chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Rash, Vaccination site erythema
Clinical narrative: Redness turning into rash that is creeping down arm; Low grade fever; Feeling achy; Headache; Redness at injection site; Pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Redness turning into rash that is creeping down arm), MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain in injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. L29L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO), ATORVASTATIN and FENOFIBRATE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain in injection site). On 27-Feb-2021, the patient experienced PYREXIA (Low grade fever). On 28-Feb-2021, the patient experienced RASH (Redness turning into rash that is creeping down arm). The patient was treated with NAPROXEN SODIUM (ALEVE) on 27-Feb-2021 for Pain, at a dose of 220mg 2 tabs. At the time of the report, RASH (Redness turning into rash that is creeping down arm) had not resolved and MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PAIN (Pain in injection site) and PYREXIA (Low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Redness turning into rash that is creeping down arm; Low grade fever; Feeling achy; Headache; Redness at injection site; Pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Redness turning into rash that is creeping down arm), MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain in injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. L29L20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMPRO), ATORVASTATIN and FENOFIBRATE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain in injection site). On 27-Feb-2021, the patient experienced PYREXIA (Low grade fever). On 28-Feb-2021, the patient experienced RASH (Redness turning into rash that is creeping down arm). The patient was treated with NAPROXEN SODIUM (ALEVE) on 27-Feb-2021 for Pain, at a dose of 220mg 2 tabs. At the time of the report, RASH (Redness turning into rash that is creeping down arm) had not resolved and MYALGIA (Feeling achy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PAIN (Pain in injection site) and PYREXIA (Low grade fever) outcome was unknown.            Action taken with mRNA-1273 in response to events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Hypertension, Oxygen saturation
Clinical narrative: High blood pressure; Dizziness; Fatigue; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), DIZZINESS (Dizziness), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm pain). On 25-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 26-Feb-2021, the patient experienced HYPERTENSION (High blood pressure). At the time of the report, HYPERTENSION (High blood pressure), DIZZINESS (Dizziness), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood pressure measurement: 160/85 mmHg High and 160/92 mmHg High. On 26-Feb-2021, Oxygen saturation: 98-99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. Treatment medications were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: High blood pressure; Dizziness; Fatigue; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), DIZZINESS (Dizziness), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm pain). On 25-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 26-Feb-2021, the patient experienced HYPERTENSION (High blood pressure). At the time of the report, HYPERTENSION (High blood pressure), DIZZINESS (Dizziness), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood pressure measurement: 160/85 mmHg High and 160/92 mmHg High. On 26-Feb-2021, Oxygen saturation: 98-99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. Treatment medications were not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination complication, Vaccination site bruising, Vaccination site pain, Vaccination site vesicles
Clinical narrative: "Big spot circle" around 4 inches in diameter with blisters on it on the injection site; Itching; "big spot circle" around 4 inches in diameter with blisters on it on the injection site; Soreness on the area of the injection; Not feeling very good; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling very good), VACCINATION SITE VESICLES ("Big spot circle" around 4 inches in diameter with blisters on it on the injection site), PRURITUS (Itching), VACCINATION SITE BRUISING ("big spot circle" around 4 inches in diameter with blisters on it on the injection site) and VACCINATION SITE PAIN (Soreness on the area of the injection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (Not feeling very good) and VACCINATION SITE PAIN (Soreness on the area of the injection). On 25-Feb-2021, the patient experienced VACCINATION SITE VESICLES ("Big spot circle" around 4 inches in diameter with blisters on it on the injection site), PRURITUS (Itching) and VACCINATION SITE BRUISING ("big spot circle" around 4 inches in diameter with blisters on it on the injection site). On 17-Feb-2021, VACCINATION COMPLICATION (Not feeling very good) and VACCINATION SITE PAIN (Soreness on the area of the injection) had resolved. On 27-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, VACCINATION SITE VESICLES ("Big spot circle" around 4 inches in diameter with blisters on it on the injection site) and VACCINATION SITE BRUISING ("big spot circle" around 4 inches in diameter with blisters on it on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. Treatment done by Cortisone cream.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU received on 20 JUL 2021: Events Outcome was updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: fever reached to 100.7; chills; headache; muscle pain; nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal), Allergy NOS and Glaucoma. Concomitant products included DEXLANSOPRAZOLE (DEXILANT) for Acid reflux (oesophageal), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, MONTELUKAST SODIUM (SINGULAIR) for Allergy NOS, VALACICLOVIR from an unknown date to 25-Feb-2021 for Antiviral treatment, LATANOPROSTENE BUNOD (VYZULTA) for Glaucoma.