chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Gingival bleeding, Gingival swelling, Oral disorder
Clinical narrative: gums bleed; Top and bottoms gums swelled; blisters; Oral lessons started about 6 weeks after vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of GINGIVAL BLEEDING (gums bleed) in a 77-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.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ORAL DISORDER (Oral lessons started about 6 weeks after vaccination). On an unknown date, the patient experienced GINGIVAL BLEEDING (gums bleed) (seriousness criterion medically significant), GINGIVAL SWELLING (Top and bottoms gums swelled) and BLISTER (blisters). At the time of the report, GINGIVAL BLEEDING (gums bleed), GINGIVAL SWELLING (Top and bottoms gums swelled), ORAL DISORDER (Oral lessons started about 6 weeks after vaccination) and BLISTER (blisters) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took blood pressure medications as concomitant medication. No treatment information was provided by the reporter.  Company comment This case concerns a 77-year-old female subject who experienced the serious events of gingival bleeding, and non-serious events of gingival swelling, oral disorder, blisters, and scratches . The events occurred approximately 2 months 2 weeks after the first dose, and 1 month 2 weeks  after the second dose of Spikevax. The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report. Based on medical review of the available data, the case has been assessed as non-serious.   This case was linked to MOD-2021-319711 (Patient Link).; Sender's Comments: This case concerns a 77-year-old female subject who experienced the serious events of gingival bleeding, and non-serious events of gingival swelling, oral disorder, blisters, and scratches . The events occurred approximately 2 months 2 weeks after the first dose, and 1 month 2 weeks  after the second dose of Spikevax. The rechallenge was not applicable as the patient had already completed the 2 recommended doses of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report. Based on medical review of the available data, the case has been assessed as non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ear congestion, Inappropriate schedule of product administration, Nasal congestion, Sinus congestion, Tinnitus
Clinical narrative: ringing in both their ears  worse, more persistently on the left one; feel like partially plugged; congestive sinus; congestive nose; first dose on 13Mar2021 and the second dose on 06Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS, EAR CONGESTION, SINUS CONGESTION, NASAL CONGESTION, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13Mar2021 and the second dose on 06Aug2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, 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 experienced TINNITUS, EAR CONGESTION, SINUS CONGESTION, NASAL CONGESTION, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13Mar2021 and the second dose on 06Aug2021). The patient was treated with FLONASE ongoing since an unknown date for Sinus congestion, at a dose of 1 dosage form and EAR DROPS ongoing since an unknown date for Ear ringing, at a dose of 1 dosage form. At the time of the report, TINNITUS, EAR CONGESTION, SINUS CONGESTION, NASAL CONGESTION, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 13Mar2021 and the second dose on 06Aug2021) outcome was unknown.            No concomitant medications was provided by the reporter. As per the source document patient had taken medication for high blood pressure and Statins for cholesterol.
Sex: U
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: Very sensitive to light; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Very sensitive to light) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPHOBIA (Very sensitive to light). At the time of the report, PHOTOPHOBIA (Very sensitive to light) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Facial discomfort, Feeling abnormal, Muscle twitching, Nervousness
Clinical narrative: facial twitches in hands and legs/facial twitch had her up all night; tremors in hands and legs / shaking; nervous/raw nerves; anxiety/anxious; facial contractions on left side of face; couldn't do 2 things at once / freezes if things come at same time; This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE TWITCHING (facial twitches in hands and legs/facial twitch had her up all night), TREMOR (tremors in hands and legs / shaking), NERVOUSNESS (nervous/raw nerves), ANXIETY (anxiety/anxious) and FACIAL DISCOMFORT (facial contractions on left side of face) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included CLONAZEPAM (CLONOPIN), PREDNISONE and TOCILIZUMAB (ACTEMRA) for an unknown indication.  No medical history was reported by reporter.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, 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 experienced MUSCLE TWITCHING (facial twitches in hands and legs/facial twitch had her up all night), TREMOR (tremors in hands and legs / shaking), NERVOUSNESS (nervous/raw nerves), ANXIETY (anxiety/anxious), FACIAL DISCOMFORT (facial contractions on left side of face) and FEELING ABNORMAL (couldn't do 2 things at once / freezes if things come at same time). At the time of the report, MUSCLE TWITCHING (facial twitches in hands and legs/facial twitch had her up all night), TREMOR (tremors in hands and legs / shaking), NERVOUSNESS (nervous/raw nerves), ANXIETY (anxiety/anxious), FACIAL DISCOMFORT (facial contractions on left side of face) and FEELING ABNORMAL (couldn't do 2 things at once / freezes if things come at same time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 reported by reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: facial twitches in hands and legs/facial twitch had her up all night; tremors in hands and legs / shaking; nervous/raw nerves; anxiety/anxious; facial contractions on left side of face; couldn't do 2 things at once / freezes if things come at same time; This spontaneous case was reported by a nurse and describes the occurrence of MUSCLE TWITCHING (facial twitches in hands and legs/facial twitch had her up all night), TREMOR (tremors in hands and legs / shaking), NERVOUSNESS (nervous/raw nerves), ANXIETY (anxiety/anxious) and FACIAL DISCOMFORT (facial contractions on left side of face) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included CLONAZEPAM (CLONOPIN), PREDNISONE and TOCILIZUMAB (ACTEMRA) for an unknown indication.  