chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Product administered to patient of inappropriate age
Clinical narrative: 16-year-old patient who received the Pfizer vaccine as the first dose on 30JUL2021 and the second dose of the covid-19 vaccine as Moderna on 27AUG2021; A 16 year old patient received second dose of the covid-19 vaccine as Moderna; Received two manufacturers of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received two manufacturers of the vaccine), OFF LABEL USE (16-year-old patient who received the Pfizer vaccine as the first dose on 30JUL2021 and the second dose of the covid-19 vaccine as Moderna on 27AUG2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received second dose of the covid-19 vaccine as Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received two manufacturers of the vaccine). On an unknown date, the patient experienced OFF LABEL USE (16-year-old patient who received the Pfizer vaccine as the first dose on 30JUL2021 and the second dose of the covid-19 vaccine as Moderna on 27AUG2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received second dose of the covid-19 vaccine as Moderna). On 27-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Received two manufacturers of the vaccine) had resolved. At the time of the report, OFF LABEL USE (16-year-old patient who received the Pfizer vaccine as the first dose on 30JUL2021 and the second dose of the covid-19 vaccine as Moderna on 27AUG2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received second dose of the covid-19 vaccine as Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided.  No Treatment medications was provided.  patient received the Pfizer vaccine as the first dose on 30JUL 2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: lower back hurt where she couldn't sleep; Her left  arm where she received all 3 shots was sore all three times.; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back hurt where she couldn't sleep) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03F21A2, TT2643 and TT2643) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica (PMR) and Back disorder NOS (Lower Back problems). Concurrent medical conditions included Autoimmune disorder.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back hurt where she couldn't sleep) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back hurt where she couldn't sleep) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) outcome was unknown.            No concomitant medication were provided by the reporter.  Patient had take Tylenol for able to sleep because her back hurt again.   This case was linked to MOD-2021-306253 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Inappropriate schedule of product administration
Clinical narrative: feeling lightheaded; I started feeling like I lost a lot of energy.; I feel like I've had a couple of times when my chest hurts; Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021); This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I feel like I've had a couple of times when my chest hurts), ASTHENIA (I started feeling like I lost a lot of energy.), DIZZINESS (feeling lightheaded) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EW0181 and EW0180) for COVID-19 vaccination.     Family history included Skin cancer (The patient's father died of skin cancer.) and Aneurysm cerebral (The patient's mother had an aneurysm in her brain & she died from it.).   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021)). On 04-Jul-2021, the patient experienced CHEST PAIN (I feel like I've had a couple of times when my chest hurts). On 20-Jul-2021, the patient experienced ASTHENIA (I started feeling like I lost a lot of energy.). On an unknown date, the patient experienced DIZZINESS (feeling lightheaded). On 20-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(02Jun2021/ 20Jun2021)) had resolved. At the time of the report, CHEST PAIN (I feel like I've had a couple of times when my chest hurts), ASTHENIA (I started feeling like I lost a lot of energy.) and DIZZINESS (feeling lightheaded) outcome was unknown.            The consumer stated that he received first dose of the Moderna COVID-19 vaccine on 02 June 2021 and did not have any side effects. No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right injection site arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not  provided.   This case was linked to MOD-2021-306148 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not follow the recommended dosing schedule; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not follow the recommended dosing schedule) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014A20A and 040A21A) 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 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not follow the recommended dosing schedule). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not follow the recommended dosing schedule) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: He felt a little sore; Tired for 2 days.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (He felt a little sore) and FATIGUE (Tired for 2 days.) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 from April 2020 to May 2020, Shingles and Organ transplant. Concurrent medical conditions included Immunocompromised, Sleep disorder and Memory deficit. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes zoster immunisation, MULTIVITAMINS [VITAMINS NOS] and GINKGO BILOBA (GINGKO BILOBA) for Memory impairment, CLONAZEPAM (KLONOPIN) for Sleep disorder.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYALGIA (He felt a little sore) and FATIGUE (Tired for 2 days.). In April 2021, MYALGIA (He felt a little sore) and FATIGUE (Tired for 2 days.) had resolved.            No treatment information was provided.  The patient post receiving their second dose felt a little sore and tired for 2 days. The patient identified their gender as non-binary and was qualified for the 6 month booster shot according to the Department of Health in as the patient had an organ transplant and was immunocompromised.  The patient was taking concomitant medications which included Valtrex, prophylactic or treatment for herpes zoster or shingle, Klonopin to help with sleep and multivitamins and ginkgo to help with memory.   The patient also reported that they had COVID virus which started in April 2020 and ended in May 2020.   This case was linked to MOD-2021-306193, MOD-2021-306228 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms
