chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Grand mal seizure occurred 1 month after GARDASIL #3.  8/22/08 Reviewed ER medical records of 12/2/2007. FINAL DX: seizures Records reveal patient experienced seizure in car (passenger) on way to school w/LOC & laceration of tongue.  Was postictal & confused.  no incontinence.  Neuro consult by phone.  Loaded w/anti-seizure med & was to be seen in neuro office next day. 4/8/09 Received Neuro consult 6/9-12/15/2008. FINAL DX: idiopathic generalized tonic-clonic & partial seizure disorder Records reveal patient experienced recurrent seizures 4/08 & had stopped antiseizure meds prior.  Meds changed.  Again stopped meds 6/08 & had partial seizure.
Information has been received from a physician concerning a 61 year old female with type II diabetes mellitus, hypertension, gastroesophageal reflux disease (GERD), hepatitis B carrier and mitral valve prolapse who on the morning of 26-OCT-2006 was vaccinated with a dose of Pneumovax 23 (lot #655289/0958F). Concomitant therapy included ESTRACE, hydrochlorothiazide (manufacturer unknown), PREVACID, ACTOS, GLUCOTROL and ZESTORETIC. On 26-OCT-2006, at 21:00, the patient developed local pain, tenderness, erythema and induration at the injection site which extended distally to below the elbow. The patient was seen in the physician's office, and subsequently, the local pain, tenderness, erythema and induration at the injection site began to improve after 18 hours. On 01-NOV-2006, the patient was recovered. Additional information is not expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-MAY-2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-JUN-2016 the patient was treated by a physician for the onset of severe vesicular rash accompanied by a weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed acyclovir (ZOVIRAX) and oxycodone-acetaminophen for management of his painful symptoms. As further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever. Unstoppable chills, mild nausea, couldn?t eat, had to lay down, swelling and large bruises on arm that shot was given, pain from bruises, mild headache.
patient was given liquid DTAP-IPV portion of Pentacel without the ActHIB lypholized powder portion, no AE; Initial information received on 28-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a nine weeks old male patient who received a first 0.5 ml dose of liquid DTAP-IPV portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], without the ActHIB lypholized powder portion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.   On 09-May-2019, the patient received a 0.5ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Liquid vial: Lot: C5408AA, Powder: Lot: C5542AA and Carton: Lot: C5542AA, expiry date for all 08-Sep-2019) via unknown route in the right thigh.  It was an actual medication error case due to inappropriate reconstitution technique.  No side effects reported.  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.
We were notified by Pharmacy today of a recall on this particular lot.  The product was improperly short-dated from our supplier, and since there aren't expiration dates printed on the boxes, the product had expired on 9/30/2022, and was in fact expired when we administered it.  The patient has suffered no deleterious effects
Patient stated that she broke out in all over rash the next day following her COVID vaccine of Pfizer.  I advised her to take Benadryl and use hydrocortisone cream.   I also told her that if it got worse or did not get better to seek care from a doctor.
Pt had a witnessed syncopal event the resulted in a ground level fall after receiving his vaccine. Pt had LOC for about 20s and noted to have sustained a contusion over right superior orbital ridge, nasal bridge, and minor mucosal break on anterior tongue. Pt was evaluated by medical staff and EMS, AOx4. After a 30min period of observation that included oral hydration and oral nutrition, pt recovered and was released. Vitals: HR 54, BP 95/58, 98%O2, BG 101
Patient reported experiencing rash across chest starting about 36 hours after receiving her shingrix shot. It is a fine, red rash that does not itch. It has begun to fade after 2 days, but is still visable.
Local pain, near deltoid initially. Pain and blotchy redness moved down to biceps area and lateral arm after 2 days.
Racing heart. Shortness of breath. Fogginess. Dizziness. Leg pain/cramping. Stomach cramps. Symptoms last about 24 hours then decreased. Racing heart continued for approx. 3 days and fogginess/leg cramping persisted for 10 days.
Severe headache, severe itchiness to scalp, eyes, ears, face, neck, chest, back, arms
Patient was underage at the time of event (14 years old). Mother used her information when creating the first 1st dose which was not caught at time of check in. Mother consented on file when patient came back for 2nd dose.
History essentially obtained by discussion with other providers and from review of the chart.  Patient apparently had last known well approximately 930 this morning.  Was found by her daughter to have left-sided weakness, left facial droop, and confusion and was brought to a local facility for evaluation.  Transferred directly to IR for intervention after receiving tPA following imaging which revealed a right M1 MCA occlusion.  Underwent thrombectomy on arrival which was at least partially successful though there was some continued occlusion.  Admitted for further cares.  Incidentally found COVID positive 01/28/2022.
Migraine began day of injection which downgraded to headache in days following.  Other symptoms beginning day after injection on April 9... muscle pain, joint pain, eye pain, sensitivity to light, fatigue, nausea.  All these symptoms have continued as of today April 18.
Patient had a seizure within 1 minute of receiving the Gardasil vaccine. She reported an immediate pounding headache, dizziness and hallucinations. Her blood pressure also dropped quite low. Took a half hour to be able to sit up.
