chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Condition aggravated, Sleep disorder, Urticaria
Clinical narrative: Originally received a shot in July-August of 2021, and shortly moved in to a new residence. Started getting breakouts of hives, mostly on my left shoulder, my upper back, and the insides both arms/forearms/armpits. They would always flare up especially bad late at night, shortly before going to bed  Originally believed it was some other element, such as a food or fragrant chemicals that I may be having a reaction to, or that it may be stress-induced hives. Took a regimen of medication (cannot recall at the moment the exact intake, but it was about twenty pills over six days) that helped boost my immune system, and then wean me off to a point that it could "calm down" again, and hopefully the hives would go with it, as was described by my nurse. After the regimen, my hives calmed down but never went away completely, though they never flared up like they had been. On February 8th, I received the booster for Moderna (the vaccine listed on this report), and by the end of the week (the earliest I can remember it happening was on the Sunday following), my hives started flaring up again, same pattern as before, but much worse than last time. Now, they're all down my back, down the sides and inside of my legs and knees, on the top of my feet, the backs of my hands, on my upper chest and belly, on my forehead and back of head underneath my hair, as well as all the same places they were showing up before. They also itch much worse, to the point that it is sometimes difficult to fall asleep because of them. Due to the similar time both flare ups occurred after getting a vaccine, my nurse came to the conclusion it was happening due to the vaccine or an ingredient in the vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Headache, Immune system disorder, Oral mucosal blistering, Stomatitis
Clinical narrative: Mouth broke out in extreme  sores and blisters, headache. Couldn't figure it out, heard from other women my age experiencing same strong  ridge along inner cheeks in mouth. Extreme headache returned a month later. Mouth would  break  out periodically. Went to two  doctors who determined it was  varicella/zoster  virus running  rampant  since vaccine cause immune system to overreact. Extremely painful herpetic outbreaks now come when immune stem down. Have seen a number of doctors and have appt w neurologist to get MRI to see if trigeminal nerve affected by varicella/zoster. Debilitating when it comes
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Varicella zoster virus infection, Viral titre increased
Clinical narrative: Mouth broke out in extreme  sores and blisters, headache. Couldn't figure it out, heard from other women my age experiencing same strong  ridge along inner cheeks in mouth. Extreme headache returned a month later. Mouth would  break  out periodically. Went to two  doctors who determined it was  varicella/zoster  virus running  rampant  since vaccine cause immune system to overreact. Extremely painful herpetic outbreaks now come when immune stem down. Have seen a number of doctors and have appt w neurologist to get MRI to see if trigeminal nerve affected by varicella/zoster. Debilitating when it comes
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blister, Blood test, Chest X-ray, Erythema
Clinical narrative: Within 13 hours, I broke out in full body hives and red bumps covering the majority of my body with the exception of my feet and face. For the past 24 days, I have itched from head to toe. I have developed blisters on the back of my leg. Multiple times a day, I break out in a severe case of hives redness and red bumps and itching that is uncontrollable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Urine analysis, Urticaria
Clinical narrative: Within 13 hours, I broke out in full body hives and red bumps covering the majority of my body with the exception of my feet and face. For the past 24 days, I have itched from head to toe. I have developed blisters on the back of my leg. Multiple times a day, I break out in a severe case of hives redness and red bumps and itching that is uncontrollable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination. No Medical History information was reported. In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided by reporter. Pharmacist gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Date the vial was initially stored in the refrigerator 14-Jan-2022. Date(s) of administration of vaccines were reported as 14-Feb-2022, 15-Feb-2022, 16-Feb-2022, 18-Feb-2022, 21-Feb-2022. The vial did not undergo any temperature excursions. Treatment medication was not provided by reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram pulmonary, C-reactive protein, Chest X-ray, Chest pain, Dyspnoea
Clinical narrative: c/o CP and SOB, diagnosed with pericarditis, prescribed NSAID taper and colchicine,  discharged home
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Human chorionic gonadotropin, Metabolic function test
Clinical narrative: c/o CP and SOB, diagnosed with pericarditis, prescribed NSAID taper and colchicine,  discharged home
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Red blood cell sedimentation rate, Troponin
Clinical narrative: c/o CP and SOB, diagnosed with pericarditis, prescribed NSAID taper and colchicine,  discharged home
