chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: it was warm to touch; has about the size of their fist; vaccination site on their arm it's sore and it really hurts; vaccination site on their arm is burning; arm began to swell at the injection site; arm began to turn red at the injection site; had a rash that itched at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts), VACCINATION SITE SWELLING (arm began to swell at the injection site) and VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Patient can not have e shot in left arm because many lymph nodes were removed due to  breast cancer. Ans it was advised that patient should have the next vaccine on right thigh.). Concurrent medical conditions included Drug allergy. Concomitant products included PRAVASTATIN from 06-Jan-2020 to an unknown date for Cholesterol.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE SWELLING (arm began to swell at the injection site), VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) and VACCINATION SITE PRURITUS (had a rash that itched at the injection site). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts) and VACCINATION SITE PAIN (vaccination site on their arm is burning). On 30-Mar-2021, VACCINATION SITE SWELLING (arm began to swell at the injection site), VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) and VACCINATION SITE PRURITUS (had a rash that itched at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts) and VACCINATION SITE PAIN (vaccination site on their arm is burning) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May 2021 VAERS concomitant medication, medical history and new events were added and action taken was updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: it was warm to touch; has about the size of their fist; vaccination site on their arm it's sore and it really hurts; vaccination site on their arm is burning; arm began to swell at the injection site; arm began to turn red at the injection site; had a rash that itched at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts), VACCINATION SITE SWELLING (arm began to swell at the injection site) and VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Patient can not have e shot in left arm because many lymph nodes were removed due to  breast cancer. Ans it was advised that patient should have the next vaccine on right thigh.). Concurrent medical conditions included Drug allergy. Concomitant products included PRAVASTATIN from 06-Jan-2020 to an unknown date for Cholesterol.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE SWELLING (arm began to swell at the injection site), VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) and VACCINATION SITE PRURITUS (had a rash that itched at the injection site). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts) and VACCINATION SITE PAIN (vaccination site on their arm is burning). On 30-Mar-2021, VACCINATION SITE SWELLING (arm began to swell at the injection site), VACCINATION SITE ERYTHEMA (arm began to turn red at the injection site) and VACCINATION SITE PRURITUS (had a rash that itched at the injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (it was warm to touch), CONDITION AGGRAVATED (has about the size of their fist), VACCINATION SITE PAIN (vaccination site on their arm it's sore and it really hurts) and VACCINATION SITE PAIN (vaccination site on their arm is burning) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May 2021 VAERS concomitant medication, medical history and new events were added and action taken was updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). At the time of the report, PAIN IN EXTREMITY (Arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information was provided.   This case was linked to MOD-2021-036613 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site induration
Clinical narrative: Soreness of the arm; Rigid near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) and VACCINATION SITE INDURATION (Rigid near the injection site) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and ROSUVASTATIN for an unknown indication.    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 (Soreness of the arm) and VACCINATION SITE INDURATION (Rigid near the injection site). The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) and VACCINATION SITE INDURATION (Rigid near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: Test was negative for any antibodies; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Test was negative for any antibodies) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Pancreas transplant. Concomitant products included MYCOPHENOLATE SODIUM (MYFORTIC) and TACROLIMUS (PROGRAF) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Test was negative for any antibodies). The patient was treated with Immunotherapy (replimune) for SARS-CoV-2 antibody test negative. At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Test was negative for any antibodies) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided
Age: 73.0
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 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 039K20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Malaise, Product dose omission issue
