chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Maternal exposure during pregnancy
Clinical narrative: Received the first shot while pregnant; Had covid-19 following the first shot; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot while pregnant) and COVID-19 (Had covid-19 following 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot while pregnant) and COVID-19 (Had covid-19 following the first shot). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Received the first shot while pregnant) had resolved and COVID-19 (Had covid-19 following the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.  Company Comment: This is a case of maternal exposure during pregnancy and COVID 19 infection after first dose of Moderna vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Causality for maternal exposure during pregnancy and COVID 19 is not applicable.; Sender's Comments: This is a case of maternal exposure during pregnancy and COVID 19 infection after first dose of Moderna vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. Causality for maternal exposure during pregnancy and COVID 19 is not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.   This case was linked to MOD-2021-302211 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: extreme dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extreme dizziness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Scoliosis, Neurological disorder NOS, Dystonia, Anemia, Sulfonamide allergy, Allergy to antibiotic, Drug allergy (most oral antifungals) and Drug allergy (muscle relaxant: Baclofen).    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (extreme dizziness). At the time of the report, DIZZINESS (extreme dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-302183, MOD-2021-302231 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Vomiting
Clinical narrative: dizziness; redness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ERYTHEMA (redness) and VOMITING (vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), ERYTHEMA (redness) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness), ERYTHEMA (redness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter  Treatment information was not provided    Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: The red spot on her arm is now 6 to 8 inches across arm and bubbled up red; By 3am the 3rd day she had a red spot a little bigger than silver dollar; Sore Arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.     This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ERYTHEMA (By 3am the 3rd day she had a red spot a little bigger than silver dollar) and SWELLING (The red spot on her arm is now 6 to 8 inches across arm and bubbled up red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 029A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore Arm). On 29-Aug-2021, the patient experienced ERYTHEMA (By 3am the 3rd day she had a red spot a little bigger than silver dollar). On 30-Aug-2021, the patient experienced SWELLING (The red spot on her arm is now 6 to 8 inches across arm and bubbled up red). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ERYTHEMA (By 3am the 3rd day she had a red spot a little bigger than silver dollar) and SWELLING (The red spot on her arm is now 6 to 8 inches across arm and bubbled up red) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-302416 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeding disorder, Headache, Nausea, Pain in extremity
Clinical narrative: I was pretty weak/Felt very weak; bad headache; fever; Nausea; couldn't eat anything; dry heaves; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), ASTHENIA (I was pretty weak/Felt very weak) and HEADACHE ( bad headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Acid reflux (oesophageal) and Blood pressure. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), TELMISARTAN for Blood pressure, EVOLOCUMAB (REPATHA) for Cholesterol.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm). On 28-Aug-2021, the patient experienced FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), HEADACHE ( bad headache), PYREXIA (fever) and NAUSEA (Nausea). On 29-Aug-2021, the patient experienced ASTHENIA (I was pretty weak/Felt very weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm) was resolving and FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), ASTHENIA (I was pretty weak/Felt very weak), HEADACHE ( bad headache), PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that reaction from this previous dose was worse and more intense.   This case was linked to MOD-2021-302268 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: I was pretty weak/Felt very weak; bad headache; fever; Nausea; couldn't eat anything; dry heaves; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), ASTHENIA (I was pretty weak/Felt very weak) and HEADACHE ( bad headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol, Acid reflux (oesophageal) and Blood pressure. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), TELMISARTAN for Blood pressure, EVOLOCUMAB (REPATHA) for Cholesterol.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm). On 28-Aug-2021, the patient experienced FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), HEADACHE ( bad headache), PYREXIA (fever) and NAUSEA (Nausea). On 29-Aug-2021, the patient experienced ASTHENIA (I was pretty weak/Felt very weak). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm) was resolving and FEEDING DISORDER (couldn't eat anything), RETCHING (dry heaves), ASTHENIA (I was pretty weak/Felt very weak), HEADACHE ( bad headache), PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated that reaction from this previous dose was worse and more intense.   This case was linked to MOD-2021-302268 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb mass, Peripheral swelling, Vaccination complication
Clinical narrative: Lump under bend of both arms; Swollen right armpit 1-2; Reaction to the vaccine; Swollen left arm; Second dose given 13 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 13 days after first dose), PERIPHERAL SWELLING (Swollen left arm), LIMB MASS (Lump under bend of both arms), VACCINATION COMPLICATION (Reaction to the vaccine) and PERIPHERAL SWELLING (Swollen right armpit 1-2) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer, Asthma and Lung disorder NOS.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 13 days after first dose). On 29-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swollen left arm) and VACCINATION COMPLICATION (Reaction to the vaccine). On 30-Aug-2021, the patient experienced LIMB MASS (Lump under bend of both arms) and PERIPHERAL SWELLING (Swollen right armpit 1-2). On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given 13 days after first dose) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen left arm), LIMB MASS (Lump under bend of both arms), VACCINATION COMPLICATION (Reaction to the vaccine) and PERIPHERAL SWELLING (Swollen right armpit 1-2) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment information was mentioned.  The patient also stated that she also experienced Swollen Left arm bend towards the forearm (about 2.5-3") on 30-AUG-2021.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a patient) 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 was not provided by the reporter. Treatment information was not provided. The vaccine had been placed in the refrigerator from the Freezer on 12-Jul-2021, and thus it had  expired on 11-Aug-2021. 5 patients were vaccinated with expired vaccine, first patient on 24-Aug-2021, second on 26-Aug-2021 and last 3 patients were on 27-Aug-2021.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered 1st dose of Moderna COVID-19 vaccine to 15 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of Moderna COVID-19 vaccine to 15 year old) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of Moderna COVID-19 vaccine to 15 year old). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered 1st dose of Moderna COVID-19 vaccine to 15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: follow-up received and no new information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold
