chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a mini stroke; occasional feeling like I was going to fall over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Primary biliary cholangitis" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; URSODIOL; VITAMIN D [VITAMIN D NOS]. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EL9261, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 53-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9261, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 53-year-old, for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 15Oct2021, outcome "recovered", described as "occasional feeling like I was going to fall over"; CEREBROVASCULAR ACCIDENT (medically significant) with onset Dec2021, outcome "recovered", described as "I had a mini stroke". The events "i had a mini stroke" and "occasional feeling like i was going to fall over" required emergency room visit. The patient underwent the following laboratory tests and procedures: Tests: Unknown Results, notes: Many tests to find the cause; SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of cerebrovascular accident, feeling abnormal.  Clinical course: After receiving the 3rd shot, patient started having an occasional feeling like she was going to fall over. This symptom continued and got worse until she had a mini stroke. The shot was 05Oct and she had stroke sometime in the mid Dec. No covid prior vaccination. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Dizziness, Headache, NauseaVomiting, chills, flushing, Narrative:
arm soreness; This is a spontaneous report from a non-contactable consumer (patient wife). An elderly male patient of unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient medical history included covid prior vaccination. The patient concomitant medication was not reported. The patient experienced arm soreness on an unknown date in Jan2021. The outcome of the event arm soreness was unknown  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Tingly sensation with pain in my left fingertips pointing finger and two beside them then went to tingly pain in my left toes and went to tingly pain in my right toes left heel tingly pain shot up my left leg and tingly pain in my right fingertips the pain comes and goes but I currently still have it.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-DEC-2015, the patient was treated by a Dermatologist for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  She was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
12 hours after first dose of vaccine I had side effects of chills and fatigue 15 hours after second dose of vaccine I experienced chills, aches/pains, and could not sleep at all.  The only relief was hot baths.     With both vaccines I experienced dizziness and fatigue that is lingering well after both doses of vaccine were given.  Dizziness comes and goes but is consistently happening daily.
I had been having nausea - and had been having some nausea before the vaccine - nausea continued. It comes and goes in phases for me.  The doctor did a gastric emptying study test. It showed delayed Gastric Emptying. I have a follow up - upper endoscopy scheduled - that is schedule for July 7th, - and I'm on a low residue diet.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 14-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660974 with expiration date 20-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
No symptoms.  Vaccine Administration Error.  Vaccine was administered from an adult vial.  0.3 ml was given to this patient for approx 30 mcg of Pfizer vaccine.  This is calculated to be double the supposed dose.
Child screamed cont, could not be consoled fr 330-9PM; No fever or sz local redness & swelling child fell asleep @ 9PM, was fine in AM;
The patient developed sudden onset hearing loss of the right ear. the hearing loss is severe. occured about 2 weeks after the booster vaccination. was Pfizer.
on 2/5/2021 patient began having shortness of breath and chest pain, chest pain was slightly releived when sitting and leaning forward but would return in any other position. Pain worsened with exertion. Pain persisted from 8am until Emergency services were sought. Patient SOB also worsened throughout day, he was able to check his oxygen saturations prior to ER arrival which showed low oxygen and a heart rate >100, it was at that time patient was transported to ER.
Injection sites still cause pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Aug2021 at 14:30 as dose 1, single (Lot number: FC3183) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sensitivity" (unspecified if ongoing); "kidney 3- chronic pain" (unspecified if ongoing); "Known allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Aug2021 at 15:45, outcome "not recovered", described as "Injection sites still cause pain". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: product=COVID 19, brand=Pfizer, lot number=FC8193, administration date=15Sep2021, administration time=01:00 PM, dose number=2, vaccine location=Right arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks reported as yes.
Pt became faint two minutes after receiving vaccine. Diapoheritc, pale, low pulse and blood pressure, brief seizure like activity. Took approximately twenty minutes to fully recover.
Mother reports approx. 3wks after the injection, that her daughter with complaint of increase depression, mood swings, headache, stomach pain and developed chest pain in Jan 2009. Went to Emergency Room in 8/13/08. May 8, 2009 with chest pain and heart racing. Fever. 104 still.
Friday injection site hurt almost immediately (first dose didn't feel anything until 6 hours after shot)... started to ice arm an hour after appointment and continued to ice throughout the day Friday.   Saturday morning the injection side was significantly swollen (bump and felt like a knot) and continues to be swollen and ache as of Monday a.m.   Have a red circular patch around injection site which also occurred after first shot and lasted 10 days.  Saturday woke up with bad headache... took tylenol and slept.. headache gone by late afternoon.   Sunday morning woke up covered in a rash that was from my neck to below my belly button on front side, entire back area (including neck) and both sides of torso.  Took 2 doses of Benadryl on Sunday.  Rash has faded (not as red) and took another dose of Benadryl Monday morning.
