chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have received the 3 vaccines, first one 1-22-08,4-1-2008 and 8-21-2008  I became ill in February 2008, had bloody stools, diarrhea, nausea, cbc was done at that time i had a wbc of 13.0 a colonoscopy was done in April 2008 this was negative.  i have had headaches(migraines) that have occured more often.  I received my 3rd shot on 8-22-08 i had a bruise and swelling from this. I started to feel ill, lightheaded, nausea and vomiting as well as diarrhea and stomach pains times 1 week before , i ended up in the ER on 9-4-8 with excruitiating abdominal pain, painful urination.  My WBC at that time was 17.5, my urinalysis was within normal limits and the CT confirmed an appendicitis. I had surgery that evening. 9/22/08-records received for DOS 9/4-9/5/08-DC DX: Appendicitis. Presented with C/O abdominal pain times one day and diarrhea times one week. Surgery, laparoscopic appendectomy.
lump, warmth and itching at the injection site; lump, warmth, and itching at the injection site/the place where she had the shot (injection site) started to get itchy and warm; lump, warmth, and itching at the injection site/the place where she had the shot (injection site) started to get itchy and warm; This is a spontaneous report received from a contactable consumer (patient). A 83-year-old female patient received PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) in right arm on 06Mar2021 (at the age of 83-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in Mar2021, few days after receiving vaccination patient noticed a lump, warmth, and itching at the injection site. Patient asked if she could get the second shot in the same arm if the lump was still there, she was left-handed and sleep on her left side. She would like to get it in right arm which was the same as her first shot. Patient asked if it was normal to occur this many days after. She was reading the side effects and explained after 2-3 days of getting the shot, she was fine. After a few days, she noticed the place where she had the shot (injection site) started to get itchy and warm. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from an office manager concerning her 13 year old daughter who on 14-Sep-2004, was vaccinated with the first dose of 0.5 ml of GARDASIL. On 14-Nov-2006, the patient received the second dose of 0.5 ml of GARDASIL and on 15-MAR-2007, the patient received her third 0.5 ml dose of GARDASIL. One year later, on 15-Apr-2009, the patient saw her pediatrician because of a loss of pigmentation in the skin of her face. The patient was referred to a dermatologist who, after performing a skin biopsy, diagnosed the patient with vitiligo. The patient has had several laser treatments to try to help the vitiligo which have been unsuccessful. At the time of the report vitiligo subsisted.  Additional information has been requested.
redness / inch below the injection site; heat / inch below the injection site; swelling about an inch below the injection site; pain at the site; fatigue; muscles aches; headache; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd February 2021, 1 week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced erythema, localized feeling of warmth and local swelling. On an unknown date, the patient experienced injection site pain, fatigue, muscle pain and headache. On an unknown date, the outcome of the injection site pain, fatigue, muscle pain and headache were recovered/resolved and the outcome of the erythema, localized feeling of warmth and local swelling were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, headache, erythema, localized feeling of warmth and local swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The case was reported by patient's parent. In January 2021 a week before reporting, the patient received the 2nd dose of Bexsero. The patient had the usual side effects of pain at the site, fatigue, muscle aches and headache that resolved with 2 days.  On the day of reporting, the patient developed redness, heat and swelling about an inch below the injection site. The reporter wanted to know was it common.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Fever-Mild
Patient erupted in a raised, pimply, itchy rash on upper chest  running  around and from neck line  to midway down chest. Rash at 1 month later was still very obvious but less itchy  according to patient. This was not reported until he came in for his 2nd dose.
Patient claims he had very severe left arm pain after flu shot given. He claims that it is very hard to move arm. I recommended that he call his MD.
Immediate lips/tongue tingling, right neck started to hurt, had benadryl 50mg po, progressively worse, trouble clearing throat, had epi and IM benadryl and sent by EMS to hospital, SOB, wheezing, EC- epi, Decadron, admitted and  then intubated and had epi infusion.
Information has been received from a healthcare worker referring to an unspecified patients of unknown age and gender. On unspecified dates from 15-JUN-2015 through 13-AUG-2015, the patients were received improperly stored doses of (Oka/Merck) VARIVAX lot #L002217, expiration date 21-JAN-2017 (strength, dose and route were not reported) (incorrect product storage). No adverse effects reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt was given flumist vaccine in approx. 15-20 minutes pt called from car and stated that pt's throat felt clogged. No drooling. Breathing ok. Per Dr recommendation pt sent to Glenbrook ER.  This information was included in the 15-day VAERS report submitted on 20 JUNE 2006.
Started as sore arm expected after vaccine administration; arm continued to worsen until visited doctor 12/23/2014.  Doctor prescribed prescription strength Naproxen.
A spontaneous report has been received from a Health Professional concerning an 11 year old, male patient. Patient relevant, history concurrent disease and concomitant drugs were not reported. The reporter stated that child pulled back and right eye was sprayed with FLUMIST QUADRIVALENT (intranasal). The nurse stated they flushed the eye out. At the time of reporting, the event of right eye sprayed with FLUMIST QUADRIVALENT was improving. The reporter assessed the event of right eye sprayed with FLUMIST QUADRIVALENT to be non serious.