Clinical narrative: felt like he fell in a big tub of ice; after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt like he fell in a big tub of ice) and CHILLS (after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and FENOFIBRATE for Blood pressure high.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced FEELING COLD (felt like he fell in a big tub of ice) and CHILLS (after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast). At the time of the report, FEELING COLD (felt like he fell in a big tub of ice) outcome was unknown and CHILLS (after 2nd dose, chills for 5-10 minutes/chills came out of "nowhere," went away fast) had resolved.            Treatment information was not provided.  Patient contracted COVID 2 weeks ago but he is doing great and fine. Patient received second dose on a Saturday morning and he had chills on Tuesday at 7 pm for 5-10 minutes.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Patient received expired Moderna Covid-19 vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received expired Moderna Covid-19 vaccine). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.  One dose was given 24AUG2021, second expired dose given 26AUG2021, and the last 3 doses were given on 27AUG2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest pain, Chills, Dizziness
Clinical narrative: fever of 100.1°F; very fatigue; had chills; headache; I had a large knot under my injection site arm; large knot under my injection site arm, & it caused shooting pain across my chest; flu-like symptoms; My whole body was tender; soreness all over my body; joint pain; I couldn't sleep that night, because of soreness at the injection site; I couldn't sleep that night, because of soreness at the injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DIZZINESS (Dizziness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included COPD. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (Dizziness). On 27-Aug-2021, the patient experienced SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site) and INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site). On 28-Aug-2021, the patient experienced LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), TENDERNESS (My whole body was tender), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache). On 29-Aug-2021, the patient experienced PYREXIA (fever of 100.1°F). At the time of the report, SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), TENDERNESS (My whole body was tender), INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), PYREXIA (fever of 100.1°F), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100.1 (High) fever of 100.1°F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Limb mass
Clinical narrative: fever of 100.1°F; very fatigue; had chills; headache; I had a large knot under my injection site arm; large knot under my injection site arm, & it caused shooting pain across my chest; flu-like symptoms; My whole body was tender; soreness all over my body; joint pain; I couldn't sleep that night, because of soreness at the injection site; I couldn't sleep that night, because of soreness at the injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DIZZINESS (Dizziness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included COPD. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (Dizziness). On 27-Aug-2021, the patient experienced SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site) and INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site). On 28-Aug-2021, the patient experienced LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), TENDERNESS (My whole body was tender), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache). On 29-Aug-2021, the patient experienced PYREXIA (fever of 100.1°F). At the time of the report, SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), TENDERNESS (My whole body was tender), INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), PYREXIA (fever of 100.1°F), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100.1 (High) fever of 100.1°F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Sleep disorder, Tenderness
Clinical narrative: fever of 100.1°F; very fatigue; had chills; headache; I had a large knot under my injection site arm; large knot under my injection site arm, & it caused shooting pain across my chest; flu-like symptoms; My whole body was tender; soreness all over my body; joint pain; I couldn't sleep that night, because of soreness at the injection site; I couldn't sleep that night, because of soreness at the injection site; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms) and DIZZINESS (Dizziness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included COPD. Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE) for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (Dizziness). On 27-Aug-2021, the patient experienced SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site) and INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site). On 28-Aug-2021, the patient experienced LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), TENDERNESS (My whole body was tender), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache). On 29-Aug-2021, the patient experienced PYREXIA (fever of 100.1°F). At the time of the report, SLEEP DISORDER (I couldn't sleep that night, because of soreness at the injection site), LIMB MASS (I had a large knot under my injection site arm), CHEST PAIN (large knot under my injection site arm, & it caused shooting pain across my chest), INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), TENDERNESS (My whole body was tender), INJECTION SITE PAIN (I couldn't sleep that night, because of soreness at the injection site), MYALGIA (soreness all over my body), ARTHRALGIA (joint pain), PYREXIA (fever of 100.1°F), FATIGUE (very fatigue), CHILLS (had chills) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Body temperature: 100.1 (High) fever of 100.1°F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Metamorphopsia