Rash at site developed 28 hours spread to other areas 48-96 hours after vaccine.
Havrix vaccine administered 7/31 in pm. No fever on 7/31. 8/1 temperature 102 at 7pm, mom gave tylenol then temp at 10 pm to 103. Mom has been giving tylenol.Temp 8/2 at 2 am 103.7. No seizure activity, no cold symptoms.
Day after receiving flu vaccine, fever 103, achy, sore throat, light headed x 2 days.
Round, red mark at injection site appearing about a week after vaccination. Slightly itchy and tender to push on.
Woke up 3:30 AM with splitting headache, red burning eyes, diffuse body aches. 9:00 AM ran a low grade fever of 99.6 most of the day (normal body temp is low at 95- 96 degrees) with headache, body aches, occ. shooting pains in knees and mild chills like a mild flu. Left arm soreness like a DPT shot.
Immediately after MMRSQ in right arm child developed approx 3cm bright red slighty swollen wheals & flair given p Benadryl child in no discomfort, Phone F/U at24 hours-reaction gone child fine
Site of injection, moved into arm, then shoulder and continued in nerve on back of shoulder.  Ice and Mobic...did not/has not helped.
Pt recvd 2 doses of Engerix-B 8JUL92 following dose 2 had numbness, h/a & tingling in arms & lower extremities;
Pt recvd dose Hep B vax 26FEB91 & devel h/a & gastrointestinal sx, n,v,d, noc sweats, fatigue; Lab eval revealed sl inc liver function tests, including SGPT of 56; Hep A virus Antibody was pos; MD felt Hep A was late recovery & noninfectiou
VIOLENT CHILLS; PAIN IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAY-2021, the subject experienced pain in arm. On 29-MAY-2021, the subject experienced violent chills. The action taken with covid-19 vaccine was not applicable. The patient was recovering from violent chills, and the outcome of pain in arm was not reported. This report was non-serious.
Sudden sore throat and some body aches.  I took 2 Advil, went to bed.  I woke at 2 a.m. to get some water.  Then I passed out on the floor and when I came to, I had vomiting.  This occurred 3 times throughout the night/early morning of January 15, 2013.  I also had a terrible headache, which I still have.  This was my first flu shot in 11 years.  I don't know if the sickness was because of the shot or coincidental. I felt excellent prior to the flu shot.
On 6/17/22 at approximately 2:45pm the patient was given 0.2 ml of the adult dose (12+) of the Pfizer vaccine in error for her second dose. The medical assistant that administered the vaccine immediately informed the office supervisor and doctor taking care of the patient. The patient was called back to the office and the doctor spoke with the patient's mother and examined the child, who was not experiencing any adverse side effects. The doctor discussed with the parent what side effects to look out for and when to follow up. The patient was called on 6/18/22 at around 4:30pm to follow up on how she is doing. The mother stated that the patient is doing perfectly fine and will follow up if any side effects develop. The medical assistant received a verbal warning and was re-educated on proper vaccine administration.
Shot to left arm at 250?pm 8/2/21 . Hearing suddenly gone by 5 pm.  24 hours later exactly almost the left ear did the same thing
After vaccines child developed red maculopapular rash on face, trunk and left thigh. Resolved over 15 minutes, no breathing problems. Alert and playful.
I received my second COVID-19 vaccine at 820 am on 1/9/2021. I was feeling well, no signs of illness prior to the injection. Around 6 pm I developed at headache, 7 pm developed fevers, chills, and a cough. The fevers, chills, headache, and cough were gone the next day by about 1 pm. The cough returned the following day and persisted getting worse each day leading to wheezing and shortness of breath.  I had a negative COVID-19 test and negative chest x-ray. The PCP has diagnosed me with bronchospasms possibly associated with the vaccine as the cough came on following the vaccine. I have no know asthma, but they are also going to rule out an underlying asthma that could have been triggered by the vaccine.  I have been taking oral prednisone and using steroid inhalers with significant improvement, but the symptoms have not completely resolved. I am still under the care of my PCP for ongoing management.
2 days post Hib vaccine administered (2nd dose) developed rash on legs. Within 2 days it was all over both legs, in 2 more days it covered both arms. Lasted 2 1/2 weeks.
Redness at injection site 8 x 7.5 cm superficial redness. No induration.
Headache, fever, chills, muscle aches, fatigue. Started 14 hours after vaccine and lasted for 12 hours. I took Tylenol and Ibuprofen and rested til it went away.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 18th July 2018, the patient experienced tingling of extremity, numbness of upper extremities and erythema. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the tingling of extremity, numbness of upper extremities and erythema were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, tingling of extremity, numbness of upper extremities and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX vaccine on an unknown arm and her arm was sore and throbbing that first day and the evening of next day, she noticed a spot by her elbow on the arm where she received the injection was numb and sometimes tingling. The patient provided contact details of the physician.
the patient received expired Daptacel/ no AE; Initial information received on 09-Apr-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via phone.  This case involves a 10 months old female patient who was vaccinated with an expired 0.5 ml third dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5180AA and expiry date: 06-Apr-2019) via intramuscular route in the left thigh on 09-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) and POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Documents held by the sender: none.