No medical history was reported by reporter.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, 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 experienced MUSCLE TWITCHING (facial twitches in hands and legs/facial twitch had her up all night), TREMOR (tremors in hands and legs / shaking), NERVOUSNESS (nervous/raw nerves), ANXIETY (anxiety/anxious), FACIAL DISCOMFORT (facial contractions on left side of face) and FEELING ABNORMAL (couldn't do 2 things at once / freezes if things come at same time). At the time of the report, MUSCLE TWITCHING (facial twitches in hands and legs/facial twitch had her up all night), TREMOR (tremors in hands and legs / shaking), NERVOUSNESS (nervous/raw nerves), ANXIETY (anxiety/anxious), FACIAL DISCOMFORT (facial contractions on left side of face) and FEELING ABNORMAL (couldn't do 2 things at once / freezes if things come at same time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 reported by reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder
Clinical narrative: Oral lesions; This spontaneous case was reported by a nurse and describes the occurrence of ORAL DISORDER (Oral lesions) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (blood pressure medications were used). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL DISORDER (Oral lesions). The patient was treated with LYSINE at a dose of i G daily and VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of twice a day for 1 day. At the time of the report, ORAL DISORDER (Oral lesions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included Blood pressure medication.   Patient had no history of Herpes or any other oral health issues   This case was linked to MOD-2021-319675 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes got swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes got swollen) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced LYMPHADENOPATHY (lymph nodes got swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes got swollen) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Musculoskeletal stiffness, Tremor
Clinical narrative: Two middle fingers on my a I vaccination side are shake; Two middle fingers on my a I vaccination side are stif; I have allergies; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Two middle fingers on my a I vaccination side are shake), MUSCULOSKELETAL STIFFNESS (Two middle fingers on my a I vaccination side are stif) and HYPERSENSITIVITY (I have allergies) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    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 TREMOR (Two middle fingers on my a I vaccination side are shake), MUSCULOSKELETAL STIFFNESS (Two middle fingers on my a I vaccination side are stif) and HYPERSENSITIVITY (I have allergies). At the time of the report, TREMOR (Two middle fingers on my a I vaccination side are shake), MUSCULOSKELETAL STIFFNESS (Two middle fingers on my a I vaccination side are stif) and HYPERSENSITIVITY (I have allergies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Nausea
Clinical narrative: he had indigestion after 2nd dose; nauseous after 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of DYSPEPSIA (he had indigestion after 2nd dose) and NAUSEA (nauseous after 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient was immunocompromised with health conditions since birth).   On 11-Mar-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 DYSPEPSIA (he had indigestion after 2nd dose) and NAUSEA (nauseous after 2nd dose). At the time of the report, DYSPEPSIA (he had indigestion after 2nd dose) and NAUSEA (nauseous after 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No Treatment medication information provided. cross linked with MOD21-143355   This case was linked to MOD-2021-319756 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: "arm is tiny bit sore" from 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN ("arm is tiny bit sore" from 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (patient was immune compromised since birth).    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN ("arm is tiny bit sore" from 3rd dose). At the time of the report, VACCINATION SITE PAIN ("arm is tiny bit sore" from 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had reported of taking Flu vaccine on 09-Sep-2021 along with the third dose of Moderna vaccine.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-319735, MOD-2021-319838 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: Blood pressure just dropped, blood pressure went down to 60/95; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure just dropped, blood pressure went down to 60/95) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concomitant products included CLONIDINE, OLMESARTAN and AMLODIPINE for Blood pressure.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced HYPOTENSION (Blood pressure just dropped, blood pressure went down to 60/95). At the time of the report, HYPOTENSION (Blood pressure just dropped, blood pressure went down to 60/95) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information does not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Retching, Sinus headache, Vomiting