Clinical narrative: Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass; She felt funny; This spontaneous case was reported by a pharmacist and describes the occurrence of METAMORPHOPSIA (Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass) and FEELING ABNORMAL (She felt funny) 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 METAMORPHOPSIA (Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass) and FEELING ABNORMAL (She felt funny). At the time of the report, METAMORPHOPSIA (Distorted vision for 1,5 days/mainly on her left eye/it seemed like looking through a glass) and FEELING ABNORMAL (She felt funny) 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.   Concomitant product use was not provided by the reporter. The patient took unspecified headache medication for treatment. Patient had distorted vision for 1,5 days, mainly on her left eye.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to the patient.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to the patient.) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment information was not  provided.  Nurse have 5 patients that were vaccinated with Moderna Covid-19 vaccine that expired on 11AUG2021.  The vaccine had been placed in the refrigerator from the Freezer on 12JUL2021. There were a total of 5 ten dose vials. that had expired past the beyond use date of 11AUG2021 in the refrigerator.  The vaccine under went no temperature excursions. The vials were taken from the refrigerator for administration and exposed to room temperature fro 5 minutes. One dose was given 24AUG2021, second expired dose given 26AUG2021, and the last 3 doses were given on 27AUG2021. The remaining doses of the Moderna Covid-19 vaccine that were not given were wasted and disposed of today 30AUG2021.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm hurt; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Pyrexia, Vaccination site pain
Clinical narrative: Sweating; Throbbing headache; Soreness in left injection site arm; Fever; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Throbbing headache), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness in left injection site arm), PYREXIA (Fever) and FATIGUE (Tiredness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Throbbing headache), HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness in left injection site arm), PYREXIA (Fever) and FATIGUE (Tiredness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at a dose of 7 Advil day.. On 23-Mar-2021, HEADACHE (Throbbing headache) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Soreness in left injection site arm), PYREXIA (Fever) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.    This case was linked to MOD-2021-302399, MOD-2021-028030 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Influenza, Vomiting
Clinical narrative: flu shot; diarrhea; vomiting; sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea) and INFLUENZA (flu shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced ILLNESS (sick). On 29-Aug-2021, the patient experienced VOMITING (vomiting). On 30-Aug-2021, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced INFLUENZA (flu shot). At the time of the report, ILLNESS (sick), VOMITING (vomiting), DIARRHOEA (diarrhea) and INFLUENZA (flu shot) outcome was unknown.            This case was linked to MOD-2021-302245 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Immediate dizziness; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Immediate dizziness) and NAUSEA (Nausea) 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 DIZZINESS (Immediate dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Immediate dizziness) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. Pharmacist stated that -according to the information of moderna  patient should not get the second dose since this was an immediate reaction. and asked about the second vaccine -should she get the Janssen vaccine as her second dose?
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effect). At the time of the report, VACCINATION COMPLICATION (adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm soreness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included TRANYLCYPROMINE SULFATE (PARNATE), CLONAZEPAM (KLONOPIN), LAMOTRIGINE (LAMICTAL) and EZETIMIBE (ZETIA) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm soreness). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Headache and Fatigue, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported the arm soreness lasted for about a day. The patient can be contacted via email or phone.   This case was linked to MOD-2021-302232 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling of that portion of it started immediately; Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow) and VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Swelling of that portion of it started immediately). In August 2021, the patient experienced VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. In August 2021, VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) had resolved. At the time of the report, VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it's from the shoulder to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  The patient took Tylenol initially for 2 days and then Advil was used when it started hurting again and was put hot prior to work and then iced it.  The patient's pain and swelling went away after vaccination but it started again during training that was probably around 17th or 18th of August and was still painful. Patient had no other symptoms.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Headache, Illness
Clinical narrative: couldn't get the second dose as it had an unexpected back to back surgery; Headache; so tired; Nauseated; body aches, hurt all over/sore; pretty sick/got sick; had no energies, had to go to bed; The patient thought it was sinusitis; it was red around, localized; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized) and PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery) in a 58-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 on 04-Nov-2020, Cancer and Surgery (2 surgeries after first dose of vaccine).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery). At the time of the report, ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Product dose omission issue, SARS-CoV-2 test, Sinusitis
Clinical narrative: couldn't get the second dose as it had an unexpected back to back surgery; Headache; so tired; Nauseated; body aches, hurt all over/sore; pretty sick/got sick; had no energies, had to go to bed; The patient thought it was sinusitis; it was red around, localized; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized) and PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery) in a 58-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 on 04-Nov-2020, Cancer and Surgery (2 surgeries after first dose of vaccine).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery). At the time of the report, ILLNESS (pretty sick/got sick), ASTHENIA (had no energies, had to go to bed), SINUSITIS (The patient thought it was sinusitis), ERYTHEMA (it was red around, localized), PRODUCT DOSE OMISSION ISSUE (couldn't get the second dose as it had an unexpected back to back surgery), HEADACHE (Headache), FATIGUE (so tired), NAUSEA (Nauseated) and MYALGIA (body aches, hurt all over/sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Within 1 hour had a severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Within 1 hour had a severe headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Within 1 hour had a severe headache). At the time of the report, HEADACHE (Within 1 hour had a severe headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.