Clinical narrative: feeling sick; blood sugar is low; cancelled his appointment for the second dose in the series; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), BLOOD GLUCOSE DECREASED (blood sugar is low) and PRODUCT DOSE OMISSION ISSUE (cancelled his appointment for the second dose in the series) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (cancelled his appointment for the second dose in the series). On an unknown date, the patient experienced MALAISE (feeling sick) and BLOOD GLUCOSE DECREASED (blood sugar is low). At the time of the report, MALAISE (feeling sick), BLOOD GLUCOSE DECREASED (blood sugar is low) and PRODUCT DOSE OMISSION ISSUE (cancelled his appointment for the second dose in the series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: right swollen lip; tingling sensation in lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling sensation in lip) and LIP SWELLING (right swollen lip) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling sensation in lip). On 22-Mar-2021, the patient experienced LIP SWELLING (right swollen lip). At the time of the report, PARAESTHESIA ORAL (tingling sensation in lip) and LIP SWELLING (right swollen lip) 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 information was reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Experienced side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Experienced side effects) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ADVERSE EVENT (Experienced side effects). At the time of the report, ADVERSE EVENT (Experienced side effects) outcome was unknown. Not Provided           Concomitant medication information not provided.  Treatment information not provided.     Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Arm sore; Felt like had cold; body was so  cold; Body was shaking so bad; Swelling a lot; Felt like she had covid but much worse; Chest and rib hurt when she breathed; Back hurt when she breathed; Fever really high; Felt like tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad) and SWELLING (Swelling a lot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad), SWELLING (Swelling a lot), FEELING ABNORMAL (Felt like she had covid but much worse), DYSPNOEA (Chest and rib hurt when she breathed), BACK PAIN (Back hurt when she breathed), PYREXIA (Fever really high) and FATIGUE (Felt like tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. At the time of the report, PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad), SWELLING (Swelling a lot), FEELING ABNORMAL (Felt like she had covid but much worse), DYSPNOEA (Chest and rib hurt when she breathed), BACK PAIN (Back hurt when she breathed), PYREXIA (Fever really high) and FATIGUE (Felt like tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included thyroid medicine. The patient reported that she felt much better and mentioned that it was her worse night in all her life, she was about to go to the hospital. The patient does not  want to receive the second dose.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia, Swelling, Tremor
Clinical narrative: Arm sore; Felt like had cold; body was so  cold; Body was shaking so bad; Swelling a lot; Felt like she had covid but much worse; Chest and rib hurt when she breathed; Back hurt when she breathed; Fever really high; Felt like tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad) and SWELLING (Swelling a lot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad), SWELLING (Swelling a lot), FEELING ABNORMAL (Felt like she had covid but much worse), DYSPNOEA (Chest and rib hurt when she breathed), BACK PAIN (Back hurt when she breathed), PYREXIA (Fever really high) and FATIGUE (Felt like tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. At the time of the report, PAIN IN EXTREMITY (Arm sore), NASOPHARYNGITIS (Felt like had cold), FEELING COLD (body was so  cold), TREMOR (Body was shaking so bad), SWELLING (Swelling a lot), FEELING ABNORMAL (Felt like she had covid but much worse), DYSPNOEA (Chest and rib hurt when she breathed), BACK PAIN (Back hurt when she breathed), PYREXIA (Fever really high) and FATIGUE (Felt like tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included thyroid medicine. The patient reported that she felt much better and mentioned that it was her worse night in all her life, she was about to go to the hospital. The patient does not  want to receive the second dose.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus test, Herpes zoster
Clinical narrative: developed shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (developed shingles) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HERPES ZOSTER (developed shingles). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency and CALAMINE for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (developed shingles) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Herpes virus test: positive positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medications reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen and had red spots on the area from the  site only; swollen and had red spots on the area from the  injection site only; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (swollen and had red spots on the area from the site only) and VACCINATION SITE ERYTHEMA (swollen and had red spots on the area from the  injection site only) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swollen and had red spots on the area from the  site only) and VACCINATION SITE ERYTHEMA (swollen and had red spots on the area from the  injection site only). On 22-Mar-2021, VACCINATION SITE SWELLING (swollen and had red spots on the area from the  site only) and VACCINATION SITE ERYTHEMA (swollen and had red spots on the area from the  injection site only) 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.   The patient was prescribed to take Benadryl even after her Adverse event has subsided as treatment.