chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case PHEH2016US026304 is an initial spontaneous report received from medical assistant on 07 Oct 2016. This report refers to 6 month old patient of unknown gender (off label use). Medical history and concomitant medication was not reported. The patient was vaccinated with single dose FLUVIRN (batch number: 1618521, expiry date not reported) at a dose of 0.5 ml intramuscular on 06 Oct 2016. No adverse event was reported following this medication error.
No adverse effects reported; Incorrect route of product administration; This spontaneous report was received from a registered nurse concerning a patient of unknown age, gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 28-JUN-2019, the patient was vaccinated with one dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) (lot number R031636 with expiration date on 01-NOV-2020) intramuscular (incorrect route of product administration) rather than subcutaneous for prophylaxis (strength and frequency were not reported). No adverse effects reported
About 21 hours after vaccination, I woke up extremely lightheaded and fainted twice with no memory of what happened after waking up on the floor.
1/23/2021 started with itching 1/26/2021  developed swelling/rash, soreness -> treated w/ Benadryl prn 1/29/2021 rash/swelling resolved
Patient stated he had first Moderna vaccine on 04/09/2021 and on the following Monday, started to have a headache, which he ahs been having almost daily. He has relief with Advil and Tylenol. He stated he has a history of headaches, but not this consistently. reviewed with him it may be from the vaccine but referred to his provider since he knows his history and he can assess further.
my arm still hurts where they gave me the shot.; muscle is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (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), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "my arm still hurts where they gave me the shot."; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "muscle is still sore". Therapeutic measures were taken as a result of vaccination site pain, myalgia.  Additional information: The patient got the second shot over a month ago. And her arm still hurts where they gave her the shot. The muscle is still sore. Sometimes she has to take Advil cause it hurts.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine at 10:50am on 10/11/2017. He stated he started to get watery eyes and sinus issues around 8:00pm that evening. Between 9pm-10pm he started to experience blurred vision, tremors, shakes, fatigue, and needed assistance walking. He went to a local Emergency Department around 11pm. He stated that upon arrival he had a 102.1 fever. He had a chest x-ray done to rule out pneumonia which was negative. He also had blood work drawn which he stated was all within normal limits.
Fever, chills, headache and extremely tired. Slept for 18 hours  after vaccination.  Feel much better now.
On 8/7/2022, I had fever, joint pain, nausea, headache, fatigue, and chills. Just a few days later, I lost my sense of taste. I also lost my appetite and had a headache at one point. The only medicine I took to relieve my symptoms was ALEVE, which helped some. I was pretty sick for about ten days. However, I was back to normal (for the most part) within three weeks, though I did have fatigue for about a month longer.
Adverse reactions started on 01/30/18 at approximately 6:00 p.m.; eyes and face started to swell;  profuse sweating and rapid heart rate. These reactions lasted approximately 20 minutes. The following day extreme fatigue, nausea and body aches; loss of appetite; poor sleep pattern that night. Unable to work on Feb. 1st and Feb. 2nd due to extreme fatigue, unable to sleep due to coughing for hours during the night.
Adverse event reported by nurse . Per RN report,  early this morning the patient's mother heard him call out. When she entered his bedroom she observed "the tail end of a Grand Mal seizure."  RN notes that the mother reported symptoms such as stiffness and flailing which was thought to be consistent with a tonic-clonic seizure. Patient was not incontinent, but did experience a period of confusion following the episode, thought be a post-ictal  period. EMS was summoned at 8:10am and transported the patient to the emergency department for assessment. RN reports that the patient has no previous history of seizure. Symptoms have resolved and RN reports that the patient has had no recurrent symptoms or seizures while in the emergency department.
