chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine and left clinic area with his mother. After 8-minutes, this Provider was called with reports of someone who had collapsed. When this provider arrived, Patient was sitting upright on the floor with his mother by his side. He was alert and oriented to person, place, time, and situation. He was answering questions appropriately but felt lightheaded and nauseaous. Assisted patient to a laying-down position and elevated patient's feet to maintain blood pressure. Asked patient's mother if she would like for this provider to call an ambulance, and she declined. She stated that he has a history of passing out after vaccines, and this was not communicated to this provider previously. Mother states he was walking and then felt dizzy and lowered himself to the ground. He did not hit his head and there were no injuries. He did not lose consciousness, but mother states he stopped responding to her for about 30 seconds. After ensuring patient was stable, this provider returned to clinic to obtain blood pressure cuff. BP was 112/58 and heart rate 72. After several minutes, assisted patient back to clinic area and had him lay on an exam table. Patient nauseous and vomited a few times. Patient given a water bottle, and pt's mother bought candy for quick-acting sugar. Patient stated he had not had anything to eat and drink today. Patient remained in clinic and monitored for one hour until he felt okay to walk out to car. It was offered several times to call an ambulance, and pt and mother declined. Advised patient and mother to rest and get something to eat/hydrate upon leaving. Strict precautions were advised as to when to seek emergency medical attention. Pt and mother verbalized understanding.
right side face swelling (cheek), tachycardia and blood pressure of 161/121. Administered epinephrine and called 911, recipient was taken to an emergency room
I spoke with PUI sister PUI 2618857 who advised the PUI was released from  the facility. She believes the PUI may have contracted COVID from the facility. She reported the facility advised her no visitors were allowed because they've had an RSV outbreak. PUI is hospitalized as of 08/11 - moved to ICU  but now released to Med Surge floor. PUI has congestive heart failure and a number of other health issues.
Information has been received from a consumer referring to his 27 weeks old son. The patient's concurrent or historical condition was not provided. On 30-MAY-2016, the patient was vaccinated with first dose of ROTATEQ (oral, dose and lot number unknown) (drug used for unapproved schedule). Concomitant therapy was not provided. According to the doctor's instruction the date of 2nd dose was 30-JUN-2016. But the reporter came to known from Merck website that, the 3rd dose should be given before 32 weeks of age. His son's age was 32 week plus 3 days on 01-JUL-2016. His 2nd dose was still pending. Additional information has been requested.
12/01/2011 Rash started appearing randomly all over body. Mild, generalized papular rash on arms, chest and back appearing like pinpoint scabs. No vesicles or discharge. Less than 50 lesions. Patient is advised to clinic in 2 days for a follow up.
large ileocolic intussusception complicated by bowel perforation requiring surgical repair and ileostomy, also complicated by Acinetobacter radioresistens bacteremia.
The morning after the shot, patient experienced chills and developed a fever >99-degrees F. Around 1pm the fever reached 103-degrees F. Reporter advised patient to take 1000mg acetaminophen, and apply a cold washcloth to forehead, then recheck in 30 minutes.
Extreme sudden onset fatigue, fever of 101.2, chills, joint and muscle pain throughout, nausea, headache, sensation of heart pounding, HR elevated from my baseline of low to mid 80s bpm, although still wnl (93-97bpm and regular).  My baseline HR of 80s is due to being 30lbs overweight at this time.  When at my normal weight, HR is in 60s-70s.  Sensation of being in a fog, difficulty retaining simple self-test at home Covid-19 antigen rapid test instructions, needing to go back to instructions over and over. O2 saturation is 99%  according to my home pulse oximetry.   Rapid test was negative.   I also feel like my BP might be low, but can't seem to get the cuff on due to the severe fatigue and weakness.  No one available to do it for me.
Right ankle pain; bruise; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 13Apr2021 09:15 (Batch/Lot Number: EW0162), at same age, as single dose for covid-19 immunisation. Medical history included Non-Hodgkin's lymphoma 9 years ago, prediabetes, and chronic migraines. Concomitant medications included metformin; simvastatin; and levothyroxine sodium (LEVOTHYROXIN). The patient experienced right ankle pain, and bruise on 14Apr2021 09:45. No treatment was received. No covid prior vaccination. No covid test post vaccination. No known allergies. Patient is not pregnant at time of vaccination. The outcomes of events were recovering.  No follow-up attempts are needed. No further information is expected.
Pt recvd flu vax 25OCT89 & on 16NOV89 had complete iridoplegia (pupil dilated) in eye having the cataract surgery; MD thinks flu shot responsible for the adverse event;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 31-JUL-2013 the patient was vaccinated with M-M-R II  lot # 1119AA (expiration date 12-JUL-2013) (albumin status: HSA). No concomitant medications were reported. It was reported that a dose of expired M-M-R II was administered "today" (21-JUIL-2013). No adverse effects were reported. No further details were provided. Additional information has been requested.
