chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 102.5 within 3 hrs of injection, and very swollen and painful arm. Headache becoming more intense over next 5-6 hours. 5 a.m. (14 hours post injection) woke with nausea, vomiting, much more severe headache, and runny nose. Ate something and took 1/2 Norco and 2 Advil. Headache 10 on scale of 10 painwise. Slept but woke 3 hours later with same level of headache, nausea, and temp steady at 102.5. 24 hours post injection, still severe headache (10/10), no more nausea but no appetite. Took 1/4 Norco after drinking smoothie and Pepto, slept 3 more hours. Woke  8 pm to same headache, temp still 102.5. Just gutted it out until about 2 a.m. was able to take another 1/2 Norco and 2 Advil and slept until 8 a.m., nearly 48 hours post shot. No more drugs, and headache was somewhat abated, 5/10. Appetite came back slightly, enough to eat and take two more Advil. Now 74 hrs post shot am symptom free other than persistent but slight headache.Did not contact doctor as I did not think there was anything he would have been able to do for me.
FEVER, EXCESSIVE THRIST, EMESIS X 1, DIARRHEA, NAUSEA FOR 48 HRS
This spontaneous report as received from a physician regarding a female patient of unknown age. Medical history and concurrent conditions were not reported. On 07-JUL-2015, the patient received improperly stored PROQUAD (Merck) (lot number was reported as L009208, expiry date: 17-SEP-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was not concomitant medication reported. No adverse effects was reported and no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
On 3/30/22 I first experienced arm pain which progressed until I had difficulty moving my left arm, fatigue, pain from buttocks to toes on right side, could not bend knee and was completely stiff by day 3. Extreme back pain and had to use a cane for 3 and half weeks, and also remained fatigued with weakness. The symptoms resolved after 3 and a half weeks, and I was taking Motrin for the pain with no relief. I have sought care from an immunologist/allergist,  rheumatologist, and also saw 2 hand surgeons.
Pt states 48hrs after 1st Hep (9/19/08) felt nauseous & achy but thought it was stress. 48hrs after 2nd Hepatitis B nausea was worse, had severe muscle aches & joint aches, severe headache, ulcers on roof of mouth & tongue felt swollen.
This spontaneous report was received from a registered nurse. It was reported that GARDASIL had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392, 1210USA000959, 1210USA000960, 1210USA000961, 1210USA000962. Additional information has been requested.
erratic blood pressures, as low as 70/30, orthostatic hypotension, chest pain, light headedness, itchiness
1st shot flu symptoms exactly  12 hours was feeling better 12 hrs later,,,,,,  2nd shot flu like symptoms 16 hours after shot  , day 2 had weird headaches for 5days,had covid in october ,still no taste or smell
Patient started with a nose bleed. Inside of nose became crusty and filled with scabs.  Has lasted until now - 11/4/09.
25 minutes following inoculation I experienced throat swelling, cough, itchiness of throat, tightness of chest, wheezing, vertigo, nausea, sneezing. Arrived home and immediately took benadryl in hope of improvement with steroid inhaler  3 hours later it progressed to headache of occipital region, fatigue,  continued chest tightness even after use of inhaler, runny nose, fever, body aches, continued nausea and loss of appetite.  By 3am all over body itchiness, 2 bouts of emesis, stomach pain, severe joint pain, increased fatigue   By 830am, itchiness of face and continued all over body aches, joint pain not relieved, throat still mildly swollen, sensitivity to light.  Noon of the 27th, weakness continued, dizziness, numbness of forearms with intermittent muscle spasm of forearms and r calf.   3pm gi issues inclusive of belching, bloating, loose stools, acid reflux.  By 730pm ocular pressure and continued migraine like headache to occipital region. Itching has not resolved. No hives. Bout of emesis.  2300 hours some slight relief of itching and some improvement in throat swelling. No other changes.  0600 hours 28th, continued migraine like headache, nausea with body of emesis, dizziness, Injection site soreness has not improved, body aches remain,  joint pain remains, itchiness with mild improvement, ocular pressure is now mild, dizziness,  brain fog, forearms continue to feel numb, fatigue and weakness, cough and congestion,  mild chest tightness and itchiness of throat.
Red, spotty rash that started on back of neck and covered front/back of body. Benadryl given 1 hour after first noticing, with no improvement. Conditioned worsened on 8/13/12 where it was all over face.  Some spots were deep red, almost purplish.  Taken to doctor at 9:30am 8/13/12 and diagnosed with Erythema Multiforme.
