chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Only took 1 shot 1 day later, lip blisters like cold sores . Rash on arms ,legs back liquid fill blister rash, roof of mouth was like it had been burned. lots of bleeding from mouth. scaring this went on for months
consumer only receiving the Dtap-IPV portion and not the ActHib from pentacel, no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 6 months old male patient who only received the 0.5 ml DTAP-IPV portion and not the ACT-HIB] from vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot: UJ148ABA, expiry date: 03Feb2021, Act-Hib: lot: UJ148AB, expiry date: 03Feb2021, Vial: Lot: U6424BA, expiry date: 03Feb2021) via intramuscular route in the right thigh (anterior lateral right thigh), on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no 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 and Module VI of the 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.
Patient reported left arm, 3rd-5th digit numbness, depression, SOB, upset stomach, back pain, headache, and throat pain from day of receiving vaccine to today 9/20/21.
8 hrs after, severe numbness burning in arms and legs. Weakness in hands Numbness in facep
At 1841 client stated "I feel something in my heart." RN responded immediately. Client was already sitting on anti-gravity, alert and oriented x4. PHN  arrived at 1842. First vitals at 1842: blood pressure 107/70, pulse 94, oxygen sat 98%. Client stated she "felt palpitations, some pressure on chest and shortness of breath for a few seconds." Client denied dizziness, headache, chest pain, or blurry vision. Mother was primary historian and stated this is normal for client with anything that involves pain. Mother stated client has very low tolerance to pain. Per Mother the symptoms client stated were "her normal course". Medical history of anxiety, medication: birth control, could not recall name at this time, and allergy to Keflex. At 1844 client stated chest pressure was improving. Client denied chest pain or shortness of breath. Client alert and oriented x4, answering all questions.  Vitals at 1847: blood pressure 100/68, pulse 88, oxygen sat 99%. Per client, "feeling normal." Vitals at 1852: blood pressure 103/73, pulse 90, oxygen sat 99%. Per client "feeling fine." Vitals at 1902: blood pressure 98/65, pulse 82, oxygen sat 99%. Per client ready to stand and walk to observation area to meet rest of family. Client walked to observation area with steady gait. EMTstayed with client. Last vitals at 1912: blood pressure 99/61, pulse 85, oxygen sat 99%. EMT advised client and client's Mother on following up with medical provider and gave ER precautions. Client left facility with steady gait at 1915.
Vaccine was administered about 16 hours after vial was opened and vaccine drawn into syringe. Vaccine was get in refrigerator after being drawn up. No adverse outcomes or symptoms at time of report
Patient developed Chest pain at 0700.  Came on suddenly.  Pressure, squeezing and tightness that radiated up to his shoulder.
patient called me and said her arm was red, warm, and she had a rash the size of a person's palm around the injection site. I instructed her to go to her dr because it sounded like the signs of an infection. she went to her dr & got a prescription for cephalexin
they administered the expired diluent to a patient, with no reported adverse event; Initial information received on 03-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had administered the expired diluent to a patient, with no reported adverse event after receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5 ml once of suspect HIB (PRP/T) vaccine strength, formulation, expiration date and lot number not reported via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious event they administered the expired diluent to a patient, with no reported adverse event (product preparation error) (unknown latency).  Action taken was not applicable.  corrective treatment: not reported for the event (they administered the expired diluent to a patient, with no reported adverse event).  Outcome: Unknown for the event they administered the expired diluent to a patient, with no reported 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 the guidelines. 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.
First light dizziness increased to severe dizziness. Feeling the need to vomit  No ability to swallow Shortness of breath Rapid heartbeat (130) Paramedics took vitals blood pressure and heart rate.  I was asked to lay on gurney which I refused.  I sat in chair.  Paramedics monitored for 45 minutes until everything returned to normal.  Walked to car by paramedics.  Mom needed to drive home I was unable to.