Clinical narrative: back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae; back was spasming every 10 seconds and lasted 48 hours; felt like somebody stabbed her in her back next to her ribcage and vertebrae; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae), MUSCLE SPASMS (back was spasming every 10 seconds and lasted 48 hours) and BACK PAIN (felt like somebody stabbed her in her back next to her ribcage and vertebrae) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bone disorder.    On 13-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 BACK PAIN (back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae), MUSCLE SPASMS (back was spasming every 10 seconds and lasted 48 hours) and BACK PAIN (felt like somebody stabbed her in her back next to her ribcage and vertebrae). At the time of the report, BACK PAIN (back started aching/felt like somebody stabbed her in her back next to her ribcage and vertebrae), MUSCLE SPASMS (back was spasming every 10 seconds and lasted 48 hours) and BACK PAIN (felt like somebody stabbed her in her back next to her ribcage and vertebrae) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications, Muscle relaxers, NSAID, narcotics, anti-inflammatory, anxiety meds, lidocaine patches on back.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PYREXIA (Fever). On 30-Aug-2021, PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, Body temperature: 103 (High) 103 degree Fever at 11AM. On 28-Sep-2021, Body temperature: 102 (High) 102 degree Fever at 11 AM. On 29-Sep-2021, Body temperature: 101 (High) 101 degree Fever 11AM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Gait disturbance, Pyrexia
Clinical narrative: Dizziness that almost made her fall; Dizziness that almost made her fall; Fever (99,7F); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness that almost made her fall), GAIT DISTURBANCE (Dizziness that almost made her fall) and PYREXIA (Fever (99,7F)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035621A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Diabetes. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, ANASTROZOLE (ARIMIDEX) for Cancer, METFORMIN for Diabetes.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced DIZZINESS (Dizziness that almost made her fall), GAIT DISTURBANCE (Dizziness that almost made her fall) and PYREXIA (Fever (99,7F)). At the time of the report, DIZZINESS (Dizziness that almost made her fall), GAIT DISTURBANCE (Dizziness that almost made her fall) and PYREXIA (Fever (99,7F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 99.7 (High) She now she has a 99.7 F fever..         No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: felt woozy/felt a little woozy; felt like they were coming down with something; 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 DIZZINESS (felt woozy/felt a little woozy) and FEELING ABNORMAL (felt like they were coming down with something) 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.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt woozy/felt a little woozy) and FEELING ABNORMAL (felt like they were coming down with something). At the time of the report, DIZZINESS (felt woozy/felt a little woozy) and FEELING ABNORMAL (felt like they were coming down with something) had resolved.            The concomitant history was not reported. The treatment history was not provided.  It felt like they were coming down with something. This lasted for about 10 days.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Insomnia, Vaccination site pain
Clinical narrative: Couldnt sleep; Lower back hurt; Her left  arm where she received all 3 shots was sore all three times.; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldnt sleep), BACK PAIN (Lower back hurt) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. TT2643 and TT2643) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica and Autoimmune disorder NOS.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 INSOMNIA (Couldnt sleep), BACK PAIN (Lower back hurt) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Sleep difficult, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldnt sleep), BACK PAIN (Lower back hurt) and VACCINATION SITE PAIN (Her left  arm where she received all 3 shots was sore all three times.) outcome was unknown.      Concomitant medications were not reported.   This case was linked to MOD-2021-306205, MOD-2021-306266 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Heart rate
Clinical narrative: She started with sharp chest pain on her right side within an hour.; She slowly started to feel discomfort in chest on right side/Her chest feels tight.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (She started with sharp chest pain on her right side within an hour.) and CHEST DISCOMFORT (She slowly started to feel discomfort in chest on right side/Her chest feels tight.) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, METFORMIN and LIRAGLUTIDE (SAXENDA) for an unknown indication.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced CHEST PAIN (She started with sharp chest pain on her right side within an hour.) and CHEST DISCOMFORT (She slowly started to feel discomfort in chest on right side/Her chest feels tight.). At the time of the report, CHEST PAIN (She started with sharp chest pain on her right side within an hour.) and CHEST DISCOMFORT (She slowly started to feel discomfort in chest on right side/Her chest feels tight.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Heart rate: 100 to 127 (abnormal) 100 to 127 beats per minute.     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.   Patient treatment method included deep breathing techniques.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her left arm where she received all 3 shots was sore all three times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her left arm where she received all 3 shots was sore all three times) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. TT2643) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (PMR), Autoimmune disorder NOS (Autoimmune condition) and Back disorder (Has always had lower back problems).    On 09-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 VACCINATION SITE PAIN (Her left arm where she received all 3 shots was sore all three times). At the time of the report, VACCINATION SITE PAIN (Her left arm where she received all 3 shots was sore all three times) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment medication was not provided.   This case was linked to MOD-2021-306253, MOD-2021-306205 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Muscle spasms, Muscle twitching
