chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 90-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, 14 days after receiving SHINGRIX, the patient experienced leg pain, swelling of legs, walking difficulty and knee pain. The patient was treated with Ice Pack (No Medication). On an unknown date, the outcome of the leg pain and knee pain were unknown and the outcome of the swelling of legs and walking difficulty were recovered/resolved. It was unknown if the reporter considered the leg pain, swelling of legs, walking difficulty and knee pain to be related to SHINGRIX. Additional details were provided as follows: Around 2nd or 3rd October 2018, the patient received 2nd dose of SHINGRIX. About 2 weeks later, the patient developed pain in upper part of his leg and he had difficulty walking. Then the patient developed swelling in his leg and severe pain went down to his foot. The patient saw his physician and they tested for a blood clot which was negative. It was 3 weeks till the time of reporting after the event started and he still had pain in his left foot, left lower leg and left knee if he touched it. It does not usually hurt with regular activity. The swelling went down within about 24 to 36 hours after it peaked, but it did onset gradually. The patient was treated the swelling with ice packs. The reporter did not consent to follow-up.
Chest pain, mild fever, increased heart rate, headache, increased blood pressure prompted call to pediatricians office and subsequent visit to ER.
Patient presented to clinic with mom. Patient seen and evaluated. Per mom, patient received vaccines on 6/6/2023. She developed a red bump at site of injection that has not gone away. No fevers. Normal po intake and activity. Otherwise acting normally. Patient in NAD and very social. Examination revealed a 2 X 3 cm erythematous raised area. It is not warm and does not seem to be tender to exam based on patient's response to it being touched. There is no fluctuance. There is no inguinal LAD. Lungs are CTA with good air movement. Exam consistent with localized vaccine reaction. Conservative therapy recommended with instructions to seek care if it does not improve within 7-10 days, or any worsening symptoms. Staff instructed to report the reaction through VARS
Patient in office today, received Prevnar-13 and high dose influenza vaccines. He went home and took a nap.  Woke up and at dinner could not grasp a utensil or feed himself. It is bilateral hands. This hand weakness persists at 18 hours later.
Patient tested positive for COVID-19 after completing the full Pfizer vaccine series, 71 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/20/21 .   Tested positive on 4/1/21.   NOT hospitalized. "Symptoms reported: fatigue, runny nose;  Symptom onset date: 4/1/2021"
I received the shot a little after 5pm.  Afterwards my arm hurt, I was tired, and my head hurt - all expected.  However at 7pm I could feel something strange spreading across my face.  My left side of my face became numb and swollen.  I went to urgent care the next day and they said I had inflammation in my facial nerve and prescribed me prednisone.  I'll be on the prednisone for another 8 days, tapering.  My face and head have continued to be numb and swollen.  Today for the first time, it feels a little better.  Today is a week since I received the vaccine.
I had COVID-19 in June of 2020. I was unvaccinated at the time, and I was sick for around 6 months. During, and since that, I have had 20 -30 heart palpations a day. I had my first vaccine March of 2021, my second in April of 2021, and then I got COVID-19. In June of 2022, I was still having heart palpitations. I had an ultrasound and they found valve damage which they are attributing to COVID-19. I have had 2 booster shots since then. In March of 2023, I started having heart pressure. They did an EKG and found heart enlargement. I then had my next booster in September of 2022. I have another ultrasound and stress test scheduled for later this year. During all of that time, I was not on any medication. In April of this year, they put me on a reflux medication to see if it was causing the heart pressure. I will say, that each time I received a vaccine, it seems that the heart palpitations slowed down.
The patient is a 54 y.o. female with history of hypertension, migraine who presents for evaluation of chest pain.  Patient reports that she received a Covid vaccine yesterday in her left arm.  Today, the patient reports onset of substernal chest pain, aching nature, nonradiating, without alleviating or exacerbating factors.  Patient denies a prior history of chest pain is unsure if it is related to the diffuse body aches from the recent vaccine.  Patient reports that there is achiness also in her left upper extremity, which she reports is likely due to the vaccine.  No associated shortness of breath.  No fever.  No cough.  No prior cardiac history.  No history of DVT or PE.  Patient with remote history of smoking.  Patient also with a family history of cardiac disease.