Information has bee received from a physician concerning a female with latex allergy who on an unknown date was vaccinated with a dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot number nor reported). Concomitant therapy included poliovirus vaccine. Ten minutes later the face swelled up and the child was immediately sent to the allergist. At the time of this report the outcome was unknown.
a bad stiff neck on my left side; one of my lymph nodes were swollen; the pain on my left side of my neck; This is a spontaneous report from a contactable consumer (the patient).  A non-pregnant 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 30Jan2021 at 10:45 AM (at the age of 82-years) as a single dose for COVID-19 immunization. Medical history included asthma, and hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 05:00 AM, the patient woke up with a bad stiff neck on her left side. When she touched her neck, she realized that one of her lymph nodes were swollen, and pain on her left side of my neck. The patient was not sure whether the pain on her left side of her neck had anything to do with this swollen node. After four days, she still had the swollen node and a lot of pain on her left side of her  neck. No treatment was given. The clinical outcome of bad stiff neck on my left side, one of her lymph nodes were swollen, and pain on her left side of my neck was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  Information on lot number was requested.
Headache First severe headache, then neck pain and myalgias, chills, right arm pain at vaccine site and loss of appetite; All resolved with tylenol.   Narrative:  First severe headache, then neck pain and myalgias, chills, right arm pain at vaccine site and loss of appetite; All resolved wit tylenol.
no additional AE; PROQUAD that underwent a temperature excursion was administered to two patients; This spontaneous report has been received from a healthcare business professional referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 25-MAY-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) for prophylaxis (lot # T028298, expiration date 16-FEB-2022 (strength, dose,  route of administration and anatomical location were not reported), which underwent a temperature excursion at 6.96 Fahrenheit (F) for 15 min (product storage error temperature too high). The temperature excursion was detected by a data logger. There was no previous temperature excursion. No additional adverse event or information was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006420:
Rash appeared about 1 mo p/pt recvd flu vax @ clinic on 18NOV91; Rash continues w/occasional remission; suggested reviewing all changes in lifestyle, ie foods, soaps, clothing, lotions, etc;
The patient has not had any side effects outside of the typical response expected from the Janssen vaccine. However, the error occurred due to the fact that the vial the vaccine was drawn up from was opened the day prior (Tuesday, 7/13/21 at roughly 2pm), which has a BUD of 6 hours in the refrigerator after it is punctured. The pharmacist who administered the vaccine wasn't aware that the vial had been punctured the day prior and not the day the vaccine was actually administered, which was Wednesday, 7/14/21 at 10:38am.  The patient has been made aware of the situation and is currently not experiencing any negative or out of the ordinary side effects. He was informed to contact us if he begins to. Due to the lack of data/studies on whether or not the patient should receive another dose of the vaccine, the patient has elected to not receive another dose and has accepted the potential the vaccine may not be as effective as the CDC has described due to it being administered past it's BUD. The manufacturer of Janssen has been notified of the error as well. Vials will now be disposed of at the end of each work day in order to prevent another error like this from occurring again.
Child received imm on 9/15/05. Dtap 3, Hib 4, MMR 1, Varicella 1, Hep A 1. Very difficult child to immunize. Left leg swelled at site of Dtap on 9/1605. On 09/17/05 rash followed, got progressively worse. Trip to ER on 9/20/05. Cortizone cream given to mom.
This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 15-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
7/26--7/27 6y.o. female with PMH of COVID in early June and constipation who presented with abdominal pain few hours prior to presentation on 7/25/2022 evening. Patient was diagnosed with constipation by PCP 3 weeks ago and was prescribed Miralax half a cup a day. Since then she has been having intermittent abdominal pain but recently it increased in intensity. She presented to ER on Thursday (7/21/22) for similar complain and was discharged after observation for several hours. UA and Urine culture was sent at the time which was negative for any signs of UTI. However, last night she endorses significant abdominal pain and was uncomfortable regardless of position, thus mother brought her to the ER again. She also has 3 episodes of NBNB vomiting (1 large, 2 small). She had had no more vomiting since. Her last bowel movement was yesterday, happened 3x, has soft consistency, but per mother was very small, small balls" In the EC her CMP, CBC, and UA were unremarkable. An ultrasound of the appendix did not visualize the appendix. Her abdominal xray showed scattered gas in the small and large bowel without pathologic distension, and no signs of obstruction or free air. She received a NS bolus, zofran, and enema. She only had a few flecks of stool that came out after the enema so she was admitted for bowel cleanout. The initial plan was for her to receive Golytely through an NGT, however after it was placed imaging to assess the location of the NGT it was found that it needed to be advanced another 10 cm. The patient then pulled out her NGT so the decision was made to trial oral golytely. Overnight she tolerated 50 mL of Golytely every hour. Her Golytely was then titrated up to goal rate to 14 ounces / hour which she continued until her bowel movements were nearly clear. She was maintained on IVF while she was taking Golytely. She was discharged home with the guidance to increase miralax to 1 cap per day and follow up with pediatrician to titrate dose to one full soft bowel movement per day.