Intermittent chest pain/Chest pain every 20 to 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Intermittent chest pain/Chest pain every 20 to 30 minutes) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced CHEST PAIN (Intermittent chest pain/Chest pain every 20 to 30 minutes). At the time of the report, CHEST PAIN (Intermittent chest pain/Chest pain every 20 to 30 minutes) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided.   This case was linked to MOD-2021-375118, MOD-2021-375044 (Patient Link).
Employee has an unwitnessed fall landing on her back statin she hit her head, no loss of consciousness.
Pt was administered Prevnar 20 instead of Prevnar 13 per CDC guidelines. Pt is fine no signs or symptoms of any kind. Mom has been informed of the error. Pt seems to be doing just fine. Still no signs or symptoms
Hives on arms, legs, abdomen and back.  Feeling itchy.  Lasted for 2 days.  Gave Benadryl to address the itchiness.
Redness and itching at injection site Severe joint pain in neck, shoulder, hipd, knees, ankles for 36 hours
Aches and headache started after dinner the day of the shot. Slightly elevated temperature by around 10pm (99 deg F). Escalating fever and chills throughout the night, reaching at least 100.4 F. Cranial pressure and aches throughout Monday, as well as fatigue (more than just due to bad sleep). Monday night had more chills (did not check for fever) and aches. Tuesday morning felt ok enough to go to work, but by 11:30 chills set in again. Measured a temperature of 101.6 F around 2PM. Fever, chills, and aches continued into the evening. Tuesday night experienced sweats, but no chills or aches. By Wednesday all symptoms had resolved.
Moderate to severe headaches with  severe fatigue for about 36 hours; started 1-2 hours after shot; took 200 mg OTC ibuprofens and rested. Recovered without problems.
Initial report received from a health care professional on 28 May 2010. A 6-month-old male infant, with medical history not reported, received an injection (route and site not provided) on 06 May 2010 of PENTACEL, lot number C3557AA, and developed a febrile seizure and was hospitalized overnight and released. The outcome was not reported. Documents held by sender: None.
pt recvd vax 7SEP94 & exp black & blue area @ inj site,poss fever,stomach cramps,nausea,h/a;9SEP94 exp large red area @ inj site,which was painful;swollen area inj site,cellulitis,dizziness,BP 155/97;pressure behind eye;+ketones urine
Pts right arm was swollen and red 12cm X 12cm, accompanied by a fever. Pt had blotchy red on polio arm at site. 3 day post vax the affected area measured 11cm X 12cm with pain and headache.
I got up with a sore throat, with a headache. I was hosting the book club at house that day, so I thought I need to test to make sure that I don't spread anything to anyone. The home COVID-19 test came back positive; I called the doctor's office, spoke to the nurse. I was prescribed PAXLOVID. The PAXLOVID helped me to recover. I feel much better now, I feel that having to be in bed for five days has thrown my back out and I am still having problems.
I experienced a breakthrough case of COVID-19 with heavy congestion, coughing, sore muscles and upset stomach.
I have pain at the injection site on my left arm. It is almost 3 months later.  I feel it mostly at night if I roll over onto that arm but I also feel it sometimes during the day.  I can "bear" it but thought I should report this as an adverse effect.
I had a cough, runny/stuffy nose and sore throat before getting the booster, and it ended up getting worse. I went to the doctor soon after getting the booster and was diagnosed with an upper respiratory infection.
Patient reports feeling very hot and throwing up twice two hours after his vaccine.  He had not eaten anything today and he was safely at home.  When he called the pharmacy, he was feeling better.  The pharmacist guided him on next steps.
4 pox to back, chest, face, arm and 4cm x 6 cm welt at the site of injection.  Treatment: unknown.
Started on 10/2/21 with a nose bleed.  We were able to get the bleeding stopped at home.  Started bleeding again on 10/3/21, it took longer but we got it stopped and it did start bleeding again later in the day just not as bad.  Monday, 10/4/21 could not get the nose to stop bleeding.  It was pouring out of his nose.  Called 911 and went to Hospital.  They were unable to stop the bleed and ended up packing.  Were told to follow up with primary care dr in 48 hours.  Wednesday 10/6/21 - went to primary care dr and he took out the packing.  About 1:00 pm on Thursday 10/7/21 it started to bleed again.  We contacted his ENT and made an appointment for Friday.  They were able to clean the nose and cauterize the bleed and it has been fine since.  Don't know that this was related to vaccine but he has never had an issue with nose bleeds in the past.