Left arm had redness, swelling and warmth to injection site.  Patient came to PCP on 04/20/15 to report symptoms.  Advised to take Benadryl as needed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 at 15:30 as dose 1, single (Batch/Lot number: unknown), in right arm, on 25Feb2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 12Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 24Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+" (unspecified if ongoing). Concomitant medication(s) included: BIKTARVY, start date: 09Jan2009. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022 at 12:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient had no Known Allergies. Other medication in 2 weeks were reported as, yes. Anti-viral details for Covid 19 Treatment with Pfizer Paxlovid, Treatment start date was 13Jun2022 and Treatment stop date was, 18Jun2022. Indication was, Treatment of COVID-19. Adverse Events were, Horrible taste in mouth, diarrhea, muscle and joint pain in back and legs.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA192700, 2019SA193109, 2019SA193112, 2019SA193110, 2019SA193113, 2019SA193107, 2019SA193106, 2019SA193105, 2019SA192698 and 2019SA192699. (Same reporter).  This case involves a 9 months old female patient who received 0.5 mL dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (lot UI969AAB, expiry date- 04-Apr-2020) via intramuscular route in unknown administration site on 28-Jun-2019, which was previously exposed to temperatures below 32 degrees F.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 48 year old female patient with Erythromycin and Morphine reactions/allergies. Pertinent medical history was not reported. On 08-NOV-2013, the patient was vaccinated with PNEUMOVAX23 lot # J004747 exp date 20-JUL-2014, 0.5 ml, intramuscular for immunization. Concomitant medication was not reported. In November 2013, the patient experienced swelling around the injections site, about 7 inches in length, redness and pain. The patient did not seek for medical attention. No treatment was given for the events. No lab diagnostics performed. The outcome of swelling around the injections site, about 7 inches in length, pain and redness was reported as not recovered. This is one of two reports from the same source. Additional information has been requested.
This case is part of a cluster of three children who received DAPTACEL (lot number C3718AA) and each developed vaccination site and/or localized reactions. Initial report received on 27 April 2011 from a health professional. A 5 year old female patient, with no known allergies and no concomitant medications, received a fifth left deltoid intramuscular injection of DAPTACEL (lot number C3718AA) and a fourth right deltoid intramuscular injection of IPOL (lot number G1068-1) on 19 April 2011. The patient had no illness at the time of vaccination. On 20 April 2011, the patient had swelling, redness, heat, itching and blisters on the left arm. By 23 April 2011, the blisters were gone and the other symptoms remained with swelling to the elbow. The patient's recovery status was unknown. Follow-up information was received from a health care professional on 27 May 2011. The patient's outcome was reported as recovered (date not reported). The events for the other two children are captured in cases 2011-02508 and 2011-02510. Documents held by sender: none.
Information has been received from a certified medical assistant concerning a 5 year old patient with no pertinent medical history or drug allergies, who on 16-JUL-2007 was vaccinated with a 0.5mL SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 126F). There was no concomitant medication. On approximately 18-JUL-2007 the patient developed a raised red bump at injection site, and symptoms described included being itchy, hard, and warm to the touch. No labs or diagnostic studies were performed. The patient was treated with topical antihistamine cream for the itch. Subsequently, the symptoms resolved and the patient recovered. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested.
Autism. Severe depressive and receptive language delay. Does not understand new words each week. Does not recognize names of body parts. Difficult to manage; kicking and screaming. Does not interact with teacher or classmates. Inability to follow commands; unable to play with toys presented. Becoming increasingly frustrated and crying. Bangs head and hits himself.
8 year old female presented with fever and vesicle in back of left ear, on scalp, and forehead. 2-3 vesicles on back and abdomen. Also complained of headache. T 100.7 PO.