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Pain at injection site; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 11:45 (Formulation: solution for injection, Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20May2021, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 20May2021, outcome "recovering", described as "Tiredness". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional information: Vaccination site pain and Fatigue were treated with TYLENOL and rest. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My glands near my left clavicle became swollen; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 10:00 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16May2021, outcome "recovered" (May2021), described as "My glands near my left clavicle became swollen". Therapeutic measures were not taken as a result of lymphadenopathy. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.No Known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. 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 EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No Treatment medication was reported.  No vials undergo any temperature excursions.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: fever; chills; swollen lymph nodes under the left arm; body aches/ pain; Flu like symptoms; This case was received via VAERS on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swollen lymph nodes under the left arm) and PAIN (body aches/ pain) in a 58-year-old female 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) (Intramuscular) at an unspecified dose. On 29-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (chills), LYMPHADENOPATHY (swollen lymph nodes under the left arm) and PAIN (body aches/ pain). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills), LYMPHADENOPATHY (swollen lymph nodes under the left arm) and PAIN (body aches/ pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Issues with menstrual cycle.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Issues with menstrual cycle.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Issues with menstrual cycle.). At the time of the report, MENSTRUAL DISORDER (Issues with menstrual cycle.) had not resolved.            No concomitant medications reported.  No treatment medications reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Muscular and skeletal pain below the waist; Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj; Fever 24 hrs; Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj; Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Muscular and skeletal pain below the waist), MYALGIA (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj), PYREXIA (Fever 24 hrs), HEADACHE (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) and INJECTION SITE PAIN (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced BONE PAIN (Muscular and skeletal pain below the waist), MYALGIA (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj), PYREXIA (Fever 24 hrs), HEADACHE (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) and INJECTION SITE PAIN (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fever, at a dose of UNK UNK, q6h. On 13-Jun-2021, BONE PAIN (Muscular and skeletal pain below the waist), MYALGIA (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj), PYREXIA (Fever 24 hrs), HEADACHE (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) and INJECTION SITE PAIN (Muscular and bone pain (not ache!) below the waist for 48 hours, fever 24 hrs, headache, sore @ inj) had resolved.            Concomitant product use was not provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (I have had my period for 14 days so far with COVID-19 shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Keflex) and Drug allergy (phenergan). On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (I have had my period for 14 days so far with COVID-19 shot). At the time of the report, HEAVY MENSTRUAL BLEEDING (I have had my period for 14 days so far with COVID-19 shot) outcome was unknown. No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Shortness of breath with very little exertion; Tightness in the chest.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath with very little exertion) and CHEST DISCOMFORT (Tightness in the chest.) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight, Sleep apnea (Have a CPAC machine.), Irritable bowel syndrome, Hashimoto's disease and Diabetic.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 06-May-2021, the patient experienced DYSPNOEA (Shortness of breath with very little exertion) and CHEST DISCOMFORT (Tightness in the chest.). At the time of the report, DYSPNOEA (Shortness of breath with very little exertion) and CHEST DISCOMFORT (Tightness in the chest.) had not resolved.            No Concomitant medications were provided  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up information contains no new information
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Catheterisation cardiac, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Chest pain; blood pressure 158/96; Dizziness; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and BLOOD PRESSURE INCREASED (blood pressure 158/96) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012120A) for COVID-19 vaccination.     Concurrent medical conditions included Arrhythmia (Rowing crew, pickleball), Tightness in chest and Shortness of breath.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form once. On 06-Mar-2021, the patient experienced DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced CHEST PAIN (Chest pain) and BLOOD PRESSURE INCREASED (blood pressure 158/96). On 08-Jul-2021, DIZZINESS (Dizziness) and DYSPNOEA (Shortness of breath) had not resolved. At the time of the report, CHEST PAIN (Chest pain) and BLOOD PRESSURE INCREASED (blood pressure 158/96) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Catheterisation cardiac: negative (Negative) Left and right catheterization were all negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received on 8 Jul 2021 included new adverse event. On 04-Aug-2021: Significant Follow up.Dose tab is added in product tab
