chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Small asthma episode; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Small asthma episode) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Small asthma episode). The patient was treated with ALBUTEROL [SALBUTAMOL] for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (Small asthma episode) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site erythema
Clinical narrative: Injection site redness, swelling, hot/warm; injection site redness; Injection site redness, swelling; Injection site redness, swelling, hot/warm, painful; fever; Chills; On and off headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful) and PYREXIA (fever) in a 65-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.     No medical history was reported.  Concomitant products included LISINOPRIL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy.    On 05-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 VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful), PYREXIA (fever), CHILLS (Chills), HEADACHE (On and off headache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful), PYREXIA (fever), CHILLS (Chills), HEADACHE (On and off headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for these events.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site redness, swelling, hot/warm; injection site redness; Injection site redness, swelling; Injection site redness, swelling, hot/warm, painful; fever; Chills; On and off headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful) and PYREXIA (fever) in a 65-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.     No medical history was reported.  Concomitant products included LISINOPRIL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy.    On 05-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 VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful), PYREXIA (fever), CHILLS (Chills), HEADACHE (On and off headache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE WARMTH (Injection site redness, swelling, hot/warm), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE SWELLING (Injection site redness, swelling), VACCINATION SITE PAIN (Injection site redness, swelling, hot/warm, painful), PYREXIA (fever), CHILLS (Chills), HEADACHE (On and off headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment for these events.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph glands in throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph glands in throat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph glands in throat). At the time of the report, LYMPHADENOPATHY (Swollen lymph glands in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No new information reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: Severe body ache / hands and feets are stinging; Her feets are red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe body ache / hands and feets are stinging) and ERYTHEMA (Her feets are red) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Severe body ache / hands and feets are stinging) and ERYTHEMA (Her feets are red). At the time of the report, PAIN (Severe body ache / hands and feets are stinging) and ERYTHEMA (Her feets are red) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Rash, Urticaria
Clinical narrative: Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone; Neck itchy; Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone; had chills for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone), PRURITUS (Neck itchy), RASH (Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone) and CHILLS (had chills for 6 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy. Concomitant products included LOSARTAN, ATORVASTATIN, VITAMIN B NOS and VITAMIN D NOS for an unknown indication.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CHILLS (had chills for 6 hours). On 11-Mar-2021, the patient experienced URTICARIA (Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone), PRURITUS (Neck itchy) and RASH (Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 10-Mar-2021, CHILLS (had chills for 6 hours) had resolved. At the time of the report, URTICARIA (Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone), PRURITUS (Neck itchy) and RASH (Severe hives and rash in the middle of the front of the neck, down to collar, and even on collar bone) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information reported
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Body aches; Felt like he had a fever; Headache; Nauseous; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Felt like he had a fever), HEADACHE (Headache), NAUSEA (Nauseous) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (Felt like he had a fever), HEADACHE (Headache), NAUSEA (Nauseous) and CHILLS (Chills). On 15-Mar-2021, PYREXIA (Felt like he had a fever), HEADACHE (Headache), NAUSEA (Nauseous) and CHILLS (Chills) had resolved. At the time of the report, PAIN (Body aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Chills, Oral herpes, Pyrexia
Clinical narrative: Chills; Fever; Fever blister on the top lip and a cluster of 4 blisters on the bottom lip; Pimple on the lip; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (Fever blister on the top lip and a cluster of 4 blisters on the bottom lip), ACNE (Pimple on the lip), CHILLS (Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included METFORMIN, SOLIFENACIN SUCCINATE (VESICARE), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ACNE (Pimple on the lip). On 08-Mar-2021, the patient experienced ORAL HERPES (Fever blister on the top lip and a cluster of 4 blisters on the bottom lip). On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with DOCOSANOL (ABREVA) for Blister, at an unspecified dose and frequency. At the time of the report, ORAL HERPES (Fever blister on the top lip and a cluster of 4 blisters on the bottom lip), ACNE (Pimple on the lip), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on the right side of the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles on the right side of the neck) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HERPES ZOSTER (shingles on the right side of the neck). At the time of the report, HERPES ZOSTER (shingles on the right side of the neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.    The patient was prescribed an antiviral (unspecified) by her HCP.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia
Clinical narrative: Tingling Sensation in the Head; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling Sensation in the Head) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ATORVASTATIN, LISINOPRIL and CARVEDILOL for Blood pressure high.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PARAESTHESIA (Tingling Sensation in the Head) and HEADACHE (Headache). On 14-Mar-2021, PARAESTHESIA (Tingling Sensation in the Head) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: fatigue; muscle PAIN; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle PAIN) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No relevant medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (chills). On 14-Mar-2021, the patient experienced FATIGUE (fatigue) and MYALGIA (muscle PAIN). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at a dose of 800 milligram. At the time of the report, CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle PAIN) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included unspecified blood pressure pills.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: chills; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills) and MYALGIA (Body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever). On 13-Mar-2021 at 3:00 AM, the patient experienced CHILLS (chills) and MYALGIA (Body aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. On 14-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, CHILLS (chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101 (High) 101 degrees Fahrenheit and 104 (High) 104 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified high blood pressure medication and an unspecified cholesterol medication.   Treatment included aspirin for the fever.
