chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On October 2, 2009 a technician at a Medical Group gave me a shingles shot (Merck's ZOSTAVAX NDC 0006-4963-00) that had been ordered by pharmacy on 9/24/00. I imagine you would call my reaction in October normal: warm arm and a little coughing. In mid  February I developed a cough that went on to wheezing and what felt like "stopped up, full ear" in my left ear. I visited my family doctor, three times over about six weeks. she told me  I had fluid in my ears and prescribed over the counter drugs MUCINEX DM, CLARITIN D, as well finally a course of a five day Z Pas although she suspected a virus since nothing was helping me. On April 12, 2010 I visited Dr. after a check up of my chest and series of hearing tests, doctor told me I had asthma and also that a virus had struck the nerves in the Eustachian tube of my left ear causing substantial hearing loss. Dr. ordered an MRI and put me on prednisone to see if it would relieve or diminish my hearing loss and asked me to return in three weeks' time. On Monday, May 3, 2010 I returned to doctor's office to undergo a second set of hearing tests and to learn the results of my MRI. Dr. told me that prednisone had not improved the hearing in my left ear and that it has experienced a permanent 50% hearing loss. I told Dr. that I had read on the web that a possible cause of "ear fullness" hearing loss is the reaction of chickenpox virus, explaining to him that because I was covered from head to foot and down my throat chickenpox when I was eleven years old (1952). I had though it wise to have a shingles shot. I asked Dr. if I should report my hearing loss to the pharmaceutical company . He replied that it was doubtful that a direct correlation could be proven but if I wanted to report it to do so. Hopefully information will be helpful to Merck's research scientist - After my first inhalation of ADVAIR, my coughing and wheezing stopped and after taking ADVAIR for its full course, one week. I have not had to take anymore.
A red itchy rash on upper chest and approximately 30 min of wheezing. Pt. used BENADRYL - 2 doses and did not have to have any other doses (within 2 hrs of onset of Sx.).
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient experienced non-serious events tired with RINVOQ(UPADACITINIB).  The patient reported that she was very tired for two to three days after her Covid injection.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event(s) of tired with RINVOQ(UPADACITINIB) was no reasonable possibility.  No treatment medications information were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient receiving Hepatitis A (adult dose) and by age Hepatitis B (ped/adolescent dose) for 12 month Post Stem Cell revaccination and travel. Nurse administered HBV (adult dose). Patient will not be 20 yrs of age until 8/21/2018.
Cardiac dysrhythmia. Paxoxsymal A-fib, atrial tachycardia.
Received her initial COVID vaccine and she ended up developing COVID after that; Received her initial COVID vaccine and she ended up developing COVID after that; This is a spontaneous report from a contactable consumer.   A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: EW0191; Expiration Date: 01Sep2021) as DOSE 1, SINGLE (at the age of 63 years) for covid-19 immunisation.  The patient medical history included hypertension. Concomitant medication included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported.  The patient received her initial COVID vaccine and she ended up developing COVID after that (medically significant) on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957591 similar report from same reporter, second dose
noticed a single hive on right arm an hour after injection but mistook for bug bite. around 11pm realized entire right forearm had broken out in hives. experiencing itchiness on right side of body. notable since the injection was received in left arm. there is a possibility this outbreak is related to another allergy and not the vaccine but I am unsure.
approx 3hrs p/vax pt began to shake intermittently for 20mins;some shaking was generalized w/grimacing, whining, eyes closed & LOC;the majority of the shaking was the rt leg only temp was 101.4;
beginning around 9:30 pm on the date of the vaccine I began having severe chills,  this lasted until around 2am on 6/3/21. beginning on the morning of 6/3/21 I experienced fatigue to the degree that I became SOB after taking a shower and returned to bed.  of the next 24 hours I spent all but 5 hours sleeping due to extreme fatigue.  (this is completely out of norm/character for me).  The fatigue improved enough for me to stay awake more than a couple of hours at a time by 6/4, but I continued to experience fatigue and SOB with moderate exertion through 6/6/21.
