chrisvoncsefalvay/vaers-outcomes huggingface dataset:
became nauseous; This case was reported by a consumer and described the occurrence of nausea in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the dose and became nauseous.  The patient asked was there any advice to minimize this side effect and he or she was scheduled to get the second dose soon.
Pt recd 1st dose of Hep B vax on 20DEC90 & 11FEB91 recvd 2nd dose of Hep B & devel an urticarial rash; testing for Hep B antibody was pos;
Very irritable for next 48 hours- arching back, inconsolable,  hard crying. Loss of appetite for 1 week following  Sudden refusal to take a bottle (because of sore throat/mouth?) Day 9- fever (didn't check temp) Day 10- rash of red dots all over stomach and back, few on face and neck, white of eyes look gray
One week after receiving vaccine, I had a MRI with gadolinium containing contrast used.  I have had this contrast at least 3 or 4 times in the past 6 years with no problems. (last time was August 2020).  This time, I had allergic reaction minutes after receiving contrast.  Teeth and nose tingled, eyes itched.  After MRI was done, nurse observed red flushed face, so put me in room for observation.  Over next hour, arms and hands got red and itchy, and got hives in several places.  Part of legs also reacted same.  They finally gave me 25 mg. shot of benadryl, which helped all areas except one.  That evening I still had a itchy rash about the size of a tennis ball on the upper right arm, which is where I had the COVID
Shot was initially painful. Severely sore arm, can barely lift it.  Overall joint pain, fatigue, cold feeling, headache, no fever as of this time, loss of appetite.
Rash on face two days after the injection; This is a spontaneous case from reported by other health professional to agency (reference number: SEQ19-03544) and initially received on 30-Sep-2019, concerning a 67-year-old, female patient.     The patient's current medical conditions included hypertension and osteoporosis.   The patient's concomitant medications included beta blockers and osteoporosis medication (as reported).    On 26-Sep-2019, the patient was administered Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscularly, batch number: 261199, expiration date: Jun-2020) for prevention of influenza.  On 28-Sep-2019, two days after the vaccination, the patient developed a rash on her face. Rash began to fade and turned to a pink colour.   On an unspecified date in 2019, the patient recovered from the event of rash on face.   The case was assessed as non-serious and the reporter did not provide causality assessment to Flucelvax QIV.  Follow up was received from other health professional on 14-Nov-2019: Start date for the event was confirmed as 28-Sep-2019 and the outcome was changed from resolving to resolved. Narrative was amended accordingly.  Company comment: The event is considered as related to Flucelvax QIV.; Sender's Comments: The event is considered as related to Flucelvax QIV.
This initial spontaneous report was received from a physician referring to a 4 month old infant of unknown gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 16-SEP-2015 at 15:29 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
On 6-10-07 patient began with rash on chest, arms, neck and lips a little swollen. Parent advised by on call nurse practitioner to give Benadryl by mouth and call in the am if symptoms worse. Patient presented in office on 6-11-07 with symptoms worsened. Dr diagnosed patient with reaction to vaccine (Hep A) and advised to continue Benadryl.
headache; diarrhea; low-grade fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: A female patient of an unspecified age receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller has a doctor's appointment for blood work and asked if it's okay since she already took the 1st dose on the 21Jan2021. She had a headache, diarrhea, and low-grade fever after the 1st dose in Jan2021. The patient underwent lab test which included body temperature: with result low-grade Fever on Jan2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
shot does not mean you won't get them/ suspected vaccination failure; Shingles; Worst Pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shot does not mean you won't get them/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Worst Pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by patient via interactive digital media. The reporter reported that his or her friend received Shingles vaccine and she is absolutely in the worst pain now over the three months. The reporter stated that vaccine received does not mean that you did not experience shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Received on immunizations on 10-23-08- Broke out i rash (generalized) and periodic temp (101)- no temp today, but still rash- irritable at first but not anymore.
Joint pain-Daily; Burning sensations-Frequently; Tingling and numbness-Frequently; Blurry vision-Daily; Fatigue-Daily;
28OCT98 lt arm w/lump, redness, itching since 22OCT98 now has diffuse redness 8cm width 4cm height, warm to touch;advised compress;2NOV98 presents w/sl redness lt arm w/firm area approx 1/2";relief noted w/ice pack;
I started itching the next day after the second vaccine.; Later on that day, the hives appeared. I have been to the urgent care to get treated. I reported it to my doctor. I have been breaking out in hives for the last 3 weeks after the second vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 01Nov2021 10:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "shellfish" (unspecified if ongoing). No covid prior vaccination. Concomitant medication(s) included: INSULIN. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: Oct2021, when the patient was 50 years old, for covid 19 immunization. The following information was reported: PRURITUS (medically significant) with onset 02Nov2021, outcome "not recovered", described as "I started itching the next day after the second vaccine."; URTICARIA (medically significant) with onset 02Nov2021, outcome "not recovered", described as "Later on that day, the hives appeared. I have been to the urgent care to get treated. I reported it to my doctor. I have been breaking out in hives for the last 3 weeks after the second vaccine.". The events "i started itching the next day after the second vaccine." and "later on that day, the hives appeared. i have been to the urgent care to get treated. i reported it to my doctor. i have been breaking out in hives for the last 3 weeks after the second vaccine." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (10Nov2021) negative. Therapeutic measures were taken as a result of pruritus, urticaria included injection of benadryly and prednisone.  The lot number for bnt162b2 was not provided and will be requested during follow up.