Clinical narrative: Sinus headache; Intermittent dry heaves; Temperature of 101.3F; Threw up yellowish-orange fluid which tasted bitter and might have been bile; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE, FEVER of 101.3F, Intermittent dry heaves, and VOMITING in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399902 and 014F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced SINUS HEADACHE, FEVER of 101.3F, Intermittent dry heaves, and VOMITING. The patient was treated with ASPIRIN for Sinus headache and Fever, at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE, FEVER of 101.3F, Intermittent dry heaves, and VOMITING had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Body temperature: temperature of 101.3f (High).          No concomitant information was reported. He took aspirin which did not provide any relief. An hour before they called (1:00pm, EST), he had a temperature of 101.3F. He took a couple of aspirin.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Her arm was sore; She had a little headache for the day; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Her arm was sore) and HEADACHE (She had a little headache for the day) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced PAIN IN EXTREMITY (Her arm was sore) and HEADACHE (She had a little headache for the day). At the time of the report, PAIN IN EXTREMITY (Her arm was sore) outcome was unknown and HEADACHE (She had a little headache for the day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. 10-Sep-2021 patient got her second dose in her left arm at 9:40 AM, lot 053E21A, no expiration date reported. The same day around 4 PM her arm was sore, and she had a little headache. By 6 PM she had a chill. At 11:30 PM she woke up burning hot. Patient then felt nauseous, got up, and felt lightheaded. She went into the bathroom because she thought she would be sick to her stomach. She was sweating profusely and laid on the floor. According to her husband she lost consciousness for less than a minute. She came too and her nightgown and hands were drenched in sweat and then she vomited. After a minute or two she sat in the chair until the ambulance came at 11:45PM. They monitored her vitals and they were normal, so she did not go to the hospital. She was exhausted and went back to bed and woke up at 2:45 AM burning up and nauseous. She was propped up in bed, was given a cool washcloth and felt better. She went back to sleep. She woke up dehydrated and exhausted and drank a lot of fluids: 2 bottles of a sports drink and lots of water. By sunday she was fine.   This case was linked to MOD-2021-317642 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 screening, Erythema, Periarthritis, Vaccination complication
Clinical narrative: red patch; COVID arm; Frozen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red patch), VACCINATION COMPLICATION (COVID arm) and PERIARTHRITIS (Frozen shoulder) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: VACCINES (Shingles).    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (red patch), VACCINATION COMPLICATION (COVID arm) and PERIARTHRITIS (Frozen shoulder). At the time of the report, ERYTHEMA (red patch), VACCINATION COMPLICATION (COVID arm) and PERIARTHRITIS (Frozen shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19 screening: positive (Positive) COVID-19 positive.         No concomitant medications were reported.  No treatment medications were reported.   This case was linked to (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna first dose and Pfizer second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna first dose and Pfizer second dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-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 INTERCHANGE OF VACCINE PRODUCTS (Moderna first dose and Pfizer second dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Moderna first dose and Pfizer second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided by the reporter. No treatment information provided   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Pigmentation disorder, Pruritus, Rash
Clinical narrative: water blisters/blisters dried up; scabbed; left brown marks/3 little dots on that arm; burning sensation; itching; rash; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (water blisters/blisters dried up), SCAB (scabbed), PIGMENTATION DISORDER (left brown marks/3 little dots on that arm), RASH (rash) and BURNING SENSATION (burning sensation) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 BLISTER (water blisters/blisters dried up), SCAB (scabbed), PIGMENTATION DISORDER (left brown marks/3 little dots on that arm), RASH (rash), BURNING SENSATION (burning sensation) and PRURITUS (and itching). At the time of the report, BLISTER (water blisters/blisters dried up), SCAB (scabbed), PIGMENTATION DISORDER (left brown marks/3 little dots on that arm), RASH (rash), BURNING SENSATION (burning sensation) and PRURITUS (and itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No clear treatment information. some unknown cream  used for the skin spots . No concomitant medication provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Scab
Clinical narrative: water blisters/blisters dried up; scabbed; left brown marks/3 little dots on that arm; burning sensation; itching; rash; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (water blisters/blisters dried up), SCAB (scabbed), PIGMENTATION DISORDER (left brown marks/3 little dots on that arm), RASH (rash) and BURNING SENSATION (burning sensation) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 BLISTER (water blisters/blisters dried up), SCAB (scabbed), PIGMENTATION DISORDER (left brown marks/3 little dots on that arm), RASH (rash), BURNING SENSATION (burning sensation) and PRURITUS (and itching). At the time of the report, BLISTER (water blisters/blisters dried up), SCAB (scabbed), PIGMENTATION DISORDER (left brown marks/3 little dots on that arm), RASH (rash), BURNING SENSATION (burning sensation) and PRURITUS (and itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No clear treatment information. some unknown cream  used for the skin spots . No concomitant medication provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 34-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest X-ray, Ear infection, SARS-CoV-2 antibody test, Sinusitis