stomach ache; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: Patient received first dose of the Pfizer BioNTech Covid 19 vaccine on Tuesday. She then developed a stomach ache then it went away, then the next day she had a stomach ache and diarrhea. Then "today" she was experiencing horrible pain in her stomach and diarrhea, similar to when she eats something with gluten (AE transmittal due to side effects, declined transfer to drug safety). Patient asked will her second dose be from the same Lot number. Patient asked if the vaccine contain gluten. Patient asked how does the vaccine work? How will be the second dose different from the first; How long will the diarrhea last; After getting vaccine, typically how soon the onset usually was; Will the side effects be worse than with the first dose?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient nearing the end of his 30-min observation after Pfizer #2 today. Reports that he had severe pruritis after the first dose which began 4 hrs after injection.  LMD prescribed premed of diphenhydramine 25 mg PO today which pt took on schedule. Very mild pruritis today, no SOB or rash. Rx Pt handed a single pill diphenhydramine 50 mg to be taken later today, timed to be taken at 6 hrs after the first dose. Pt understands and knows not to be driving today.
Vaccine administered by RN on 2/02/2021 at 11:50am.  Location was at Nursing Home.  Coordinating facility for vaccines is the Health District. Within five minutes after vaccine administration, the patient's co-worker informed the patient that she had some redness on her neck. Patient left dining hall where vaccines were being administered and upon return, RN with HD asked patient how she was feeling.  The patient was noted to have a red neck and chest with some petechiae on neck and chest. Patient c/o headeache and numb right arm, same arm used for vaccine.  At 12pm, 25mg PO of Diphenhydramine was given by RN. The patient c/o nausea and started to vomit. HR was assessed by RN at a radial rate of 106 BPM. Patient stated her head was hurting worse and continued to vomit. RN, called EMS. Cold compress given to patient and patient was assisted to restroom by RN. Upon exiting the restroom, patient started vomiting again and stated her throat was itching and tongue felt swollen. She stated she was allergic to vanilla and her throat felt the same as when she reacts to vanilla. RN, attempted to visually inspect the patient's throat/tongue/mouth and noted that back of the mouth was edematous and unable to visually see the throat. 12:11 pm, 0.3 mg of epinephrine administed by EPIPEN into right lateral thigh. EMS arrived at 12:15pm. Patient assessed by EMS and agreed to transport to Hospital for evaluation. EMS and RN assisted patient to stretcher for transport. Nursing Supervisor, with Health District notified by phone by RN.
My COVID-19 symptoms started on 02/18/2023 over night my symptoms got worse. I had a sore throat, cough, exhausted, headaches, and body aches. I tested with home COVID-19 test with was positive on 02/19/2023. I waited  for 1 hour and tested positive again. I send a message to my doctor that evening. I explained to him about my symptoms and how I was feeling. He called me on Monday and prescribe me  Paxlovid for 5 days.  I have not recovered fully. I still have respiratory congestions, cough,  headaches, and tiredness.
4/22- within minutes I felt dizziness and unsteady but was sporadic. As the day continued, became more fatigued. 4/23 - Continued with previous symptoms and added headache, more fatigue, nausea, and chemical taste will all food/drink 4/24 - Continued with above symptoms and added: muscle aches, joint stiffness, extreme nausea and vomiting and weakness, severe fatigue. Went to ER for evaluation. (see below) Received IV fluids and Zofran In the 3 days since the ER visit, I am still unable to eat any solid food and can only drink after taking Zofran
Mom reports pt had a sz approx 1 hr p/shots; lips turned bluish purple, mom conveys pt cried during sz; 12AUG91 MD reported pt did not sz but was shaking, chilling; To ER observed & had no recurrent problem;
chills; body aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 08:30 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1 SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 28May2021 16:45, outcome "not recovered", described as "chills"; PAIN (non-serious) with onset 28May2021 16:45, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 28May2021 16:45, outcome "not recovered", described as "Headache". Therapeutic measures were not taken as a result of chills, pain, headache.  Additional Information: The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021 at 16:45, 6 days after second vaccination, the patient began to experience chills, body aches and headache, lasted three days. The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
103 F fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: PYREXIA (non-serious), outcome "unknown", described as "103 F fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After every Pfizer COVID vaccine he gets 103 F fever and was out from work for 2 days. After 2 days, the patient returned to baseline. The event took place after use of product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling and erythema of the upper arm after w/pain  after booster shot. TX: supportive ? of warm compress.
