chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed Bell's Palsey on August 17th, 2007.  She was taken to an immediate care clinic in Wisconsin.    Patient was on vacation at time.  12/06/2007 MR received for OV 8/18/2007 with DX:  Bell's Palsy.  Pt presented with L sided facial swelling.  Smile is asymmetric as pt cannot bring L side of mouth into smile.Orbicularic oculi muscles (+) for weakness on L. Txd with Amoxicillin pending Lyme's test. Lot # updated in VAERS database (0954F).
VACCINE LEAKED/DRIBBLED OUT WHILE ADMINISTERING THE IM INJECTION INTO HIS LEFT ARM. I BELIEVE OVER 1/2 THE DOSE WAS ADMINISTERED BUT THERE IS NO WAY FOR ME TO COMPLETELY VERIFY THIS. I SPOKE TO HIS MOTHER, ABOUT WHAT HAD JUST OCCURRED AND SHE, ALONG WITH THE PATIENT, DID NOT FEEL IT WAS NECESSARY TO ADMINISTER ANOTHER IMMEDIATE DOSE TODAY. THEY STATED THEY WOULD BE BACK FOR THEIR 2ND DOSE IN 3 WEEKS.
Patient was administered Influenza vaccine around 08:00AM.  He remained at the outreach clinic site for at least 15 minutes after he was immunized.  He then returned to his workplace around 11:30AM.  Soon after he felt lightheaded, dizzy, and weak.  He was transported to the Emergency Room via ambulance.
Patient presented to the ED and was subsequently hospitalized for ruptured aneurysm of common iliac artery within 6 weeks of receiving covid vaccination.
Patient with history of CHF and COPD, wears 2 L O2 at baseline. Seen in the ED on 10/24 for shortness of breath, fever, cough, nausea, and vomiting. She requested a COVID test which was done in the ED, and she was discharged home. The COVID test came back positive. On 10/27, the patient returned to the ED via EMS with progressively worsening symptoms and was admitted 10/27 - 11/5. She was diagnosed with COVID pneumonia infection and started on dexamethasone 6 mg daily. Patient was discharged but readmitted hours after discharge due to sudden onset of altered mental status of unclear etiology en-route to hospital. Patient ultimately was discharged 11/9.
had life long injuries; This case was reported by a consumer via interactive digital media and described the occurrence of injury in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injury. On an unknown date, the outcome of the injury was not recovered/not resolved.   It was unknown if the reporter considered the injury to be related to Shingles vaccine.  Additional details were received as follows: The case was reported by the reporter for the father. The age at vaccination was not reported. The reporter stated that my father had life long injuries due to the shingles vaccine and was now in the law suit against the company.
Information has been received from a physician concerning an 8 week old female with abdominal pain, crying and spitting up, suspected acid reflux and or/colic due to a belly ache who on 12-JUL-2007 was vaccinated with Rotateq PO first dose (LOT # 655685/1109F). Concomitant therapy included PREVNAR, PEDIARIX and HIB conj vaccine (unspecified carrier) (mfr. unknown). The physician reported that on 05-JUL-2007 the patient was seen because of concerns with feeding, spitting up crying, which was being treated with MYLACON which was not working. The patient was placed on therapy with ZANTAC for suspected acid reflux and or colic due to a "belly ache". The physician reported seeing the patient on 12-JUL-2007 at approximately 8 weeks of age and the patient was noted to be much better and AANTAC was helping alot". The patient received her two months vaccinations which included PREVNAR, PEDIARIX and Hib conj vaccine (unspecified carrier (mfr. unknown) administered that day. The patient was seen again on 01-AUG-2007 and was noted to be crying gagging and screaming intermittently. The symptoms appeared to improve when the baby was placed against the health care providers shoulder with belly against the shoulder. It was reported that the symptoms started to improve when a vibration pillow was used. The physician's examination noted normal bowel sounds, no diarrhea no fever, no vomiting. It was reported that ZANTAC was increased without improvement. The patient was to have an abdominal xray. Crying, gagging and screaming were considered to be a significant disability by the physician. Additional information has been requested.