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lump on left collar bone thats painful/lump by my collar bone thats sore and painful; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lump on left collar bone thats painful/lump by my collar bone thats sore and painful) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gastric bypass since 2009. Concurrent medical conditions included Anemic, Fibromyalgia and Bronchitis.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced LYMPHADENOPATHY (Lump on left collar bone thats painful/lump by my collar bone thats sore and painful). At the time of the report, LYMPHADENOPATHY (Lump on left collar bone thats painful/lump by my collar bone thats sore and painful) outcome was unknown.            No concomitant medication was provided.   No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received contains non-significant information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site mass, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump at injection site/injection site is a swollen lump about 3 inches in diameter), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) and VACCINATION SITE RASH (a 3" rash at injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis and Hashimoto's disease. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) 1 dosage form. On 09-Jun-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 16-Jun-2021, the patient experienced VACCINATION SITE MASS (a lump at injection site/injection site is a swollen lump about 3 inches in diameter) and VACCINATION SITE RASH (a 3" rash at injection site). On 09-Jun-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, VACCINATION SITE MASS (a lump at injection site/injection site is a swollen lump about 3 inches in diameter) and VACCINATION SITE RASH (a 3" rash at injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Cutaneous) was unknown. No concomitant medication details was reported. No treatment medication details was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Prolonged menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Prolonged menstrual bleeding) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Hypertension, Irritable bowel syndrome, Anxiety and Food allergy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OLIGOMENORRHOEA (Prolonged menstrual bleeding). At the time of the report, OLIGOMENORRHOEA (Prolonged menstrual bleeding) had not resolved.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided.  The patient started a menstrual cycle and had not stopped bleeding since. Prior to being vaccinated, the patient had a period every 3-5 months.  On an unknown date, the patient had multiple tests done (unspecified) and possibly an ablation procedure or IUD (intrauterine device) inserted to stop the bleeding.  No treatment information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Inflammation, Neck pain, Peripheral swelling, Vaccination complication
Clinical narrative: terrible reaction to COVID 19 vaccine; Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.; Swelling &inflammation of my arm; Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present; Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.), INFLAMMATION (Swelling &inflammation of my arm), CHEST PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present), NECK PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) and VACCINATION COMPLICATION (terrible reaction to COVID 19 vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PERIPHERAL SWELLING (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.), INFLAMMATION (Swelling &inflammation of my arm), CHEST PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) and NECK PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present). On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible reaction to COVID 19 vaccine). At the time of the report, PERIPHERAL SWELLING (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present.), INFLAMMATION (Swelling &inflammation of my arm), CHEST PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) and NECK PAIN (Swelling &inflammation of my arm, chest & neck w/ excruciating pain from 5/12/2021 to present) had not resolved and VACCINATION COMPLICATION (terrible reaction to COVID 19 vaccine) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Additional Information received included newevent was added.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dry mouth, Heart rate increased, Hyperhidrosis, Night sweats
