chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disorientation, Dizziness, Headache
Clinical narrative: Disoriented; Dizziness; No energy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disoriented), DIZZINESS (Dizziness), ASTHENIA (No energy) and HEADACHE (Headache) had not resolved.            No relevant concomitant medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Experienced diarrhea later that afternoon; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Experienced diarrhea later that afternoon) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Experienced diarrhea later that afternoon). On 09-Mar-2021, the patient experienced NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 09-Mar-2021, DIARRHOEA (Experienced diarrhea later that afternoon) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Concomitant products included vitamins and eye drops for glaucoma.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Paraesthesia, Swelling face, Urticaria
Clinical narrative: Swelling of the face, first right and then left side; feels like needles; Red all over; Tingling; Broke up in hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling of the face, first right and then left side), URTICARIA (Broke up in hives), PAIN (feels like needles), ERYTHEMA (Red all over) and PARAESTHESIA (Tingling) 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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced URTICARIA (Broke up in hives), ERYTHEMA (Red all over) and PARAESTHESIA (Tingling). On an unknown date, the patient experienced SWELLING FACE (Swelling of the face, first right and then left side) and PAIN (feels like needles). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 2 tablets, some times 3.. At the time of the report, SWELLING FACE (Swelling of the face, first right and then left side), URTICARIA (Broke up in hives), PAIN (feels like needles), ERYTHEMA (Red all over) and PARAESTHESIA (Tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Antibiotic, Another Antibiotic (didn't specify), Benadryl 2 tablets, some times 3, Steroids. No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information was received and contact number was updated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Extremely sleepy; Arm hurts; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts). At the time of the report, SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided Caller provides consent for Safety to follow up with them or their HCP.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Fatigue, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Hot flashes; Inability to maintain body temp; Waking up drenched in sweat; Problems sleeping at night; Body aches; Headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat), INSOMNIA (Problems sleeping at night) and PAIN (Body aches) in a 41-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.     Concomitant products included MEDROXYPROGESTERONE ACETATE and NAPROXEN for an unknown indication.    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 HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat), INSOMNIA (Problems sleeping at night), PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 27-Feb-2021, PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat) and INSOMNIA (Problems sleeping at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Tylenol PM. Patient has taken Tylenol PM to help relieve symptoms, with no relief. HCP information gathered. Patient agreed for follow up with Safety.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain
Clinical narrative: Hot flashes; Inability to maintain body temp; Waking up drenched in sweat; Problems sleeping at night; Body aches; Headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat), INSOMNIA (Problems sleeping at night) and PAIN (Body aches) in a 41-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.     Concomitant products included MEDROXYPROGESTERONE ACETATE and NAPROXEN for an unknown indication.    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 HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat), INSOMNIA (Problems sleeping at night), PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 27-Feb-2021, PAIN (Body aches), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. At the time of the report, HOT FLUSH (Hot flashes), BODY TEMPERATURE FLUCTUATION (Inability to maintain body temp), HYPERHIDROSIS (Waking up drenched in sweat) and INSOMNIA (Problems sleeping at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included Tylenol PM. Patient has taken Tylenol PM to help relieve symptoms, with no relief. HCP information gathered. Patient agreed for follow up with Safety.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Urticaria
Clinical narrative: Did not give her the second covid-19 vaccine; Severe hives for 3 weeks; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of URTICARIA (Severe hives for 3 weeks) and INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (Severe hives for 3 weeks). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine). At the time of the report, URTICARIA (Severe hives for 3 weeks) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication including thyroid meds was reported Treatment using diphenhydramine was reported  Reporter did not want to share email, does not have any other patient info   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter stated intentional omission of second dose, event updated
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site mass, Vaccination site pruritus
