chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an 82 year old female patient with thyroid disorder, high blood pressure and penicillin allergy (anaphylactic shock) refers to herself. On 06-JUN-2012 the patient was vaccinated with ZOSTAVAX (route and dosage was unknown). Concomitant therapies included unspecified thyroid medication, hydrochlorothiazide (manufacturer unknown) and losartan potassium (manufacturer unknown). The patient reported that in October 2013 she was diagnosed with shingles after receiving ZOSTAVAX. The patient saw her physician to seek medical attention. No lab diagnostics studies were performed. The patient also reported that she was taking 1 gram/day of Valacyclovir which was causing her to have bad constipation. At the time of the report, the outcome of shingles was reproted as not recovered. The outcome of bad constipation was unknown. Additional information is not expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 21-JAN-2014, the patient was inoculated with ZOSTAVAX 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 14-AUG-2015, the patient was treated at a physician's office for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. 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. Additional information has been requested.
I was pretty nauseous; pretty bad headache, I would say migraine level; pretty bad headache, I would say migraine level; This is a spontaneous report from a contactable consumer reporting on himself. A 15-years-old male patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection) via an unspecified route of administration, administered in Arm Left on 19Jun2021 10:00 (Batch/Lot Number: EW0217; Expiration Date: 30Sep2021) as single dose (at age of 15-years old) for covid-19 immunization. Medical history included Allergy to penicillin (10 years ago). The patient previously received first dose of bnt162b2, solution for injection administered on 29May2021 sometime around the morning in left arm (Lot Number: EW0180 and Expiration Date: 31Aug2021) for COVID-19 immunization. There were no concomitant medications. No additional vaccines administered on same date of the Pfizer Suspect. No relevant tests done. No prior vaccinations (within 4 weeks). It was reported that, on 19Jun2021 around 06:00, migraine which began at first on the day he received the second dose of the covid vaccine, an hour or so later. Then it came back again today. Until about 10:00 it was the same, then it got better and on the same day the patient experienced pretty bad headache. On 22Jun2021 06:45, about 45 minutes afterwards he was pretty nauseous, it got a little bit worse between 8:00 and 10:00, but currently he was better. Caller's mother was also on the line. She asked, what stage should we got the doctor and wanted to know how long the side effects might last and when they should be concerned. The patient did not visit to emergency room or physician office due to adverse events. The outcome for event headache was not recovered, for nausea and migraine it was recovering. No PQC was involved.   Information on the lot/batch was available, Additional information has been requested.
local rxn to tetanus inj, 2" x 4" red swollen area to lt deltoid;tx instructed on ice locally, Ibuprofen as needed;local rxn to tetanus inj;
Information has been received from a physician's assistant concerning an 9 week old male infant with no drug reactions or allergies and a history of "premature (born at 34 weeks)" who on 17-JAN-2011 was vaccinated with a first dose of ROTATEQ orally (lot # 668967/1201Z). Concomitant therapy included: a dose of PENTACEL and a dose of PREVNAR. on 20-JAN-2011 the patient experienced bloody diarrhea. The child tested negative for rotavirus but positive for C. difficile toxin. Complete blood cell count (CBC), "OMP" were also performed, although, the results were not provided. The patient was treated with metronidazole. On 11-FEB-2011, the patient had recovered. The patient sought unspecified medical attention. Upon internal review, bloody diarrhea was determined to be an other important medical event. Additional information has been requested.
Swelling occurred under left arm and torso roughly 24 hours after injection. Swelling was roughly 4 inches across and 2 inches tall. Treated with repeated icing and high dose ibuprofen. Swelling stopped growing. Over the course of the next 10 days swelling has subsided to near normal.
pt recvd vax 13JAN93 & 22JAN93 exp flu-like sx consisting of lethargy, h/a, body aches, fever & cold sx; sx were worse @ noc; pt was treated w/Motrin;
Intense pain at ~24hrs post injection which lasted ~18hrs. Pain radiated down to lower arm..could not lift arm at all.