Clinical narrative: felt like pulling sensation under heart that lasted a day; had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body; Started having muscle spasms under her left rib cage; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Started having muscle spasms under her left rib cage), CHEST DISCOMFORT (felt like pulling sensation under heart that lasted a day) and MUSCLE TWITCHING (had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D2A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced MUSCLE SPASMS (Started having muscle spasms under her left rib cage). On an unknown date, the patient experienced CHEST DISCOMFORT (felt like pulling sensation under heart that lasted a day) and MUSCLE TWITCHING (had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body). At the time of the report, MUSCLE SPASMS (Started having muscle spasms under her left rib cage), CHEST DISCOMFORT (felt like pulling sensation under heart that lasted a day) and MUSCLE TWITCHING (had  crazy muscle twitches that don't go away for 4 weeks/She feels muscle twitches inher fingers, left pinky toe, bottom lip, and throughout her whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Neck pain, Pyrexia, Throat irritation
Clinical narrative: Pain in the back of the neck; Scratchy throat; Aches; Fever of about 101.5 that lasted for a few hours; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the back of the neck), THROAT IRRITATION (Scratchy throat), MYALGIA (Aches) and PYREXIA (Fever of about 101.5 that lasted for a few hours) 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 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced NECK PAIN (Pain in the back of the neck), THROAT IRRITATION (Scratchy throat), MYALGIA (Aches) and PYREXIA (Fever of about 101.5 that lasted for a few hours). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, Neck pain, Throat irritation and Pyrexia, at an unspecified dose and frequency. On 02-Sep-2021, PYREXIA (Fever of about 101.5 that lasted for a few hours) had resolved. At the time of the report, NECK PAIN (Pain in the back of the neck), THROAT IRRITATION (Scratchy throat) and MYALGIA (Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 101.5 (High) Fever of about 101.5 that lasted for a few hours.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications includes an antidepressant.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Polychondritis
Clinical narrative: Relapsing polychondritis three times/ affects the cartilage and its in the ears; This spontaneous case was reported by a consumer and describes the occurrence of POLYCHONDRITIS (Relapsing polychondritis three times/ affects the cartilage and its in the ears) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A. and 026L20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced POLYCHONDRITIS (Relapsing polychondritis three times/ affects the cartilage and its in the ears) (seriousness criterion medically significant). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency; PREDNISONE (oral) for Adverse event, at a dose of 20 mg for 10 days and MOMETASONE for Adverse event, at a dose of 0.1 crm. At the time of the report, POLYCHONDRITIS (Relapsing polychondritis three times/ affects the cartilage and its in the ears) had not resolved.            Patient was first time treated with cortisone and antibiotics, second time with an oral antibiotic and cortisone cream, third time with prednisone and a cream Mometasone .  Patient had relapsing polychondritis three times since 09 MAY 2021. Patient had experienced  the first two relapsing in the left ear where several weeks were passed between these two episodes and the last episode occurred in the right ear and it was reoccurring. Patients previous doctor thought it was eczema but ENT diagnosed it as relapsing polychondritis.  Based on the current available information and temporal association between the use of the product and the start date of the event relapsing polychondritis, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event relapsing polychondritis, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Contusion, Vaccination site discolouration, Vaccination site pain
Clinical narrative: purplish red in color, 2 to 4 inches in size on the same arm of injection site; Massive bruises (arm to breast); Sore arm (injection site); Arm pit was hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (purplish red in color, 2 to 4 inches in size on the same arm of injection site), CONTUSION (Massive bruises (arm to breast)), VACCINATION SITE PAIN (Sore arm (injection site)) and AXILLARY PAIN (Arm pit was hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore arm (injection site)). 30-Aug-2021, the patient experienced AXILLARY PAIN (Arm pit was hurting). On 02-Sep-2021, the patient experienced CONTUSION (Massive bruises (arm to breast)). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (purplish red in color, 2 to 4 inches in size on the same arm of injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (purplish red in color, 2 to 4 inches in size on the same arm of injection site), CONTUSION (Massive bruises (arm to breast)), VACCINATION SITE PAIN (Sore arm (injection site)) and AXILLARY PAIN (Arm pit was hurting) outcome was unknown.            Relevant concomitant medications were not provided.  Reporter stated that the massive bruises are present on her left arm to breast which are purplish red in color, 2 to 4 inches in size.  reporter stated that she used ice pack.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Caller said he felt like he got hit by a truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Caller said he felt like he got hit by a truck) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 FEELING ABNORMAL (Caller said he felt like he got hit by a truck). At the time of the report, FEELING ABNORMAL (Caller said he felt like he got hit by a truck) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-306383 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Pain in extremity, Vaccination site bruising
Clinical narrative: blood in urine; Whole arm hurt; Bruising at the injection site for several days; This spontaneous case was reported by a patient and describes the occurrence of BLOOD URINE PRESENT (blood in urine), PAIN IN EXTREMITY (Whole arm hurt) and VACCINATION SITE BRUISING (Bruising at the injection site for several days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN IN EXTREMITY (Whole arm hurt) and VACCINATION SITE BRUISING (Bruising at the injection site for several days). On 11-Aug-2021 at 6:00 PM, the patient experienced BLOOD URINE PRESENT (blood in urine). On 12-Aug-2021 at 6:00 PM, BLOOD URINE PRESENT (blood in urine) had resolved. At the time of the report, PAIN IN EXTREMITY (Whole arm hurt) and VACCINATION SITE BRUISING (Bruising at the injection site for several days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any concomitant medications.  It was reported that the patient did not take any treatments for the events.