Clinical narrative: Ear infection; Sinusitis; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection) and SINUSITIS (Sinusitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced EAR INFECTION (Ear infection) (seriousness criterion medically significant) and SINUSITIS (Sinusitis) (seriousness criterion medically significant). At the time of the report, EAR INFECTION (Ear infection) and SINUSITIS (Sinusitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, Body temperature: 103 f (High) Temperature of 99F which increased to 103F. On an unknown date, Chest X-ray: normal (normal) Clear Results. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Clear, Antibody test showed patient had got vaccine..   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided. The treatment medication was reported as some unknown antibiotics and steroids for sinusitis and ear infection.  On an unspecified date after the second dose patient had got sick for another week. Patient had been sick for 5-5 weeks.  Company Comment: This case concerns a 63-year-old female patient with no relevant medical history reported who experienced serious unexpected events of sinusitis and ear infection. The events occurred after the second dose of Spikevax however, the exact time to onset was unknown. Rechallenge was not applicable since the events occurred after the second dose of Spikevax. The reporter did not provide causality assessment. The benefit-risk relationship of drug is not affected by this report   This case was linked to MOD-2021-319851 (Patient Link).; Sender's Comments: This case concerns a 63-year-old female patient with no relevant medical history reported who experienced serious unexpected events of sinusitis and ear infection. The events occurred after the second dose of Spikevax however, the exact time to onset was unknown. Rechallenge was not applicable since the events occurred after the second dose of Spikevax. The reporter did not provide causality assessment. The benefit-risk relationship of drug is not affected by this report
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Second vaccine administered less than 21 days; Mixed series vaccinations administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine administered less than 21 days) and INTERCHANGE OF VACCINE PRODUCTS (Mixed series vaccinations administered) in a 3-week-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 vaccine on 09-Sep-2021.    On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine administered less than 21 days) and INTERCHANGE OF VACCINE PRODUCTS (Mixed series vaccinations administered). On 13-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine administered less than 21 days) and INTERCHANGE OF VACCINE PRODUCTS (Mixed series vaccinations administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  It was reported that the gave the pharmacist gave Moderna COVID-19 vaccine on 13-Sep-2021 to a patient who was at the pharmacy asking for their flu vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow-up received and does not contain any new information.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, 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 experienced MALAISE (did not feel well). At the time of the report, MALAISE (did not feel well) outcome was unknown.            No concomitant medications were reported. No treatment medications were mentioned   This case was linked to MOD-2021-306534, MOD-2021-306464 (Patient Link).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: still sick from getting the COVID shot/side effects for 3 weeks; covid from a covid shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot) in a 20-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot). At the time of the report, ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment was provided. No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site reaction
Clinical narrative: Experiencing "Covid arm"; swelling of the arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Experiencing "Covid arm") and PERIPHERAL SWELLING (swelling of the arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Experiencing "Covid arm") and PERIPHERAL SWELLING (swelling of the arm). At the time of the report, VACCINATION SITE REACTION (Experiencing "Covid arm") and PERIPHERAL SWELLING (swelling of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product details were provided by the reporter. No Treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pruritus
Clinical narrative: 3 Large blotches on the left arm after 3rd shot/Itchy blotches on left arm  after 3rd shot; Itching left arm injection site after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching left arm injection site after 3rd shot) and RASH MACULAR (3 Large blotches on the left arm after 3rd shot/Itchy blotches on left arm  after 3rd shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. BU0C21A, 029M19A and 007M20X) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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 13-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Itching left arm injection site after 3rd shot). On 15-Sep-2021, the patient experienced RASH MACULAR (3 Large blotches on the left arm after 3rd shot/Itchy blotches on left arm  after 3rd shot). At the time of the report, VACCINATION SITE PRURITUS (Itching left arm injection site after 3rd shot) and RASH MACULAR (3 Large blotches on the left arm after 3rd shot/Itchy blotches on left arm  after 3rd shot) had not resolved.            Concomitant product use was unknown by the reporter. Treatment information was not provided. The patient states that she did not contact her doctor and she was not using any medication but placed Ice on it once.   This case was linked to MOD-2021-320257 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: my daughter who has a heart murmur was down 14 days after the first one; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (my daughter who has a heart murmur was down 14 days after the first one) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles, Sleep disorder (inability to sleep on her left side.) and Dizziness. Concurrent medical conditions included Heart murmur and Osteopenia.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (my daughter who has a heart murmur was down 14 days after the first one). At the time of the report, MALAISE (my daughter who has a heart murmur was down 14 days after the first one) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Non-significant follow up include no new information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination complication, Vaccination site pruritus