One week after the shot, the injection site has turned red, warm, swollen and itchy.
Shoulder discomfort and sight pain at sight of tetanus injection given x3 weeks (L) arm. No fever, no redness at sight.
Left leg pain developed on 8/16/21 in the evening. Acute and unremitting pain started at approximately 2000 hours 8/17/21. The patient could barely walk and was transported to the ER. A large clot in his left iliac artery was found and patient underwent emergency surgery on 8/18/21 at approximately 0300 hours.
pt recvd flu vax 18OCT93 & on 21OCT93 exp severe myalgia & muscle strain; pt could not move neck; pt also exp pain in upper arm & back of neck & lt side & redness @ the inject site; pt was seen by a MD; pt devel a hive-like rash on face;
Extreme fatigue, body/bone aches/pain, fever (101.5F), nausea, swelling (lymph) under armpit.
I started with a sore throat and the next day I had chills and fever and felt bad. I was exposed with my daughter, and she called me when she tested positive. I was having difficulty breathing and I then called ambulance.  I was admitted to the hospital I was in a fib and had low oxygen level.  They ran heart test because my heart rate was elevated. I was in the hospital for four days and was given Remdesivir in my IV three times which helped the oxygen levels. Because I was in a fib the doctor changed a bunch of my medication. I was discharged and I have to take oxygen if I do a lot of activities. I did follow up with my cardiologist and my lung doctor. A fib did resolve itself.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse called to have the stability of improperly stored GARDASIL (lot # and dose unspecified) evaluated; there was in-house stability data which did support the vaccine. The nurse also stated during the telephone call that there was an unspecified patient in the office at that time who needed a dose of GARDASIL administered. It was unknown if this improperly stored vaccine was actually administered to this unspecified patient. No adverse effect was reported. Additional information has been requested.
One day 1,  after vaccine, patient had flu-like symptoms with low grade fever, nausea, headache, body aches x 4 days.    Around day 3, symptoms of severe headache with stiff neck and dry cough started along with tingling and numbness of shoulders, arms, hands, lips, legs bilaterally.   These symptoms continue today.
No additional AEs were reported.; an expired dose of MMR II vaccine was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. The patient's medical history, concurrent conditions or concomitant therapies were not reported.  On 09-JUN-2023, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #u017524, expiration date: 03-JUN-2023 (strength, route of administration, and indication were not provided) (expired product administered). No additional adverse events were reported.
Never had the second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 3 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient asked, if he/she should get the 2nd dose at the time of reporting or if he/she was okay.
red bumpy rash on the tummy, bruise like rash on back, fever currently at 101.4, red throat was tested for flu and strep both came back negative. slight deliriousness, sore through and cough, runny nose.
ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: anaphylactic reactions to many medications. The patient received covid-19 vaccine ad26.cov2.s (Janssen series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced anaphylactic reaction specifically lips swelled, throat swelled, and stabbing in chest when first go it .The reactions lasted for two weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211234835-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is labeled per RSI and is therefore considered potentially related.
Intractable migraine, fever, hypotension, hypoglycemia,  severe body pain, syncope
About 20 minutes after the vaccine injection,  I became extremely weak, the weakness travelling from my ankles up the rest of my body. I was too weak to walk and  I was also dizzy, confused, and had heart pounding.
REDNESS, SWELLING, PAIN AND DISCOMFORT AT INJECTION SITE AND DOWN THE UPPER ARM. PATIENT WAS ADVISED TO REST, TAKE BENADRYL, AND APPLY HYDROCORTISONE. HE WAS ALSO ADVISED TO SEE A PHYSICIAN IF THIS DID NOT IMPROVE OVER THE NEXT DAY.
Deep pain upper left back going to top of shoulder and under arm pit. Left upper arm & forearm just above & below elbow felt as if something was tightened around arm. Pain in back of left hand to knuckles, strange painful sensation to skin of same hand. Occasionally left hand would go extremely cold. (thermometer gun would read low, right hand would read 98.3) Upper left back and shoulder pain worse when laying and upon waking. 1/20 had neck pain also. During day when active deep pain continued, but was able to manage & tolerate to function. The worst of pain was from 1/17/21 to 1/23/21, and seems to be a little better these past few days. Hand is still randomly going cold.  Forearm pain comes and goes now.
Tdap given in Lt Deltoid client noted extreme swelling and redness the following morning at infectioon site. The redness and swelling progressed down the lower arm toward the bend of the arm. Client taken to MD on 10/10/12 and was told the area was infected and client placed on amoxicillin. Client is being encouraged to apply hot and cold compresses to the inflamed site. Will do follow up call Monday 10/15/2012.
30 year old female presents for first Pfizer vaccine dose.  Patient was informed to wait 15minutes after injection. 10 minutes after the patient received the Pfizer covid vaccine, the patient was experiencing  feeling hot, dizziness and light headedness. Patient was assessed by healthcare worker and was walked down to the ER.
