ringing in ears after first shot) and HEADACHE (very bad headache) outcome was unknown. Not Provided          This case was linked to MOD-2021-047851 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contact information updated- non-significant followup
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose exceeding 42 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose exceeding 42 days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose exceeding 42 days). On 06-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose exceeding 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of inappropriate schedule of product administration, for mRNA-1273, lot #unknown, with no associated AEs.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration, for mRNA-1273, lot #unknown, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Rhinorrhoea, Vaccination site pain
Clinical narrative: Runny nose; Fever; Chills; nausea/queasy; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (nausea/queasy) and VACCINATION SITE PAIN (Soreness at the injection site) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (nausea/queasy) and VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, RHINORRHOEA (Runny nose), PYREXIA (Fever), CHILLS (Chills), NAUSEA (nausea/queasy) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment medication information not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia, Pain
Clinical narrative: She is walking like a cripple person; Pain is so intense in her hip area; Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (She is walking like a cripple person), PAIN (Pain is so intense in her hip area) and MYALGIA (Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and DESMOPRESSIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced GAIT DISTURBANCE (She is walking like a cripple person), PAIN (Pain is so intense in her hip area) and MYALGIA (Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (She is walking like a cripple person), PAIN (Pain is so intense in her hip area) and MYALGIA (Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Urinary tract infection
Clinical narrative: Urinary Tract Infection; Inappropriate dose of vaccine administered; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00115719) for COVID-19 vaccination.     Concurrent medical conditions included Heart rate irregular. Concomitant products included METOPROLOL for Heart rate irregular.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 19-Feb-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered). On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). The patient was treated with TETRACYCLINE for Urinary tract infection, at a dose of 500 mg, for 7 days. On 19-Feb-2021, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: event outcome updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Stomach Upset; Fever; Headache; Muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach Upset), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (quarantined herself for 14 days even though she did not get sick.) in August 2020. Concomitant products included COLESTIPOL, METFORMIN and LEVOTHYROXINE for an unknown indication.    On 15-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Upset), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Stomach Upset), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 f (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment medications were not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Stomach Upset; Fever; Headache; Muscle aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach Upset), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (quarantined herself for 14 days even though she did not get sick.) in August 2020. Concomitant products included COLESTIPOL, METFORMIN and LEVOTHYROXINE for an unknown indication.    On 15-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach Upset), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches) and FATIGUE (Fatigue). At the time of the report, ABDOMINAL DISCOMFORT (Stomach Upset), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101 f (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment medications were not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination.     The patient's past medical history included Vasculitis (In 1984 and 1988 he had hospitalization for vasculitis in fingertips and toes) in 1984 and Cyanosis (Vasculitis resulted in cyanosis of just tips of toes and fingers(1984 and 1988).) in 1984. Concurrent medical conditions included Atrial fibrillation, Chronic lymphocytic leukemia since 2011, Cholesterol (Borderline cholesterol), Stroke (Previous minor stroke), Hypothyroidism, Blood pressure since 2005, Penicillin allergy, Allergy to antibiotic (Allergy to Cephalosporins) and Allergy to antibiotic (Allergy to Avalox). Concomitant products included METOPROLOL TARTRATE for Blood pressure, LISINOPRIL for Blood pressure and Atrial fibrillation, ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism, APIXABAN (ELIQUIS) for Stroke.   On 25-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021 at 3:00 AM, the patient experienced PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10). On 26-Feb-2021 at 3:10 AM, PAIN (Extreme pain on the tips of his toes on the left foot/On a scale of 1-10 it was 10) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. Patient has stated that in 1984 and 1988 he had episodes with toe and finger tip it became infarcted and felled of dead tissues and he had resolved with residual effects of damage of finger and toe tips.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Added secondary reporter details, Added concomitant medication information. On 30-Jul-2021: Added patient details, patient's other relevant history were added, Added Concomitant medications and its indication.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Pain, Pyrexia, Tongue discomfort