Severe fever (104°), chills,  nausea, joint pain, ringing in left ear
pt had an earlier hosp admission 1 wk before this hospitalization, dx with pneumonia and COPD exacerbation, was dc'd to home; 1/13/22 back to ED with c/o worsening SOB especially with exertion; sore throat, non-productive cough, states O2 sats at home in the 80s; found to be positive for COVID; treated with ABX, steroids, O2 supplementation; pt's status worsened; transferred to ICU; AKI; increase in O2 needs; placed on BiPAP; family made pt DNR/DNI; pt expired in the hospital
had a very bad flu; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who had a very bad flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination. Information on batch number cannot be requested.  On an unknown date the patient developed a non-serious event "had a very bad flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE . It was reported "The last 25 years I got flu shot only once. I had a very bad flu that year. Never before and never after. So no more flu shot for me."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (had a very bad flu).  At time of reporting, the outcome was Unknown for the event had a very bad flu.
FOOT EXOSTOSIS; ACHILLES TENDONITIS; This spontaneous report received from a consumer via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported.  On an unspecified date, the patient experienced foot exostosis, and achilles tendonitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from foot exostosis, and achilles tendonitis. This report was non-serious.
Fever - 100.4; body aches; mild headache and fatigue. And then about midweek, I was starting to walk downstairs at work and I had to grab onto rails so I wouldn't fall - had become so dizzy. I tried to get into my regular doctor -  he was full until April 5. I went into walk-in clinic - I  had to grab onto a board there (dizzy) and they told me to get to ER. My heart was rapid heart beat by time I got to ER. They had to give me wheelchair so I wouldn't fall over to go into the ER room. Horrible bruising on wrist - because the first IV didn't take. They gave me a bag of fluids - and gave me Meclizine to help dizziness subside and two Tylenols for headache. I'm taking 3  (per day)- 25 mg chewable HCI Meclizine. If symptoms aren't as bad I just take a half of one. Still needing the medication because I still have the pressure in the ear comes up and I need to take the Meclizine and Benadryl to get the pressure to go down.
pt recv vax & had episodes of becoming pale & staring;no sz activity was noted;pt recovered w/in 24hr;
Patient reports fever of 100.5 F and Chills. Patient reports aches and flu like symptoms. Patient reports 5-6 bouts of light diarrhea.
had the shot and then had shingles/ suspected vaccination failure; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows; The age at vaccination was not reported. The reporter stated that, the patient had shot and then had shingles three after. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Extreme fatigue for 7 days; Lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 03May2021 at 09:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history reported that the patient's colon removed due to ulcerated colitis in 1992. The patient had known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and loperamide (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 08Apr2021 at 09:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 18:00, the patient experienced extreme fatigue for 7 days and lightheadedness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as results of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue for 7 days and lightheadedness was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
local cellulitis @ lt thigh immun site; immun given 18JAN94 hospitalized 27JAN for 3x4cm induration irritability rx w/Nafcillin/Cefotaxime;
A non-serious, spontaneous report of fever of 102 F has been received from a mother concerning her eight-year-old daughter subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 22-Sep-2009. On the evening of 26-Sep-2009, the patient started running fever of 102 degrees Fahrenheit. The outcome of the adverse event was not reported.
Patient was hospitalized due to breakthrough COVID-19 infection. Patient received 2nd dose of vaccine on 08/21/2021. Patient was hospitalized from 12/21/21 to 12/23/21. Below is copied from discharge summary:   Hospital Course:  Patient is a 26 y/o F with Hx of sickle cell anemia and HTN who presents with back pain today, found meeting sepsis criteria with likely viral illness as source vs other and with elevated ret countconsistent with sickle cell crisis.   Sepsis with acute organ dysfunction likely 2/2 COVID -Meeting sepsis on admit based on fever, tachycardia and suspected source of infection -LA of 2 -> 0.7 -BCx2 NGTD -UA WNL -Chest Xray clear -Resp panel with COVID   Acute sickle cell crisis/ Sickle cell anemia/ Acute on chronic back pain on chronic opioids: -Hgb stable at 9gr    HTN: -Controlled -Resume home meds   GERD: -Resume ppi   Marijuana use: -Would benefit from cessation   Patient is discharged in stable condition with stable vital signs. All questions rearding hospital course and plan of care after discharge have been answered to satisfaction. Prescriptions for medications needed to be taken after discharge have been given to patient. Patient has been instructed to follow up with PCP MD within the next 7 days after discharge. Patient verbalizes understanding all given instructions and has no further doubts regarding discharge.