Clinical narrative: Cottonmouth; Chest pain; fast heartbeat; Night sweats; excessive sweating after walking; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Cottonmouth), CHEST PAIN (Chest pain), HEART RATE INCREASED (fast heartbeat ), NIGHT SWEATS (Night sweats) and HYPERHIDROSIS (excessive sweating after walking) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038c21a) for COVID-19 vaccination.     Multiple sclerosis and possible dementia.  The patient's past medical history included Multiple sclerosis and Dementia.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter once. On 01-Jul-2021, the patient experienced DRY MOUTH (Cottonmouth), CHEST PAIN (Chest pain), HEART RATE INCREASED (fast heartbeat ), NIGHT SWEATS (Night sweats) and HYPERHIDROSIS (excessive sweating after walking). At the time of the report, DRY MOUTH (Cottonmouth), CHEST PAIN (Chest pain), HEART RATE INCREASED (fast heartbeat ), NIGHT SWEATS (Night sweats) and HYPERHIDROSIS (excessive sweating after walking) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided. no treatment information is provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red painful rash growing from injection site to elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red painful rash growing from injection site to elbow) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     The patient's past medical history included Parkinson's disease. Concurrent medical conditions included Allergy to allopathic drugs, Penicillin allergy and Blood pressure high.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter once. On 07-Jul-2021, the patient experienced RASH ERYTHEMATOUS (red painful rash growing from injection site to elbow). At the time of the report, RASH ERYTHEMATOUS (red painful rash growing from injection site to elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Pain in extremity
Clinical narrative: bruising; skin painful on right leg to touch; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising), PAIN IN EXTREMITY (skin painful on right leg to touch) and HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Depression, Anxiety and Seasonal allergy.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 20-Jul-2021, the patient experienced CONTUSION (bruising), PAIN IN EXTREMITY (skin painful on right leg to touch) and HEADACHE (headache). At the time of the report, CONTUSION (bruising), PAIN IN EXTREMITY (skin painful on right leg to touch) and HEADACHE (headache) had not resolved.            It was reported by the reporter that she experienced pain in leg right side. Concomitant medications were not reported by the reporter. Treatment information was not provided by the reporter.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza
Clinical narrative: Diarrhea/horrible diarrhea; Flu symptoms, but much worse; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/horrible diarrhea) and INFLUENZA (Flu symptoms, but much worse) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Serious COVID-19 infection) on 15-Mar-2020. Concurrent medical conditions included Penicillin allergy.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced DIARRHOEA (Diarrhea/horrible diarrhea) and INFLUENZA (Flu symptoms, but much worse). The patient was treated with LOPERAMIDE for Diarrhea, at a dose of 1 dosage form as necessary. On 24-Jul-2021, DIARRHOEA (Diarrhea/horrible diarrhea) had resolved. On 25-Jul-2021, INFLUENZA (Flu symptoms, but much worse) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow up information received and contains no Significant Information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Panic attack
Clinical narrative: confusion, light headed,  walls closing in, can't handle being in crowds; confusion, light headed,  walls closing in, can't handle being in crowds; confusion, light headed,  walls closing in, can't handle being in crowds; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion, light headed,  walls closing in, can't handle being in crowds), DIZZINESS (confusion, light headed,  walls closing in, can't handle being in crowds) and PANIC ATTACK (confusion, light headed,  walls closing in, can't handle being in crowds) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Blood pressure, heartburn, back pain.     On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) unknown. On 20-May-2021, the patient experienced CONFUSIONAL STATE (confusion, light headed,  walls closing in, can't handle being in crowds), DIZZINESS (confusion, light headed,  walls closing in, can't handle being in crowds) and PANIC ATTACK (confusion, light headed,  walls closing in, can't handle being in crowds). At the time of the report, CONFUSIONAL STATE (confusion, light headed,  walls closing in, can't handle being in crowds), DIZZINESS (confusion, light headed,  walls closing in, can't handle being in crowds) and PANIC ATTACK (confusion, light headed,  walls closing in, can't handle being in crowds) had not resolved.            Blood pressure, heartburn, back pain -test are done No treatment medication was provided No concomitant medication was provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: feeling spaced out; Lightheaded, woozy when standing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded, woozy when standing) and FEELING ABNORMAL (feeling spaced out) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheaded, woozy when standing). On 25-Jul-2021, the patient experienced FEELING ABNORMAL (feeling spaced out). On 25-Jul-2021, DIZZINESS (Lightheaded, woozy when standing) had not resolved. At the time of the report, FEELING ABNORMAL (feeling spaced out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications was reported.   No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up information received contains significant information the adverse event feeling abnormal updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Dizziness, Fatigue, Muscle contractions involuntary
