chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches, headache, runny nose. By 1:00AM on 10/03/2014 severe chills, fever began.  By 3:00AM fever spiked to 103.  Then later in night sweats began.  Continued on and off for most of 10/03/2014.  Fever gradually decreased. Fever finally hit my normal of 97 by 10/04/2014 at 8:00AM.  Headache remained until 10/05/2014.  Rest of symptoms gone. All OK by 10/06/2014. Only medication taken during this time was Tylenol.
No adverse effects; patient received unspecified dose of ROTATEQ that was improperly stored; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-AUG-2019, the patient was vaccinated with improperly stored unspecified number of doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S009940, expiration date 04-OCT-2020, orally (dose was not reported) for prophylaxis. There was no adverse effect reported. On 13-AUG-2019 and 14-AUG-2019, the administered doses of vaccine experienced the temperature excursion of 34.1 degrees Fahrenheit for 4 hours 33 minutes. Previous temperature excursions included 34.7 degrees Fahrenheit for 3 hours 2 minutes. The data logger was involved.
Case number PHEH2014US004936 is an initial spontaneous report received from a nurse on 06 Mar 2014 with a follow up report received from the nurse on 27 Mar 2014. The report refers to 16 year old male patient. His current condition included allergy to 'ASA' and sulfonamide. His vaccination history included vaccination with MENVEO (batch number: not reported) which was well tolerated on an unknown date. It was reported that his vaccination status was up to date. On 06 Mar 2014 at 09:08 am, he was vaccinated with an expired dose of MENVEO (batch number: M11071, expiry date: 30 Dec 2013) intramuscularly at a dose of 0.5 ml into left deltoid. No adverse event was reporting following this administration error. Follow up report receive from the nurse on 07 mar 2014: Updated patient demographics (height and weight), current condition (allergy to sulfonamide and 'ASA'), vaccination history (MENVEO) and vaccination details (expiry date, time, site and dose).
Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced allergy to vaccine, while he/she received vaccine DIPHTHERIA AND TETANUS TOXOIDS. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unspecified date, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site. The patient developed a non-serious Allergies to Tetanus-Diphtheria toxoids Td (Unknown latency) following the administration of DIPHTHERIA AND TETANUS TOXOIDS. (Other relevant tests included No lab data.) Final diagnosis was allergy to vaccine. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of document held by sender: none.
Headache, NauseaVomiting, HYPERtension & Tachycardia Narrative:
12/18 - developed headache and nausea. 12/19 - developed fever and fatigue and cough. 12/20 - temp to 100.7 with cough and some body aches. 12/21 - feels the same as 12/21 but with bad headache and fatigue. She is taking TYLENOL and ibuprofen for the symptoms. She feels she's the same today as she was yesterday. She stayed home from work 12/21. Because of her prolonged symptoms and fever with cough - a COVID-19 PCR nasopharyngeal swab test was performed. This case back as "DETECTED" on 12/21.
Patient admitted to hospital with shortness of breath, diarrhea, cough, and pneumonia due to Covid after vaccination.
Pt was given HPV #1 and soon after fainted, hit his head on a keyboard nearby and then per mom had "seizure" (body shaking) and drooling. Episode < 1 min.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021 at 4:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 4:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 87.45.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
24JUL93 rt arm real sore; 25JUL93 knot under arm & swelling & fever @ site of inject; 26JUL93 swelling spread to underarm;
Information has been received from a health professional concerning a patient who on 1-MAY-2007 was vaccinated with a dose of Recombivax HB (lot number 652882/0106F).  It was reported that the patient received the vaccine accidentally, the child was supposed to have receive Hep A (MSD).  Concomitant therapy also given on 01-MAY-2007 included ActHIB (SANOFI PASTEUR) (lot# UF072AA), DTaP (AVENTIS PASTEUR) (lot# AC14B047AA) and OPV (AVENTIS PASTEUR) (lot # Z0421).  It was reported that the nurse who administered the vaccine thought the child was to get Recombivax HB.  There was no product confusion.  The patient had already completed the Recombivax HB series on 22-MAY-2006.  It was reported that the childs parents have not reported any difficulties since the injection.  No medical attention was sought.  The child's status is unknown.  No product quality complaint was involved.  Follow up information was received.  Other vaccines administered on 01-MAY-2007 were added to the report.  There was no adverse event reported.  No further information is available.
Vaccine gievn 9/9/05 rt deltoid.  Wthin 2-4 hours developed diarrhea, listlissness, chills, sweating, sense of warmth, mild numbenss in rt arm, fatigue and low grade fever.  At 72 hrs redness at injection site,  approx. 3.0cmx3.5cm, no induration.  Other symptoms had faded except for pain at injection site.  Tx with Motrin only.
Mom states infant started having diarrhea, vomiting, fever up to 102 on 4-15-09. Was put in hospital on 6-19-09 for dehydration. Received IV fluids and was released home on 6-22-09. Mom states stool culture was positive for Rotavirus.  8/19/09 MR received for DOS 4/17-18/2009 with Impression:  dehydration. diarrhea. Pt presented with 1 day hx of fever, vomiting and foul smelling, watery diarrhea.  Admitted to tx dehydration due to decreased UO.  Rotavirus found in stool.