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient did receive the 1st shot in the left arm and experienced little fatigue the next day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient did receive the 1st shot in the left arm and experienced little fatigue the next day) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Patient did receive the 1st shot in the left arm and experienced little fatigue the next day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Patient did receive the 1st shot in the left arm and experienced little fatigue the next day) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.    This case was linked to MOD-2021-055252 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site of left shoulder after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site of left shoulder after 2nd dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site of left shoulder after 2nd dose). At the time of the report, VACCINATION SITE PAIN (Pain at injection site of left shoulder after 2nd dose) had not resolved. Not Provided          concomitant medicines was not reported by reporter   treatment information was not provided   The action taken with mRNA-1273 with the events was considered as not applicable   This case was linked to MOD-2021-055237 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Influenza, Insomnia, Nasopharyngitis
Clinical narrative: tinnitus, it usually goes away, but not in this; blurry vision, mostly on her left eye; ¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨; every time she had a bad cold; influenza or flu it seems to be that the virus protein produce this on me; really bad achy joints, that subsided 1 week ago; Headache that subsided one week ago; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus, it usually goes away, but not in this), VISION BLURRED (blurry vision, mostly on her left eye), INSOMNIA (¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨), NASOPHARYNGITIS (every time she had a bad cold) and INFLUENZA (influenza or flu it seems to be that the virus protein produce this on me) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Y3AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus (Patient has a history of tinnitus which usually would resolve with anti-inflammatory medications and proper diet.). Concurrent medical conditions included Asthma. Concomitant products included VITAMINS NOS for an unknown indication.    On 22-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 TINNITUS (tinnitus, it usually goes away, but not in this), VISION BLURRED (blurry vision, mostly on her left eye), INSOMNIA (¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨), NASOPHARYNGITIS (every time she had a bad cold), INFLUENZA (influenza or flu it seems to be that the virus protein produce this on me), ARTHRALGIA (really bad achy joints, that subsided 1 week ago) and HEADACHE (Headache that subsided one week ago). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TINNITUS (tinnitus, it usually goes away, but not in this), VISION BLURRED (blurry vision, mostly on her left eye), INSOMNIA (¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨), NASOPHARYNGITIS (every time she had a bad cold), INFLUENZA (influenza or flu it seems to be that the virus protein produce this on me) and HEADACHE (Headache that subsided one week ago) outcome was unknown and ARTHRALGIA (really bad achy joints, that subsided 1 week ago) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Asthma medication in spring as needed. Treatment medication included anti-inflammatory meds and diet for influenza and Tylenol as needed. Patient stated her doctor was evaluating on giving her a dexamethasone shot for her tinnitus and then giving her the 2nd shot of the Moderna vaccine 2 weeks after that, on day 42.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: tinnitus, it usually goes away, but not in this; blurry vision, mostly on her left eye; ¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨; every time she had a bad cold; influenza or flu it seems to be that the virus protein produce this on me; really bad achy joints, that subsided 1 week ago; Headache that subsided one week ago; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus, it usually goes away, but not in this), VISION BLURRED (blurry vision, mostly on her left eye), INSOMNIA (¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨), NASOPHARYNGITIS (every time she had a bad cold) and INFLUENZA (influenza or flu it seems to be that the virus protein produce this on me) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Y3AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus (Patient has a history of tinnitus which usually would resolve with anti-inflammatory medications and proper diet.). Concurrent medical conditions included Asthma. Concomitant products included VITAMINS NOS for an unknown indication.    On 22-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 TINNITUS (tinnitus, it usually goes away, but not in this), VISION BLURRED (blurry vision, mostly on her left eye), INSOMNIA (¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨), NASOPHARYNGITIS (every time she had a bad cold), INFLUENZA (influenza or flu it seems to be that the virus protein produce this on me), ARTHRALGIA (really bad achy joints, that subsided 1 week ago) and HEADACHE (Headache that subsided one week ago). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TINNITUS (tinnitus, it usually goes away, but not in this), VISION BLURRED (blurry vision, mostly on her left eye), INSOMNIA (¨the tinnitus is severe, it does not go away, it is so bad that i can not think or sleep well¨), NASOPHARYNGITIS (every time she had a bad cold), INFLUENZA (influenza or flu it seems to be that the virus protein produce this on me) and HEADACHE (Headache that subsided one week ago) outcome was unknown and ARTHRALGIA (really bad achy joints, that subsided 1 week ago) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Asthma medication in spring as needed. Treatment medication included anti-inflammatory meds and diet for influenza and Tylenol as needed. Patient stated her doctor was evaluating on giving her a dexamethasone shot for her tinnitus and then giving her the 2nd shot of the Moderna vaccine 2 weeks after that, on day 42.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Swollen tongue