Guillain-Barre. presented with acceding weakness, numbness/tingling in hands/feet and upper leg pain/low back pain
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, the patient experienced seizure and fainting episodes.  The patient sought unspecified medical attention.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Upon internal review the seizure episodes were considered to be an other important medical event.  Additional information has been requested.
Got Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got Covid) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer, dose 2), Pfizer (Pfizer and dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got Covid). At the time of the report, COVID-19 (Got Covid) outcome was unknown.            No concomitant medication was reported. Patient got boosted twice with Moderna. Patient not had any side effects nor did get very ill, although got Covid, it was mild. No treatment medication was reported.   Reporter did not allow further contact
bones hurt which was very painful; hard time breathing; uncontrolled bowel movement in the car; didn't feel better; urinated; started to have the shakes; couldn't walk; screaming in pain again; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones hurt which was very painful), DYSPNOEA (hard time breathing), ANAL INCONTINENCE (uncontrolled bowel movement in the car), MALAISE (didn't feel better), MICTURITION URGENCY (urinated), TREMOR (started to have the shakes), GAIT DISTURBANCE (couldn't walk) and PAIN (screaming in pain again) in a 62-year-old female patient 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, the patient experienced BONE PAIN (bones hurt which was very painful) (seriousness criterion hospitalization), DYSPNOEA (hard time breathing) (seriousness criterion hospitalization), ANAL INCONTINENCE (uncontrolled bowel movement in the car) (seriousness criterion hospitalization), MALAISE (didn't feel better) (seriousness criterion hospitalization), MICTURITION URGENCY (urinated) (seriousness criterion hospitalization), TREMOR (started to have the shakes) (seriousness criterion hospitalization), GAIT DISTURBANCE (couldn't walk) (seriousness criterion hospitalization) and PAIN (screaming in pain again) (seriousness criterion hospitalization). At the time of the report, BONE PAIN (bones hurt which was very painful), DYSPNOEA (hard time breathing), ANAL INCONTINENCE (uncontrolled bowel movement in the car), MALAISE (didn't feel better), MICTURITION URGENCY (urinated), TREMOR (started to have the shakes), GAIT DISTURBANCE (couldn't walk) and PAIN (screaming in pain again) outcome was unknown.            Company Comment: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.
Rapid onset of high fever, weakness, body aches, headache  lasted until mid-morning next day
Pain at the injection site when immunization given. About 2 days later noticed problem lifting arm when putting in shirt. Still with pain when raising arm. Pain is positional. Tx: PT, NAPROSYN limit to 100 WT, ROM, heat. Recheck 1 week.
REDNESS AND SWELLING IN THE ARM FROM THE INJECTION SITE DOWN PAST HER ELBOW. LASTED 3 DAYS. STARTED THE DAY OF INJECTION ON 10/13, APPEARED TO GO AWAY ON SATURDAY 10/16
This spontaneous report was received from a medical assistant referring to a 22 year old male patient. Information about the patient's medical history, concurrent conditions and concomitant medication was not reported. On 18-DEC-2012, the patient was vaccinated with the first dose of GARDASIL (dose, route, anatomical location, lot # and expiration date were not reported). Then, on 20-DEC-2013, the patient received the second dose of GARDASIL (dose, route, anatomical location, Lot # and expiration date were not reported) for prophylaxis. The reporter stated that the patient received (also reported as would receive) on 01-NOV-2016 a dose of GARDASIL 9 (lot # L038503, expiration date 18-DEC-2017, dose, route and anatomical location were not reported). No adverse effect was reported. Additional information has been requested.; Sender's Comments: , MERCK 1611USA000896:Mfr number.
By 1997, I was 44 years old. In September of 1997, I had initial symptoms of polymyositis, a debilitating auto-immune condition. In 1979, at age 26, I had seven large dental mercury-amalgam fillings placed in my mouth. They were not replaced with 'white' composite fillings until June 2007, at age 54. I also had a number of flu-shots and other vaccine shots, containing thimerosal, between 1997 and 2004. I am now permanently disabled, have been in bad shape for at least 2.5 years, and believe the constant inflow of mercury into my body, due to the amalgams, and subsequent exacerbations due to thimerosal have both caused the polymyositis and have been responsible for further deterioration in my health.
Discolored area on the patients leg with a hard knot that would not go away for quite some time.
Left arm soreness which increased over 2-3 days.  Pain subsided and no longer a factor, however, now have a reddened area adjacent to injection site with noticeable warm area.  No pain even on palpation.
2nd dose / Significant arm pain again; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date.. please refer the case US2020AMR226395).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced significant arm pain upon 2nd dose. The reporter does believe pain was related Shingrix administration.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR226395:Same reporter
1. Immediate intense ache in arm; fever, chills, fatigue, body aches at night; skin temperature on body was extremely high - 102.7 2. Low fever, chills, fatigue next day 3. Felt better but had a strange "blister" emerge on my hand - raised bump, blister, very itchy 4. Blisters started to emerge over the next few days all over - mostly my hands, arms & legs - very itchy and uncomfortable 5. Continued blisters