COVID-19 pneumonia; Acute hypoxemic respiratory failure; Acute Encephalopathy; End-stage renal disease; Nonischemic cardiomyopathy; Chronic combined systolic and diastolic heart failure; Essential hypertension; Hyperlipidemia; Diabetes mellitus type 2?poorly controlled; Diabetic neuropathy; Depression
Employee was given a Flu vaccine and PPD shortly after. Syncopal episode after PPD skin test was given.
No adverse event noted by patient, however report filled due to usage of unapproved vaccine manufacturer for age group.
Day  after vaccine 4/14/21, injection site became itchy.  Patient scratching site. On 4/16 area became red, swollen, tender, burning and had some drainage from the affected area.  She went to her PCP and was treated with Keflex and Benadryl.  4/20 Pt sates the area has improvement however returned to PCP and was given Prednisone because area still has the burning sensation.
pt recv vax & pt devel 35-40 spots that broke open, oozed clear liquid & scabbed on back, face & head;also devel a few on stomach;it was noted only two of the spots really bubbled;pt MD didn't originally think it was chickenpox felt allerg
nurse administered a MENACTRA vaccine one day after the expiration date, with no adverse event; Initial information received on 08-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient to whom nurse administered a MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] vaccine one day after the expiration date, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENB) for Prophylactic vaccination.  On 07-Jun-2022, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6951AA; expiry date: 06-Jun-2022, strength, expiry date: unknown) solution for injection at a dose of 0.5 ml total via intramuscular route in the deltoid as Immunization.  On 07-Jun-2022, the nurse administered a MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE one day after the expiration date, with no adverse event (expired product administered) (latency: same day). He asked if it needs to be repeated.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event nurse administered a menactra vaccine one day after the expiration date, with 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 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.
parents found emesis in bed in AM day p/vax;T103.8 x 3 or 4 saw MD 4/26/99 & each day thereafter x 4;watery diarrhea & vomiting x 6 days;sx lasted 1wk & improved w/o medication;
Lack of appetite; Fever of 100.5F°; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), PYREXIA (Fever of 100.5F°), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old patient of an unknown 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 DECREASED APPETITE (Lack of appetite), PYREXIA (Fever of 100.5F°), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, DECREASED APPETITE (Lack of appetite), PYREXIA (Fever of 100.5F°), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) 100.5F°.         No concomitant and treatment medications were provided. The patient reported that they don't have any pre-existing conditions.   This case was linked to MOD-2021-398590.
Pt recvd vax & exp sz of unk description approx 6 hrs p/vax; 4DEC92 did not feel well w/fever, chills, nausea, bodyaches, dizzy, blurred vision & chest pain; sinus problems; t104;
Heart racing Pulse: 87 Respirations :16 SPO2: 100% BP 130/78 Drunk water, rest to normal then discharged tp home
Rash/hives all over body one month after second shot. Unable to control and manage with steroids, anti-histamines, and cream.
Pt. received HPV #1, MCV4 #1, and Tdap booster. Once pt. received HPV vaccine she started to feel faint, 30 seconds later pt. was observed having convulsions that lasted approximately 2-3 seconds. Then patient relaxed for 30-45 seconds and had one more episode of convulsions that lasted for 4-5 seconds, approximately. After last episode pt. felt slightly better and was helped up and taken to bed to lay down on her left side. 911 was called. Dr. evaluated pt before paramedics arrived. Pt. A and O x 3 and transported to emergency room for further evaluation.
pt recv vax AUG95 & SEP95 pt devel a chicken-pox like rash on leg, thigh & chest;pt also had impetigo in the nose area;
PATIENT PASSOUT AFTER VACCINE WAS ADMINISTER. SHE COMPLAINED OF SOB BEFORE PASSING OUT. EPIPEN WAS ADMINISTERED AT 12;35 AND EMT ARRIVED AT 12:44. PATIENT RECOVERED AND REFUSE GOING TO THE HOSPITAL.
Numbing from head down to whole body, throwing up, could not walk, paralysis. Spouse had to take her to ER. She was treated with fluids, Mg, antibiotics. She was diagnosed with bladder infection .Later developed blister in the mouth
R arm - red, non-raised rash approximately 20 mm wide x 40 mm length rash, itchy. Hydrocortisone cream applied.