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.7 (High) 100.7 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment  information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever reached to 100.7; chills; headache; muscle pain; nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal), Allergy NOS and Glaucoma. Concomitant products included DEXLANSOPRAZOLE (DEXILANT) for Acid reflux (oesophageal), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, MONTELUKAST SODIUM (SINGULAIR) for Allergy NOS, VALACICLOVIR from an unknown date to 25-Feb-2021 for Antiviral treatment, LATANOPROSTENE BUNOD (VYZULTA) for Glaucoma.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.7 (High) 100.7 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment  information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: weak; Headache; Moaning from Achiness; Pyrexia; Didn't feel good; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of   in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included ATORVASTATIN, PRAMIPEXOLE and TRAZODONE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. Unknown          The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Pain on right leg and hip; Severe muscle aches; starting to feel it in left leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on right leg and hip), MYALGIA (Severe muscle aches) and ARTHRALGIA (starting to feel it in left leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O14M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on right leg and hip), MYALGIA (Severe muscle aches) and ARTHRALGIA (starting to feel it in left leg). At the time of the report, PAIN IN EXTREMITY (Pain on right leg and hip), MYALGIA (Severe muscle aches) and ARTHRALGIA (starting to feel it in left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided.  Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MASS ("Goose egg" in arm), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia and Thyroid disorder. Concomitant products included AMLODIPINE for Blood pressure high, ROSUVASTATIN for Hypercholesterolemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 18-Feb-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 MASS ("Goose egg" in arm), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Red injection site). At the time of the report, MASS ("Goose egg" in arm), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by an other and describes the occurrence of HEADACHE (headache) and FATIGUE (Fatigue) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.            no concomitant medication reported no treatment information provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Parosmia
Clinical narrative: dizziness; Smells gasoline; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIZZINESS (dizziness) and PAROSMIA (Smells gasoline) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Hypertension, MULTIVITAMINS, VITAMIN B COMPLEX, VITAMIN E NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CALCIUM CARBONATE, COLECALCIFEROL (CALTRATE VIT) for Supplementation therapy, LEVOTHYROXINE for Thyroid activity decreased.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 27-Feb-2021, the patient experienced DIZZINESS (dizziness) and PAROSMIA (Smells gasoline). On 25-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, DIZZINESS (dizziness) and PAROSMIA (Smells gasoline) had resolved.            No treatment was provided. The patient informed that had the symptoms from first vaccination as stated in the report. They only lasted for a few hours and then subsided. The patient did not have any symptoms (other than sore arms after both shots) after second Moderna vaccination   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information  received on 29 Apr-2021 contains updated event outcome. On 13-Jul-2021: Follow up information received on 13 Jul-2021 contains updated event outcome.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Poor quality sleep, Pyrexia
Clinical narrative: Sleepiness/i was sleepy all day; Temperature 100, never reaching more than 100.3; very dizzy; Restless; woke up earlier that her usual time; feeling very tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time), SOMNOLENCE (Sleepiness/i was sleepy all day), DIZZINESS (very dizzy) and PYREXIA (Temperature 100, never reaching more than 100.3) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Patient has been suffering from high blood pressure since long term.) since 2007, Allergy and Osteopenia. Concomitant products included LORATADINE for Allergy, BENAZEPRIL HCL for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRINE) for Heart disorder, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for Osteopenia.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (feeling very tired) and CHILLS (chills). On 26-Feb-2021, the patient experienced RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time) and DIZZINESS (very dizzy). On an unknown date, the patient experienced SOMNOLENCE (Sleepiness/i was sleepy all day) and PYREXIA (Temperature 100, never reaching more than 100.3). On 26-Feb-2021, SOMNOLENCE (Sleepiness/i was sleepy all day), PYREXIA (Temperature 100, never reaching more than 100.3) and CHILLS (chills) had resolved. At the time of the report, RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time), DIZZINESS (very dizzy) and FATIGUE (feeling very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant follow-up: Updated outcome and stop date of the event chills. Added medical history, concomitant medications and additional events of sleepiness, pyrexia.