This spontaneous report as received from a nurse refers to a male patient of unknown age. On an unspecified date in January 2017 the patient was vaccinated with ZOSTAVAX. On an unspecified date in 2017 the patient experienced eczema. The outcome of eczema is unknown.
nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown), administration date: Jan2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown, second vaccine shot 4 weeks later.), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown), administration date: Sep2021, for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown), administration date: Mar2022, for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown".  Additional information: Patient and his wife received the first Pfizer vaccine Jan2021 and second vaccine shot 4 weeks later. They received the first Pfizer booster Sep2021 and the second booster Mar2022. They got the new omicron booster 12Sep2022. They were so happy to remain COVID free until 5 days ago. They looked forward to the new vaccine to protect them from the omicron variant. Their symptoms have been nothing more that nasal congestion but wanted to pass on the information about the new booster fail.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200079864 same reporter/drug/AE, different patients;
Information has been received from a licensed practical nurse concerning a 25 year old female who on 27-FEB-2008 was vaccinated IM in the left deltoid with a first 0.5 ml dose of GARDASIL (Lot #660387/1967U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 28-FEB-2008 the patient experienced pruritus and developed urticaria and was treated with BENADRYL.  Subsequently, the patient recovered.  On 23-APR-2008 she was vaccinated with a second dose of GARDASIL (Lot #660387/1967U) and on 28-APR-2008 experienced pruritus and developed urticaria and was treated with BENADRYL.  The patient sought medical attention via telephone.  Subsequently, the patient recovered.  Additional information has been requested.
Within 24 hours after shot began experiencing severe stomach cramping, mild nausea and severe diarrhea. She became hypotensive requiring fluid boils and hypoglycemic requiring stress dosing for adrenal insufficiency. 18 hours after symptoms began is still experiencing severe diarrhea and gas.
Patient had a syncope episode on 7/20/12 at around 7:30pm, her pupils were dilated during & after episode, patient was sent to ER that night, from there they were sent to tx. for further testing.
Moderna on 8/12 and 9/8. Positive on 11/5
Joint pain; Muscle soreness; Headache; Sweats; Fatigue; This is spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP-7534), via an unspecified route of administration in the right arm on 17Mar2021 (at the age of 24-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included topiramate (MANUFACTURER UNKNOWN) and zolpidem (AMBIEN), both from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unspecified), via an unspecified route of administration in the left arm on 24Feb2021 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks, prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 15:00, the patient experienced joint pain, muscle soreness, headache, sweats and fatigue. The patient did not receive treatment for joint pain, muscle soreness, headache, sweats and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of joint pain, muscle soreness, headache, sweats and fatigue was not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
pt was innoculated with #3 dose of Phizer at 11:12 on Oct.2,2021. At 11:25 pt was sitting in observation when pt c/o chest pain,dizziness, weakness with slight shortness of breath- PT was A/OX3- EMS was notified by staff member - BP was 118/60 hr 68. at 11: 30 pt reported no change in s/s, BP 130/67 hr 60. at 11:34, EMS arrived on the scene- vital signs were taken:BP 133/84 hr97,  99% on RA, NSR on monitor- pt stated no change in s/s to EMS, who with pt consent.  transported pt via stretcher to local hospital. Pt remained A/OX3 throughout incident.
That evening 12/08/15 I had congestion, light muscle weakness and sudden, medium fatigue.  That has continued to date. By 12/09/15 morning I also had light headache, sore throat & light nausea.  Continued off and on to date. By evening 12/09/15 I had "Charley horse" cramping of lower right hamstring and aching in both hips (front of body).  That subsided after a few hours. During the night the nausea and muscle weakness increased.  My thighs were incredibly sore, as if I had been weightlifting (although I hadn't exercised at all in a week).  That continues through now. I also have medium abdominal pain but I think that's menstrual cramps.
Patient was appeared fine after vaccine.  She walked to her care with mom and seemed to have fainted. No one is sure if she lost consciousness. Pulse 92, respirations 20, B/P 120/60. She complained of headache and was transported via EVAC to hospital.
Itching, Redness, Slight swelling reported to pharmacy 9/11/2015 at 11:00 AM.