Contracted Covid-19. Fever and flu like symptoms for 6 days.; Contracted Covid-19. Fever and flu like symptoms for 6 days.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Apr2021 (Lot number: EN6199) at the age of 46 years as dose 2, single and intramuscular, administered in arm left, administration date 11Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The patient did not receive any other vaccine in four weeks. There were no concomitant medications (did not receive other medications in two weeks).The patient had no Covid prior vaccination and tested covid post vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "recovering" and all described as "Contracted Covid-19. Fever and flu like symptoms for 6 days.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (31Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' concurrent conditions, medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (albumin status unknown for any of the reported lot # at the time of reporting; dose was not provided) with the following lot # and expiration dates: M015931, 30-MAR-2018; M002419, 12-JAN-2018; L037356, 28-SEP-2017; L040961, 19-OCT-2017. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003299: US-009507513-1612USA003300: US-009507513-1611USA010369.
Anaphylaxis - rash and hives from head to toes, severe itching, difficulty breathing, and chest pain.  Oxygen Saturation was at 87 when I arrived.  Treated with dexamethasone sod phosphate PF last given at 5:45 PM, diphenhydrAMINE (Benadryl) last given at 5:45 PM, EPINEPHrine last given at 5:45 PM, famotine last given at 6:08 PM, GI cocktail oral suspension last given at 6:44 PM, hydrocortisone last given at 8:18 PM, LORazepam last given at 5:48 and 6:45 PM, ondansetron last given at 5:48.
Test Positive 01/07/2022  Thrusday 01/06/2022 was feeling unwell headache, cough, sore throut , fever and tired.  Day 5 started to feeling a cough pick up and day 12 nigh time coughing fit through out the night.
6" X 3" PAINFUL RED SWELLING  BY INJECTION SITE; HEADACHE.
L arm swollen within 48 hrs after shot given-whole upper arm swollen, skin tight and red.
Patient had DTAP and MMR given 05/01/2003, and had increased inflammation at site of DTAP injection.  No respiratory complaints.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on 23-OCT-2021 for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Patient tested positive for COVID-19 with both home kit rapid test and a nose swab test that she took at her physicians office. Patient was not sure if the nose swab test that she took at her doctor's office was a PCR  (polymerase chain reaction) test.  Patient stated tested positive twice and HCP (health care professional) diagnosed with COVID-19. Patient had symptoms of fever, cough and chills an aches in body that started 28-DEC-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000209379.; Sender's Comments: V0- 20211264268-Covid-19 vaccine ad26.CoV-2.s- Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Shot was administered into tendon and joint causing continued discomfort that has not gone away. After a year of discomfort, therapy was started for 3 months and is ongoing at home with minimal improvement. The discomfort feels like I got the shot yesterday, even though it was over 2 yrs. ago. The discomfort caused me to skip a year of protection from the flu. And changed my immunization site to my rear.
Tested positive for COVID-19 on 1/10/23 presenting with mild cold symptoms
12 minutes after administration I began to have dizziness, tingling to extremities, palpitations, headache, and nausea. I was tachycardic at 115 and my bp was 150/94. I was taken to the ER. +nystagmus upon neuro exam. Vitals remained abnormal for approximately 2 hours. I was given meclizine, zofran, reglan, benadryl, and 1 liter of NS. I was discharged home at 1830.  The next day the headahche and nausea continued with the new symptoms of body aches, left axilla swelling/pain, and pain at injection site.  I continue to have intermittent dizziness, headache, and nausea.
The employer called and stated that she had a grand mal seizure 1 hour after having her vaccine.  Her employer stated that she has a history of seizures and that her neurologist had told her she could receive the vaccine but that it could trigger a seizure. Patient was taken by ambulance to the hospital.
CHILLS; This spontaneous report received from a consumer concerned a male 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious.