Clinical narrative: massive rash that burned and Itched; muscle contractions in hands; nervousness; dizziness,; bruising on my calves; horrendous reaction; massive rash that burned and Itched; massive rash and swelling all over neck, face and ears; massive rash and swelling all over neck, FACE AND EARS; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,) and CONTUSION (bruising on my calves) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Causes itchiness all over body).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 60 UNK. At the time of the report, BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: less than 10 (Low) low and 139 (Low) After three days, my platelet count was up to 139.         No concomitant medication were not provided.  Treatment medication includes 60 mg of steroids    Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021.Updated lab data. Added event horrendous reaction.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Platelet count, Rash, Rash pruritic, Swelling
Clinical narrative: massive rash that burned and Itched; muscle contractions in hands; nervousness; dizziness,; bruising on my calves; horrendous reaction; massive rash that burned and Itched; massive rash and swelling all over neck, face and ears; massive rash and swelling all over neck, FACE AND EARS; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,) and CONTUSION (bruising on my calves) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Causes itchiness all over body).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 60 UNK. At the time of the report, BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: less than 10 (Low) low and 139 (Low) After three days, my platelet count was up to 139.         No concomitant medication were not provided.  Treatment medication includes 60 mg of steroids    Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021.Updated lab data. Added event horrendous reaction.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: massive rash that burned and Itched; muscle contractions in hands; nervousness; dizziness,; bruising on my calves; horrendous reaction; massive rash that burned and Itched; massive rash and swelling all over neck, face and ears; massive rash and swelling all over neck, FACE AND EARS; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,) and CONTUSION (bruising on my calves) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Causes itchiness all over body).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 60 UNK. At the time of the report, BURNING SENSATION (massive rash that burned and Itched), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions in hands), NERVOUSNESS (nervousness), DIZZINESS (dizziness,), CONTUSION (bruising on my calves), VACCINATION COMPLICATION (horrendous reaction), RASH PRURITIC (massive rash that burned and Itched), SWELLING (massive rash and swelling all over neck, face and ears), RASH (massive rash and swelling all over neck, FACE AND EARS) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: less than 10 (Low) low and 139 (Low) After three days, my platelet count was up to 139.         No concomitant medication were not provided.  Treatment medication includes 60 mg of steroids    Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-Jul-2021.Updated lab data. Added event horrendous reaction.
Age: 45.0
Sex: M
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 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-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). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 103.         Relevant concomitant medications were not reported.  Company Comment: Very limited information regarding the date of vaccine administration and the start date of the event have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding the date of vaccine administration and the start date of the event have been provided. Further information has been requested.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash where injection site is; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash where injection site is) in a 31-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced INJECTION SITE RASH (Rash where injection site is). At the time of the report, INJECTION SITE RASH (Rash where injection site is) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment information was not provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Mentrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Mentrual bleeding) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced INTERMENSTRUAL BLEEDING (Mentrual bleeding). At the time of the report, INTERMENSTRUAL BLEEDING (Mentrual bleeding) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INTERMENSTRUAL BLEEDING (Mentrual bleeding) to be possibly related.    No treatment was provided. No concomitant was provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: malaise; Muscle ache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), MYALGIA (Muscle ache), NAUSEA (nausea) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise), MYALGIA (Muscle ache), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, MALAISE (malaise), MYALGIA (Muscle ache), NAUSEA (nausea) and PYREXIA (fever) had not resolved.            No concomitant medication information was provided by the reporter.  No treatment information was provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Aug-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drugs were provided. It was reported that patient felt very dizzy. Sometime nauseous, occasionally elevator like feeling and fever. (99.1).