Clinical narrative: Swelling from top of left shoulder to the neck after second shot; Itching left arm injection site after second shot; Weird reaction after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Weird reaction after second shot), SWELLING (Swelling from top of left shoulder to the neck after second shot) and VACCINATION SITE PRURITUS (Itching left arm injection site after second shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029M19A and 007M20X) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Weird reaction after second shot). On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching left arm injection site after second shot). On 04-Mar-2021, the patient experienced SWELLING (Swelling from top of left shoulder to the neck after second shot). On 06-Apr-2021, VACCINATION COMPLICATION (Weird reaction after second shot), SWELLING (Swelling from top of left shoulder to the neck after second shot) and VACCINATION SITE PRURITUS (Itching left arm injection site after second shot) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Syncope, Visual impairment
Clinical narrative: fainting; dizziness; almost falling; progressive altered vision/started to loss his vision reduced to 80%; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (fainting) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 079c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), DIZZINESS (dizziness), FALL (almost falling) and VISUAL IMPAIRMENT (progressive altered vision/started to loss his vision reduced to 80%). At the time of the report, SYNCOPE (fainting), DIZZINESS (dizziness), FALL (almost falling) and VISUAL IMPAIRMENT (progressive altered vision/started to loss his vision reduced to 80%) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information were provided by the reporter.  No treatment information was provided.  Company comment: This case concerns a 77-year-old, male subject who experienced the serious events of syncope, and non-serious events of dizziness, fall, and visual impairment . The events occurred approximately 1 day after the first dose of Spikevax.  There was no rechallenge as at the time of the events, as the patient was yet to receive the second dose of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a 77-year-old, male subject who experienced the serious events of syncope, and non-serious events of dizziness, fall, and visual impairment . The events occurred approximately 1 day after the first dose of Spikevax.  There was no rechallenge as at the time of the events, as the patient was yet to receive the second dose of the vaccine. The patient's medical history was not provided. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Fever of upto 102.1 for about 48 hours; Extreme soreness at injection site; All-over joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of upto 102.1 for about 48 hours), VACCINATION SITE PAIN (Extreme soreness at injection site) and ARTHRALGIA (All-over joint pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B71A and 025AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and HIV disease since September 2010. Concomitant products included DOLUTEGRAVIR SODIUM, LAMIVUDINE (DOVATO) from October 2020 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, 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 experienced PYREXIA (Fever of upto 102.1 for about 48 hours), VACCINATION SITE PAIN (Extreme soreness at injection site) and ARTHRALGIA (All-over joint pain). At the time of the report, PYREXIA (Fever of upto 102.1 for about 48 hours), VACCINATION SITE PAIN (Extreme soreness at injection site) and ARTHRALGIA (All-over joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.1 (High) 102.1 degrees.         No treatment was provided by the reporter.  Patient mistakenly took 2nd dose a month earlier.   This case was linked to MOD-2021-305663 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in his left injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain in his left injection site arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN 81), AMOXICILLIN, TRAMADOL, DEXAMETHASONE and LEVOFLOXACIN for an unknown indication.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (Pain in his left injection site arm). At the time of the report, VACCINATION SITE PAIN (Pain in his left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   This case was linked to MOD-2021-321103.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches in left side of the brain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches in left side of the brain) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches in left side of the brain) (seriousness criterion hospitalization). At the time of the report, HEADACHE (headaches in left side of the brain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment information not reported.  This case concerns a  male patient of unknown age, who experienced the expected non-serious event of Headache. The event occurred an unknown number of days after receiving a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The event was downgraded to non-serious since the source document does not include any information to support the seriousness criteria.; Sender's Comments: This case concerns a  male patient of unknown age, who experienced the expected non-serious event of Headache. The event occurred an unknown number of days after receiving a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The event was downgraded to non-serious since the source document does not include any information to support the seriousness criteria.