chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tinnitus; sore arm; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (tinnitus) and PAIN IN EXTREMITY (sore arm) in a 121-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Feb-2021, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included acetaminophen (Tylenol).  No relevant concomitant medications were reported.
This case was reported by a pharmacist via out of hour services and described the occurrence of soreness gum in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included soreness gum. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced soreness gum. On an unknown date, the outcome of the soreness gum was unknown. It was unknown if the reporter considered the soreness gum to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced sore gums on one side for a couple days, then on the other side after getting SHINGRIX.
Initial report received from a healthcare professional on 01 October 2012. A 29-year-old female patient had received first intramuscular (IM) dose of FLUZONE vaccine (Lot number UH716AA) in left deltoid on 20 September 2012. The last menstrual period date was unknown and the expected date of delivery is in 2013. At the time of report the patient did not experience any adverse event. The patient health during pregnancy and risk factors was unknown. The patient medical history and previous pregnancy details were unknown. Follow-up information was received 05 February 2013 from a health care professional. Based upon new information received, this case now meets seriousness criteria and has been upgraded from nonserious to serious. According to the reporter, the patient had a miscarriage and was actually not pregnant at the time of vaccination (date of conception and date of last menstrual period were not reported). The patient's outcome was not reported. List of documents held by sender: None.
Feb. 26-2 days after 1st shot, unconscious, blood sepsis, nausea, on a ventilator, severe pneumonia in right lung.  In ICU for 3 days, normal ward 3 days, treated with antibiotics  Mar. 26-2 days after 2nd shot, unconscious, blood sepsis, blood clot, heart failure, kidney & liver damage, treated with Eliquis and antibiotics.  At hospital in ICU for 2 days, normal ward 3 days.  Continuing with Eliquis, increased Metoprolol.  Follow-up with kidney specialist and Cardiologist PA.
Information has been received from a registered nurse concerning a 69 year old female with the following drug allergies PAMELOR, PAXIL, "BENZINATE", CECLOR and ZITHROMAX and a history of osteoporosis, irritable bowel syndrome, anxiety, diverticulosis, and mitral valve prolapse who on 16-OCT-2006 was vaccinated in the left deltoid with Pneumovax 23 (lot #651404/0352F), 0.5 ml, IM.  Concomitant therapy included CITRUCEL, ATIVAN, ZOLOFT, CLARINEX, FORTEO, REQUIP and vitamins (unspecified).  On 18-OCT-2006, the patient was examined and complained of fever, pain and warmth left axilla and under arm area.  The physician diagnosed cellulitis (also reported as pain and erythema) and prescribed ice compresses and KEFLEX.  A verbal report from the patient stated that the symptoms were improving.  Further information has been received from the registered nurse who requested a lot number check be performed because several patients had a reaction to this Pneumovax 23 lot number.  Follow up information has been received from the physician.  The patient had laboratory test performed and white blood cell count was within normal limit.  The patient recovered from the cellulitis left arm after 18-OCT-2006.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met the requirements of the agency and was released.  Additional information is not expected.
Based on the additional information received on 07 March 2016, this case initially considered as non-serious was upgraded to serious due to death of the patient. Initial unsolicited report received from a physician on 03 December 2015. This case involves a male patient (age unknown) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose in series and site of administration were not reported) on 2 September 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced flu symptoms, exhaustion and body ache. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Follow up information received from Physician on 07 March 2016. It was reported that, patient's details could not be obtained as patient died (details not provided) on an unspecified date. Sender's Comments: Initial case, reported events was flu symptoms, exhaustion and body ache with patient has since Deceased (from other reason)" date was not reported and in follow-up reported that patient has since Deceased (from other reason)" date was not reported. limited information was provided in document. Additional information on patient's medical history and concomitant medications, health status at vaccination, final diagnosis and complementary investigations ruling out alternative etiology and autopsy report are needed for complete assessment. Based on available information, role of vaccine cannot be established. Reported Cause(s) of Death: death nos.