Sex: F
Vaccine: COVID19
Symptoms: Heat illness, Lethargy, Pyrexia
Clinical narrative: lethargy; Dry Heat; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), HEAT ILLNESS (Dry Heat) and PYREXIA (Low grade temperature) 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 LETHARGY (lethargy), HEAT ILLNESS (Dry Heat) and PYREXIA (Low grade temperature). At the time of the report, LETHARGY (lethargy), HEAT ILLNESS (Dry Heat) and PYREXIA (Low grade temperature) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: a syringe that malfunctioned during administration; medication squirted out during administration; based on the current case data, this case has been classified as invalid. this spontaneous case was reported by a nurse and describes the occurrence of device connection issue (a syringe that malfunctioned during administration) and accidental underdose (medication squirted out during administration) 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) at an unspecified dose. on an unknown date, the patient experienced device connection issue (a syringe that malfunctioned during administration) and accidental underdose (medication squirted out during administration). at the time of the report, device connection issue (a syringe that malfunctioned during administration) and accidental underdose (medication squirted out during administration) outcome was unknown.        the action taken with mrna-1273 (Moderna covid-19 vaccine) (unknown route) was unknown    For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms, Muscle tightness
Clinical narrative: problem with sleeping; has this bad muscle issue in the back, muscle is tight; horrible stretches; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (problem with sleeping), MUSCLE TIGHTNESS (has this bad muscle issue in the back, muscle is tight) and MUSCLE SPASMS (horrible stretches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No reported medical history.  Concomitant products included NAPROXEN, LOSARTAN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced INSOMNIA (problem with sleeping), MUSCLE TIGHTNESS (has this bad muscle issue in the back, muscle is tight) and MUSCLE SPASMS (horrible stretches). At the time of the report, INSOMNIA (problem with sleeping), MUSCLE TIGHTNESS (has this bad muscle issue in the back, muscle is tight) and MUSCLE SPASMS (horrible stretches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified steroid topical cream. The patient had problem sleeping and all of sudden she was wide awake, she slept for 2 hours a most. The patient had see her chiropractor for muscle issue and horrible stretches and was told that her muscle was tight.  Concomitant medications included Steriod Topical Cream  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Adverse event) 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 ADVERSE DRUG REACTION (Adverse event). At the time of the report, ADVERSE DRUG REACTION (Adverse event) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity, Restlessness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), DISCOMFORT (uncomfortable during the night) and RESTLESSNESS (restless) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. 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 PAIN IN EXTREMITY (arm hurt), DISCOMFORT (uncomfortable during the night) and RESTLESSNESS (restless). The patient was treated with CARBIDOPA MONOHYDRATE, LEVODOPA (CARBIDOPA + LEVODOPA) (oral) at a dose of 25 UNK; TAMSULOSIN (oral) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (BABY ASPIRIN) (oral) ongoing since an unknown date at an unspecified dose and frequency and PRAVASTATIN (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt), DISCOMFORT (uncomfortable during the night) and RESTLESSNESS (restless) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: patient declined further FUP
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Pain in extremity
Clinical narrative: sore arm; chills; tired; cough; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (tired), COUGH (cough) and VACCINATION SITE PAIN (Vaccination site pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (tired), COUGH (cough) and VACCINATION SITE PAIN (Vaccination site pain). On 08-Mar-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (tired), COUGH (cough) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported. No medical history was provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; chills; tired; cough; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (tired), COUGH (cough) and VACCINATION SITE PAIN (Vaccination site pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (chills), FATIGUE (tired), COUGH (cough) and VACCINATION SITE PAIN (Vaccination site pain). On 08-Mar-2021, PAIN IN EXTREMITY (sore arm) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (tired), COUGH (cough) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported. No medical history was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: aches all over body - she hurt all over; chills; fever; aches in muscles/pains in muscles; aches in joints/pains in joints; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches all over body - she hurt all over), CHILLS (chills), PYREXIA (fever), MYALGIA (aches in muscles/pains in muscles) and ARTHRALGIA (aches in joints/pains in joints) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN (aches all over body - she hurt all over), CHILLS (chills), PYREXIA (fever), MYALGIA (aches in muscles/pains in muscles) and ARTHRALGIA (aches in joints/pains in joints). At the time of the report, PAIN (aches all over body - she hurt all over), CHILLS (chills), PYREXIA (fever), MYALGIA (aches in muscles/pains in muscles) and ARTHRALGIA (aches in joints/pains in joints) outcome was unknown.            No concomitant information was reported. No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Fatigue, Feeling abnormal, Headache
