chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 6-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  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 rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
This case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract congestion in a elderly female patient who received Influenza vaccine Quadrivalent. Concomitant products included BREO. On 19th October 2017, the patient received Influenza vaccine Quadrivalent. On 20th October 2017, 1 days after receiving Influenza vaccine Quadrivalent, the patient experienced upper respiratory tract congestion, wheezing, cough, general body pain and sickness. On an unknown date, the outcome of the upper respiratory tract congestion, wheezing, cough, general body pain and sickness were not recovered/not resolved. It was unknown if the reporter considered the upper respiratory tract congestion, wheezing, cough, general body pain and sickness to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient planned to follow-up with the physician on an unknown date. It was reported that the patient had a flu shot (unknown manufacturer) and got sick from the flu shot the next day and experienced congestion, body aches, wheezing and coughing. The reporter wanted to remain anonymous and wanted to disconnect and limited information was provided. This case was linked with case US2017165608, reported by same reporter for same event.
tested positive for covid-19 after dose 1, but had symptoms before; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid-19 after dose 1, but had symptoms before) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included METHOTREXATE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for covid-19 after dose 1, but had symptoms before). At the time of the report, COVID-19 (tested positive for covid-19 after dose 1, but had symptoms before) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include Methotrexate, Eloquis, Blood pressure. Treatment information not provided.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (strength, dose, frequency, anatomical location, lot number and expiration date were not reported), intramuscular, which was improperly storage. No adverse events were reported. Additional information has been requested.
I received the vaccine and my left arm was sore and it is still sore today with pain and left arm cannot move it to the back with some pain and cannot lay on the left side either. I have received vaccines for many years and this year it bothers me.
Mother of patient called on 09-24-2020@1015 to report redness & swelling at injection site - both legs, (R) side worse than (L) side. Pt came in to clinic for appointment on 09-25-2020 as redness & swelling on (R) thigh worsened.
Developed seizure 36 hrs post-vaccination. Experienced four episodes over a four hr period of eyes rolling back, moaning, gurgling, tonic-clonic movement, and brief 15 min post-ictal periods. Temp 100.8F.
Information has been received from a nurse practitioner concerning a 22 year old female who in approximately 2006, "3 or 4 years ago" complete the series of 3 dose GARDASIL (therapy dose, route and site unknown) at her pediatrician's office. "Recently", in "a last month" (in July 2010) the patient had been tested positive for oncogenic type of HPV infection (pap came back ASCUS). The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the nurse practitioner. The nurse reported that the patient did not have a PAP with an ASCUS result, but had a "swab for sexually transmitted disease (STD)" only. The result of that test was positive for high risk HPV (type unspecified). The nurse also stated that the patient was a virgin when she completed the vaccine series. No further information is available.
Information has been rec'd from a hlth professional concerning a child who in August 1998 was vaccinated with one dose of varicella virus vaccine live. Subsequently the pt experienced chickenpox. Medical attention was sought. 3 other pt's had a similar experience following vaccination with varicella virus vaccine live (WAES00042794 and 00061292-0001183). No further information is available.
This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ orally, lot # M043838 with expiration date of 18-JUN-2018, for prophylaxis (dose and frequency were not reported) that experimented a temperature excursion according to a digital data logger. No adverse effects were reported. The temperature excursion frame was between 31°F / -1°C or colder, and lasted 1 hour and 37 minutes. No previous temperature excursion was reported. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1707USA001986: US-009507513-1707USA001987:
Chills after 6hrs, headache after 12hrs, severe headache after 15hrs, dry heaves and shortness of breath after 18 hrs.
i have a blotchy rash on my arms and legs. that is somwhat itchy. it also is in my head.