Clinical narrative: body aches; diarrhea; stomach cramps; fever; felt like tongue was on fire; diarrhea.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 17-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea.), PYREXIA (fever), TONGUE DISCOMFORT (felt like tongue was on fire), DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach cramps) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIARRHOEA (diarrhea.). On 12-Mar-2021, the patient experienced PYREXIA (fever) and TONGUE DISCOMFORT (felt like tongue was on fire). On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach cramps). On 15-May-2021, the patient experienced PAIN (body aches). On 12-Feb-2021, DIARRHOEA (diarrhea.) had resolved. On 15-Mar-2021, TONGUE DISCOMFORT (felt like tongue was on fire) had resolved. At the time of the report, PYREXIA (fever), DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach cramps) and PAIN (body aches) outcome was unknown.            Concomitant medication information not provided.  Treatment information was not provided.   This case was linked to MOD-2021-047859 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in ears got worse after second shot) and HEADACHE (very bad headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in ears got worse after second shot) and HEADACHE (very bad headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Ringing in ears, at a dose of 1 dosage form. At the time of the report, TINNITUS (Ringing in ears got worse after second shot) had not resolved and HEADACHE (very bad headache) outcome was unknown.            No Concomitant medications was reported   This case was linked to MOD-2021-047842, MOD-2021-047851 (Patient Link  Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contact information updated
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash erythematous, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red rash; site of injection started itching; Headache; Pain on the site of injection; Tenderness; Swelling of the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PAIN (Pain on the site of injection), VACCINATION SITE PAIN (Tenderness), VACCINATION SITE SWELLING (Swelling of the site of injection) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain on the site of injection), VACCINATION SITE PAIN (Tenderness) and VACCINATION SITE SWELLING (Swelling of the site of injection). On 13-Mar-2021, the patient experienced HEADACHE (Headache). On 14-Mar-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and VACCINATION SITE PRURITUS (site of injection started itching). At the time of the report, RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PAIN (Pain on the site of injection), VACCINATION SITE PAIN (Tenderness), VACCINATION SITE SWELLING (Swelling of the site of injection), HEADACHE (Headache) and VACCINATION SITE PRURITUS (site of injection started itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Paraesthesia, Tinnitus, Vaccination site pain
Clinical narrative: significant tinnitus on both ears; tingling fingers; fatigue; pain behind left knee; localize pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (significant tinnitus on both ears), PARAESTHESIA (tingling fingers), FATIGUE (fatigue), ARTHRALGIA (pain behind left knee) and VACCINATION SITE PAIN (localize pain on injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced TINNITUS (significant tinnitus on both ears), PARAESTHESIA (tingling fingers), FATIGUE (fatigue), ARTHRALGIA (pain behind left knee) and VACCINATION SITE PAIN (localize pain on injection site). On 24-Feb-2021, PARAESTHESIA (tingling fingers), FATIGUE (fatigue), ARTHRALGIA (pain behind left knee) and VACCINATION SITE PAIN (localize pain on injection site) had resolved. At the time of the report, TINNITUS (significant tinnitus on both ears) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: right arm pain; right shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm pain) and ARTHRALGIA (right shoulder pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history information was reported.  Concurrent medical conditions included Heart valve regurgitation, Depression, Anxiety, Dry eyes, Narcolepsy (Patient reported that she is a non-smoker, doesn't drive due to narcolepsy and is a small "thin" person.) since 2000, Low blood pressure and COPD. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), PHENELZINE SULFATE (NARDIL), CLONAZEPAM, ZINC SULFATE (SOOTHEYE) and MINERALS NOS, VITAMINS NOS (CENTRUM PLUS) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (right arm pain) and ARTHRALGIA (right shoulder pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (right arm pain) and ARTHRALGIA (right shoulder pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-063790 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Depression.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified antidepressant and blood pressure medication.  No treatment information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity, Paraesthesia oral
Clinical narrative: a Metallic Taste in Mouth; Arm Pain; "Tingling" Sensation of Tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (a Metallic Taste in Mouth), PAIN IN EXTREMITY (Arm Pain) and PARAESTHESIA ORAL ("Tingling" Sensation of Tongue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) and VITAMIN D NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSGEUSIA (a Metallic Taste in Mouth), PAIN IN EXTREMITY (Arm Pain) and PARAESTHESIA ORAL ("Tingling" Sensation of Tongue). At the time of the report, DYSGEUSIA (a Metallic Taste in Mouth), PAIN IN EXTREMITY (Arm Pain) and PARAESTHESIA ORAL ("Tingling" Sensation of Tongue) 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia, Pyrexia
Clinical narrative: gets cold; fever; aches all over; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (gets cold), PYREXIA (fever) and MYALGIA (aches all over) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (gets cold), PYREXIA (fever) and MYALGIA (aches all over). At the time of the report, FEELING COLD (gets cold), PYREXIA (fever) and MYALGIA (aches all over) outcome was unknown.            The reporter noted that the product lot # for dose 2 was difficult to read and may have been 049A21A. No concomitant medications were reported.  No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-047965 (Patient Link).