chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd March 2020, the patient received Shingles vaccine. On 23rd March 2020, 1 hr after receiving Shingles vaccine, the patient experienced fever. On 23rd March 2020, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient had slight fever.
I woke up on 1/23/21 @ 3:30 a.m. with aches, chills, and low-grade fever, which I was told to expect.  I went back to sleep and slept much of the morning, afternoon, and evening of 1/23/21.  I alternated Tylenol and Advil in 3-hour intervals.  However, as the day wore on, my fever started going up, at one point reaching 107 degrees  (8:00 p.m. on 1/23/21) with a temporal thermometer.  I checked this with an oral thermometer to be sure, and it read 105 degrees.  Fortunately, I was able to take a cool shower and re-medicate with Advil, and my fever came down to 102.    By morning on 1/24/21, it was 100.7 and never got above that again.  The body aches and headache and low-grade fever lasted into the day on Monday, 1/25/21, on which I had to use a sick day at work.    During the morning and afternoon on Monday, 1/25/21, I noticed a strange feeling in my chest--a sort of pressure or tightening--for just a couple of seconds--and then it went away.    Tuesday, 1/26/21, I felt more myself, but I still have a lot of exhaustion and fatigue, though no fever, and the headache has diminished quite a bit.
I experienced a pain in my arm at the injection site. My left arm was really sore. I still have the pain in my shoulder.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site edema in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site edema. In May 2018, the outcome of the injection site edema was recovered/resolved.  It was unknown if the reporter considered the injection site edema to be related to SHINGRIX. Additional information was received as follows: The case was reported by the pharmacy intern. The age at vaccination was not reported. The reporter did not know the exact date of the vaccination but estimated it to be around 20th May 2018. The patient received SHINGRIX on the left arm. The patient experienced fluid build up at the injection site, the day following the injection. The build up also migrated a little down the arm. It lasted for approximately one week. The reporter did not have any additional details.
Patient came in for a second Moderna shot. Vaccinator noted  a hard stop in signing him up for administration-which said vaccine series completed. RN went to the immunizations tab in the patient's chart and noted that in the Vaccine Registry a Pfizer dose had been given at a pharmacy on 1/7/21. Then, the patient had come to clinic and received a Moderna dose on 4/07/21-that dose was administered. Patient then returned for second dose in Moderna series on 5/05/21.
Information has been received from a physician's assistant (PA) concerning a 6 yr old male who on 04May00 was vaccinated SC (631073/0450J). The PA reported that on 15Jun05, the pt presented to the office with a case of varicella characterized by several hundred lesions on his back, trunk, face and a few on his extremities. The pt was also noted to have a low grade fever. The pt was treated with ibuprofen and at that time of this report was recovering from the varicella. Additional information has been requested.
Patient was given his first dose of Pfizer COVID 19 primary series today in the clinic. The dose he was given expired yesterday.   Post injection, no signs or symptoms of adverse reaction. Patient instructed to monitor for symptoms such as redness or swelling at injection site, etc.  Or report any additional symptoms that may arise.  Pfizzer customer service notified.  They advised to continue to monitor for all the same signs of symptoms of a typical COVID vaccination,  and continue on schedule as normal for repeat doses.
one red spot above lip, 2 on neck, not edematous; almost gone by the time reached the ER;
heart failure 2.5 weeks after 2nd dose of moderna that doctor attributed to covid vaccine
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 61-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Fever; Chills; Sever headache; Nausea; diarrhea; Felt extremely tired; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19 in Dec2020. The patient's concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced fever, chills, sever headache, nausea, diarrhea and felt extremely tired. The events were considered as non-serious. The patient underwent lab tests and procedures which included Covid-19 test in Dec2020 which shows positive results. The outcome of the event felt extremely tired was recovered after 24 hours, whereas outcome of rest all events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
red swollen lump @ site of inject x 4 days, arm pain, inc temp, fatigue-gen weakness/achiness; episode of syncope, chills/sweats;
PULMONARY EMBOLISM, UNSPECIFIED. 12/8/2021 PULMONARY EMBOLISM, UNSPECIFIED. ACUTE RESPIRATORY FAILURE 12/15/2021 PULMONARY EMBOLISM, UNSPECIFIED. ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/8/2021 PULMONARY EMBOLISM, UNSPECIFIED.
patient stated that he had to call the ambulance because he couldn't move. He vomited, was nauseous and aspirated his vomit. He was in the hospital with pneumonia
Rash: hive looking on arms, back, part of neck and stomach.  Fever: about 100F, Hydrocortisone/anti-itch cream.
arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 25Sep2021 16:00 (Lot number: FC3183) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: Overweight prior to vaccine. No any illness at time of vaccination. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "arm sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. Patient received 1st dose and his arm was sore for a few days, no after symptoms.  No follow-up attempts are possible. No further information is expected.
spasms and weakness in the upper arm; weakness in the upper arm; A spontaneous report was received from a consumer (United States) who was a patient who received Moderna's COVID-19 Vaccine, and who experienced spasms (muscle spasms) and weakness in the upper arm (muscular weakness).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient received their Moderna vaccine on an undisclosed date.  They reported having a reaction and stated that they were having spasms and weakness in the upper arm and wished to know if that was normal.  No additional information was provided.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the events, spasms and weakness in the upper arm, was not provided.   The outcome of the events, spasms and weakness in the upper arm, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
When I pushed the plunger to inject the  vacccine, most of the vaccine did not go into the arm and flowed down his arm onto the floor. The patient agreed that he felt most of it, go down his arm.  Since most of the vaccine did not enter the muscle, I used my professional judgement and assembled another dose and administered the second vaccine.
pt recvd vax 13DEC94 & 24JAN95 devel acute gastroenteritis (camphylobacter);also devel disseminated intravascular coagulation (thrombotic), acute renal failure, & peripheral arterial embolization; pt was hospitalized on 28JAN95;
pt recvd vax 20SEP03; that same date devel chest pain, redness/soreness @ the inject site, fever general aches;
Information has been received from a nurse practitioner concerning a 17 year old white female who at 9 am on 29-JUL-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) (lot# 660557/0072X) 0.5 ml IM in her left deltoid. Concomitant therapy included (DESOGEN). At 8 am on 12-AUG-2008 (also reported as 13 to 14th August) the patient noted a pruritic rash beginning on her trunk and extending down her legs and arms. Within 24 hours, her plantar surfaces were swollen and she developed a pruritic rash. Then the patient developed swollen lips and a dry cough with shortness of breath within 48 hours. The patient was prescribed 3 weeks course of Prednisone oral, an unspecified "antihistamine" and an Albuterol inhaler. The patient had a chest x-ray on an unspecified date which was negative. A pulmonary function test was performed on an unspecified date with a normal result. A Lyme disease enzyme-linked immunosorbent assay for "pulmonary edema" and her events were confirmed as an allergic reaction. The patient was recovered from the allergic reaction. The patient sought medical attention in the office. Additional information is not expected.
Lymph node swelling tender on palpation supraclavicular on the same side  Adv that supraclavicular lymph swelling is a normal reaction but may take 10 days (up to a couple weeks) to fully resolve, can uses APAP PRN or warm compresses and keeping hydrated to help, provided phone number to call if issues persist/worsen and PCC/Covid line will check back tomorrow
This case was reported by a consumer via call center representative and described the occurrence of sickness in a 45-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. The patient's past medical history included influenza (last year had flu twice). Concurrent medical conditions included immune system disorder. On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced sickness, cough and sniffles. On an unknown date, the outcome of the sickness, cough and sniffles were unknown. It was unknown if the reporter considered the sickness, cough and sniffles to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional information was reported as follows: In 2018, the patient was sick entire winter with coughing and sniffling all the time. The call center representative asked all questions to reporter, but unable to obtain additional information. The patient gave permission for her doctor to be contacted.
Pt recvd vax & the next day had flu-like sx for 1-2 days; sx subsided;
(R) Bells palsy - parents noted dropping of (R) side of mouth 12/29 pm, eyelid weakness next AM. Seen 12/30 and 1/3. Sx nearly resolved after 5 day Prednisone.
Wife reported within 1 hour of receiving vaccine, severe h/a. During that night, achy , chills, sweats, temp 101 degrees. Remained in bed for 19 hrs. Notified MD- Tylenol and liquids- treatment . 2nd day after vaccine. sweating, nausea, dizzy. Last flu vaccine apprx. 10 yrs
ear pain; eye dry; sore throat; Bell's palsy on the left side of my face; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old patient of an unspecified gender received first dose of BNT162B2), via an unspecified route of administration on 27Mar2021 16:00 (Batch/Lot Number: ER8733) as single dose in left arm for covid-19 immunisation.  Medical history included hypertension and blood cholesterol increased from an unknown date. Concomitant medications included evolocumab (REPATHA) 420mg monthly intramuscular for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported.  At 8:30 pm, four days after the COVID vaccine (on 31Mar2021), patient started to have dried left eye, pain behind my left ear and real deep sore throat and took 1 tablet of Ibuprofen 200mg orally (treatment),  and went to bed and then the next morning, woke up with total paralysis on the left side of face, lip was dripping, eye wouldn't close and was diagnosed with Bell's palsy by the doctor. Outcome of events was not recovered.