Within 24 hours the patient developed body aches and pains and spike in blood pressure of 180/90 based on personal reporting by the patient. Over the next 7 days the patient developed a rash with pain and itching around the injection site. She also reports pain in her hips that alternates between a muscular type pain and a sciatica type pain.
8/17/06 4:00AM client c/o headache, dizziness, nausea, fever, unk temp, shortness of breath and soreness at injection site. Visited Dr's office PM of 4/17/06 was feeling better at time of visit. Recovered.
I received my 4th dose on 04/18/2022 and my adverse event started on 06/25/2022 sore throat; after couple of days I started having runny nose and after 1 week I had a cough with clear mucus. I never had any fever. I took 5 COVID-19 tests in between 06/25/2022-07/10/2022 was all negative. 07/14/2022 I did a tele health they prescribed me benzoate (TESSALON) 200 milligrams. I started on 07/15/2022 and I stopped yesterday 07/19/2022. If my cough doesn't go away clearly I will take it again. As of now I feel better.
Patient received Td injection intradermally, instead of a PPD test, two to three years after receiving her regular Td booster shot.  Patient was suppose to received a PPD skin test and developed a nodule at the injection site.  Doctor gave her a prescription for PREDNISONE and DOXYCYCLINE.  Patient noted to the doctor that after a PPD test she was given literature for a Td immunization instead.  She was sent for chest x-rays and administered another PPD skin test.  Both x-ray and the PPD test turned out to be negative.  An incident report form was filled out at the doctor's office.  Patient is still experiencing symptoms of pain, itchiness, muscle soreness and a feeling of a knot at injection site, a month after injection.  Patient did not experience any reactions to the previous Td injection.  Follow up received on 01/08/09:  Patient stated that she continues having breathing difficulties, although she is not sure if it's from Td vaccination.  She has muscle pain in her chest and arms, she is experiencing more pain in the arm where Td was administered.  The Td administration site looks like a "big mosquito bite", a nodule approximately 1/2inch by 1/2inch in size and very red.  The injection site is not warm to the touch and does not itch.  Pt. said that she just had an MRI to identify the cause of breathing difficulties and is waiting for the results.  Follow up received on 01/15/09:  Patient stated that since the time she was administered Td vaccination intradermally, she has had a persistent non-tender, non-pruritic, erythematous nodule (approximately 0.5 inches in diameter at the injection site.  The nodule has not changed in size for the past two months.  She also notes mild continued muscle soreness and weakness in the affected arm.  She has not received any additional therapies for these symptoms and they are not adversely affecting her ability to work or carry out daily life.
On same day of #1 vaccine experienced sore arm, headache, body aches, fever, decreased energy.  Symptoms lasted 2 days. On same day of #2 vaccine experienced same symptoms as above, but lasted 5 days.  Early May 2021 developed "ringing in ears" and has continued until today 7/29/21. Complains of HA, difficulty sleeping, difficulty focusing.   Has seen GYN, PCP and Chiropractor.  No relief.  Employer sent to Urgent care  on 7/29/21.
I woke up early on the 3rd of October. I knew something was not correct. My chest didn't feel normal. I checked my pulse and saw I had a very fast heartbeat. I laid in bed for a while waiting for a change it didn't. My smart watch EKG said I was in AFIB. I called my local Cardiologist, left a message. I got my wife up and taken to the ER where I was admitted. I was diagnosed very quickly that I was in AFIB. I don't know what all they did to me. I was admitted and put on IV's and at least two different medications. CARDIZEM was the medication given that I noticed when they. MULTAQ was another medication. When they discharged me the put me on MULTAQ 400mg twice a day. And I was taking ELIQUIS at that time I have Leiden Factor 5 G mutation. It is genic and I take ELIQUIS for the rest of my life. They increased that dosage as well.
This spontaneous report as received from a nurse refers to a unspecified 15 year old patient. On 13-APR-2018 the patient was vaccinated with first dose of GARDASIL 9 from lot N014464 expiry date 19-DEC-2017 for prophylaxis. On 09-FEB-2018, the patient received the second dose of GARDASIL 9 from lot N019104 expiry date 3-FEB-2020 and on 13-APR-2018, the patient received third dose of GARDASIL 9 from lot reported as "N02969"  expiry date 17-MAY-2020 (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA007821.