Received Both Doses of Heplisav-B, Patient Titer Shows Nonresponder; Initial Report Received on 28-SEP-2022  This is a spontaneous report, received from a physician regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On unknown dates, patient received both doses of HEPLISAV-B.   The physician reported that the titer showed patient was a nonresponder.   The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious. Since the dosing interval, time to serological marker testing, titer and clinical manifestations of hepatitis B were not provided, the case does not qualify for confirmed immunological failure or confirmed clinical failure.; Sender's Comments: The company assessed the event as non-serious. Since the dosing interval, time to serological marker testing, titer and clinical manifestations of hepatitis B were not provided, the case does not qualify for confirmed immunological failure or confirmed clinical failure.
Worsening (increasing / more frequent) atrial fibrillation episodes (not responsive to medication) Immediately after getting Pfizer vaccinated (late September), in early October, I have been dealing with Afib episodes every 7-10 days. These episodes are not responding to my Pill in the Pocket meds, and have been lasting 2-4 days each. (historically,  Afib episodes occurred every 4-6 weeks).   from primary care visit 11.12.21:  Paroxysmal afib Follows with Cardiology  Symptomatic when he is in AFib Currently takes metoprolol and flecainide if he feels himself go into afib (pill in pocket, per cardiology).  Since his COVID vaccinations he has noticed that he seems to be in AFib more frequently, and that the medications are not always effective at getting him out of AFib.  Get symptoms every couple of weeks now -due to his increased symptom frequency as well as fact that it it does not consistently respond the flecainide I do think that ablation is worth considering.  He will call Cardiology to set up an appointment to discuss
I had a fast-beating heart, SVP. I went to the emergency room, where upon arrival they ran a lot of tests. I cannot remember all of them. I do know I had an EKG. I was given medicine via an IV. I was released from the hospital once my heart rate returned to normal and told to follow up with my doctor. I have followed up with him, he has put me on medication, ran test I don't remember them, and I am going to have a procedure done.
Pt recvd vax & exp electric shock, loss of strength, syncope, pain, dec ROM, sharp pain radiating down arm; poss conversion react;
Severe headache horizontal from the end of each eyebrow side to side over eyes, severe neck pain, pain radiating in shoulders up to back of head behind ears, chills, fever, face cheeks are bright red, leg pain in both thighs, hard to walk, injection site pain, nauseated
Roughly two to three months  after getting my Moderna booster, I began feeling winded after activity, noticed my heart beat would race with any activity, including walking in the house.  I began having night sweats and trouble sleeping.  My resting heart rate went from in the 50's to the 80's and would often hover around 110 just walking from room to room in my house.   At one point, my heart rate elevated while laying in bed and I was covered in sweat and felt like my heart would beat right out of my chest and this lasted for hours.  Nothing I did could stop my racing heart of cool me off.   This was unusual because I am 52, 135 lbs and consider myself to be fit.  I suddenly was unable to eat without my heartbeat elevating, climb stairs, work in the yard, go for a walk in the neighborhood or simply lay down to sleep...all would cause my heart beat to elevate or race and I was having increased "hot flashes".  I noticed my hands would shake when I was typing or cooking and I felt like my brain was in a fog.    At first I thought it was related to Menopause and visited my gynecologist.  A blood test was ordered and that is when we discovered I had an issue with my thyroid.  I was sent to an endocrinologist who confirmed I had symptoms of both Grave's and Hashimoto's brought on my antibodies attacking my thyroid.  I had not abnormal tests prior to the vaccine and never had any symptoms.
