chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In APRIL 2017, the patient was treated by a healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
During a follow-up call, patient explained that she had severe body aches and fever for ~2 days post vaccination. On day 2 post vaccination, she also noticed some facial swelling around the nose and lips. On day 3 she felt completely fine and "normal." She stated her husband is a doctor and he does not believe she had an allergic reaction, but just a reaction of the immune system to the vaccination.
Had hearing loss with my TDAP booster / was permanent; This case was reported by a consumer via media and described the occurrence of hearing loss in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, immediately after receiving Tdap Vaccine, the patient experienced hearing loss (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Tdap Vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The reporter stated that, he or she had hearing loss with his or her TDAP booster, it happened shortly after receiving the TDAP booster vaccine and was permanent. The reporter stated that, he or she do not think would get it again.
mom 1st noticed swelling of rt arm 28APR AM; rt arm & 1/2 of lower arms wollen, tight, hot to touch; t101 dx allergic react; given DPh;
Information has been received from a physician concerning a patient with no medical history or drug allergy who on 16-JUL-2002 was vaccinated with VARIVAX (Merck). There was no concomitant medication. Subsequently the patient developed chickenpox on face, arm, and legs. The patient did not have any lab diagnostics studies performed. The patient was seen by a physician. At the time of the report the patient was recovering. Additional information has been requested.
Injection  site was sore for first day, beginning to get worse next morning.  It hurt so much it woke me up at 0530 April 1, 2021.  The pain moved to my left shoulder joint, radiating down my back on the left side.   By 11:00 am,  April 1, 2021, all of my main joints ached:  both shoulders, both hips, both knees were aching.  And very exhausted the day after injection and  slightly tired the third day.  Left Shoulder joint still aches..
Patient developed decreased appetite, increased fatigue, complaints of right lower leg pain, headache.  The following day patient developed a small cluster of pustules on right ankle with continued headache, fatigue, and loss of appetite.  The patient was seen by Dr. who ordered a CBC and CMP to rule out leukemia.  At the end of the week the patient developed several pustules along her L4 and L5 dermatome, which was diagnosed as shingles.  The patient was prescribed acyclovir.  The patient had no known chicken pox exposure other than the vaccine.
pt broke out w/c-p rash on torso & extremities x 4;devel scabbing w/newly erupted vesicles w/in 24hr;
pt recv vax & w/in 1wk post vax pt exp lesions scattered over arms & trunk;pt was found to have atrophoderma;dx was confirmed by biopsy;lesions cont to devel as of 14MAR96;
I95.9 HYPOTENSION 4/3/2022 RIGHT HIP OSTEOPOROTIC FX, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 RIGHT HIP OSTEOPOROTIC FX, INIT J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 RIGHT HIP OSTEOPOROTIC FX, INIT J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/11/2022 RIGHT HIP OSTEOPOROTIC FX, INIT I95.9 HYPOTENSION 4/3/2022 ABNL WEIGHT LOSS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 ABNL WEIGHT LOSS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 ABNL WEIGHT LOSS J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/11/2022 ABNL WEIGHT LOSS I95.9 HYPOTENSION 4/3/2022 PARKINSONS DISEASE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 PARKINSONS DISEASE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 PARKINSONS DISEASE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/11/2022 PARKINSONS DISEASE I95.9 HYPOTENSION 4/3/2022 CHRONIC PAIN SYNDROME J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 CHRONIC PAIN SYNDROME J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 CHRONIC PAIN SYNDROME J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/11/2022 CHRONIC PAIN SYNDROME I95.9 HYPOTENSION 4/3/2022 RIGHT HIP DISLOCATION, INIT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 RIGHT HIP DISLOCATION, INIT J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/3/2022 RIGHT HIP DISLOCATION, INIT J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/11/2022 RIGHT HIP DISLOCATION, INIT
got COVID on 12Feb2021; Got COVID on 12Feb2021; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer-sponsored program. A male patient (husband) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunisation. Medical history included neoplasm malignant with some radiotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Feb2021, patient experienced got COVID. On 21Feb2021 'bam' infusion was given as treatment. On 12Feb2021, patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of got COVID on 12Feb2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Seizure lasting 2 minutes. Taken to er. Hospitalized for 3 days and all tests negative. Started on anticonvulsants
Shot 1 given Dec 29 in the morning. I had no symptoms. I got very sick at about 4:30pm Symptoms: muscle aches, chills, fever, headache, SOB, chest pain, sore throat, cough. I ended in the ED because I couldn?t manage my asthma and my HR was high on Wed. I was diagnosed with Covid as I found out my husband gave it to me. Then a couple days later my asthma got worse and I ended up in the ED overnight. They were able to get better management in my Asthma.  I was sick for 3 weeks. Went back to work week four 1/25 Monday and 1/27 they cleared me to get the second dosage of the vaccine. I got the vaccine 3:20 pm and at 5:00 I walked my son in Kung Fu and then waited in my car. I ended up passing out in my car at approx 5:15 pm and my 8 year old son knew something was wrong and had to wake me up.  I could barely drive home I felt very drunk. When I got home my temp spikes to 101.3. I had extreme muscle pain, fatigue, chills, sore throat, chest pain, cough, SOB. My left arm swelled up where I was injected and I couldn?t move my arm. I was told I couldn?t take anything tylonel or Ibuprofen for 8 hours. I suffered. Even when I could take something my body was very painful. This lasted  wed, thurs, and Friday morning.