Extreme body aches while maxed out on Tylenol and Ibuprofen, low grade fever, nausea and vomiting, massive headache, sore throat (probably from vomiting), and swollen lymph nodes.  Affected my daily activities and could not go to work.  I am a pharmacist, and this did really impact my job as my boss had to get other pharmacists from other cities to cover my shifts.   My work has a protocol related to covid, they will not let me back for a week.
Starting on day 6 Lethargic, day 7 got a 101.3 fever for 3 days, aches, red under eyes, ankles hurt. After 3 days of fever and more days of lethargy she got 2 days of body rash. 14 days since injections and she is still not fully back to normal energy.  Gave ibuprofen as needed and rest. Slept 12+ hours with the fever.
Nose pain; Body ache; Tiredness; Swollen Nose; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 3 weeks after receiving Shingrix, the patient experienced nasal edema. On 21st September 2020, the patient experienced general body pain and tiredness. On an unknown date, the patient experienced nasal pain. The patient was treated with paracetamol (Tylenol). On 10th October 2020, the outcome of the nasal edema was recovered/resolved. On an unknown date, the outcome of the general body pain, tiredness and nasal pain were recovered/resolved.   It was unknown if the reporter considered the general body pain, tiredness, nasal pain and nasal edema to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced feeling tired,body aches,nose pain and swollen nose which was recovered till the time of reporting. The patient's nose was swollen on both sides for 2 and half weeks. The patient had taken tylenol for pain. The customer inquired has this reaction been reported before? Patient stated, "no one could explain why this happened. The patient informed that the pain and swelling resolved on 10th October 2020.  The batch lot numbet and expiration date was unknown. The patient wanted to consult with HCP before providing consent to follow up. The patient was provided medical information phone number for her HCP. No further information was available. This case as linked with case US2020206847 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206847:same reporter
Information has been received from a consumer concerning her daughter who was vaccinated with two doses of MMR II. Subsequently the patient experienced equivocal titers for mumps. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Immune system is low; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer-sponsored program. The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 05Feb2021, for COVID-19 Immunization. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2021, outcome "unknown", described as "Immune system is low".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Just had light arm pain on day of injection, about 18 hours after, when I woke up, I had body aches, chills, and 102 degree fever. Lasted the entire day Saturday. On day 3, I was back to normal, with exception to the sore arm, but it was getting better.
On 2/1/00, the pt developed a rash on his right leg. He was seen by a physician who noted that it was initially a small papular rash on an erythematous base which looked like early poison ivy. On 2/3/00, the pt was seen by a physician and the rash had reportedly progressed to obvious vesicles spread over the pt's right leg. He was dx with varicella and treated with Acyclovir
Pt recvd vax @ 11AM & mom reports that approx 15 mins later pt began coughing (which lasted about 15 mins) then c/o itching all over & feeling sleepy; pt slept a while & mom noted swellng of face; pt taken to clinic w/hives;
9/21/12 Friday night started to have nausea, Saturday 9/22/12 didn't feel well in the morning. Saturday night felt sick- headache, fatigue, dizziness, nausea. Sunday went to ER + Tuesday. Was tested for flu. Test negative. Sick Wednesday & Thursday. Missed 2 days of work.
patient received ActHIB with expired diluent, no adverse event; Initial information received on 19-Mar-2020 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a patient (age and gender not reported) who received a dose of expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot number unknown, powder expiry 27-Jun-2020 and diluent expiry 13-Mar-2020) via unknown route and unknown administration site on an unknown date for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was reported that they administered ActHIB on yesterday. ActHIB powder has an expiration date of 27-Jun-2020 and the diluent has an expiration date of 13-Mar-2020.   It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
On June 26th started to feel sick and had chills for 24 hours and it went away. On July 5th found out she had covid.
Severe headache; This is a spontaneous report from a non-contactable consumer. A 47-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 for second dose at single dose at right arm for COVID-19 immunization. The first dose was on 30Dec2020 on left arm for COVID-19 immunization, at age of 47-year-old.  Medical history included cancer (former cancer patient). Allergies to medications, food, or other products was unknown. The patient was not pregnant at the time of vaccination. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine sodium (SYNTHROID), estradiol (ESTROGEN). The patient experienced severe headache lasting all day and currently since this morning when she woke up on 21Jan2021 06:00.  Seriousness criteria was not results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Prior to vaccination and since the vaccination, the patient was not diagnosed with COVID-19. There was no treatment received for the adverse event. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
~24 hours after vaccination, individual was in the shower and passed out. Patient remembers getting in the shower, and woke up on the floor of the shower. Patient does not know for how long, probably not more than an hour. Patient had not eaten that day.Afterward, patient had a headache for about a day. Patient has been well since Sunday. Patient did not feel need to seek care in ED or doctor's office. Patient came to office to file a report. Scheduled an appointment with provider on Thursday.