Pediarix was given in lieu of the Flu vaccine that was ordered.   They are very similar in appearance,
Cold hands and feet; Chills; Back of the head aches; Stinging in injection arm; This is a spontaneous report from a contactable consumer. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9265, expiry date: unknown), via an unspecified route of administration in the left arm, on 28Jan2021, at single dose, for covid-19 immunization, at an urgent care center. Medical history included known allergies to seafood. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included metformin, and hydrochlorothiazide, telmisartan. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced cold hands and feet, chills, back of the head aches and stinging in injection arm on 28Jan2021. No treatment was given for the events. The patient was recovering from the events. The events were assessed as non-serious.
70 year old female with 2inch round area of erythema, warmth and tenderness at injection site began shortly after receiving injection and sought treatment 4 days later.Patient placed on keflex for treatment of possible cellulitis secondary to injection.
Shingle on right waist, only 1 location on body. Appears to be mild as only 2 scabs have now formed. At first thought it was eczema and applied Triamcinolone acetonide 0.1% to area.  Pin prick feeling occasionally occurred. Thought was armrest in heavy equipment used at work pressing on "eczema" spot. Night of 12-08 could not sleep because of pain from prickly feeling. Told my wife at 5am. She said sounds like shingles. She called the hospital hotline and was told I should go to urgent care in next 24 hours. Physician Assistant prescribed valACYclovir 1 g tablet (3 times a day for 7 days), gabapentin 100mg capsule (only took 1 used ibuprofen there after), mupriocin 2% oinment (3 times a day apply to shingle spot). Still using this until the 2 scabs go away.  Prickly feeling has stopped.
Right arm extreamly sore for several days.  So sore that having trouble sleeping and using the arm.  Arm still sore after 6 days. Upset stomach for 3 or 4 hours after shots.  This started about 15 minutes after the shots.
L. arm soreness; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced some soreness in the left arm after receiving the 1st dose of Shingrix. The reporter did not consent to follow up. For the tolerance of 2nd dose, refer the case- US2020192546.
This spontaneous report was received from a physician refers to a 20 years old male patient. Patient's medical history included pneumonia. On 10-SEP-2012, the patient was vaccinated intramuscularly with lot # (672041/1477AA) (expiry-14-MAY-2013) PNEUMOVAX23. Concomitant medications included Z-PAK and TAMIFLU. On 11-SEP-2012, the patient experienced a pretty nasty, marked, warm and red eight-inch-by-five-inch cellulitis where the vaccine was administered. Patient was seen in an urgi-care center. Treatment included prednisone, BENADRYL and REFLEX. The outcome of a pretty nasty, marked, warm and red eight-inch-by-five-inch cellulitis where the vaccine was administered was reported as not recovered. The relatedness for a pretty nasty, marked, warm and red eight-inch-by-five-inch cellulitis where the vaccine was administered was unknown for PNEUMOVAX23. Additional information is not available.
Suppression of immune system the first 4 weeks of life. Resistant to Rx oral meds. Frequent infections for 2 1/2 years. Severe adult type mononucleosis with liver enzymes increased. Delayed maturity of nervous system. (Excellent mother, not working. 2 1/2 year breast feeding).
This spontaneous report was received from a healthcare worker refers to a 12 year old female patient. The patient pertinent medical history included scholiosis. On 19-JUN-2014, the patient was vaccinated with first dose of GARDASIL lot # J009788 (0.5 ml) intramuscular. On 19-JUN-2014, three minutes after the administration of the dose, the patient experienced black vision, nausea and sweating. The healthcare worker reported that the patient did not faint and was sitting for the injection. The reporter stated that after 20 minutes, the symptoms resolved. No further information was provided. The outcome of the events was reported as recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified dose of oral, ROTATEQ, (lot number and expiration date were not reported); the doses were exposed to temperatures outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
ON 3 JAN 06, AT 09:00, PT RECEIVED 2ND DOSE OF HEP A IN UPPER LEFT ARM, AND FLU VACCINE IN LOWER LEFT ARM. PT RETURNED TO SICK CALL TODAY COMPLAINING OF REALLY ITCHY BUMPS ON BILATERAL TRICEPS REGION, NECK, BREASTS, UPPER AND LOWER TORSO AND BILATERAL THGHS. PT HAD NO OTHER COMPLAINTS. PT WAS SEEN BY HEALTH CARE PROVIDER FOR FOLLOW UP CARE.
Within 24 hours post vax, the child developed marked swelling of left upper arm and shoulder (as described by ER physician). Admitted under 23 hours observation, received antibiotics and discharged the next day without problems.
Severe pain in left hand. Swelling of knuckles on hand of last two fingers. Cannot bend hand or make a fist. Bodily pains all over.
pt recv vax 25JUL96 & devel blotchy red, flat rash gen 7AUG96;pt taken to ER same day-MMR rxn no tx given;8AUG96 rash spread red, hot to touch, fever 101, brought to clinic;tx for ear infect 29JUL96;ATB for pink eye also;