Child developed a fever at daycare the day after receiving Hepatitis A vaccine.  He was taken to ER after having a febrile seizure. His temperature was 101.7 when arriving to the ER.  Physical exam was completely normal so there was not another reason for a fever or seizure. He is going to follow up in our office tomorrow 05/12/21. We have not received the records from ER.
Vomiting (1/9) in the evening; mild headache, body aches, fatigue  (1/10)
This spontaneous report was received from a healthcare worker professional referring to a unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients' were vaccinated with an improperly stored dose of GARDASIL 9 lot # L045711 with expiration date of 08-MAY-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. The healthcare worker stated, the GARDASIL 9 was exposed to a temperature excursion of 11.8 degrees C for a time frame of 2 hours and 35 minutes. I was called due to a data logger. Previous excursions also were reported, with a minimum of temperature of -0.3 degrees C for 15 hours and 42 minutes and a maximum of 11.8 degree C for 18 hours 55 minutes. Furthermore, no adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT said her arm was itchy and it was burning and felt a little drowsy..  Had her sit awhile.   she said she was feeling a little better.  Told her to put on a cold compress when she got home.  I called her at 8 oclock and she said it still itched but it was getting better. will follow up with her tomorrow
pt recv vax OCT96;pt also taking zocor, cardizem, inderal & carafate;3wk p/vax pt devel flu sx from which pt subsequently recovered;6wk later exp similar sx but worse which included myalgia, cough, wheezing & t102;pt has not yet recovered;
A increased heart rate of about 100bpm started roughly 20 minutes after injection. This lasted for about 24 hours before lowering to the more regular rate around 70-80bpm.
Approximately 5 minutes after receiving shots, patient walked to front of office and was standing at front desk when he fell backwards and fainted. He had a loss of consciousness for approx 1-2 minutes then recovered. He was still very confused and complained of pain so he was sent to the ER via ambulance where a normal head CT was done and patient was diagnosed with concussion.
Redness with swelling and tenderness developed at site of Varicella vaccine on right upper arm one day after vaccination.  Seen in office 8/26.  Area much improved per mother but still a red area, about size of 50 cent was present.
Initial unsolicited report received from a physician on 17-Jul-2015. A 49 years old male patient, whose medical history and concomitant medications were not reported had received first dose of DIPTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (batch number: U5235AA, expiry date not reported) in his left deltoid on 13-Jul-2015. Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were reported as NKA (No known allergies). Illness at the time of vaccination was reported as none. On 14-Jul-2015, a day after vaccination patient experienced pain in his left arm and elbow with decreased range of motion. The patient required Emergency Room visit. It was reported that there was some improvement on the next day as there was a limited range of motion in elbow. Laboratory investigations and corrective treatments were not reported. At the time of this report the outcome of the event was recovering. Documents held by sender: none. Follow up information received from physician on 28 August 2015. The patient did not receive any vaccine four weeks prior to date of 13 July 2015. The patient did not have any known allergies and birth defect was unknown. Patient medical history reported as non-contributory with no prior chronic condition. On an unspecified date the patient was recovered from the events.
This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 10/06/22 Pt was given the PCV13 and the Influenza vaccinations (Inactivated or Recombinant) simultaneously. We were not given the paper work on these vaccinations until after they were administered.  On 10/07/22 around 6pm Pt had a seizure. He wet himself, started drooling, was unresponsive, his lip drew to one side, and he was very hot. We took most of his clothes off to cool him down and tried to get him to respond but it was apparent he couldn't. This lasted approx. 10 mins. Eventually he was able to talk to us and slept for an hour afterwards. I also noticed his entire thigh were the PCV 13 Vaccine was administered was very red. I (his mother) had seizures when I was his age; due to this, had we been given the paperwork prior to administration of the vaccinations (which clearly states seizures are an adverse affect if the influenza and pcv13 if they are given simultaneously) we would not have consented. We feel the doctor should not have administered these two vaccinations simultaneously to our son, knowing the adverse affect it can have and we are currently in the process of finding a new physician for him.