Clinical narrative: tongue swelling; lips swelling; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (tongue swelling), LIP SWELLING (lips swelling) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (tongue swelling), LIP SWELLING (lips swelling) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWOLLEN TONGUE (tongue swelling), LIP SWELLING (lips swelling) and CHILLS (chills) had not resolved.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Hypoaesthesia, Hypoaesthesia eye
Clinical narrative: Shingles; Still has numbness on the face and up the eye; Still has numbness on the face and up the eye; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), HYPOAESTHESIA (Still has numbness on the face and up the eye) and HYPOAESTHESIA EYE (Still has numbness on the face and up the eye) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 HERPES ZOSTER (Shingles), HYPOAESTHESIA (Still has numbness on the face and up the eye) and HYPOAESTHESIA EYE (Still has numbness on the face and up the eye). At the time of the report, HERPES ZOSTER (Shingles) was resolving and HYPOAESTHESIA (Still has numbness on the face and up the eye) and HYPOAESTHESIA EYE (Still has numbness on the face and up the eye) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.Treatment medication included eye drops. Patient stated that he developed shingles after a couple of days of receiving the first dose of vaccine. He's still recovering from it as he still has numbness on his face and up his eye. Patient said that he went to the doctor who prescribed him some medicine but he's not taking them anymore for a couple of weeks now. He's also been to the eye doctor who prescribed him some eye drops. He says "it hasn't been fun". His second dose is scheduled on Thursday 25-Mar-2021 and he wants to know if it is safe for him to take it. He also wants to know for how many days can he postpone it.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Nasopharyngitis, Nausea
Clinical narrative: Experienced colds; Loss of appetite; Sickness in the stomach; Chills; Wanted to throw up; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Experienced colds), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Sickness in the stomach), CHILLS (Chills) and NAUSEA (Wanted to throw up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced NASOPHARYNGITIS (Experienced colds), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Sickness in the stomach), CHILLS (Chills) and NAUSEA (Wanted to throw up). At the time of the report, NASOPHARYNGITIS (Experienced colds), DECREASED APPETITE (Loss of appetite), ABDOMINAL DISCOMFORT (Sickness in the stomach), CHILLS (Chills) and NAUSEA (Wanted to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lacrimation increased
Clinical narrative: allergic reaction; eyes were running so bad; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (eyes were running so bad) and HYPERSENSITIVITY (allergic reaction) in a 62-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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced LACRIMATION INCREASED (eyes were running so bad). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LACRIMATION INCREASED (eyes were running so bad) and HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: Hives around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives around the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction (Patient stated that she had a tooth extraction due to infection and was on two different antibiotics and broke out in a rash.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Hives around the injection site). At the time of the report, VACCINATION SITE URTICARIA (Hives around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include supplements.Treatment information was not provided. Patient stated that she experienced hives at the injection site after a week of receiving the vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 66 days outside of his first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (66 days outside of his first dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, 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 (66 days outside of his first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (66 days outside of his first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated adverse events.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Arthralgia, Arthritis, Back pain, Fatigue