Providing report while still recuperating so final outcome TBD.  Some arm soreness at site of injection but normal activity and diet until 4 am with onset of chills, body aches, and other flu like symptoms. Temperature not measured but may have been feverish. In bed until about 1 pm, still on couch at 4 pm.
Not sure about the time this occured - pt stated he experienced extreme weakness/fatigue after a fairly short bike ride on Monday 8/17/15.
Pain, redness and mild swelling in the arm. Eye & joints pain, mild fever, feel sleepy, tired and bit sick (flu-like symptoms).
Foot swollen after 1st; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 14:00 (Lot number: EW0181) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PENICILIN" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: VERAPAMIL taken for blood pressure measurement. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "Foot swollen after 1st". The event "foot swollen after 1st" was evaluated at the physician office visit. Therapeutic measures were taken as a result of peripheral swelling.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events result in doctor or other healthcare professional office/clinic visit and treatment received for the adverse event was Water pill. The patient received Verapamil medications within 2 weeks of vaccination for Blood Pressure.  No follow-up attempts are possible. No further information is expected.
Suffered a stroke on 06/06 , temporary paralysis in the left extremities of the body, and loss of speech.
No side affected but patients mom stated he was 12 years old , but when reviewing the info he is 11 years and 11 month old
"The patient felt tired and dizzy and her tongue got tight"/anaphylactic shock; This spontaneous report has been received from a medical assistant referring to a female patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.         On an unknown date, the patient experienced anaphylactic shock, the reporter stated that the patient "felt tired and dizzy and her tongue got tight". The patient used an unspecified dose of diphenhydramine (BENADRYL), and subsequelty, recovered from the adverse event. The medical assistant, reported that the reaction was not life-threatening. At the reporting time, the causality assessment was not provided.  Upon internal review, anaphylactic shock was deteremined to be medically significant.
This was his second HPV vaccine.  This was more painful than the first.  It felt "like the needle was going to pop off".  Continue to have left arm pain after two weeks with weakness and difficulty lifting left arm.
Swelling, hot, itchy where shot was given, fever, dizzy, heart racing, pale, horse voice, dry cough, swelling of throat, light headed, itchy face, head and legs. Still experiencing itchy symptoms, swelling in hands feet and shot area. Swelling, hot, red and raised where the shot was given. Hives at times, shot area still red and sore. Hoarse voice, cough at times, swollen hands and feet. Itchy in various places, eyes head, arms, chin, mostly face.
I had the Pfizer COVID-19 booster (#3) on 10/16/2021.  In the following week, I developed terrible joint pain in the ankles and phalanges bilaterally. My feet do not hurt when I am sitting/lying.  If I try to walk --- they hurt!  I walk like I am 95 years old. I am not overweight (BMI: 20) and in the past have walked 5-7 miles/day.  I have been taking 600 mg PO 2-3 times/day prn --- it helps some but the pain is never gone.   So I may have undiagnosed arthritis. The literature says that COVID_19 vaccination is encouraged for those with arthritis (if I do have) -- it reduces the likelihood of spreading the virus, being hospitalized, or dying. In the meantime, I can hardly walk since receiving the booster ~ 1 month ago.
Information has been received from a registered nurse concerning a 47 year old male with no medical history and an allergy to codeine who on 02-NOV-2007, at 9:00, was vaccinated subcutaneously into the left arm with a second 0.5 ml dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655414/1470F). There was no concomitant medication. On 04-NOV-2007, at 15:30, the patient developed a two inch red circle around injection site that was reported as sore to the touch. The patient denied any nausea, vomiting, or fever, and there was no swelling. There was no illness at the time of vaccination. Unspecified medical attention was sought. No diagnostic laboratory test was undertaken. There were no reported adverse events following prior vaccinations. The patient recovered on 06 NOV 2007. A product quality complaint was not involved. Additional information is not expected.
Vagal loss of consciousness, patient lost conscious for 10 seconds, was placed in supine position and feet were elevated.  Patient regained consciousness and had no further difficulty.