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Somnolence
Clinical narrative: Sleepiness/i was sleepy all day; Temperature 100, never reaching more than 100.3; very dizzy; Restless; woke up earlier that her usual time; feeling very tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time), SOMNOLENCE (Sleepiness/i was sleepy all day), DIZZINESS (very dizzy) and PYREXIA (Temperature 100, never reaching more than 100.3) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high (Patient has been suffering from high blood pressure since long term.) since 2007, Allergy and Osteopenia. Concomitant products included LORATADINE for Allergy, BENAZEPRIL HCL for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRINE) for Heart disorder, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for Osteopenia.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (feeling very tired) and CHILLS (chills). On 26-Feb-2021, the patient experienced RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time) and DIZZINESS (very dizzy). On an unknown date, the patient experienced SOMNOLENCE (Sleepiness/i was sleepy all day) and PYREXIA (Temperature 100, never reaching more than 100.3). On 26-Feb-2021, SOMNOLENCE (Sleepiness/i was sleepy all day), PYREXIA (Temperature 100, never reaching more than 100.3) and CHILLS (chills) had resolved. At the time of the report, RESTLESSNESS (Restless), POOR QUALITY SLEEP (woke up earlier that her usual time), DIZZINESS (very dizzy) and FATIGUE (feeling very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant follow-up: Updated outcome and stop date of the event chills. Added medical history, concomitant medications and additional events of sleepiness, pyrexia.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Pyrexia
Clinical narrative: hot and cold at the same time; chills real bad; fever of 101.6 F for about 3 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills real bad), PYREXIA (fever of 101.6 F for about 3 hours) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold at the same time) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cardiac arrest (he had 2 times heart attack). Concurrent medical conditions included Diabetes.    On 25-Feb-2021 at 4:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (chills real bad) and PYREXIA (fever of 101.6 F for about 3 hours). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hot and cold at the same time). At the time of the report, CHILLS (chills real bad), PYREXIA (fever of 101.6 F for about 3 hours) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold at the same time) outcome was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Chills, Impaired work ability, Injection site mass, Injection site pain
Clinical narrative: pain in arm injjection local; uncomfortable; Fever; in bed 20 hours; very sick; unable to get up; too sick to walk; shaking; moaning; dry heaves; Fever; chills; pain in arm; could not sleep; locally warm to touch; locally felt lumpy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking) and MOANING (moaning) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025T20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 07-Jan-2021, the patient experienced POOR QUALITY SLEEP (could not sleep), PAIN IN EXTREMITY (pain in arm), INJECTION SITE WARMTH (locally warm to touch) and INJECTION SITE MASS (locally felt lumpy). On 05-Feb-2021, the patient experienced TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), the first episode of PYREXIA (Fever) and CHILLS (chills). On 06-Feb-2021, the patient experienced BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), MALAISE (uncomfortable), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE PAIN (pain in arm injjection local) and the second episode of PYREXIA (Fever). At the time of the report, BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), MALAISE (uncomfortable), PAIN IN EXTREMITY (pain in arm), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE WARMTH (locally warm to touch), INJECTION SITE MASS (locally felt lumpy), INJECTION SITE PAIN (pain in arm injjection local), CHILLS (chills) and the last episode of PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She takes no concomitant medications and has no health conditions. She  mentioned that she is extremely healthy person. No treatment medication were reported.She drank fluids to help with the fever. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Malaise, Moaning, Mobility decreased, Muscular weakness
Clinical narrative: pain in arm injjection local; uncomfortable; Fever; in bed 20 hours; very sick; unable to get up; too sick to walk; shaking; moaning; dry heaves; Fever; chills; pain in arm; could not sleep; locally warm to touch; locally felt lumpy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking) and MOANING (moaning) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025T20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 07-Jan-2021, the patient experienced POOR QUALITY SLEEP (could not sleep), PAIN IN EXTREMITY (pain in arm), INJECTION SITE WARMTH (locally warm to touch) and INJECTION SITE MASS (locally felt lumpy). On 05-Feb-2021, the patient experienced TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), the first episode of PYREXIA (Fever) and CHILLS (chills). On 06-Feb-2021, the patient experienced BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), MALAISE (uncomfortable), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE PAIN (pain in arm injjection local) and the second episode of PYREXIA (Fever). At the time of the report, BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), MALAISE (uncomfortable), PAIN IN EXTREMITY (pain in arm), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE WARMTH (locally warm to touch), INJECTION SITE MASS (locally felt lumpy), INJECTION SITE PAIN (pain in arm injjection local), CHILLS (chills) and the last episode of PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She takes no concomitant medications and has no health conditions. She  mentioned that she is extremely healthy person. No treatment medication were reported.She drank fluids to help with the fever. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Retching, Tremor