1/5 @5:15, called out 1/6 due to low grade fever, sore throat, body chills, headache.
Information has been received from a physician concerning a 24-month-old male who on an unspecified date was vaccinated with a dose of varicella virus vaccine (Oka/Merck). Subsequently, approximately one year after being vaccinated with varicella virus vaccine live (Oka/Merck) the patient developed varicella-like lesions on his chest. It is not known how many lesions were present. The lot number was unavailable. The patient sought unspecified medical treatment. The outcome is reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Initial report received from a healthcare professional on 03 SEPTEMBER 2013. A 37-year-old male patient had received IMOGAM (batch number H1290-2, dose number, route and site of administration not reported) and first dose of IMOVAX (batch number H1091-1, route and site of administration not reported) on 03 SEPTEMBER 2013.  The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 02 SEPTEMBER 2013, same day after vaccination, the patient had experienced dry or waxy mouth Complimentary investigation and corrective treatments were not reported. The outcome of the event was unknown. List of document held by sender: none.  Follow up information received from a healthcare professional on 10 OCTOBER 2013. Updates made to patient demographics product details and event ongoing.
fatigue; fever-like aches; fever-like aches; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (received 1st dose on an unknown date, refer case US2021AMR156348).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced fatigue, pain and fever. On an unknown date, the outcome of the fatigue, pain and fever were recovered/resolved.   It was unknown if the reporter considered the fatigue, pain and fever to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient received the 2nd shot of shingles vaccine this year and experienced fatigue and fever-like aches for 24 hours. The patient was better on the next day and reported that it was so much better than getting shingles. No further information reported. For tolerance of 1st dose refer case US2021AMR156348; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156348:Same reporter,1 dose
At site of vacine, left deltoid, had induration, redness, warm to touch, itching, Covered area of upper arm. Saw MD advised cold compresses, Claritin for itching.
Patient experienced body aches, light headed, headache, fever; Patient experienced body aches, light headed, headache, fever,; Patient experienced body aches, light headed, headache, fever,; Patient experienced body aches, light headed, headache, fever,; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced body aches, lightheaded, headache, fever, all on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever and Nausea--Better 9/23/18 AM worked Then occured again and missed work 9/24/18 and better 9/24/18, No problem just wanted to report adverse reaction which didn't happen with first dose.
Narrative: Low grade fever that persisted several days after administration of the second dose of the OCVID vaccination.
center of chest (in between breast) sore and tender to touch.  taking (2) advil 200 mg tablets twice daily
Having serious Hives all over body, since 2nd day of Vaccination, taken Allergy medicine will result temporary relief, but continuously in 12 hours will have hives again.
4/10 pt devel after vax rash like sunburn, started itching. 4/11 joint pain, hands/feet swelling, fever 101, flushed, severe fatigue. 4/12 saw m.d. gave meds.some sx stopped. rash, redness/extreme fatigue 4/18, then SOB, m.d. meas 02=95.
he felt like he had been through hell and back; felt that the left arm was gonna fall off; Fatigue/fatigue in knees and back; fever of 102 F; chills; nausea; This spontaneous case was reported by a health care professional and describes the occurrence of MALAISE (he felt like he had been through hell and back), VACCINATION SITE REACTION (felt that the left arm was gonna fall off), FATIGUE (Fatigue/fatigue in knees and back), PYREXIA (fever of 102 F) and CHILLS (chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (he felt like he had been through hell and back), VACCINATION SITE REACTION (felt that the left arm was gonna fall off), FATIGUE (Fatigue/fatigue in knees and back), PYREXIA (fever of 102 F), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) on 18-Mar-2021 at a dose of 2 dosage form  at 5am. On 18-Mar-2021, PYREXIA (fever of 102 F) outcome was unknown. At the time of the report, MALAISE (he felt like he had been through hell and back), VACCINATION SITE REACTION (felt that the left arm was gonna fall off), FATIGUE (Fatigue/fatigue in knees and back), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 102 (High) 102F.     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.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Reporter information was added.Patient demographics were added.Events were added.