Clinical narrative: arm weakness; Sharp pain in the knee; Pain in the hips; headache; brain frog; Felt leg weakness; Felt fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Felt leg weakness), MUSCULAR WEAKNESS (arm weakness), FEELING ABNORMAL (brain frog), HEADACHE (headache) and FATIGUE (Felt fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (NORVASC) and LABETALOL for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Felt fatigue). On 04-Mar-2021, the patient experienced LIMB DISCOMFORT (Felt leg weakness) and FEELING ABNORMAL (brain frog). On 05-Mar-2021, the patient experienced HEADACHE (headache). On 08-Mar-2021, the patient experienced ARTHRALGIA (Pain in the hips). On 09-Mar-2021, the patient experienced ARTHRALGIA (Sharp pain in the knee). On 11-Mar-2021, the patient experienced MUSCULAR WEAKNESS (arm weakness). On 10-Mar-2021, ARTHRALGIA (Sharp pain in the knee) had resolved. At the time of the report, LIMB DISCOMFORT (Felt leg weakness), MUSCULAR WEAKNESS (arm weakness), FEELING ABNORMAL (brain frog), HEADACHE (headache), FATIGUE (Felt fatigue) and ARTHRALGIA (Pain in the hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: other OTHER.         Patient went to the Urgent Care . Urgent care gave her a Norvasc to bring the blood pressure down.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness
Clinical narrative: arm weakness; Sharp pain in the knee; Pain in the hips; headache; brain frog; Felt leg weakness; Felt fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Felt leg weakness), MUSCULAR WEAKNESS (arm weakness), FEELING ABNORMAL (brain frog), HEADACHE (headache) and FATIGUE (Felt fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE BESILATE (NORVASC) and LABETALOL for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Felt fatigue). On 04-Mar-2021, the patient experienced LIMB DISCOMFORT (Felt leg weakness) and FEELING ABNORMAL (brain frog). On 05-Mar-2021, the patient experienced HEADACHE (headache). On 08-Mar-2021, the patient experienced ARTHRALGIA (Pain in the hips). On 09-Mar-2021, the patient experienced ARTHRALGIA (Sharp pain in the knee). On 11-Mar-2021, the patient experienced MUSCULAR WEAKNESS (arm weakness). On 10-Mar-2021, ARTHRALGIA (Sharp pain in the knee) had resolved. At the time of the report, LIMB DISCOMFORT (Felt leg weakness), MUSCULAR WEAKNESS (arm weakness), FEELING ABNORMAL (brain frog), HEADACHE (headache), FATIGUE (Felt fatigue) and ARTHRALGIA (Pain in the hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: other OTHER.         Patient went to the Urgent Care . Urgent care gave her a Norvasc to bring the blood pressure down.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: difficulty to swallow; eyelids swollen; swelling in right hands and wrists; Itchy; red; Broke out in hives and worsened; felt pretty tired; typical sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (typical sore arm), FATIGUE (felt pretty tired), PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy) and ERYTHEMA (red) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (typical sore arm). On 08-Mar-2021, the patient experienced FATIGUE (felt pretty tired). On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy), ERYTHEMA (red) and URTICARIA (Broke out in hives and worsened). On 12-Mar-2021, the patient experienced DYSPHAGIA (difficulty to swallow) and SWELLING OF EYELID (eyelids swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (typical sore arm) had resolved. On 08-Mar-2021, FATIGUE (felt pretty tired) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy), ERYTHEMA (red), URTICARIA (Broke out in hives and worsened), DYSPHAGIA (difficulty to swallow) and SWELLING OF EYELID (eyelids swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported treatment of events was with cetirizine (Zyrtec) 20mg and methylprednisolone 6-day pack.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: difficulty to swallow; eyelids swollen; swelling in right hands and wrists; Itchy; red; Broke out in hives and worsened; felt pretty tired; typical sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (typical sore arm), FATIGUE (felt pretty tired), PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy) and ERYTHEMA (red) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PAIN IN EXTREMITY (typical sore arm). On 08-Mar-2021, the patient experienced FATIGUE (felt pretty tired). On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy), ERYTHEMA (red) and URTICARIA (Broke out in hives and worsened). On 12-Mar-2021, the patient experienced DYSPHAGIA (difficulty to swallow) and SWELLING OF EYELID (eyelids swollen). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (typical sore arm) had resolved. On 08-Mar-2021, FATIGUE (felt pretty tired) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling in right hands and wrists), PRURITUS (Itchy), ERYTHEMA (red), URTICARIA (Broke out in hives and worsened), DYSPHAGIA (difficulty to swallow) and SWELLING OF EYELID (eyelids swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported treatment of events was with cetirizine (Zyrtec) 20mg and methylprednisolone 6-day pack.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort, Sinusitis