Within 30min of receiving Moderna covid vaccine patient felt intense burning pain under skin that moved from arm to face and torso, over the next week it spread to back of head, upper back, bilateral upper extremites.  Described as intense sunburn pain, severe and excruciating without skin rash, hives, blistering.  No neurologic deficits of weakness, motor dysfunction.
July 22, 2019 5:00 pm injection of Shingrix.  July 23, 2019 8:00 am Extreme headache, nausea, chills, very tired, redness and swelling at injection site (left arm). July 24, 2019 3:00 pm still have same symptoms but mild.
She received 2 hep b shots and 1 tdap shot between 2014-2015. No reaction then other than discomfort and fevers. 2018 dx with type one diabetes. No family history of it.
Systemic: Numbness (specify: facial area, extremities)-Moderate, Systemic: drowsy-Moderate, Additional Details: Pt did not want to get the COVID shot / employer mandated.  States she had an anaphylactic reaction to the flu shot and had numerous allergies.  I administered the shot, had her sit down.  I came back in about 2 minutes.  She said she felt numb and kept trying to close her eyes.  I told the other pharmacist to call 911.  I stayed with the pt and made her talk to me the entire time until EMS arrived.  They took her off in a stretcher
Within one week of receiving his one-year vaccines (MMR, Chicken pox) my son developed a fever (102 F) for two days, and the fourth night woke up screaming and unable/unwilling to open his eyes.  The baby felt cold, so we took his temperature rectally and it was 95 F.  We called the pediatrician and he directed us to the hospital emergency room.  They ran blood tests, and found no evidence of bacterial infection per conversations with the attending physician.  His temperature warmed to 98 F while at the hospital and we went home.  Over the next week his temperature dropped again (twice), but levelled out at ~96 F, but with no hospital visit.  He had blood culture work done the following week, but again they found nothing.  He has since been fine, and appears normal.  A friend who has a 2 year old boy, said the same exact symptoms happened within 1 week of her son recieving his one year vaccines (MMR + chicken pox), but the temperature drop was more excessive (93 F taken at the hospital).  04/27/2007 MR received for ER visit of 03/06/2007 for C/o infant waking up screaming and feeling cold to touch and hx. of cough x 3 weeks.  Initial rectal temp 94.9'F up to 99.7 2 hours later. PE: WNL except bilteral hyperemic TMs and clear rhinorrhea. DX:  Bilateral otitis Media. URI.
1 hour after shot, became apneic, eyes rolled up. Went to ER and had another episode there; jerking and stiffening, eyes rolled up. Attempted intubation. Gave phenobarbital and Ativan. No fever. Medical Records received on 1/20/2005 states dehydration and gastroenteritis. Follow-up information received from Product Quality indicated that the lot number, 197440F, was not a valid lot number for PREVNAR. Information regarding PREVNAR was received from a pediatrician via a company representative regarding a 4-month-old male patient who experienced a non-febrile seizure. At 4 months of age, the patient received a dose on 14-Dec-2004. The patient also received a dose of PEDIARIX (GSK) and a dose of PEDVAX-HIB (Merck) on 14-Dec-2004. On 14-Dec-2004, the patient experienced a non-febrile seizure. He was given "two rescue breaths" at home and was taken to an emergency room. The patient was then admitted to a hospital. The patient was then admitted to a hospital. An electroencephalogram and "electrolytes" were normal. Further treatment details were not provided. The patient recovered on an unspecified date. The reporting physician considered the event to be life threatening. The reporter indicated that, "no such reaction occurred at 2 month immunizations." Information regarding this event has been forwarded to Merck and GSK, manufacturers of the concomitantly administered vaccines. Information received from Product Quality indicated that the initially reported lot number, A7440F, was not a valid lot for PREVNAR. The physician's office was contacted on 18-Feb-2005, and another lot number was provided, 197440P (which was the only other number the office had recorded in the patient's chart). This lot number was also reported to be invalid by Product Quality.
About 6 hours after the vaccination, I began to experience flu like symptoms. I had a slight fever but did not check until the next morning. At that time, it was 100.0. At the onset, I had severe ringing in my ears. As of today (4/30/19 at 1 PM), I still have a lot of ringing in my ears. I pretty much felt lethargic until approximately 6:30 PM on 4/27. I had no energy and felt like a dead body. I also felt nauseous at times and a bit dizzy, but the dizzy part could have been due to the fever.