This spontaneous report as received from a physician refers to a 6 patients of unknown age who were vaccinated with doses of ZOSTAVAX (lot# not reported). Physician had mentioned that 6 other patients who were given ZOSTAVAX had had some reactions at the injection site like "redness and swelling." At the time of reporting, the patient outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Soreness/aching; Not feeling quite right; Extreme tiredness; Chill; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness/aching), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Jan-2021, the patient experienced PAIN (Soreness/aching) (seriousness criterion medically significant), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache). At the time of the report, PAIN (Soreness/aching), FEELING ABNORMAL (Not feeling quite right), FATIGUE (Extreme tiredness), CHILLS (Chill) and HEADACHE (Headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Approximately 12 hours after shot (Adacel)administered, upper part of right arm became bright red, very hot, and hard lump the size of walnut appeared at site. Arm became very painful and doctor on untit suggested a visit to the ER. Continued to have arm pain and swelling for several days as well as as moderate headache. Went to ER on 11/23. Instructed to apply ice and take benadryl
Tinnitus, I've never had it but it started within a day or 2 of getting the booster
It was a documented Covid infection on 08/22/2021. It began with symptoms similar to a sinus infection. I had a runny nose, cough, and a headache. Eventually after I was confirmed it was Covid I had a severe headache, fever, dizziness, SOB, loss of smell, fatigue, and I did not have loss of taste. I did receive monoclonal antibody infusion as treatment on 08/27/2021. Symptoms lasted until 08/28/2021.
Suspected vaccination Failure; Shingles on the base of the spine to the right side; Scabbing; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2019, the patient received Shingrix (intramuscular). In August 2019, less than 2 months after receiving Shingrix, the patient experienced scab. On 17th August 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and scab were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles and scab to be related to Shingrix.  It was unknown if the reporter considered the vaccination failure, shingles and scab to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix on left arm. The patient broke out with shingles on the base of spine to the right side.  At the time of reporting, the patient was recovering with formation of scab. The reporter did not consent to follow-up.  No further details were provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirmation were unknown.
Swollen throat, bumps on tongue, tightness in chest, and extremity tremors.
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: Patient recieved vaccine around 5 pm on 11/02/21 and felt tired/fatigued that evening.  He woke up at 7 am with chills and fever of 100 F and took 800 mg of ibuprofen.   His wife called pharmacy at 4 pm on 11/03 concerned that his fever was 101 F.
Information has been received from a physician concerning an overweight 10 year old female who on 28-JUL-2007 was vaccinated with the second SC dose of Varivax (Lot# 656922/0450U). Concomitant vaccinations included Gardasil (duration and dose not reported). "Within 24 hours," on 29-JUL-2007 the patient developed a nodule, and local injection site pain and swelling. On 29-JUL-2007 the physician and nurse reported that the patient had MRSA characterized by erythema and was hospitalized. Lab diagnostic studies performed included a TB skin test. The patient was treated with Clindamycin (HCL) 450 mg TID for 5 days. Subsequently, the patient recovered and was discharged from the hospital on 01-AUG-2007. There was no product quality complaint. Additional information has been requested.
swelling & redness noted 24hr p/vax given 5NOV96;7NOV96 redness noted on inner aspect of rt arm-red area measure around complete arm-below inj site;elbow area not indurated;
This spontaneous report was received from a licensed practical nurse, referring to a 16 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 24-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # L004014 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Post vax, pt had hives on arms, legs and on face. NP prescribed Benadryl. Pt had no other complaints, only hives. Per FNP, approximately 1.5 hours, post Hep A, noted pt scratching arms and noted fine papular pink rash spreading to legs and face. No respiratory symptoms. Given Benadryl.
Following vaccine administration, the patient went to the observation station.  Within 2 minutes of sitting down, the patient exhibited loss of consciousness, with muscle rigidity, eyes rolling back, diaphoresis, paleness, and was not responsive.  Medical team immediately initiated assessment and care and called 911.  BP taken, 84/60, pulse 64.  Emergency medical personnel arrived on scene within 4 minutes and transported the patient to the hospital.
Pt Presented with Chronic S.O.B And Chronic cough. Pt was treated with Asperin, Azithromycin, Cestriaxone. Pt Still hospitalized.