Approx 4hrs post vax pt noticed a numbness in lt arm; Tingling, h/a & dizziness immediately followed; Following day feeling okay x/vomiting; Called MD;
Information has been received from a physician concerning a 21 year old female who on 02-APR-2008 was vaccinated IM with the first dose of GARDASIL vaccine (660387/1967U). the physician reported that the patient experienced nausea and vomiting after administration of the first dose of GARDASIL vaccine. The patient sought unspecified medical attention in the physician's office. Subsequently, the patient recovered from her nausea and vomiting. No additional information was provided. Additional information has been requested.
This spontaneous report from an adverse event tweet as received via social media from a consumer refers to a healthy 12 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL (route, lot # and expiration date were not provided). The reporting consumer published the following: healthy 12 year old girl died, on an unknown date, after unspecified HPV vaccine. It was unknown if the patient sought medical attention. It was unknown if autopsy was performed. The cause of death was not provided. The reporting consumer stated her daughter (nor son) would never get this vaccine. Clarification was received that the social media AE documented two different tweets, by two different twitter users, about the same 1 patient, regarding GARDASIL. Additional information is not expected, as there is no consent for followup.
weak, light headiness, hot, pale, almost blacked out, rapid heart rate, itchy throat, dizziness, metal taste. since 2/28 vertigo so bad cannot perform daily activites, cannot walk without assistance.  trouble swallowing, difficulty breathing, received inhaler from dr . high blood pressure, fast heart rate.. daily basis all day
Given PNEUMOVAX right shoulder 7/24/17. Increasing right shoulder pain times past 3 days.  Pain is now intense and patient is unable to move her right arm. She has difficulty getting dressed and is unable to drive. Right shoulder is very warm to the touch. There are red raised blotches around the injection site. The injection site itself is not visible. The right deltoid/shoulder is diffusely swollen and extremely tender. Patient to take Ibuprofen, Hydrocodone as needed, Zyrtec, and apply ice to the area.
Member noted differ. non-erythematous edema in area of right triceps and elbow.
Dizziness, near fainting, clammy skin, pale color was given something to eat and drink by doctor and rested in office for 15 minutes until she felt better.
Onn 2/17/22 patient was administered covid vaccine that had expired on 2/12/22.
Went to the ED 8/12/21.  Blood clot left leg.  Baby aspirin, NSAIDS
Abdominal pain and low grade fever a week after vaccine and then resolved Saw PCP a week later for regular follow up WBC noted to be slightly high, and so ordered CT Abdomen and Pelvis, and this showed Mesenteriv Vein Thrombosis. Admitted to Hospital Seen by Hematologist Treated with Anticoagulation with SQ Lovenox initially. Started Thrombophilia work up which was still pending at the time of discharge Discharged home on 4/16 on PO Eliquis and to follow up with Hematologist in 2 weeks
M-M-R II for "Was not in my system"; I got blood work done in April 2019 and it's now again showing low levels of measles, mumps, rubella; my blood work showed low levels for the measles, mumps, rubella; This spontaneous report was received from a 52 year old female patient. There were not concurrent conditions, medical history and concomitant therapies.  On an unknown date "as a child", the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route, vaccination site, lot#, expiration date and indication were not reported).  Then in 2011, the patient's underwent an unspecified blood work that showed low levels for the measles, mumps, rubella (antibody test abnormal), so the patient received a second vaccination with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route, vaccination site, lot#, and expiration date were not reported), for "was not in the patient's system".  In April 2019, the patient underwent another unspecified blood work and it was now again showing low levels of measles, mumps, rubella (antibody test abnormal).  At the time of reporting, the patient had not recovered from both antibody test abnormal. The reporter did not provide a causality assessment between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and the events.
2 1/2 in " by 4" (R) arm below redness pain induration. Bandaid Tdap fever 102 degrees.
This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of VAQTA (dose: 0.5 ml, intramuscularly, lot # 672226/1441AA) which expired on 09-AUG-2014. No adverse effects reported. Additional information has been requested.
10 days after the first dose of the vaccine I developed hives and a rash over my entire back arms and legs and ears. I also had sever itching.   I began a twice daily dose of Zyrtec and a regular dose of Benadryl. I continued the Treatment for 3 days.
inflammation of the heart; heart rate way above normal; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program . A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration in May2021 (Age at vaccination: 15 years) as dose 2, single for covid-19 immunisation. Medical history included epilepsy from when he was about 17 months, autism spectrum when he was four years old. Reported that  he was on high end of the autism spectrum; he has had that diagnosis for a long time, since he was four years old. She was babysitting him at 17 months old and he had a status seizure and then they found it was caused epilepsy. caller mentions patient has been on several different ones and had reactions; his doctor would know it; she has no product or information to provide name of product; no NDC, no lot, no expiration date. The patient experienced inflammation of the heart in May2021, heart rate way above normal in May2021. She let her grandson wear her her watch. It showed his heartbeat was way out of normal. He was seen in the ER and diagnosed with inflammation of the heart, that corrected itself he went home. she doesn't think they treated him and doesn't know which hospital emergency room it was. The patient underwent lab tests and procedures which included heart rate: heart rate way above normal in May2021 heart rate way above normal. The outcome of the events was recovered in 2021.  Follow-up activities closed. Batch/lot number not available.