SYNCOPE; CUT ON LIP FROM THE FALL; FELL; This spontaneous report received from a pharmacist concerned a 27-year-old female. The patient's height, and weight were not reported. The patient's past medical history included syncope (when she had blood draw), and concurrent conditions included fear of syringes. Patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination into Right Deltoid. No concomitant medications were reported. On 19-MAY-2021 HCP (Health Care Practitioner) reported that the patient experienced syncope after receiving the vaccine. Patient fell face down for about 5 seconds from a sitting position seconds after receiving the shot. HCP called 911. The patient experienced cut on lip from the fall. Emergency medical services mentioned it was syncope and patient did not need to go to the hospital as patient seemed to have fully recovered. HCP reported the patient mentioned this had happened to her before when she had a blood draw. She had a fear of syringes. Emergency medical services advised patient to lie down for blood draws and shots in the future. HCP did not administer any other medications to the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 19-MAY-2021, and the outcome of fell and cut on lip from the fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210540040-COVID-19 VACCINE AD26.COV2.S- Syncpoe. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
The day after my second dose (March 23rd), I experienced a very sore arm, felt feverish and too nauseated to eat evening meal.
Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, pertinent medical history or drug reactions/allergies. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M021407 with expiration date 30-APR-2018; dose unknown, route was not reported). The vaccine was exposed at 35 Fahrenheit for 24 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient reported she had a few symptoms from previous vaccine (Tdap and flu) where her arm got numb 4 hours later.   Vaccine administered at 3:11p.,m.. Patient reported feeling short of breath nurse was called out to car.  patient alert and oriented X4, skin pink w/d, at this time started complaining of not being able to swallow and holding her throat area.  Oral Benadryl 5omg administered where patient continued to complain of difficulty of swallowing and visibly looked like she was having trouble.  4:01 p.m. Epi-pen administered and 911 called.  Patient never lost consciousness but continued to complain of not being able to swallow.  Ems arrived and transferred care.
Patient states that she is experiencing a headache, low grade fever 99-99.7, neck and shoulder soreness and is 12 weeks pregnant.
Loss of consciousness.  Pt apparently has a history of  "syncopal" reaction after vaccinations. She received the vaccine and then was in waiting area when she blacked out. Just for about 10 seconds then she recovered with full awareness. Vitals 111/75 b/p, pulse 78 and SaO2 was 99%. Given water and a cookie. Did well. Vitals good with standing. She felt better then left
I started with a sore throat and then I got a headache and a cough. I tested positive for COVID-19 on July 27, 2022, with an at home test. I contacted my doctor on the same day and describe my symptoms. He offered me Paxlovid and I decided not to take it at the time and the next day I was feeling much better. The fever kept coming and going for two weeks straight.
only received part of it due to error. I got the diluent half.; only received part of it due to error. I got the diluent half.; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2022, the patient received the 1st dose of Shingrix. On 28th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.      Additional Information: GSK receipt date: 03-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received his/her first vaccination of Shingrix on Wednesday (from the date of reporting). Today (on the day of reporting), the healthcare providers nurse called to inform him/her that only received part of it due to error. The patient got the diluent half. They said to return in 4-6 weeks to get the shot again. Additional Supportive information: The patient received first dose of shingrix vaccine and the reporter (Nurse)informed to him /her received only part of it due to error. The patient got the diluent half, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication
Post vax, the pt had a febrile seizure thought to be due to viral illness and left otitis media. Seen in ER and treated with Amoxicillin for otitis media.