This spontaneous report was received from a registered nurse and refers to a 21 year old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 18-SEP-2015 at 11:11 AM, the patient was intramuscularly vaccinated with a dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose was not reported) in the right deltoid which was under temperature excursion (reported as "too cold"). No adverse experience was reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence was received.
Within an hour I had quite a bit right sided swollen lymph nodes. Another hour or two later I started having tinnitus in my right ear.  I've seen a Provider and an Audiologist. The Provider they couldn't see anything structure wrong with my ear. The Audiologist told me I had mild hearing loss on the right side.  I will do a re-check in 6 weeks.
Small seizure at 1pm on 03/14/2021.  Followed by Grand mal seizure at 5:30pm on 03/14/2021.
No antibodies for Hepatitis B; This case was reported by a consumer via other manufacturer and described the occurrence of therapy non-responder in a female patient who received HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Engerix B. On an unknown date, more than 2 years after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 23-Jan-2023 Reporter's comment: The reporter is a patient reported an adverse event on behalf of herself. The patient reported five years ago received the Engerix B vaccine, recently healthcare provider tested patient's antibodies and there were none for Hepatitis B. The patient stated suffered from an autoimmune disease. Note: The dose number was not reported hence as per guide worst case scenario was considered and one suspect with blank dose number was coded in case.
I had second shot on Frdiay, March 19. I experienced headache and low fever around 100F next day. I took 2 advil and symtons were gone. I felt Okay on Sunday March 21 and took a walk around 30 mins afternoon wearing short sleeve t shirt. I woke up with itchy and  rash on both my arms on Monday March 22 morning. Rash appeared on both arms with a clear line where short sleeves are. Looks like a sunburn but with  itchy and warm skin. Temperature was below 70F when I took a walk.  Rash was getting light but still itchy often. I did not call doctor office or took any medicine for this. I took some photos for this and please let me know if you need these photos.
Information has been received from an office manager referring to a patient of unknown age and gender. The concomitant therapy included sterile diluent. Information about concurrent condition, drug reactions/allergies and pertinent medical history was not provided. On 13-NOV-2018, the patient received VARIVAX (strength, dose, lot# and expiration date were not reported) via intramuscular route (incorrect route of product administration) for prophylaxis. Lot# and expiration date for sterile diluent used to reconstitute VARIVAX was unknown by the reporter. No adverse effects reported.
Shingles broke out on the left side of the face. Severe left eye pain.  Light sensitivity and swelling in the left eye. Itching and burning on left side of face.
Pt called , experiencing symptoms after 2nd dose Pfizer vaccine on Saturday 4/24/21. Rec'd 2nd dose outside of facility sites at a school site . Pt stated experienced minor body aches and headache. Took Tylenol Saturday and symptoms were relieved. Today 4/27 pt began experiencing itchiness on chest, back and arms. Pt works at a vaccination site and was advised by pharmacist he should call for an MD appt for an rx stronger than benadryl.   Pt denied experiencing emergency symptoms at time of call. Pt stated only symptoms are itchiness. No swelling or itchiness of face, lip, or throat, and denied difficulty breathing.  Advised to go to nearest ED or call 911 if symptoms worsen or trouble breathing or any signs of severe allergic reaction. Pt verbalized understanding.  Scheduled  telephone provider visit 4/28  confirmed phone number on file. Pt aware of appt.
Heavy irregular menstrual bleeding with cramping. Currently on day 16 of heavy bleeding. Never in my life have been irregular. I?ve been to gyno and gp for exam and bloodwork. I had two periods in a row after receiving second dose on 4/6/21. I?m still bleeding and have read other accounts of women experiencing the same.
Vaccinations occurred in the AM.  I had to wake her up from a 5 hour nap.  She had high fever-105, totally lethargic and a red rash at shot site. She did not respond to us.  We rushed her to the ER.  Where they administered Motrin and watched her until fever went down. (ER doctor said to us- that next time she gets her shots space them out and half dosage). Sent home after couple of hours. Fever broke the next day, but she was a shell of the girl she had been days before. 2 weeks later-stopped talking.