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Received third dose and is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received third dose and is not immunocompromised) 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 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced OFF LABEL USE (Received third dose and is not immunocompromised). On 01-Sep-2021, OFF LABEL USE (Received third dose and is not immunocompromised) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: COVID Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (COVID Arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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, the patient experienced VACCINATION COMPLICATION (COVID Arm). At the time of the report, VACCINATION COMPLICATION (COVID Arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter. Pharmacist states that Patient would like to know if he can get third dose?
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: some side effects from 2nd dose that lasted a day and half; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (some side effects from 2nd dose that lasted a day and half) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (some side effects from 2nd dose that lasted a day and half). At the time of the report, VACCINATION COMPLICATION (some side effects from 2nd dose that lasted a day and half) had resolved.            The treatment history was not reported. The concomitant medication was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Vaccination complication
Clinical narrative: COVID arm; itchy; very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore). At the time of the report, VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.  Reported that events lasted about 9 days.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient is reporting her adverse events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient is reporting her adverse events) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient is reporting her adverse events). At the time of the report, VACCINATION COMPLICATION (Patient is reporting her adverse events) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: got a third dose of Moderna vaccine and was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (got a third dose of Moderna vaccine and was not immunocompromised) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (got a third dose of Moderna vaccine and was not immunocompromised). At the time of the report, OFF LABEL USE (got a third dose of Moderna vaccine and was not immunocompromised) had resolved.            No relevant concomitant medications were reported. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Got head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Got head cold) 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 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 NASOPHARYNGITIS (Got head cold). At the time of the report, NASOPHARYNGITIS (Got head cold) outcome was unknown.            The Patient got tested and checked in for COVID   No Concomitant drugs were reported.  No Treatment information  were reported   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (pyrexia) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (pyrexia). At the time of the report, PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102 Fahrenheit Degree.         No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-306289 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 053E21A) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got second dose 21 days after first dose not 28 days/she got second dose earlier than what she was suppose to) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Malaise; After my second dose, high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise) and PYREXIA (After my second dose, high fever) 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 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 MALAISE (Malaise) and PYREXIA (After my second dose, high fever). At the time of the report, MALAISE (Malaise) outcome was unknown and PYREXIA (After my second dose, high fever) had resolved.            The concomitant medications were not reported. The treatment information was not provided.   This case was linked to MOD-2021-306174 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: follow up received on 8-SEP-2021 contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Got the shot in his right arm but is experiencing pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Got the shot in his right arm but is experiencing pain in the left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PAIN IN EXTREMITY (Got the shot in his right arm but is experiencing pain in the left arm). At the time of the report, PAIN IN EXTREMITY (Got the shot in his right arm but is experiencing pain in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided.   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza, Nasopharyngitis, Sneezing, Viral infection
Clinical narrative: Felt rough/felt under the weather for the next two/three days; May have had the cold; Flu; A little sneeze; A virus the day he got the shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt rough/felt under the weather for the next two/three days), NASOPHARYNGITIS (May have had the cold), INFLUENZA (Flu), SNEEZING (A little sneeze) and VIRAL INFECTION (A virus the day he got the shot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 013A21A) for COVID-19 vaccination.     The medical history information was not provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced FEELING ABNORMAL (Felt rough/felt under the weather for the next two/three days), NASOPHARYNGITIS (May have had the cold), INFLUENZA (Flu), SNEEZING (A little sneeze) and VIRAL INFECTION (A virus the day he got the shot). At the time of the report, FEELING ABNORMAL (Felt rough/felt under the weather for the next two/three days), NASOPHARYNGITIS (May have had the cold), INFLUENZA (Flu), SNEEZING (A little sneeze) and VIRAL INFECTION (A virus the day he got the shot) outcome was unknown.            Concomitant medications also include antibiotics since 26-Mar-2021 for an unknown indication. Treatment information was not provided.  Patient did not have side effects with the first dose.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Magnetic resonance imaging
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 DIZZINESS (dizzy). At the time of the report, DIZZINESS (dizzy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.         Patient was taking blood presser medication. No Treatment medications were provided.  Patient was taken other test all came back negative.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up contains no new information