Throat infection (Strep Throat Positive); scar; Pityriasis Rosea; This is a spontaneous report from a contactable consumer (patient herself). A 23-years-old non-pregnant female patient received bnt162b2 (BNT162B2, formulation: solution for injection, Lot Number: EW0150, Expiry date: Unknown) via an unspecified route of administration in Arm Left on 07Apr2021 09:15 as dose 1, single (at the age of 23 years) for COVID-19 immunization. The patient medical history was not reported and there were no concomitant medications. There were no known allergies. Prior to vaccination, patient did not have COVID-19. Covid-19 was not tested post vaccination. On 14Apr2021, the patient first noticed a scar appearing on Chest, Pityriasis Rosea and on 21Apr2021, experienced throat infection. The scar started growing over a couple of days into a circular Herald Patch appearance. Along with the growth of that one patch, smaller scars started appearing on left side of lower back. Since then, the smaller ones have grown into an almond shape larger appearance. Similar smaller ones have been noticed on underarm and appears as though more are starting to appear on stomach. Patient went to Clinic for consolation and doctor suspects it could be a reaction to vaccination and that it looks like a case of Pityriasis Rosea. No irritation or itching was reported. Purely visible with no symptoms of irritation. Therapeutic measures were taken for throat infection (Strep Throat Positive) and have been on Ibuprofen and Antibiotics (Penicillin) and therapeutic measures were not taken for other events. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
I had extreme weakness, nausea the day of the shot.  During the night, I was awakened by stinging pain in the joints of my fingers, feet, ankles, knees, hips, arms, back, neck.  Since that time, my joints seem to be loose - I have twisted both knees, both feet, both hands and my neck while doing nothing but ordinary activities.  My neck was out of joint so badly that I could not move my head up, down or to either side without severe pain.  I yawned two weeks ago and my jaw popped out of joint.  It has not recovered since - keeps popping in and out, and, as a result, I broke a crown on a molar while trying to chew a hamburger.  The stinging pain in my joints comes and goes daily.  I do not know if this will be permanent or not.
pt recvd vax & 25NOV94 devel bloody mucous; 26NOV94 pt was hospitalized for appearance of dry blood in mouth & nose mucous; 26NOV94, platelet count was 5,000-same day platelet count dec further to 1,000; also exp petechiae on extremities;
It was reported that a female pt received a TD Adult on 2/9/01. Reportedly, sometime after the vaccination, the pt developed a local reaction of 4 X 5cm at the injection site. The pt also developed a fever of 102F. These symptoms are unresolved.
Herpes Zoster diagnosis in a 2 dose varicella vaccine recipient. Painful unilateral rash, cough, and runny nose. No antiviral treatment.
Pt reported feeling nauseous and tired.  She had missed school breakfast.  Offered water and snack, symptoms resolved.  Returned to class at 1050am.  Parent was notified .
reported next day waking up and extreme fatigue, chills, fever, local swelling and pain.  continued for 12 hours with alternating Tylenol and ibruprophen for pain
Pt had red circular spots on arm, thigh (R), stomach. She claims spots appeared w/in 1 day of vaccine administration. No itch, pain, open sores. Pt's PCP was informed by RPH 6/17/16 and pt was instructed to go see PCP at 6/17/16 3:45 pm.
I experienced a breakthrough case of COVID-19 with severe congestion, sore throat, minor cough, headache and fatigue.
Patient received first dose of the Moderna covid-19 vaccine series. Patient is under recommended age of administration. No adverse events noted onsite after vaccination.