COUGH; PAIN IN BONES; TREMBLING; WHEN STOOD UP FELT LIKE SHE MIGHT LOSE BALANCE (GOES AND COMES); WHEN SHE STOOD FELT LIKE FAINT AND GO AWAY; PAIN IN MUSCLES; FEVER (GOING AND COMING LIKE CHILLS); PAINFUL BODY; FEELING DRUNK; CANNOT ORGANIZE SELF/FUNNY FEELING/OUTERSPACE FEELING; TIREDNESS; DECREASED APPETITE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced decreased appetite. On SEP-2021, the patient experienced feeling drunk. On SEP-2021, the patient experienced cannot organize self/funny feeling/outerspace feeling. On SEP-2021, the patient experienced tiredness. On 01-SEP-2021, the patient experienced painful body. On 01-SEP-2021, the patient experienced fever (going and coming like chills). Treatment medications included: ibuprofen, and paracetamol. On 02-SEP-2021, the patient experienced pain in bones. On 02-SEP-2021, the patient experienced trembling. On 02-SEP-2021, the patient experienced when stood up felt like she might lose balance (goes and comes). On 02-SEP-2021, the patient experienced when she stood felt like faint and go away. On 02-SEP-2021, the patient experienced pain in muscles. On 07-SEP-2021, the patient experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in bones, fever (going and coming like chills), trembling, painful body, and pain in muscles, had not recovered from when she stood felt like faint and go away, when stood up felt like she might lose balance (goes and comes), tiredness, decreased appetite, and cough, and the outcome of feeling drunk and cannot organize self/funny feeling/outerspace feeling was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
increased BP 148/102; having feeling of rapid heart beat; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6207, expiry date was not reported) via unspecified route of administration, in the left arm, on 25Jun2021 at 10:45 (at the age of 42-years-old) as a single dose, for COVID-19 immunization. The patient's medical history included hypothyroidism, relevant past drug history included Bactrim, allergies to Bactrim, unknown start and stop dates, unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN, strength: 88mcg) for unspecified indication. On 28Jun2021 at 03:00, patient started having feeling of rapid heartbeat and increased BP 148/102. Patient did not receive any treatment for events. Patient did require a visit to doctor or other healthcare professional office/clinic for events. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 since having the vaccine. Reporter assessed the events as non-serious. The patient underwent the lab tests and procedure included blood pressure measurement and was 148/102 on 29Jun2021. Outcome of the events was recovering.
Trouble breathing-swollen around eyes. Went to medical center ER. Albuterol inhaler and epi-pen. Prednisone x 3 days.
This case was reported by a other health professional via sales rep and described the occurrence of edema in a female patient who received SHINGRIX. On 18th January 2018, the patient received SHINGRIX. In January 2018, less than a week after receiving SHINGRIX, the patient experienced edema and erythema. In January 2018, the outcome of the edema and erythema were recovered/resolved. It was unknown if the reporter considered the edema and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's health care provided to GlaxoSmithKline field representative. The patient's symptoms resolved after five days post vaccination. The reporter provided permission to contact the patient's physician. No additional information was provided by the reporter.
Second Moderna shot in March 2021 caused 2-3 days of 102-103 degree F temperature causing severe discomfort and flu like symptoms.   Booster shot in December 2021 caused constant 100-100.5 degree temperature F for 3-4 days (2 extra strength Tylenol every few hours taken according to instructions).  Extreme constant  body and shooting  pain especially in the joints. After day 3, severe back pain between shoulder blades and spine  developed where the pain was extreme when standing. Needed to stay in bed since then. Tylenol, Advil, Naproxen, tramadol did not alleviate pain.  Contacted doctor for pain meds.
right arm hurts when she raises it; This is a spontaneous report from a contactable consumer (patient)  A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL5262) on 26Jan2021 at 16:15 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history and concomitant medications were none. On 26Jan2021 about 1 hour after vaccination at 17:15 the patient experienced  right arm hurts when she raises it. At the time of the reporting the patient had not yet recovered from the event.
After ADACEL -> Client passed out while sitting in chair. Was assisted to the ground. When on the ground client's limbs began jerking for several seconds; client woke up after about 5-6 seconds and asked "what happened? I fell asleep"; Monitored client in office for 30 minutes after episode.
Syncopal episode after receiving GARDASIL, ADACEL and PPD. ADACEL and PPD given 1st. Reaction (fainted) occurred immediately after receiving GARDASIL. Pt does have a fear of needles but has never fainted before.