Myalgia, Arthralgia, Fatigue, Sweats, Chills Narrative:
Soreness at the injection site; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that.  A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) (Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Feb2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that both she and her husband got their second vaccine shot on Saturday and they had no side effects from it except soreness at the injection site on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
While administering , patient said that she felt the pain traveling up to her neck & across her forehead & eye. The pain also traveled down to her arm & hand.  We called EMS for her & she was brought to the hospital . She got discharged after few hours in the hospital . She stated that she felt better but the symptoms were still there
Symptoms: rash, itchiness, burning sensation, eyes are swollen, high blood pressure, chills, inflammation of joints and muscle, difficulty breathing, and headache.
Rash spots (like mosquito bites) over body that are itchy.    More spots appear as the previous ones disappear.   No fever or drainage from rash.
I recived the first does of Covid 19 vaccine Pfizer-BioNtech on June 28, 2021 around 2:30 in the afternoon. I felt fine for the most part the rest of the day, just a little pain in my arm and a slight headache. I went to bed and woke up at 5:50 am on June 29, 2021. I went to the bathroom and started to overheat and my ears started ringing, then I blacked out and fainted. I woke up on laying on the bathroom floor.
Soldier was given smallpox on 1/7/08.  Pregnancy test on 1/7/08 neg.  Soldier later had pregnancy test done at local hospital on 1/27/08 positive.  Soldier was referred back to home station.
-Localized redness surrounding the subcutaneous injection site of MMR on (L) deltoid, started  1 day after shot (5/19/2020) -No other systematic symptoms.  Condition improved on 5/21/2020 when we called to Followup.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II for prophylaxis, lot # N014486 and expiration date on 10-MAY-2019. The dose, route of administration and anatomical location were not reported. The administered dose of the vaccine experienced a temperature excursion of 62.2 F for 1 hour and 15 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Mother called in and reported to me after she took patient to the doctor. Stated next morning her son's arm was red, feverish and swollen to the touch. She took the son to the doctor's office today. He put the patient on Cephalexin 500mg 1 twice daily, he says maybe cellulitis, but he asked the mom to have us report this reaction.
Per ER Attending Note 12/12/14: Patient is a 60 year old male with (R) shoulder pain and swelling after a PNEUMOVAX shot 2 days ago. Felt hot and itchy yesterday. Had some chills overnight. Today seemed more painful and comes to the ED now. Denies other rash. No CP or SOB. Otherwise doing ok. Acetaminophen 2 tablets tab prn, diphenhydramine 25-50 mg prn.
On 2/28/21 patient presented to ER for fatigue, Admitted for sepsis 2/2 to either PNA, UTI or recurrent endocarditis as well  as new onset Afib.
The patient experienced diffuse itching after vaccination; was cleared to leave vaccine clinic, but persistent symptoms led her to seek care at ED.  She was treated with Prednisone, hydroxyzine, famotidine.  PMHx: depression and anxiety; no current meds; Allergies: Hydrocodone and Oxycodone which cause pruritis.
Maternal exposure during pregnancy; Preterm delivery at 24 2/7 weeks.; This is a spontaneous report from a contactable physician. This physician reported information for both mother and fetus/baby. This is a baby report. Only this case is serious.  A 33-year-old female mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) on 28Jan2021 at single dose for Covid-19 immunization. The mother's medical history included obstructive sleep apnea, anxiety, and environmental allergies. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), calcium carbonate (TUMS), calcium chews, fluticasone propionate (FLONASE), and triamcinolone ointment. The mother had preterm delivery at 24 2/7 weeks on 20Feb2021 via emergency cesarean section. The last menstruation date was 09Sep2020. Gestational period was also reported as 22 weeks (pending clarification). The due date was reported as 10Jun2021. The fetus experienced maternal exposure during pregnancy via transplacental route on an unspecified date. The events resulted in emergency room/department or urgent care and hospitalization for 2 days. The mother had nasal swab COVID test on 20Feb2021 with negative result. The outcome of the events was recovered.  Information about lot/batch number has been requested.; Sender's Comments: Pending the clinical course of pregnancy and risk factors for premature delivery, the company considered there is not a reasonable possibility that the event premature baby was related to BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021199045 maternal case
Patient described non-injection site rash on leg. Rash was not raised. She went to hospital and they said it was just an immune response reaction (she also got one blister at injection site later in the day). Showing improvement.