RED, INFLAMED, ITCHING, AND PAINFUL. OSLO WARM TO TOUCH
sore arm; This is spontaneous report received from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (which has the lot number of M003011, expiration date 15-NOV-2017, L031196, expiration date 05-FEB-2017) (dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
with AVA #3, 5M described an immediate reaction of generalized swelling, SOB. He was treated at aid station over in foreign country, although he cannot recall what with. He was supposedly at that time given a permanent exemption to the vaccine, but it never made it into his record. With AVA #4 in Oct of 2007, he states he had a very large local reaction with swelling into his arm and shoulder, pain on a level of 8/10. This time he received a permanent exemption. Symptom: Cough, productive Start: 12/11/2003. Symptom: Angioedema, productive Start: 12/11/2003. Symptom: Dyspnea (shortness of breath) Start: 12/11/2003. Symptom: Edema @ injection site >120 mm not beyond elbow Start: 10/30/2007. Symptom: Erythema Start: 10/30/2007. Symptom: Swelling Start: 10/30/2007.  Symptom: Pain Start: 10/30/2007.
PATIENT REPORTED THAT AFTER A FEW HOURS, THE PATIENT LOST FEELING IN HER LEFT ARM (THE ARM THAT WAS INJECTED). SHE REPORTED THAT SHE CANNOT MOVE HER ARM, AND AS OF TODAY (3/13/18) SHE STILL HAS NO FEELING IN HER ARM.
Resident lives in independent living apartment on a retirement campus.  She walked in to the central vaccination clinic at the end of "booster dose" clinic being performed by our pharmacy.  Initially the resident did not have her vaccination card and said she was due.  After vaccinating her, the resident found her vaccination card in her purse.  This vaccination then noted that she had received her 2nd booster (4th total dose) approximately 2 weeks prior to this clinic at her doctor's office.  When questioned about the previous booster dose, the resident did not recall receiving it.  There must have been some level of dementia or memory loss with the patient.  We were doing the clinic at a location where we did not have access to the internet to look-up vaccine history.
Measles, mumps and rubella given right thigh at 10:25, by 10:35 large erythema, warmth to thigh spreading rapidly then hives to back at 10:45.  Intramuscular BENADRYL given 10:47.  Intramuscular Dexamethasone given at 10:58 left arm under orders from doctor.  At 11:30 no hives and no local soreness.  Follow up tomorrow.  Sent home with by mouth PREDNISONE and BENADRYL prescriptions for three days
This spontaneous report as received from a physician via field representative refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (0.65 ml, subcutaneously). No concomitant medication was reported. On an unknown date, approximately 3 days after vaccination the patient experienced exacerbation of his psoriasis. The outcome and causality of the event was unknown for ZOSTAVAX. The patient sought medical attention. A product quality complaint (PQC) was not involved. Additional information has been requested.
dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003c21a and 003c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRON, VITAMINS NOS (MULTIVIT [VITAMINS NOS]) and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced DIZZINESS (dizzy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy) had not resolved.            On the 30th Sep patient started to feel dizzy and now she continues to feel dizzy but "not the same as before.
Hard to swallow like lump in throat, throat tightness/swelling feeling.; Hard to swallow like lump in throat, throat tightness/swelling feeling.; Hard to swallow like lump in throat, throat tightness/swelling feeling.; slight rapid breathing; Hives on chest; This is a spontaneous report from a contactable Consumer or other non HCP (patient, self-reporting). A 30-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: En6203 and expiration dates were not reported), via an unspecified route of administration in Arm Left on 01Mar2021at 17:00 as first dose, single for COVID-19 immunisation. The patient was 30 years old, non-pregnant at the time of vaccination. Medical history included Known allergies: Tree nuts. Concomitant medications included Welbutrin, vyvanse, vitamin c, vitamin d, shilajit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 01Mar2021 17:30 the patient experienced Hard to swallow like lump in throat, throat tightness/swelling feeling. Hives on chest, slight rapid breathing. The patient was treated with benedryl. Therapeutic measures were taken as a result of Hard to swallow like lump in throat, throat tightness/swelling feeling. Hives on chest, slight rapid breathing. Facility type vaccine: School or Student Health Clinic. The Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was resolved.  No follow up attempts are possible. No further information is expected.