This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates since 01-SEP-2015, the patients were vaccinated with doses of VARIVAX (lot# K010338 and expiration date 22-JUL-2016, lot# K005428 and expiration date 15-APR-2016, lot# L010235 and expiration date 07-APR-2017, lot# L002868 and expiration date 27-JAN-2017 (dose and route were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Was hospitalized on  April 14th with severe pain radiating from the back to the front and groin.  No diagnosis was made. Was released on April 15 with Lidocaine Patch,  Flexeril and APAP#3. Pain persisted and I went to the local doctor. There were no visible sores yet but she agreed with the diagnosis of Shingles. She prescribed Percocet, Gabapentin and Valtrex. The pain and burning are still present and unbearable at times. No sores yet. (4/17)
Patient states he received FLUMIST on 10/25/18 during his workday. On 11/5/18 he noticed numbness and tingling in his left index finger. Intensity increased on 11/8/18 and 11/9/18. Two years prior on 10/25/16, he had the same reaction when he received FLUBLOK.
new parasthesias/tingling; new numbness; Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine; Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine; exercise intolerance; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 37-year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: SINUS BRADYCARDIA (non-serious), SINUS TACHYCARDIA (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "Fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine"; EXERCISE TOLERANCE DECREASED (non-serious) with onset Mar2021, outcome "not recovered", described as "exercise intolerance"; PARAESTHESIA (non-serious) with onset May2021, outcome "not recovered", described as "new parasthesias/tingling"; HYPOAESTHESIA (non-serious) with onset May2021, outcome "not recovered", described as "new numbness". The events "fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine", "fluctuating sinus bradycardia to tachycardia (45-190) for 4 months starting immediately after vaccine", "exercise intolerance", "new parasthesias/tingling" and "new numbness" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of sinus bradycardia, sinus tachycardia, exercise tolerance decreased, paraesthesia, hypoaesthesia. Additional information: Patient did not have known allergies. Patient did not have other vaccine in four weeks. Patient did not have COVID-19 prior vaccination. It was unknown if patient had COVID-19 tested post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Fever, dizzy, sore throat, fatigue, minor rash, sore at injection site, muscle aches especially in legs, headache
Arm swollen entire bicep area and under the arm; Warm and feverish; This is a spontaneous report from a contactable pharmacist.  A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA6780; Expiration Date: 30Sep2021), via an unspecified route of administration, administered in Deltoid Left on 18Jul2021 14:00 as DOSE 2, 0.3 ML SINGLE (age at vaccination was 45 years old) for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing hypertension, ongoing seizures and overweight ongoing. Concomitant medication(s) included zonisamide (ZONEGRAN) and levetiracetam (KEPPRA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196; Expiration Date: 30Sep2021), via an unspecified route of administration, administered in Deltoid Left on 27Jun2021 18:00 as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. On 19Jul2021, the patient had arm swollen entire bicep area and under the arm and was warm and feverish. It was reported that the patient took the vaccination as patient was overweight, had elderly parents, seeing more Delta variant. Patient had not filled this prescription for a while, so was unsure if she was still on levetiracetam. When reporter looked up vaccine information, she said that patient got the second shot 2 days ago and not a week ago (as stated by the patient). The patient did not have any other shots the same day or within 4 weeks of the Covid vaccine. Patient did not list any prior vaccine reactions or family history on the questionnaire. The outcome of both the events was recovering.  Follow-up attempts are completed. No further information is expected.
Patient received one vaccination of H1N1 on 11/09/2009 and a second on 12/02/2009.
upset stomach off and on for 3 weeks. upset stomach will feel like knots so it gets uncomfortable. occurs after eating. I was able to rule out foods to see if it was that but it continues.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unspecified date, the patient was vaccinated with RECOMBIVAX HB injection, (dosage, lot number not provided) 3 doses series, when he was a child. On an unspecified date, the antibody titer drawn showed that he failed to seroconvert. The patient was administered with one booster dose of RECOMBIVAX HB about 6 months ago and the reporting pharmacist had questioned if the series of RECOMBIVAX HB can continue. The outcome of the event was unknown. No product quality complaint was involved. The reporter had considered the event to be not related to RECOMBIVAX HB. Additional information has been requested.