9 hours after injection symptoms began with:  Fever 101.1 Chills  Headache Extreme body and joint pain Took Tylenol, pushed fluids to prevent dehydration, and rested  for 24 hours
Patient exhibited syncope immediately after immunization. Patient moved to supine position. Patient remained in pharmacy for addl 15 min for observation & provided orange juice. Patient left independently & reported no addl symptoms
Pt presented to clinic Moderna vaccine administered at around 11:55 AM; pt. stated no prior history of issues receiving vaccines. At around 12:03 PM pt. felt severely nauseous/lightheaded and attempted to stand and tell staff but immediately fainted, falling to the ground and hitting the front right side of his face on the ground. Pt. was unconscious for about 30-45 seconds. Pt. regained consciousness and able to verbalize name, DOB, location, etc. Vitals at the time taken include: BP 136/73 mmHg, O2 sat 94%, & HR 51 bpm. Called 911 and EMS arrived within about 5 mins. EMS arrived by 12:11 PM, vitals taken O2 Sat 100% & HR 68 bpm. Pt. refused transport to ED and insisted on driving himself home. Left on his own by 12:15 PM after being escorted by EMS to his car.
immun given on 11APR94; on that evening the pt had startle spells, w/stiffening of the body & irritability; episodes arms & legs staring; adm 14APR94 abn EEG; dx infantile spasms;
Numbness to R arm with swelling of fingers to R hand. Pain (severe) at injection site.
In for routine physical. Was given three vaccinations. ADACEL, MENACTRA, and VARIVAX which caused a reaction-per parents.
pt recvd vax;systemic lupus erythematous,pos ANA;by 1990 Raynaud's phenomenon lt hand;1991 pneumonia w/pleurisy;hair loss;liver func abnl;MRI,EEG diffusely abnl;leukocytosis;vasculopathy;dx encephalomyelitis;no vision rt eye;thrombocytosis
Moderna covid-19 monovalent booster administered after 9/2/22.  On 9/13/22 monovalent booster administered, no adverse reactions noted, informed pt and counseled on 10/25/22.
Pt's RA has rash in the shape of a square around the inject site. No complaints of pain or itching. The rash is red and raised.
1 wk following immun onset of fever 101 & chills lasted 4-5 days, eyes red & swollen; Seen by MD on 3JUL pt broke out in welt like areas on his face, neck, front of legs, & shoulders; Began to subside on 9JUL;
Never experienced anything like this, this was extremely painful and the worst being limitation of arm movement; Never experienced anything like this, this was extremely painful and the worst being limitation of arm movement; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiration date were unknown), via an unspecified route of administration in the arm on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received influenza vaccine years ago for immunization and would have a little fever and soreness. It was reported that the patient had all the vaccines for years and never experienced anything like this, this was extremely painful and the worst being limitation of arm movement.  Today had 95% range of motion, yesterday 85 % range of motion. The outcome of the events was unknown. The patient asked what the carrier for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was. The physician also asked how long was the average for arm limitation.  Information on lot/batch number has been requested.
This spontaneous report was received from a pharmacist refers to a 61 year old patient of an unknown gender. Concurrent conditions medical history and allergies were not reported. On 31-MAR-2015, the patient was vaccinated with a single dose of PNEUMOVAX 23, 0.5 ml, intramuscular, (lot # K005957, expiration date: 08-MAR-2015), inadvertently which had expired. No adverse effects were reported. Additional information has been requested.
OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Patient was given a second dose of flu vaccine for this season.   On 9/27/23 he was given flumist by his Pediatrician.  On 10/17/23 he was given an injectable flu vaccine.  Mom states that she notified the school teacher of his earlier vaccine and asked that the child's consent be pulled.  This info was not forwarded to public health  and child was  vaccinated during a school flu clinic.  Mom called Pediatrician yesterday who recommended she call Poison Control.  Mom was assured that child would be okay.  Today child is in school and  is doing well per the school nurse.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In January of 2010, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-JUN-2016, the patient was treated by a physician at a skin and cancer clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster with complications. The patient has been prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a nurse regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VARIVAX (lot # M023383, expiration date 11-MAY-2018, lot # M024681, expiration date 18-MAY-2018, lot # L043620 expiration date 02-FEB-2017, lot # M009766, expiration date 23-FEB-2018 and lot # M000756, expiration date 06-JAN-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 29 Fahrenheit for 2 hours and had previous temperature excursion of 1.5 degrees for 2 hours 50 minutes on 20-JUL-2016. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient about 20 years of age. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, lot number and expiry date were not reported). Immediately after receiving GARDASIL, the patient experienced seizure. The therapy with GARDASIL was discontinued and not reintroduced. On unknown date, the patient recovered. The relatedness between seizure and GARDASIL was not reported. Additional information has been requested.