Clinical narrative: MD told him, he has a slight irritation; Started with sinus infection symptoms ,did not specify, any symptom in particular; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Started with sinus infection symptoms ,did not specify, any symptom in particular) and NASAL DISCOMFORT (MD told him, he has a slight irritation) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced SINUSITIS (Started with sinus infection symptoms ,did not specify, any symptom in particular). On an unknown date, the patient experienced NASAL DISCOMFORT (MD told him, he has a slight irritation). At the time of the report, SINUSITIS (Started with sinus infection symptoms ,did not specify, any symptom in particular) and NASAL DISCOMFORT (MD told him, he has a slight irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Blood Pressure medication and cholesterol medication. Treatment details included patient was prescribed with azithromycin tablets, but has not taken any pills yet.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not provide them  a second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not provide them  a second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not provide them  a second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not provide them  a second dose) 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 and Treatment medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: headaches; fever of 101-105 F; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headaches) and PYREXIA (fever of 101-105 F) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (headaches) and PYREXIA (fever of 101-105 F). At the time of the report, HEADACHE (headaches) and PYREXIA (fever of 101-105 F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 101-105 (High) 101-105 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: pains in her stomach; Nausea; vomited; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (pains in her stomach), NAUSEA (Nausea) and VOMITING (vomited) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (pains in her stomach), NAUSEA (Nausea) and VOMITING (vomited). At the time of the report, ABDOMINAL PAIN UPPER (pains in her stomach) and NAUSEA (Nausea) outcome was unknown and VOMITING (vomited) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she vomited bunched of green liquid and had no food particles. Her temperature was 98.1. No concomitant information was reported. Patient didn't take any treatment.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Rhinorrhoea, Skin discolouration
Clinical narrative: sneezing; runny nose; warm to touch; really swollen; nauseous; really red; arm got sore and it turned pink/started fading; arm got sore; arm got sore and it turned pink and swelled up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red) and VACCINATION SITE SWELLING (really swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red) and SKIN DISCOLOURATION (arm got sore and it turned pink/started fading). On 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (really swollen), VACCINATION SITE WARMTH (warm to touch), RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red), VACCINATION SITE SWELLING (really swollen), VACCINATION SITE WARMTH (warm to touch), SKIN DISCOLOURATION (arm got sore and it turned pink/started fading), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-044704 (E2B Linked Report).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: sneezing; runny nose; warm to touch; really swollen; nauseous; really red; arm got sore and it turned pink/started fading; arm got sore; arm got sore and it turned pink and swelled up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red) and VACCINATION SITE SWELLING (really swollen) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red) and SKIN DISCOLOURATION (arm got sore and it turned pink/started fading). On 13-Mar-2021, the patient experienced VACCINATION SITE SWELLING (really swollen), VACCINATION SITE WARMTH (warm to touch), RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, NAUSEA (nauseous), PAIN IN EXTREMITY (arm got sore), PERIPHERAL SWELLING (arm got sore and it turned pink and swelled up), VACCINATION SITE ERYTHEMA (really red), VACCINATION SITE SWELLING (really swollen), VACCINATION SITE WARMTH (warm to touch), SKIN DISCOLOURATION (arm got sore and it turned pink/started fading), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-044704 (E2B Linked Report).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Headache
Clinical narrative: coughing; headache; felt different; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), FEELING ABNORMAL (felt different) and HEADACHE (headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (felt different). On 06-Mar-2021, the patient experienced COUGH (coughing) and HEADACHE (headache). At the time of the report, COUGH (coughing), FEELING ABNORMAL (felt different) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Big round circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Big round circle around injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE REACTION (Big round circle around injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Big round circle around injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.