Rash beginning on bilateral arms. On and off x 1 wk. Rash down bilateral legs and cont. on arms x 3-4 days. Began with rash to face and neck 6-8-09 comes and goes. Rash seized yesterday began again today.  7/24/09 ER records received DOS 6/3/09 and 6/22/09. Assessment: Hives/Urticaria. Hypokalemia, bulemia. Patient presents on 6/3/09 with an itchy urticarial rash on arms, legs and trunk, of one month duration. On 6/22/09 c/o syncope X2, feels weak, falling. Lightheadedness, trouble with vision. Collapsed.
Hoarseness, severe coughing - severe itching of throat. Severe draining of mucus in back of throat like water running. Tickle itching moving from tonsil to tonsil - severe cough when eating. Could not eat at times. Could not sleep for coughing.
some fluid in her nostrils; headaches form sinus areas; dry cough; sore throat and congestion in my sinuses.; sore throat and congestion in my sinuses.; fatigue; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201; Expiration Date: Jun2021), via an unspecified route of administration, administered in Left Deltoid on 22Feb2021 11:45 (at the age of 86 year old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were reported as none. Patient has no reported family history. She has the flu shot every year and has never had a reaction. On 22Feb2021, patient got her first shot, she stated that she did not had any soreness on her arm but five days after, on 27Feb2021, she woke up with a very bad sore throat and fatigue. Eventually the soreness in the throat was completely gone after 5 days, but then she got headaches from sinus areas; in the area over ears and her doctor suggested to put saline solution up her nose. When she used it, by Thursday, 04Mar2021, it began to make a difference in feeling that her sinuses were clogged up and she doesn't have issues now. At the time of report, it was reported that, she is feeling much better and only thing left was she still feels tired and has a dry cough; her cough was like some fluid in her nostrils, that she had to swallow but it is more of like, clearing the throat cough. Her second shot was scheduled on 15Mar2021, she still have a little dry cough, so she want to make sure that she is okay to get the second shot. She is a little concerned about second vaccine. Therapeutic measures in response to the event included saline solution. The outcome of the events sore throat and congestion in my sinuses, headaches from sinus areas was recovered on 04Mar2021 and of other events was recovering.  No follow-up attempts are possible. No further information is expected.
on the same evening of receiving vax pt devel h/a, chills, aching, nausea; h/a cont for next 2-3 dasy; also devel sinusitis & bronchitis tx ATB x 3 wks; c/o chills, diaphoresis, flushing 2-3xday; states has no energy; MD states poss virus;
Extreme and sudden dizziness/vertigo about four hours after injection. Symptoms lasted about three hours but became less severe with rest.
Patient was seen in the office for Vaccine administration on 5/21/07. He received 6 vaccines: Dtap, IPV, and Hep A were injected in the  left anterolateral and upper thigh. Prevnar, Hep A and Proquad were given in the right anterolateral and upper thigh. Father presented with the patient in the office today and states he was notified by patients babysitter today that the patient was having difficulty holding his bottle, that his hands would become very cold then 10-15 minutes later warm again and that the patients fingers had become "twisted" earlier and that the patient shook at one point today. Mom then came into the office and when asked if she had given Tylenol or Motrin prophylacticly on the day of the injections as she had been instructed by the nurse, she said no and today was the first treatment of Childrens Motrin since the vaccination date. She had given him 1.8ml at 7:30am today. There was no redness, swelling or erythema at any of the injection sites upon assessment today. Patients temperature in the office today was 102.8. Mother was advised to take patient to urgent care for proper evaluation.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown age and gender. Approximately on an unknown date in May 2013 (reported as throughout May and June), an unspecified number of patients were vaccinated with an unspecified number of unsupported doses of GARDASIL (lot number and expiry date reported as H016238 and 11-APR-2015 respectively, dose and route unspecified) which was exposed to as low as minus 1 degrees Celsius (C) for approximately 13 hours. No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
High fever - over 104 degrees, vomiting, chills, weakness, severe rash bottom half of right leg (& foot) with fever & swelling there. Went to doctor twice. Second time penicillin prescribed.