A non-serious spontaneous report of "inadvertently gave H1N1 vaccine to person above age 49" was received from a registered nurse concerning a 72-year-old female. On 29-Oct-2009, the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
1 day post vax devel faint erythematous, maculopapular rash;no itching or petechiae;no other sx
Fever 104-105 temporal x 1 with vomiting x3. Fever reduced with Ibuprofen. Afebrile since then, vomiting stopped.
3-3-2021 "Chest rash - 4 to 5 days ago, pt with sense of sunburn in her left axilla, radiated down her left arm. On Monday , pt noticed two ~ 2cm maculopapular rashes on her left breast with a  small 0.5cm punctate lesion at mid sternum." Covid vaccine was 2 wks prior. - "Rash progressed across her back, with more vescular lesions." "I suspect that her first COVID immunization precipitated her shingles..."
two weeks after the vaccine my son developed bells paulsy, i was told it came from a form of herpes which is the chicken pox vacine. My ten year old child has no feeling or ability to move the left side of his face.  10/17/08 Reviewed PCP office records of 8/13-10/2/2008. FINAL DX: left side Bell's palsy Records reveal patient experienced usual state of health on 8/13/08.  RTC 9/29 s/p ER visit where dx w/Bell's palsy, left side.  RTC 10/2 w/nosebleeds, HA & congestion x 3 days, dx w/allergic rhinitis & given flu shot.
Mom reported swelling of about 1" in diameter at L thigh on 4/1/03.  Mom applied ice intermittently that day. Pt's Mom brought baby to the clinic on 4/3/03 in the afternoon.  L thigh red, swollen area about 1.5" x 1.5". Area warm to touch. On 4/7/03, pt came to clinic for F/U. Swelling much less to L thigh.  F/U call made.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 30-JUL-2015 the patient was vaccinated with PROQUAD (dose, dosage #, strength and route were not reported, lot # L007229, expiry date: 03-SEP-2018). The second suspect therapy included KINRIX (administration date: 30-JUL-2015). The patient came back to the office as the patient had developed a rash all over the body on 31-JUL-2015. The outcome of the event was not reported. The reporter also requested a lot check and that lot check request was time sensitive and the reporter wanted a response quickly. This is one of several reports received from the same source. Additional information has been requested.
Pt developed malaise 4 days after HPV#1 vaccine.  Five days after, pt developed high fever (Tmax 102.6), headache, and dizziness & vertigo.  Pt described "tunnel vision" & bilateral hip pains.  10/3/08 Reviewed ER records of 9/8-9/9/2008. FINAL DX: Fever, HA Records reveal patient seen 9/8/08 after experienced malaise, low grade fever, nausea, 1 episode emesis, vertigo beginning approx 2 days s/p vaccination. D/c to home & returned to ER on 9/9/08 after being seen by PCP for fever & HA, ill appearing, dizzy, brief episode of tunnel vision, near-syncope.  LP done.  D/C to home
difficulty breathing; potential signs and symptoms of Guillain-Barre syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 92-year-old female patient who received Herpes zoster (Shingrix) (batch number 5P9DR, expiry date 20th March 2023) for prophylaxis.   On 13th October 2021, the patient received Shingrix. On 13th October 2021, less than a day after receiving Shingrix, the patient experienced difficulty breathing (serious criteria hospitalization) and guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On 14th October 2021, the outcome of the difficulty breathing and guillain barre syndrome were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing and guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The patient had received Shingrix vaccine on and 1 to 2 hours later experienced difficulty breathing and potential signs and symptoms of Guillain-Barre syndrome.  The patient was admitted to the hospital for observation. The reporter consented to follow up.
Patient states she began feeling bad 4/19/21 with a bad headache, neck hurting, aches all over, red rash all over, and a low grade fever (about 100 degrees F). States she took Aleve a couple of different times and feels better but does not feel well. Patient was advised to contact her physician today for further evaluation.