5 minutes after injection started to feel tingling of tongue and lips. After that felt tightness in my neck and chest. Went to ED for further monitoring and had a hive show up while being seen, within 10 minutes of receiving PO Benadryl.  For the following 4 days had onset of migraine headaches. Treated with oral diphenhydramine 50 mg and observed for about 1 hour.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (Severe). On 27th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles, pain, heat rash, myalgia and influenza-like symptoms. On an unknown date, the outcome of the shingles, pain and heat rash were recovered/resolved and the outcome of the myalgia and influenza-like symptoms were unknown. It was unknown if the reporter considered the shingles, pain, heat rash, myalgia and influenza-like symptoms to be related to SHINGRIX.  Additional details were provided as follows: The registered nurse reported this case for herself. The age at vaccination was not reported but it could be 55 years or 56 years. Sometime before Thanksgiving, the patient experienced very mild shingles. The shingles resolved after 3 days of intense pain, heat rash but no blisters. The reporter gave consent to follow up.
Patient reported no adverse reactions to 5th dose of Pfizer vaccine. Upon processing prescriptions administered during the day, it was discovered that patient had received an extra dose of the vaccine in error. Patient was contacted regarding this error but has not called the pharmacy back yet.
Information has been received from a nurse concerning a 14 year old female who on 09-AUG-2007 was vaccinated by "injection" (originally reported as orally) with 0.5 mL of the first dose of GARDASIL (lot #658554/0928U).  On 09-AUG-2007 the patient experienced vomiting, "within five minutes of receiving her first dose".  It was also reported that the patient received her second dose of GARDASIL (lot #659653/1448U) on 04-FEB-2008 and experienced vomiting "within five minutes of receiving the dose".  The patient sought unspecified medical attention.  Additional information has been requested. 07/08/08 Information has been received from a nurse concerning a 14 year old female with an allergy to "SEPTRA"/"rash" who on 09-AUG-2007 was vaccinated intramuscularly in the right arm with a 0.5 mL first dose of GARDASIL (lot # 658554/0928U). Concomitant therapy included ADACEL (lot # reported as "C2720AA") and MENACTRA (lot # reported as "U2386BA"), both administered intramuscularly in the left arm on 09-AUG-2007. On 09-AUG-2007, after the patient was vaccinated, she "immediately" experienced "nausea and vomiting". On 04-FEB-2008 the patient was vaccinated intramuscularly in the left arm with a 0.5 mL second dose of GARDASIL (lot # 659653/1449U) and the patient "immediately (originally reported as "within 5 minutes") had nausea and vomiting again". The nausea and vomiting subsided within 15 minutes. The patient sought unspecified medical attention. No further information is available.
PASSED OUT; SUNBURN FEELING IN VACCINE INJECTION ARM; SEVERE STOMACH ISSUES FOR A WEEK; UNSPECIFIED DISORDER OF JOINT OF SHOULDER REGION; FEELS LIKE NERVE DAMAGE; FEELING IRRITATED; FEELS LIKE THE HAIR ON ARMS HURT; ARM FROM SHOULDER TO PINKY FINGER HURTS IF SOMETHING TOUCHES IT; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, patient passed out. The patient had severe stomach issues. The patient's arm that she received the vaccine in, felt like a sunburn- no redness, rash or swelling. The patient's arm didn't hurt unless something was touching it. It was not hot to the touch but felt very strange and very sensitive from her shoulder all the way to the tip of her pinky finger on the outer portion of arm. It was very sensitive even when washing the hands. The patient felt like nerves have been damaged. It felt like hair on arm hurt. It fell irritated. These events didn't last as long-maybe a couple of days and it was gone.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, sunburn feeling in vaccine injection arm, severe stomach issues for a week, unspecified disorder of joint of shoulder region, feels like nerve damage, feeling irritated, feels like the hair on arms hurt, and arm from shoulder to pinky finger hurts if something touches it on 2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210525585.; Sender's Comments: V0;20210531194 -covid-19 vaccine ad26.cov2. s passed out. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Mom alternating Tylenol with Motrin since 4/27 then redness with peripheral urticaria on L buttocks, Left upper, Left thigh, right calf and right lower arm appeared. Contacted and seen by primary MD on 4/29.
Information has been received from a physician concerning a female patient of unknown age. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. In 2013, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU (strength, dosage schedule, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. The physician reported that the patient was seeking medical attention by contacting the physician and described the following symptoms "burning and pain in a dermatome fashion and this could possibly be Herpes Zoster" (herpes zoster cutaneous disseminated) that started on an unknown date. The physician reported that the patient had not been examined and did not have rash at the time of the call. It was unknown if the patient received treatment for the adverse event. No product quality complain was involved. At the time of reporting, the patient was not recovered from the herpes zoster cutaneous disseminated. The relatedness between the event and therapy with ZOSTAVAX was not reported. Upon internal review, herpes zoster cutaneous disseminated was determined to be medically significant. Additional information has been requested.