inflammatory reaction; burning; back pain; difficulty walking; having a lot of pain walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes mellitus" (ongoing), notes: her sister was in her 20s. The patient's concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "not recovered", described as "inflammatory reaction"; BURNING SENSATION (non-serious), outcome "not recovered", described as "burning"; BACK PAIN (non-serious), outcome "not recovered", described as "back pain"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "difficulty walking"; PAIN (non-serious), outcome "not recovered", described as "having a lot of pain walking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, burning sensation, back pain, gait disturbance, pain.  Additional information: The reporter stated that for her it slowly started after the first vaccine, after the second dose over the next couple of months she became incapacitated. Brother (patient) had the same issue, x-rayed by doctor, and nothing was found wrong and was put on pain medications. The patient reported he was also having a lot of pain walking, states he could barely walk in the store, then over thanksgiving he spent the holiday with their other sister and she was having the same problems with the pain and the walking after her first dose as well.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL. On 07-Dec-2006 the patient experienced significant arm pain, including through the passive motion. The physician reported that the patient was sent to see an orthopedic physician on 03-JAN-2007 because the patient was a dancer and could not dance with extreme pain. At the time of this report, the outcome was unknown. It was also reported that the patient was vaccinated with a first dose of GARDASIL on 12-OCT-2006 and there was no adverse experience with this initial dose. No product quality complaint involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 2/14/2007. Initial and follow-up informtion has been received froma physician and medical records concerning a 15 year old female who on 07-DEC-2006 was vaccinated intramuscularly with a second dose of GARDASIL vaccine (Lot  number 653938/0954F). On 07-DEC-2006 the patient experienced significant arm pain, including through passive motion, limitating activities. The patient was again seen in the physicia's office on 14-DEC-2006 still with "arm hurting". During physical examination, it was noted that the patient had a "small 1 cm greenish older bruise with no palpable mass in the deltoid area". The patient was treated with ALEVE, 2 tablets orally twice a day as necessary for pain. The patient returned to the physician's office on 20-DEC-2006 still with "arm sore, still unable to move to do some dance" (previously reported as could not dance with extreme pain). Physical examination noted the deltoid area with no palpable mass, tenderness to palpation by report but with no wincing or guarding, and slight hyperemia". The physician referred the patient to an orthopedic physician. The patient was seen in the orthopedic physician's office on 04-Jan-2007. According to the orthopedic physician's office notes, the patient's pain was localized to the injection site over the mid aspect of the deltoid muscles. This pain was associated with any overhead lifting and some weakness. There was no pain with rest. An x-ray of the shoulder are showed no evidence of bony abnormalities or myositis ossificans. The orthopedic physician's assessment was that the patient had "a little residual irritation from the injection site, and the pain may be associated with some residual muscle spasms". The patient was prescribed FLEXERIL. It was also reported that the patient was vaccinated with a first dose of  GARDASIL vaccine on 12-OCT-2006 and there was no adverse experience with this initial dose. Follow-up received on 7-FEB-2007 contained the following adverse experiences: rotational scoliosis (4-JAN-2007), and pharyngitis (20-DEC-2006). Additional informatinis not expected.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
This spontaneous report has been received from a medical assistant referring to a currently unknown age patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On an unknown date (when the patient was 12 years old), the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (strength, route, batch/lot #, and expiration date were not reported). On an unknown date (when the patient was 14 years old), the patient was vaccinated with the second dose of vaccine GARDASIL 9 (strength, route, batch/lot #, and expiration date were not reported). No adverse effects were reported.
Start 18 hours after vaccination.  Adverse events were 100 Degree fever and extreme muscle pain.  Events ended in 24 hours.
PATIENT COMPLAINS OF HEADACHE AND TONGUE ITCHING. PATIENT MONITORED AN ADDITIONAL 15 MINS. PATIENTS COMPLAINTS SUBSIDED.