Sometime in may I started to experience severe anxiety. I didn't see any doctor. I am being treated for anxiety as of now. I had to take more of the Alprazolam .5mgs as needed used it every day, and I rarely used.  I was using it at least once a day or twice a day.  It lasted about a week, closer to two weeks. I however do feel like things have gone back to how they were before.
Plunger stopped 3/4 of way during administration of Prevnar13 injection  Patient came into the office for Prevnar13 injection. During the injection process  the plunger stopped about 3/4 of the way through the administration and would not release the remaining medication.  Patient did not receive full dose of vaccination.   Office staff spoke with RN from the manufacturer Drug Safety department who gathered information on the situation and placed an active form on file.
numbness to her knees/feeling soft bilaterally and symmetrically/ wearing tights; weakness in her legs; This is a spontaneous report from a contactable physician (patient's daughter). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Medical history included hernia, and herniated disc in her cervical spine, but she was fine prior. The patient's concomitant medications were not reported. On 13Jan2021, her mom started to experience numbness to her knees and it was described as "feeling soft bilaterally and symmetrically"; the feeling was described as "wearing tights", the patient also had a little weakness in her legs. On 16Jan2021, the symptoms were at its worst and on 18Jan2021, her mom started to feel better. Her mom was taking Motrin and Ibuprofen. She didn't have any other symptoms. It was symmetrical and bilateral on both legs. The Physician wanted to know if this has been seen in any other patients and was it safe to get the second vaccine. The outcome of the events was recovering. Information on the Lot/Batch number has been requested.
onset of pruritic rash to lt thigh, rt elbow-day p/vax;spread of rash flobully over next several days;no vesicular lesions;rash appears to be contact dermatitis;
Patient had localized swelling on his right arm that was very red, itching, and blistered one day after receiving his vaccinations. He was instructed to use a cold compress, BENADRYL 25mg, and TYLENOL 500mg. He was also instructed to see a physician but refused.
63y.o. female with a past medical history of type 2 diabetes mellitus, ischemic cardiomyopathy, ACS s/p stent x2 on in July 2022 who presented for chief complaint of rectal bleeding.  Patient reported large blood clots per rectum for the preceding 3 days.  She is currently on aspirin and Effient for recent history of stents.  Patient denied prior history of rectal bleeding, no history of colonoscopy in the past.  Patient also reported lightheadedness, cough and pleuritic chest pain aggravated by coughing.  Patient is fully vaccinated against COVID.  In the ED patient noted to have borderline hypotension, vitals otherwise stable.  Initial labs remarkable for creatinine 1.16, glucose 264, hemoglobin 8.6 (11.5 in). Additional information for Item 18:  in July), hematocrit 27.5, COVID-positive.  Aspirin and Effient recommended to be continued per academic cardiology service.  She was started on gentle fluids and was admitted with consult to GI, infectious disease, endocrinology, and cardiology services. Patient noted to have acute drop in hgb on 10/12 requiring 1unit PRBC. She subsequently underwent EGD/colonoscopy that day which was remarkable for esophageal mucosal changes classified as Barrett's stage C2-M3 per Prague criteria, diverticulosis in the sigmoid colon without evidence of diverticular bleeding and mucosal tear in the rectum, noted to be actively bleeding for which clips x2 were placed.  Due to poor prep follow up EGD/colonoscopy recommended in 1 year which was discussed w/patient. Pt noted to have borderline BP for which antihypertensive regimen was adjusted to only Entresto at current dosage. Hold parameters were discussed with the patient and she has her own BP cuff. Patient was also treated with a 3 day course of remdesivir per ID recommendations. Endocrinology was following for T2DM and adjustments to insulin were recommended as patient reported low blood glucoses in the AM at home. Patient is stable at this time for discharge with recommendation to follow up with GI, endocrinology, and cardiology was an outpatient.