TWO DAYS AFTER DOSE OF ENGERIX-B ONSET OF ARTHRALGIS, MYALGIA, FEVER TO 104 F,CHILLS, MALAISE, FATIGUE, LOW GRADE ANOREXIA. 5-7-90 FEVER,HEART RATE 105(RESTING).TYLENOL FOR FEVER. SYMPTOMS SUBSIDE AFTER 14 DAYS. PT VERY ILL DURING 14 DAYS.
Now testing positive for COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Now testing positive for COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Now testing positive for COVID). At the time of the report, COVID-19 (Now testing positive for COVID) outcome was unknown. Not Provided          No Concomitant medications were reported.  No Treatment medications were reported.
pt recv vax 21MAY98 & 22MAY98 2 spots appeared around neck on 23MAY98;child was covered w/lesions over 200 per dad;pt has not been to office since 21MAY98;
The patient received a flu shot yesterday morning 10/16/18. The patient called back and said that they had a reaction to the flu shot. They told male that their arm had turned red and swelled and formed a "welp". They also said that they felt "sick". The patient then called back later in the day and said that they were feeling better and that her arm was getting better.
Numbness in right hand 2 hours after shot.  Cotton mouth about 20 min after shot
Patient collapsed shortly after given vaccination; has a history of syncope due to needle phobia and stated that this has happened in the past during blood draws. EMS was called and patient had normal vitals upon being checked. Epinephrine was not administered.
chest hurt; trouble breathing; My blood oxygen level was at 88. It is normally 97 or 98.; feeling cold; dizzy; couldn't walk hardly at all; shaking violently; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old male patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot number and expiry date was not reported) via an unspecified route of administration at arm left on 06Mar2021 10:00 (at the age of 71-years-old) as a single dose for covid-19 immunisation. Medical history included refractory anaemia with ringed sideroblasts, Myelodysplastic syndrome with ringed sideroblasts, tardive dyskinesia from an unknown date and unknown if ongoing. Concomitant medication(s) included DE tetrabenazine, levothyroxine sodium, sertraline, metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications in two weeks: Austedo, levothyroxine, sertraline, metformin, vit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have known allergies. He had MDS with RARS and tardive dyskinesia. He had his 2nd dose on 06Mar2021 at 10:00 AM. He went home feeling fine all day. He went to bet and woke up at 11;55 at night, shaking violently. He was feeling cold. He got up very dizzy, couldn't walk hardly at all. Went back to bed shaking. He finally fell asleep. When he awoke in the morning his chest hurt, front and back, trouble breathing. His have a pulse oximeter from his wife who passed away from COPD 2 years ago. He bloods oxygen level was at 88. It was normally 97 or 98. It was now Monday 08Mar2021. He feels better not 100% but significantly better. His question was should the vaccine lower your blood oxygen level, he knows that if someone had COPD it may have killed them. He hasn't felt that bad in his 71 years. He probably wouldn't have gotten the 2nd shot if he knew this was going to happen. No treatment was given for adverse events. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Woke up at 3:30 with nightsweats so bad that the sheets were soaked. Could feel sweat running down my back and legs, hair drenched in the morning.  Monday and Tuesday had chills, shivers, fever, hot flashes, fatigue, loss of appetite, food tases off, head felt like I wasn't getting enough oxygen and constantly felt vertigo, couldn't catch my breath. Night sweats continued for the next two nights. Soreness form the injection was extreme and even moved to the lymphnodes in my armpit.
I have been dealing with migraine and pain through my whole body; Pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  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: MIGRAINE (non-serious), outcome "unknown", described as "I have been dealing with migraine and pain through my whole body"; PAIN (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Was it possible for the covid vaccine to cause pain throughout my whole body ever since I got my 1st dose I had been dealing with migraine and pain through my whole body all my labs and testing come back normal my family Dr can't figure out what's wrong with me the only thing I had done was get vaccinated and now I'm like this.