Clinical narrative: pain in arm injjection local; uncomfortable; Fever; in bed 20 hours; very sick; unable to get up; too sick to walk; shaking; moaning; dry heaves; Fever; chills; pain in arm; could not sleep; locally warm to touch; locally felt lumpy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking) and MOANING (moaning) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025T20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 mg. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 mg. On 07-Jan-2021, the patient experienced POOR QUALITY SLEEP (could not sleep), PAIN IN EXTREMITY (pain in arm), INJECTION SITE WARMTH (locally warm to touch) and INJECTION SITE MASS (locally felt lumpy). On 05-Feb-2021, the patient experienced TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), the first episode of PYREXIA (Fever) and CHILLS (chills). On 06-Feb-2021, the patient experienced BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), MALAISE (uncomfortable), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE PAIN (pain in arm injjection local) and the second episode of PYREXIA (Fever). At the time of the report, BED REST (in bed 20 hours), MUSCULAR WEAKNESS (very sick), POOR QUALITY SLEEP (could not sleep), TREMOR (shaking), MOANING (moaning), RETCHING (dry heaves), MALAISE (uncomfortable), PAIN IN EXTREMITY (pain in arm), IMPAIRED WORK ABILITY (unable to get up), MOBILITY DECREASED (too sick to walk), INJECTION SITE WARMTH (locally warm to touch), INJECTION SITE MASS (locally felt lumpy), INJECTION SITE PAIN (pain in arm injjection local), CHILLS (chills) and the last episode of PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She takes no concomitant medications and has no health conditions. She  mentioned that she is extremely healthy person. No treatment medication were reported.She drank fluids to help with the fever. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Platelet count, Urine analysis normal
Clinical narrative: Extreme hemorrhaging from penis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Extreme hemorrhaging from penis) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer, Macular degeneration and Kidney failure. Concomitant products included RIVAROXABAN (XARELTO), BICALUTAMIDE, METOPROLOL SUCCINATE, DUTASTERIDE, ALOPURINOL, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION AREDS) and hormone injection for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HAEMATURIA (Extreme hemorrhaging from penis). At the time of the report, HAEMATURIA (Extreme hemorrhaging from penis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count:. On an unknown date, Urine analysis normal:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: body aches; little sore at injection site; swollen at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (little sore at injection site), VACCINATION SITE SWELLING (swollen at injection site) and MYALGIA (body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (little sore at injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 24-Feb-2021, the patient experienced MYALGIA (body aches). On 25-Feb-2021, MYALGIA (body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (little sore at injection site) and VACCINATION SITE SWELLING (swollen at injection site) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   This case was linked to MOD-2021-028562, MOD-2021-028562 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pruritus, Suspected COVID-19
Clinical narrative: her doctor said most likely she had been exposed to COVID-19 virus before the first shot.; second dose will be greater than day 36 if she does get it; random itchiness all over body; stinging of face and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUSPECTED COVID-19 (her doctor said most likely she had been exposed to COVID-19 virus before the first shot.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose will be greater than day 36 if she does get it), PRURITUS (random itchiness all over body) and PAIN (stinging of face and arms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRURITUS (random itchiness all over body) and PAIN (stinging of face and arms). On an unknown date, the patient experienced SUSPECTED COVID-19 (her doctor said most likely she had been exposed to COVID-19 virus before the first shot.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose will be greater than day 36 if she does get it). At the time of the report, SUSPECTED COVID-19 (her doctor said most likely she had been exposed to COVID-19 virus before the first shot.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose will be greater than day 36 if she does get it) and PAIN (stinging of face and arms) outcome was unknown and PRURITUS (random itchiness all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Reporter contact information updated, Added events 'stinging of face and arms' and 'her doctor said most likely she had been exposed to COVID-19 virus before the first shot' having outcome unknown On 22-Jul-2021: Follow-up received on 22-July-2021 and contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Paraesthesia