Clinical narrative: It looks like an allergic reaction; Bumpy injection site; Itches like crazy injection site; Red injection site; Rashes at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Mar-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021: Outcome of the events has been updated to recovered /resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: It looks like an allergic reaction; Bumpy injection site; Itches like crazy injection site; Red injection site; Rashes at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site) and VACCINATION SITE ERYTHEMA (Red injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Mar-2021, the patient experienced VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE HYPERSENSITIVITY (It looks like an allergic reaction), VACCINATION SITE MASS (Bumpy injection site), VACCINATION SITE PRURITUS (Itches like crazy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE RASH (Rashes at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021: Outcome of the events has been updated to recovered /resolved.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fear of death, Tremor
Clinical narrative: Severe shaking on entire body; Scared to death; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Neck injury NOS (damage on his neck). Concomitant products included ALBUTEROL [SALBUTAMOL] for COPD, VITAMINS NOS, CALCIUM and MAGNESIUM for an unknown indication.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death). On 08-Mar-2021, TREMOR (Severe shaking on entire body) and FEAR OF DEATH (Scared to death) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was told by his physician that he would need surgery for his damage on neck.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: follow up received no significant information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (Broke out in hives) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Broke out in hives). At the time of the report, URTICARIA (Broke out in hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment: Patient broke out in hives last weekend and has been on an oral dose of prednisone.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Her arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Her arm is hurting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE and VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (Her arm is hurting). At the time of the report, INJECTION SITE PAIN (Her arm is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site mass, Vaccination site rash
Clinical narrative: On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site; Rash around and under the injection site; Rash is slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-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 MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy). At the time of the report, VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient agreed to follow-up with safety
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Dizziness
Clinical narrative: Adverse event NOS; dizzy for 2-3 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy for 2-3 seconds) and ADVERSE EVENT (Adverse event NOS) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizzy for 2-3 seconds). On an unknown date, the patient experienced ADVERSE EVENT (Adverse event NOS). At the time of the report, DIZZINESS (dizzy for 2-3 seconds) and ADVERSE EVENT (Adverse event NOS) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products was reported.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of event updated
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness had increased; 2-2.5inch raised circle; Redness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), INJECTION SITE PRURITUS (Itchiness), INJECTION SITE SWELLING (2-2.5inch raised circle) and INJECTION SITE ERYTHEMA (Redness had increased) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN HYDROCHLORIDE;SITAGLIPTIN, METFORMIN HYDROCHLORIDE, BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID, ROSUVASTATIN;TELMISARTAN and KETOTIFEN for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness). On 08-Mar-2021, the patient experienced ERYTHEMA (Redness) and INJECTION SITE SWELLING (2-2.5inch raised circle). On 09-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness had increased). At the time of the report, ERYTHEMA (Redness), INJECTION SITE PRURITUS (Itchiness), INJECTION SITE SWELLING (2-2.5inch raised circle) and INJECTION SITE ERYTHEMA (Redness had increased) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine since an unknown date.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 06-Feb-2021, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: swelling below the knee; swelling of the toe; swelling of the feet; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling below the knee), SWELLING (swelling of the toe) and PERIPHERAL SWELLING (swelling of the feet) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 07-Mar-2021, the patient experienced SWELLING (swelling below the knee), SWELLING (swelling of the toe) and PERIPHERAL SWELLING (swelling of the feet). At the time of the report, SWELLING (swelling below the knee), SWELLING (swelling of the toe) and PERIPHERAL SWELLING (swelling of the feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported  No treatment information was provided
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Oropharyngeal pain