Two weeks later developed mental health issues and has never been sick a day in her life; This is a spontaneous report from a Pfizer group. A contactable consumer (patient was reporter's sister in law) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Two weeks after 1st vaccine in Mar2021, patient developed mental health issues and has never been sick a day in her life with outcome of unknown. All tests are normal. She has now been in the hospital 5 weeks and reporter was having to look for memory care living for patient. The outcome of event was unknown.  lot/batch number has been requested in follow-up.
received the first shot /January 2020 /not received their second shot yet.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not applicable for this report. The reporter declined to provide any demographic information. Till the time of report the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case has been linked with US2021101406 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021101406:Husband´s case
5/6/2021 admitted for for worsening dyspnea, cough and chest heaviness; discharged home on 5/11/2021.
First does was on 7-22-21, in the evening, the injection site feels tender with a small bump. On 7-23-21 left arm is very tender with a larger bump.   Very uncomfortable.
Pain LUE within one hour within 48 Hrs LUE into shoulder painful with limited motion into (L) shoulder. Slight improvement over one month-motion still limited motion, pain, lack of ability to sleep.
On 4/16/2021 2 days after taking the 1st Moderna shot the client experienced peripheral vision problems- lights flashing in both eyes, as she was trying to test the words became scrambled and she could not read what she was texting.  It lasted about 2 minutes and then her vision cleared. However, she had a headache in her left eye only that was a deep ache that started around eh corner of her left eye to the top of the arch of her eyebrow. She continue to have the deep ache in her left eye only. Then on 4/25/2021 she went to reach for a glass with her right hand and her right arm would not move. Per client as quick as it happened, it felt like a grip was on her arm and she could feel it going down her arm to to her leg and foot.  Then her lips and face also became numb on the right side only.  She called her husband for help and when he helped stand her up her whole right side was paralyzed.  He gave her an aspirin and called emergency and by the time the ambulance arrived she started to gain feeling in her right side. BP was elevated and she has not history of HTN. She was hospitalized for a day and a half and diagnosed with a TIA. Currently continues to be followed by a cardiologist and continues to have weakness on the right side.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. Additional information has been requested.
Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.; Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.; Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Apr2021 11:45 (Lot number: ER8734) at the age of 47 years as dose 2, single and intramuscular, administered in arm left, administration date 19Mar2021 11:30 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto''s thyroiditis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "acetabular labral tears" (unspecified if ongoing); "uterine fibroids" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "ovarian cyst" (unspecified if ongoing); "exercise-induced reactive airway" (unspecified if ongoing); "hx of MVA/concussion" (unspecified if ongoing), notes: Other medical history: hx of MVA/concussion; "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN; "IV CT contrast" (unspecified if ongoing), notes: Known allergies: IV CT contrast; "Latex" (unspecified if ongoing), notes: Known allergies: Latex; "Adhesives" (unspecified if ongoing), notes: Known allergies: Adhesives; "Cocoa butter" (unspecified if ongoing), notes: Known allergies: Cocoa butter. Concomitant medication(s) included: SYNTHROID; FAMOTIDINE; FISH OIL; VITAMIN D3. Past drug history included: Sporanox, reaction(s): "Known allergies"; Celebrex, reaction(s): "Known allergies"; Macrobid, reaction(s): "Known allergies".  The following information was reported: AXILLARY PAIN (non-serious), PAIN (non-serious), CONTUSION (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Left armpit and left side pain, feels like a bruise, comes and goes. At first I thought it'd go away after a few days, as it went away after my 1nd and 2nd doses.". Therapeutic measures were not taken as a result of axillary pain, pain, contusion.  Additional information: The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No covid prior vaccination. Not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Amorphous prurigenous erythema approximately 4 X 2 inches on injection site  which appear 8 days after  Moderna?s vaccine administration