Severe headache, chills, hot flashes, nausea, sleepiness, dizziness and malaise (cannot focus/function),
Initial report was received from a health care professional through another manufacturer under reference number S2012US03633 on 11 July 2012. A 15-year-old male patient had received an injection of DIPHTHERIA AND TETANUS TOXOIDS (manufacturer, lot number, route and site not reported) on 28 July 2009. On 28 July 2009, severe swelling began. On 29 July 2009, fever and flu-like symptoms began which lasted for 3 days. Past medical history and concomitant medications were not reported. The patient's outcome was not reported. Documents held by sender: None.
Initial report received from scientific literature on 04 September 2012. This case is not valid as no identified patient (subjects). The following is verbatim: "Background: The global spread of a novel influenza A (H1N1) virus in 2009 led the Health Organization (HO) to declare a pandemic. Vaccine manufacturers worldwide dramatically increased efforts for pandemic H1N1 vaccine production, to make it available to a sizable proportion of the world's population. Objectives: To investigate the feasibility of globally concerted vaccine safety assessment according to the same protocol as a proof of concept. To test the association between H1N1 vaccination and Guillain Barre Syndrome (GBS) first detected in 1976 with the introduction of the swine flu vaccine. Methods: The primary outcome of interest was the relative incidence of GBS in the 42 days following vaccination with monovalent adjuvanted and non-adjuvanted pandemic H1N1 vaccine. Cases were identified using hospital or population based health care databases. This included sentinel hospitals and databases of countries choosing to participate. All patients with GBS hospitalized in the selected institutions during the study period were classified according to the Brighton Collaboration case definition of GBS. Data analysis using the self-controlled case series method is being performed with both a pooled data set and a meta-analytic approach. Results: In total, 546 cases of GBS from 15 countries were included in the study. One hundred and forty-seven subjects with Brighton Collaboration levels 1, 2 or 3 were exposed to pandemic H1N1 vaccine, 78 of which were adjuvanted, 61 of which were non-adjuvanted vaccines, and 8 of which had missing adjuvant data. The self-controlled case series analysis is ongoing. Conclusions: This study demonstrates that a global collaboration with a common protocol is feasible and should allow for estimation of relative incidence of adverse events following exposure to different formulations of the same vaccine." The patients' outcomes were not reported. Documents held by sender: None.
My type 1 diabetes was diagnosed a year ago and has been well controlled (A1C of 5.3) with very little insulin (3 units tresiba per day). Hours after the vaccination, My blood sugar shot up to levels I haven't seen since diagnosis--up to in the 300s--with no change in diet or exercise. It's been 2 weeks and I am taking significantly more insulin than I did for the year prior, with both long-and short-acting insulin as prescribed my my doctor 10 days ago to address the issue.
Information has been received from an approximately 23 year old female consumer with no pertinent medical history or drug reactions/allergies, who on 22-JUL-2010 was vaccinated with the first dose of GARDASIL and on 23-AUG-2010 with the second dose. There was no concomitant medication. The patient reported that her menses (period of bleeding during menstrual cycle) had not changed, but the period between menses (total menstrual cycle) had increased from her normal cycle (28 to 30 days), to 40 45 days post vaccination with GARDASIL. The patient noticed increased cycle onset began after first dose of GARDASIL was administered. The patient was currently in her third cycle of menses (post vaccination with GARDASIL), which started on 08-NOV-2010 and was continuing on the date of the report. The patient had no other complaints or problems. The patient did not seek medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from a registered nurse who indicated that on 22-JUL-2010 at 2:50 p.m. the patient was vaccinated IM with a first dose of GARDASIL (lot# 665547/1318Y) in her left deltoid. The reporter stated that the patient reported a change in menstrual cycle after receiving GARDASIL. The patient previously had her menstrual period every 28-30 days. After receiving GARDASIL, the patient's menstrual periods occurred every 45-50 days. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.