Clinical narrative: Sore Throat; Muscle Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), MYALGIA (Muscle Pain) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 10-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) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), MYALGIA (Muscle Pain) and FATIGUE (Fatigue). On 18-Feb-2021, OROPHARYNGEAL PAIN (Sore Throat) and MYALGIA (Muscle Pain) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided          Concomitant medication list also included asthma medication.  No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat around injection site; Hard around injection site; Redness around injection site; Swelling around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030C20) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included IBUPROFEN and ACETAMINOPHEN for Arthritis, HYDROCHLOROTHIAZIDE, FAMOTIDINE, GABAPENTIN, MELATONIN, ALPRAZOLAM (ALPRAZOLAN), ROSUVASTATIN, UBIDECARENONE (COENZYME Q-GEL), HYDROXYZINE, CARVEDILOL, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site). At the time of the report, VACCINATION SITE WARMTH (Heat around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE ERYTHEMA (Redness around injection site) and VACCINATION SITE SWELLING (Swelling around injection site) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable. turmeric unknown strength ibuprofen 400 mg PO BID and acetaminophen 2300 mg PO daily in divided doses (as ongoing concomitant meds for pre-existing arthritis.)   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Event Outcome update
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Achy arm in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy arm in injection arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D 3), LANSOPRAZOLE, PROBIOTICS NOS, MAGNESIUM OXIDE and VITAMIN C [ASCORBIC ACID] 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 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Achy arm in injection arm). At the time of the report, PAIN IN EXTREMITY (Achy arm in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Estrogen Vaginal Cream, Omega 3 Esters, Ferrous Fumarate, Cranberry Capsules, Calcium Carbonate for an unknown indication. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Head discomfort, Headache
Clinical narrative: Uncontrolled cough over a week come in night and it's hard and dry; Lethargic feeling no desire to do anything; Congestion in head; No desire to eat; Sore throat; Sore arm; Fever on and off around 98 degree; Chill on and off; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat) and OROPHARYNGEAL PAIN (Sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension, VITAMINS NOS for an unknown indication.    On 26-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 COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache). At the time of the report, COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Uncontrolled cough over a week come in night and it's hard and dry; Lethargic feeling no desire to do anything; Congestion in head; No desire to eat; Sore throat; Sore arm; Fever on and off around 98 degree; Chill on and off; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat) and OROPHARYNGEAL PAIN (Sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension, VITAMINS NOS for an unknown indication.    On 26-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 COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache). At the time of the report, COUGH (Uncontrolled cough over a week come in night and it's hard and dry), LETHARGY (Lethargic feeling no desire to do anything), HEAD DISCOMFORT (Congestion in head), DECREASED APPETITE (No desire to eat), OROPHARYNGEAL PAIN (Sore throat), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever on and off around 98 degree), CHILLS (Chill on and off) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Poor quality sleep
Clinical narrative: arm is sore; did not sleep well; nagging headache; feeling real tired, fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is sore), POOR QUALITY SLEEP (did not sleep well), HEADACHE (nagging headache) and FATIGUE (feeling real tired, fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), POOR QUALITY SLEEP (did not sleep well), HEADACHE (nagging headache) and FATIGUE (feeling real tired, fatigue). At the time of the report, PAIN IN EXTREMITY (arm is sore) and POOR QUALITY SLEEP (did not sleep well) outcome was unknown, HEADACHE (nagging headache) had not resolved and FATIGUE (feeling real tired, fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she did drink some coffee and the fatigue eased up a little.  No concomitant medications were reported.  Treatment information was not provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore Throat; Fever - Temperature of 103.0F; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever - Temperature of 103.0F) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever - Temperature of 103.0F). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 07-Mar-2021, OROPHARYNGEAL PAIN (Sore Throat) and PYREXIA (Fever - Temperature of 103.0F) had resolved. Not Provided          No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Illness, Nausea
Clinical narrative: swelling in the left side of face; painful wrist; being sick for 2 days; heart palpations; dizziness; nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (being sick for 2 days), PALPITATIONS (heart palpations), SWELLING FACE (swelling in the left side of face), DIZZINESS (dizziness) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ILLNESS (being sick for 2 days), PALPITATIONS (heart palpations), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (Headache). On 08-Mar-2021, the patient experienced SWELLING FACE (swelling in the left side of face) and ARTHRALGIA (painful wrist). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Feb-2021, ILLNESS (being sick for 2 days), NAUSEA (nausea) and HEADACHE (Headache) had resolved. At the time of the report, PALPITATIONS (heart palpations), SWELLING FACE (swelling in the left side of face), DIZZINESS (dizziness) and ARTHRALGIA (painful wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Swelling face