Clinical narrative: massage it and move her arm; itchiness and her arm swelled up; did not feel hungry; heart was feeling funny, it dint feel quite right; hard time getting up off the sofa and to walk; hip, shoulder, elbows, neck and back hurt; hip, shoulder, elbows, neck and back hurt; gets all stiff and can hardly move; hands are big from the arthritis and make her drop stuff; arm became sore; itchiness and her arm swelled up; hip, shoulder, elbows, neck and back hurt; tired; headache; This spontaneous case was reported by a patient and describes the occurrence of JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right) and MOBILITY DECREASED (hard time getting up off the sofa and to walk) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gallbladder disease, Diabetes, Emphysema and Allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right), MOBILITY DECREASED (hard time getting up off the sofa and to walk), BACK PAIN (hip, shoulder, elbows, neck and back hurt), NECK PAIN (hip, shoulder, elbows, neck and back hurt), MUSCULOSKELETAL STIFFNESS (gets all stiff and can hardly move), ARTHRITIS (hands are big from the arthritis and make her drop stuff), PAIN IN EXTREMITY (arm became sore), PRURITUS (itchiness and her arm swelled up), ARTHRALGIA (hip, shoulder, elbows, neck and back hurt), FATIGUE (tired) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right), MOBILITY DECREASED (hard time getting up off the sofa and to walk), BACK PAIN (hip, shoulder, elbows, neck and back hurt), NECK PAIN (hip, shoulder, elbows, neck and back hurt), MUSCULOSKELETAL STIFFNESS (gets all stiff and can hardly move), ARTHRITIS (hands are big from the arthritis and make her drop stuff), PAIN IN EXTREMITY (arm became sore), PRURITUS (itchiness and her arm swelled up), ARTHRALGIA (hip, shoulder, elbows, neck and back hurt), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included 4 different blood pressure medications
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: massage it and move her arm; itchiness and her arm swelled up; did not feel hungry; heart was feeling funny, it dint feel quite right; hard time getting up off the sofa and to walk; hip, shoulder, elbows, neck and back hurt; hip, shoulder, elbows, neck and back hurt; gets all stiff and can hardly move; hands are big from the arthritis and make her drop stuff; arm became sore; itchiness and her arm swelled up; hip, shoulder, elbows, neck and back hurt; tired; headache; This spontaneous case was reported by a patient and describes the occurrence of JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right) and MOBILITY DECREASED (hard time getting up off the sofa and to walk) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gallbladder disease, Diabetes, Emphysema and Allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right), MOBILITY DECREASED (hard time getting up off the sofa and to walk), BACK PAIN (hip, shoulder, elbows, neck and back hurt), NECK PAIN (hip, shoulder, elbows, neck and back hurt), MUSCULOSKELETAL STIFFNESS (gets all stiff and can hardly move), ARTHRITIS (hands are big from the arthritis and make her drop stuff), PAIN IN EXTREMITY (arm became sore), PRURITUS (itchiness and her arm swelled up), ARTHRALGIA (hip, shoulder, elbows, neck and back hurt), FATIGUE (tired) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, JOINT RANGE OF MOTION DECREASED (massage it and move her arm), PERIPHERAL SWELLING (itchiness and her arm swelled up), APPETITE DISORDER (did not feel hungry), FEELING ABNORMAL (heart was feeling funny, it didn't feel quite right), MOBILITY DECREASED (hard time getting up off the sofa and to walk), BACK PAIN (hip, shoulder, elbows, neck and back hurt), NECK PAIN (hip, shoulder, elbows, neck and back hurt), MUSCULOSKELETAL STIFFNESS (gets all stiff and can hardly move), ARTHRITIS (hands are big from the arthritis and make her drop stuff), PAIN IN EXTREMITY (arm became sore), PRURITUS (itchiness and her arm swelled up), ARTHRALGIA (hip, shoulder, elbows, neck and back hurt), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included 4 different blood pressure medications
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Feeling abnormal, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: when he blows his nose it is bloody; runny nose; nose bleeding slightly; feels awful; felt like he was hit by a freight truck; felt bad all over; felt feverish but did not have a fever; arm was sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore), FEELING ABNORMAL (felt like he was hit by a freight truck), FEELING ABNORMAL (felt bad all over), PYREXIA (felt feverish but did not have a fever) and FEELING ABNORMAL (feels awful) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040a21a and d13m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (pituitary(surgery through sinus).) in February 2020 and Surgery. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 10-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). In February 2021, the patient experienced HEADACHE (headache). On 20-Mar-2021, the patient experienced FEELING ABNORMAL (felt like he was hit by a freight truck), FEELING ABNORMAL (felt bad all over) and PYREXIA (felt feverish but did not have a fever). On 22-Mar-2021, the patient experienced FEELING ABNORMAL (feels awful), RHINORRHOEA (runny nose) and EPISTAXIS (nose bleeding slightly). On 23-Mar-2021, the patient experienced EPISTAXIS (when he blows his nose it is bloody). On 15-Feb-2021, VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, FEELING ABNORMAL (felt like he was hit by a freight truck), FEELING ABNORMAL (felt bad all over), PYREXIA (felt feverish but did not have a fever), FEELING ABNORMAL (feels awful), HEADACHE (headache), RHINORRHOEA (runny nose), EPISTAXIS (nose bleeding slightly) and EPISTAXIS (when he blows his nose it is bloody) outcome was unknown. Not Provided