Body Aches, DA, Chills , Mild Fever,  tired and some vertigo
This spontaneous report ass received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 23-MAR-2013, the patient was administered simultaneously a dose of PROQUAD (Merck) (lot number L046507 and expiration date 17-MAY-2017, dose and route of administration were not reported) and VARIVAX (Merck) (dose, route of administration, lot number and expiration dare were not reported). No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
On the day after vaccination, patient has a raised, blotchy rash extensively on the back that is quite itchy with slight burning pain sensation. Patient came into pharmacy two days post vaccination will rash still present.
Severe whole body rash, not itchy; Left armpit pain; Booster; Other vaccine same date vaccine date 22Nov2021; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 08:30 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 22Nov2021; CLARITIN ALLERGIC; BENADRYL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03May2021, when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Leg Left, Vaccine Administration Time: 12:00 PM), administration date: 12Apr2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 08:30, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (non-serious) with onset 22Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 22Nov2021"; RASH (non-serious) with onset 23Nov2021 06:00, outcome "not recovered", described as "Severe whole body rash, not itchy"; AXILLARY PAIN (non-serious) with onset 23Nov2021 06:00, outcome "not recovered", described as "Left armpit pain". Therapeutic measures were taken as a result of rash, axillary pain.  Additional Information: The patient received prior vaccination within 4 weeks. Patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Treatment received for adverse events was reported as Claritin and Benadryl.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Date & Time started: 3/09/2021 2300 Itchy 3/09/2021 2300 dizzy 3/10/2021 0100 headache 3/10/2021 0100 eye pain 3/10/2021 0130 Fast heartbeat 3/10/2021 0130 Difficulty breathing; Shallow breathing 3/10/2021 0130 Severe Chest pain pulsing to left arm   3/10/2021 0130 Tremors 3/10/2021 0130 weakness 3/10/2021 0130 blurred vision right eye 3/10/2021 0130 joint and muscle pain whole body 3/10/2021 0130 cramping 3/10/2021 0130 nausea all continued through the 10th; Dizziness, headache, eye pain, tremors, weakness, blurred vision right eye, joint pain, and nausea continued through the 11th but got better by the evening. Weakness and blurred vision still present on the 12th.
Pt states arm is swollen where shingles shot given. Area raw and warm to touch.
Initial rxn: pain at site of rxn after approximately 15 minutes. Severe itching and large know at injection site that lasted approximately 2 weeks. During the third week patient started experiencing pain and weakness radiating in waves down arm and arm pit.
High fever and loss of appetite for +/- 72 hours. Vomited once at onset of fever. Small red dots on face during fever. After fever subsided measles type rash appeared on lower back accompanied with diarrhea every bowel movement inflaming skin on contact. Appears to have some ear discomfort. Symptoms ongoing as of 06/13.
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 recommended and/or prescribed the ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 01-MAR-2014, the patient was treated by a healthcare provider 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 his 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 (dates unknown), 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. Additional information has been requested.
Immediately following second dose of Lymerix, she experienced arthritis. On 8/17/99, at physician visit, she complained of a one month history of muscle aches, joint aches, etc. She also had a superimposed viral infection with some nausea and upset stomach, starting 8/16/99. Assessment: arthralgia (multiple sites). Dr stated it was possible the pt could have some sort of serum sickness response to the Lyme titer and a rheumatologic exam will be pursued. 9/2/99 Rheumatology consult: She has been treated by a chiropractor for many years due to pain in neck and chest caused by an automobile accident, with improvement. However, more recently, she has developed increasing symptoms of pain and stiffness in her neck, difficulty moving her neck and she awakens with pain and also has paresthesias in both arms. She has a lot of spasms in her neck and also her low back. In the mornings upon waking, she has a difficulty walking down stairs. Dx: arthralgia multiple sites, low back pain, neck pain. Rheumatologist stated that complaints of arthralgias appeared to be temporarily related to Lymerix. Another Dr visit assessment is that she is improving and treated her with Elavil and Doxycycline. The most recent information, received on 11/18/99, reports the condition of the pt is improving.
I had almost identical problems even after the first injection which lasted 2 1/2 days that time. This time, the second dose, affects were even worse. Injection site was sore almost immediately and started to get muscle pain in back of neck,gradually started aching with headache over time. About 8hrs after injection temperature started,my normal temp is 97-97.6 it went up as high as 102.8 & stayed above 99.4  for approximately 36hrs. Also had swelling of left side of face,left had noticeable swelling under it. At same time aches & pain got worse including chills & sweating which made sleeping impossible. Took aspirin to break fever which didn?t come down till 2 days after shot. By third day was still achy and extremely rundown. Will absolutely NOT go through this ever again:especially with the Moderna vaccine!