Clinical narrative: swelling in the left side of face; painful wrist; being sick for 2 days; heart palpations; dizziness; nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (being sick for 2 days), PALPITATIONS (heart palpations), SWELLING FACE (swelling in the left side of face), DIZZINESS (dizziness) and NAUSEA (nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ILLNESS (being sick for 2 days), PALPITATIONS (heart palpations), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (Headache). On 08-Mar-2021, the patient experienced SWELLING FACE (swelling in the left side of face) and ARTHRALGIA (painful wrist). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Feb-2021, ILLNESS (being sick for 2 days), NAUSEA (nausea) and HEADACHE (Headache) had resolved. At the time of the report, PALPITATIONS (heart palpations), SWELLING FACE (swelling in the left side of face), DIZZINESS (dizziness) and ARTHRALGIA (painful wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Feeling hot, Flushing, Illness
Clinical narrative: not feeling well on the way home; warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast; face tingling; chest felt heavy and  pressure in chest; face flushing; scary symptoms, felt difficult and frightening symptoms; still not totally out of woods; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest) and FLUSHING (face flushing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Pre-diabetes and Cholesterol. Concomitant products included ATENOLOL, HCTZ, FELODIPINE, ATORVASTATIN CALCIUM (LIPITOR) and ACETYLSALICYLIC ACID (ASPIRIN ) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest), FLUSHING (face flushing), TENSION (scary symptoms, felt difficult and frightening symptoms) and DISCOMFORT (still not totally out of woods). At the time of the report, ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest), FLUSHING (face flushing), TENSION (scary symptoms, felt difficult and frightening symptoms) and DISCOMFORT (still not totally out of woods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Klorcon 10MEQ for an unknown indication. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tension
Clinical narrative: not feeling well on the way home; warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast; face tingling; chest felt heavy and  pressure in chest; face flushing; scary symptoms, felt difficult and frightening symptoms; still not totally out of woods; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest) and FLUSHING (face flushing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Pre-diabetes and Cholesterol. Concomitant products included ATENOLOL, HCTZ, FELODIPINE, ATORVASTATIN CALCIUM (LIPITOR) and ACETYLSALICYLIC ACID (ASPIRIN ) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest), FLUSHING (face flushing), TENSION (scary symptoms, felt difficult and frightening symptoms) and DISCOMFORT (still not totally out of woods). At the time of the report, ILLNESS (not feeling well on the way home), FEELING HOT (warm feeling circulating and going to heart (referenced it felt as if she was injected with contrast), PARAESTHESIA (face tingling), CHEST DISCOMFORT (chest felt heavy and  pressure in chest), FLUSHING (face flushing), TENSION (scary symptoms, felt difficult and frightening symptoms) and DISCOMFORT (still not totally out of woods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include Klorcon 10MEQ for an unknown indication. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Arm is hot; Arm is itching at injection site; Arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm is hot), INJECTION SITE PRURITUS (Arm is itching at injection site) and VACCINATION SITE SWELLING (Arm is swollen) in a 71-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 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm is hot), INJECTION SITE PRURITUS (Arm is itching at injection site) and VACCINATION SITE SWELLING (Arm is swollen). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm is hot), INJECTION SITE PRURITUS (Arm is itching at injection site) and VACCINATION SITE SWELLING (Arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Other Treatment products include Hydrocortisone cream for an unknown indication.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site rash
Clinical narrative: felt really hard; itching; spot on my right arm; red rash; red rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (felt really hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (spot on my right arm), VACCINATION SITE RASH (red rash) and VACCINATION SITE ERYTHEMA (red rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE INDURATION (felt really hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (spot on my right arm), VACCINATION SITE RASH (red rash) and VACCINATION SITE ERYTHEMA (red rash). The patient was treated with KETOCONAZOLE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (felt really hard), VACCINATION SITE PRURITUS (itching), VACCINATION SITE RASH (spot on my right arm), VACCINATION SITE RASH (red rash) and VACCINATION SITE ERYTHEMA (red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.