Bled at injection site, cried inconsolably.  Nurse indicated bleeding is normal. Proceeded to cry throughout day/night.  After 48 hours, baby continued to have regular inconsolable crying spells, could not sleep, seemed in pain.  Pale bruise appeared over entire thigh.  Crying spells lasted one week, culminating with a hoarse voice.  Tried to discuss with doctor, message was not returned.  Nurse indicated it was probably teething.
pt recvd vax & cried a lot; pt2nd DTP slept until 6PM awake cried constantly for 3 hrs; sleep awaken cried for 2 1/2 hrs-high pitched @ times; leg red & hard size fifty cents; next day OK;
Patient experience chest tightness, dizziness, and attempted to lie on floor after 15 mins in observation (19:10). Vital signs was taken, initial blood pressure  was 145/90, and HR of 101, Respiratory rate of 22. Patient stated presenting the adverse reaction right after vaccination, but patient did not notify healthcare providers (RNs) until patient complain of chest pressure, patient notified 15 mins after injection. Patient requested EMS to be activate. Vitals signs was continuously monitored, until EMS arrived at 1930. Last set of vital signs was HR 123, RR 17, BP 132/82, O2sat 99%. EMS arrived At 1930 for evaluation and transport patient to hospital.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Additional Details: 1 day after shot, patient felt heart "fluttering" & chest felt "weird" but there was no pain/dyspnea. Fluttering described as ventricles taking longer than normal to contract. It was sporadic for 1 hour & lasted few seconds each time. Patient admits to being extremely fatigued & after a nap, reaction never returned. Takes no medications & healthy with no health conditions.
No additional adverse events reported; improperly stored doses of VARlVAX that was administered; This spontaneous report was received from a nurse and refers to two patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On 17-FEB-2021, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (route of administration and anatomical location were not reported), for prophylaxis. Nurse reported they had 10 lot numbers that were active in their freezer but was unsure of which lot numbers were administered: lot # T016000, expiration date 08-MAY-2022, lot # S008695, expiration date 21-MAR-2021, lot # S011952, expiration date 16-APR-2021, lot # S019461, expiration date was reported as 24-JUN-2021 but upon internal validation process, it was established as 16-APR-2021, lot # S025611, expiration date 18-AUG-2021, lot # S024366, expiration date 06-AUG-2021, lot # T022314, expiration date 30-JUN-2022, lot # T027302, expiration date 12-AUG-2022, lot # S006021, expiration date 27-FEB-2021, and lot # T000697, expiration date 07-JAN-2022.   Administered doses of vaccines were stored in the temperature of minus 6 degrees Celsius for 1 hour and 6 minutes.  There were no previous temperature excursions reported. The improper storage was not recorded by digital data logger. There was no additional adverse event reported.  Follow-up information was received from an other reporter on 08-MAR-2021.  The patient was a 36-year-old male. The patient had no illness at time of vaccination and had no pre-existing allergies, birth defects or concurrent medical conditions. There were no concomitant vaccines administered. On 17-FEB-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, subcutaneously (SQ) in the left art (LA), lot number T016000 was verified to be valid, expiration date reported and established as 08-MAY-2022. It was reported that the excursion occurred on 11-FEB-2021 at 17:03 and lasted for 1 hour and 6 minutes, and the temperature reached -6 Celsius degrees. The patient did not experience any additional adverse reactions after administration of the vaccine, and he did not require any prescription drug treatment. The vaccine was used according to the instruction and the operator was trained. The improper storage was recorded by digital data logger (previously reported as not recorded by digital data logger).   This is one of 2 reports received from the same reporter.  This report was previously non-valid due to lack of the patient's identifiers.; Sender's Comments:  US-009507513-2103USA002342:
passed out/ lost his consciousness; fainted; fell; This is a spontaneous report from a contactable consumer (parent). A 17-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter was just curious his/her stepson had an adverse reaction to Pfizer vaccine and he was in the Emergency room. The patient has passed out, fainted and lost his consciousness. The parent stated that patient fell in a concrete floor because the location he was getting the vaccine was obviously not suitable to people having adverse reaction otherwise they should be sitting on metal chairs on concrete floor, so the parent is under the assumption that he should have his heart checked out, and if the vaccine has to do with it and they just wanted to know if there's anything else with this reaction should be having a hospital lookout. The outcome of the events was unknown.    Information on the lot/batch number has been requested.
who had the first phase of the Pfizer COVID-19 had just recently got an active case of Covid; who had the first phase of the Pfizer COVID-19 had just recently got an active case of Covid; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "who had the first phase of the Pfizer COVID-19 had just recently got an active case of Covid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 43-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 30th June 2022, the patient received Havrix. On 30th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-Jun-2022 Reporters comment:  A clinical operations manager at a clinic reported that a patient received on a dose of Havrix that had expired on 24th May 2022. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was already expired in 24th May 2022, which led to expired vaccine used.
Information was received from a certified medical assistant (CMA) refers to a 16-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of GARDASIL (lot number K014191 and expiration  date 10-MAY-2017) (dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.