had arm soreness for one day/His arm was a little sore yesterday and today he is fine; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team.  A 86 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 86 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, (Lot number: Not provided)), administration date: 21Feb2021, for covid-19 immunization, reaction: "Shingles". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "had arm soreness for one day/His arm was a little sore yesterday and today he is fine".  Additional information: Patient received Pfizer vaccine on 25Mar2021 and had arm soreness for one day. Caller stated both her and her husband (86 y/o) had their first Pfizer vaccine dose 21Feb2021 and were scheduled for 14Mar2021 for their second dose. The caller received her dose and the husband had developed shingles and was advised by his physician to wait and get his second dose. The Caller narrated, "He got his second shot on 25Mar2021 after the shingles went away. His arm was a little sore yesterday and today he was fine". Caller was querying if this timing was ok for the second vaccine dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335688 same patient, different dose and event
red left eye; hives around left eye; itchy left eye; swollen left eye; Fever; Body ache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy.   On 13th February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced fever, general body pain, eye pruritus, eye swelling and hives. On an unknown date, the patient experienced eye red. On an unknown date, the outcome of the fever and general body pain were recovered/resolved and the outcome of the eye pruritus, eye swelling, eye red and hives were recovering/resolving.   The reporter considered the fever and general body pain to be related to Shingrix. It was unknown if the reporter considered the eye pruritus, eye swelling, eye red and hives to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix via intramuscularly in the left upper arm (deltoid) experienced a fever and body ache for 1-2 days then resolved.  Three to four days after the vaccine her left eye started to feel itchy and swollen and was red, also there are hives around the left eye. She does not know if this was due to Shingrix or not. She thinks it may be due to a food allergy. The events pertaining to her left eye have not yet resolved. She has given us permission to call only to obtain the lot/exp.
Pain began in left elbow with pain intensity increasing and numbness and tingling proceding up left upper arm to injection site. Physician diagnosed as "brachial neuritis" on 11/16/09.  Some advancement of pain, soreness to left shoulder. Given Neurontin 300mg p.o. bid.  11/30/09 PCP notes for DOS 11/16/09: DX: Neuropathy  Pt complained of left arm pain x1wk after H1N1 vaccine. L arm painful and numb over the deltoid muscle area. Treatment started with Neurontin. Pt's physician considered this event as injection neuropathy and pt is to return on a PRN basis.
ED reported the natural death of a 61-year-old male. 1/24/22, the decedent received a Pfizer shot (presumed booster) 1000h. Later in the morning, he noticed a growth by his groin. He presented to hospital with general surgery, 1420h, and had vitals taken showing heart rate 122 and blood pressure 138/101. He left his appointment and was later found unresponsive by a medic unit on the campus following an unwitnessed collapse. He was taken to the ED where he presented at 1555h and was pronounced at 1619h. No trauma or suspicious circumstances reported. Death Certificate cause of death= Pulseless electrical activity caused by hypertension and hyperlipidemia.
5/21/21 Rapid Heart Beat and when I showed up to the ER I was in AFIB and I was admitted.  No other heart issues before this date. 6/13/21 Rapid Heart Beat and when I showed up to the ER It was normal again and I was not admitted. I wore a heart monitor for 2 weeks and am waiting for my follow up appointment  on July 7th to find out the results of this and my current blood work.
At 5:37 pm - about one minute after getting HPV GARDASIL patient verbalized he was not feeling well, said he felt light headed and weak. Patient got really pale, body got limp, vomited and sweating profusely. Patient was given water. 20 minute later he left clinic on own.
1st dose of Covid vaccine 1/14/2021. Exposed to positive Covid caregiver 1/28/2021 got tested for Covid PCR  and 1/30/2021 reported positive result
It was reported that a 49 year old female was administered Fluzone SV 2002-2003 USP (Lot # U0934BA) on 11/15/02.  Three hours after vaccination, the pt had swelling in the calves and legs.  The area from the ankle to the knee was bright red and the area from the knee to the thigh was blotchy red.  The pt also complained of extreme itchiness and burning pain in calves.  She was seen in the ER on 11/17/02 and diagnosed with vasculitis.  The treatment included IV antibiotics, IV steroids, and IV Benadryl.  She was released with oral steroids for 10 days and referred to her dermatologist.  From additional information received from the manufacturer on 04/14/03, it was reported that the pt was given Fluzone SV 2002-2003 USP vaccination in the left deltoid at 3:00PM on 11/15/02.  Pt experienced symptoms of Vasculitis three hours later on the same day.  Pt was seen in the ER on 11/17/02.  CBC, Sed. Rate, Cardiac Enzymes and Renalytes were drawn but the only abnormal lab was elevated Sed. Rate.  It was also reported that the pt, in the past, had received numerous flu shots and would get them annually.  Pt was taking Ibuprofen for an unrelated condition.  And in September 2002, pt was given Pneumovax at a doctor's office.  Pt was healthy at the time of vaccination.
Information has been received from a physician concerning a 65 year old female patient with drug hypersensitivity to codeine and simvastatin (MSD) who on 06-JAN-2010 was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y) into her arm. On 07-JAN-2010 the patient developed an injection site reaction and pain in the arm where the vaccine was given. The physician stated that the patient was not able to lift her arm. The patient called the physician for medical attention. At the time of this report, the patient had not recovered. Follow-up information has been received from a physician who reported that on 06-JAN-2010 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # 665401/1320Y) into her arm IM. On 07-JAN-2010 the patient experienced sore arm with swelling. The patient did not seek medical attention. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information is not expected.