Clinical narrative: She had shingles; Red spot on her forehead; Tingling on her forehead; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on her forehead), HERPES ZOSTER (She had shingles) and ERYTHEMA (Red spot on her forehead) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PARAESTHESIA (Tingling on her forehead). On 20-Feb-2021, the patient experienced ERYTHEMA (Red spot on her forehead). On 25-Feb-2021, the patient experienced HERPES ZOSTER (She had shingles). At the time of the report, PARAESTHESIA (Tingling on her forehead), HERPES ZOSTER (She had shingles) and ERYTHEMA (Red spot on her forehead) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Email
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Vomiting
Clinical narrative: upset stomach; Chills; fatigue; threw up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), CHILLS (Chills), FATIGUE (fatigue) and VOMITING (threw up) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019M20A/014M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, ATORVASTATIN, DULAGLUTIDE (TRULICITY) and VITAMIN D2 for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), CHILLS (Chills), FATIGUE (fatigue) and VOMITING (threw up). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), CHILLS (Chills), FATIGUE (fatigue) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not specified.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Fatigue, Headache, Influenza like illness, Malaise
Clinical narrative: light sensitivity; didn't feel great; flu like symptoms; she turned hot then cold then hot again; arm started "itching beyond itching"; injection site became a lump the size of her hand; headaches; fatigued; arm was warm; arm was red; Arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm), PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms) and BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Immune thrombocytopenic purpura, Asthma, Diabetes and Psoriatic arthritis. Concomitant products included METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA), QUINAPRIL, METFORMIN HCL, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE, CANAGLIFLOZIN, ATORVASTATIN, EXENATIDE and SECUKINUMAB (COSENTYX) 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 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE ERYTHEMA (arm was red). On 23-Feb-2021, the patient experienced PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms), BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again), VACCINATION SITE PRURITUS (arm started "itching beyond itching"), VACCINATION SITE INDURATION (injection site became a lump the size of her hand), HEADACHE (headaches) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (arm was warm), PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms), BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again), VACCINATION SITE PRURITUS (arm started "itching beyond itching"), VACCINATION SITE INDURATION (injection site became a lump the size of her hand), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (arm was red), HEADACHE (headaches) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: light sensitivity; didn't feel great; flu like symptoms; she turned hot then cold then hot again; arm started "itching beyond itching"; injection site became a lump the size of her hand; headaches; fatigued; arm was warm; arm was red; Arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm was warm), PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms) and BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0301-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Immune thrombocytopenic purpura, Asthma, Diabetes and Psoriatic arthritis. Concomitant products included METOPROLOL TARTRATE (METOPROLOL - 1 A PHARMA), QUINAPRIL, METFORMIN HCL, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE, CANAGLIFLOZIN, ATORVASTATIN, EXENATIDE and SECUKINUMAB (COSENTYX) 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 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm was warm), VACCINATION SITE SWELLING (Arm swollen) and VACCINATION SITE ERYTHEMA (arm was red). On 23-Feb-2021, the patient experienced PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms), BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again), VACCINATION SITE PRURITUS (arm started "itching beyond itching"), VACCINATION SITE INDURATION (injection site became a lump the size of her hand), HEADACHE (headaches) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (arm was warm), PHOTOPHOBIA (light sensitivity), MALAISE (didn't feel great), INFLUENZA LIKE ILLNESS (flu like symptoms), BODY TEMPERATURE FLUCTUATION (she turned hot then cold then hot again), VACCINATION SITE PRURITUS (arm started "itching beyond itching"), VACCINATION SITE INDURATION (injection site became a lump the size of her hand), VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE ERYTHEMA (arm was red), HEADACHE (headaches) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.