Vomiting  Information has been received from a physician concerning an infant who on 25 September 2006 was vaccinated with a 2 mL PO dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine).  Subsequently the patient "threw it up".  The patient was not experiencing any known symptoms.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
6/15/2021 started with chest pain after second Pfizer COVID vaccine (given 6/12/2021), elevated troponin. resolution of symptoms. treated for suspected myocarditis. received  toradol at outside hospital and then motrin q6h. No ECG changes, normal echo
lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448; lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448; This is a spontaneous report from a contactable consumer (patient) reported that a 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Feb2021 as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for Covid-19 immunization. The patient mentioned that he received the 2nd dose on 11Feb2021 and about 2 or 3 weeks after, on 04Mar2021, he went in with his doctor for his semi-annual check up and had laboratory work done. He got his results just last weekend and it was noted that all of his lipids went way up high, particularly his triglycerides which were "extremely out of whack" and went up to 448. The patient's triglyceride and all of his lipids were elevated and he wondered if the vaccine might have affected his triglycerides and his other lipids. He was feeling well as of calling and was scheduled for a revisit with his doctor in 3 months. He was asking if that was a side effect of the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Initial report received from another manufacturer on 25 August 2008 who received the report from a health care provider.  An 18-year-old male patient had received a dose of ADACEL (lot number, route/site of administration not reported) on 11 August 2008 and fainted after an unspecified amount of time following vaccination.  The patient was revived and fully recovered within minutes.  No other symptoms were noted.  No additional details were provided.
exp aches, pains & myalgias;devel paresthesia;to MD told had viral illness given ATB;next day adm to hosp w/GBS;CT scan revealed poss infarction or small arteriovenous malformation;walking w/canes;unsteady gait-balance off; BP 160/110;
Patient stated she had flu like symptoms beginning the evening of administration. ...fever, chills, headache. She then stated that last night 4/10 her fever broke but she broke out in a rash from chest to jaw area.
brief vasovagal syncope followed by nausea and vomiting x 3 hrs.
Information has been received from a health professional concerning a 17 month old female with heart disease and asthma who on 16-SEP-2003 was vaccinated subcutaneously with the first dose of VARIVAX (Oka/Merck) (Lot #644145/0327N). Secondary suspect vaccination included MMR II (LOT #644843/1229M), DTAP, ACT HIB and PREVNAR. The health professional reported that the patient experienced zoster on chin and cheeks and mostly in the temporal region, for which the patient received no treatment. The patient did not seek medical attention. This is one of several reports received from the same source. No further information is available.
Employee reports presenting nausea, dizziness, mild cold symptoms and head ache one day after vaccine. Took TYLENOL but didn't help. Patient saw PMD for PE two days after vaccination who noticed swelling "in underarm region" while performing breast exam. Swelling lasted 2 days. Nausea, dizziness, cold symptoms and HA lasted 1 day.
Elevated heart rate and blood pressure, with dizziness, shakiness, sweating, headache, palpitations. Patient monitored for 50 minutes, given water and snacks. Released home with husband.
Severe abdominal pain on 6/5/21 off and on from 8:30am through 6:30pm. Went to Hospital Emergency Department. They performed blood tests which showed some inflammation (but obviously don?t know where) so they performed an Abdominal US which was normal. Patient continued to have severe abdominal pain and they proceeded with a CT scan with and without contrast, which was also normal. They couldn?t say if it was a reaction from the vaccine but possibly, since everything was WNL.
Diagnosed intussusception treated at hospital.  6/24/08 Reviewed hospital medical records of 5/15-5/20/2008. FINAL DX: Ileocolic intussusception, surgically reduced.  No d/c summary available. Records reveal patient experienced crampy abdominal pain, vomiting X 2 days. Seen in outlying ER, dx w/IS & transferred to higher level of care.  Air contrast enema demonstrated IS but unable to reduce.  Taken to OR for manual reduction & appendectomy.  Had been seen in ER on 5/12-13 for crying & non-bilious vomiting.  Tolerated PO fluids at that time & d/c to home.
Patient says she couldn't lift arm above head for about 3 weeks and now a decrease in range of motion of left arm. Prescriber suggested patient to take OTC pain medication.