Menstrual spotting; bloody nose; headache; fatigue; This is a spontaneous report received from a non-contactable consumer, the patient. A 34-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number unknown) via an unspecified route of administration in Arm Right on 07Apr2021 15:00 (age at vaccination 34years old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Ehlers Danlos syndrome from an unknown date and unknown if ongoing. Concomitant medication included naltrexone (NALTREXONE) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies. Prior to 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 positive for COVID-19. Timeframe between vaccination and starting of symptoms was reported as 5Hours. On 07Apr2021 20:00, the patient experienced menstrual spotting, bloody nose, headache and fatigue. It was unknown if patient received any treatment for the adverse events. The clinical outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
sweating; Pain in arm; Fever; Chest pain (left side); No bowel movement-watery; Labored breathing; Over sleeping; Passed out; Chills; Dizziness; Headache; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna COVID 19 vaccine and experienced pain in arm, dizziness, major chest pain (left side), pain in shoulder, neck, headache, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat.  The patient's medical history included congestive heart failure, high blood pressure and gout and had 3 heart attacks in lifetime. No relevant concomitant medications were reported.  On 12 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 031A21A) intramuscularly for COVID-19 prophylaxis.  On 12 Mar 2021, the patient experienced headache and dizziness. On 13 Mar 2021, the patient experienced pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, chills, labored breathing, passed out, over sleeping, no urine, sweating, fever and sore throat. Treatment for the event included nitroglycerin and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event dizziness was resolved on 12 Mar 2021. The outcome of the events chills, fever and headache was resolved on 14 Mar 2021. The outcome of the events pain in arm, major chest pain (left side), pain in shoulder, neck, no bowel movement-watery, labored breathing, passed out, over sleeping, no urine, sweating and sore throat was resolved on 15 Mar 2021.; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected loss of consciousness and NS unexpected dizziness, chest pain, dyspnea, gastrointestinal motility disorder, hypersomnia, hyperhidrosis, and expected pain in extremity, pyrexia, chills, headache.  Event onset Day 1 after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Shortly after having received the vaccines, the patient fainted face down in my office and struck her chin and sustained a laceration on her chin which required sutures.
The vaccine was given at about 9:00 a.m. and the patient developed increasingly severe pain starting at about 5:00 p.m. on the same day.  The patient stated that the injection site was higher than usual on her left lateral arm and shoulder area.  She was awakened at 5:00 a.m. on 09/21/2022 with severe left shoulder pain.  She has had ongoing pain and restricted shoulder range of motion since then .  She had tried to continue working in spite of the shoulder pain, but the condition of the shoulder is worsened and she has had to stop working starting in early September of 2023 because of the inability to work with her left hand.  She works as a certified nursing assistant and the vaccine was given as a part of a requirement for her job at the hospital. she was referred to an orthopedic surgeon, MD who recommended surgery for her shoulder. Surgery has not been accomplished because of insurance issues resulting from the workers' compensation insurance refusing to accept the vaccination as the cause of the shoulder injury.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 06-JUN-2013, the patient received improperly stored VARIVAX dose 2, from lot # 0610AE (dose, vaccination site, route, expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
patient received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 030H21B, 032B21A and 003A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
This case was reported by a physician and described the occurrence of headache in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 October 2011 the subject received a dose of FLULAVAL (details unknown). On 13 October 2011, 2 days after vaccination with FLULAVAL, the subject experienced headache and injection site blisters. At the time of reporting the outcome of the events was unspecified. An outcome date of 13 October 2011 was reported. The physician reported 3 subjects who had experienced adverse events following vaccination with FLULAVAL. This is case 1 of 3 (see case IDs A0949933A and A0949934A for details of the other reports).
This case was reported by a consumer and described the occurrence of cytomegalovirus in a 50-year-old male subject who was vaccinated with Influenza vaccine unspecified (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included glaucoma surgery. Historic medical conditions included cytomegalovirus and uveitis. Concurrent medications included Lisinopril, Simvastatin, Glaucoma eye drops (unspecified) and Anti-inflammatory. On 21 October 2013 at 14:00 the subject received a dose of Influenza vaccine unspecified (unknown, left arm). On 22 October 2013, 1 day after vaccination with Influenza vaccine unspecified, the subject experienced "CMV uveitis" and blurred vision. The patient reported the physician confirmed that the subject does not have elevated eye pressure. This case was assessed as medically serious by GSK. At the time of reporting the cytomegalovirus, uveitis and blurred vision were improved.