chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For BOTH initial (022621) and booster (032621) of Moderna, pt had moderate/severe eye reaction. Overnight about 3 days after first injection and 4 days after second injection.  Initial injection: pt went to bed on the 3rd night after vaccine having taken no medications and noted mild eye irritation. He woke up a few hours later (~midnight) to severe eye watering and blurriness which required him to keep his eyes closed with mild sinus congestion. No difficulty breathing noted. Pt had trouble getting it to stop despite taking loratadine 10mg and rinsing eyes with water. Pt seriously considered going to ER due to risk of blindness. Pt eventually fell asleep a few hours later and woke up with very sensitive eyes (irritated, very red) that took about 36h to fully recover.   Second injection: pt was on scheduled loratadine 10mg daily. Noted a similar eye irritation (this time four days after injection not three) when going to bed and took 50mg diphenhydramine (about 14h after loratadine dose). Woke up a few hours later to more minor but still debilitating eye watering with proportionally more sinus involvement. No difficulty breathing noted. Pt took an extended release pseudoephedrine, rinsed eyes with water  and waited for it to resolve about an hour or two later. Pt awoke the next morning to much less sensitive eyes than first time.   Note: due to first experience. From time of administration of second dose, pt was on scheduled naproxen (440mg loading dose followed by 220mg q12h), loratadine 10mg q24h,  and pseudoephedrine (120mg ER q24h). Pt took these scheduled days 1-3 and at time of second eye episode was only on scheduled loratadine still. Pt also had 50mg diphenhydramine on hand in case of episode.
Temperature 57.55F / time frame 8 hours and 30 minutes / Inadvertently administered improplerly stored vaccine; This spontaneous report was received from a medical student, concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and previous drug reactions, or allergies were not reported.  On 03-DEC-2021, the patient was vaccinated with a improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot #T034380 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 08-JAN-2022), as prophylaxis (strength, dose and route of administration were not provided). The vaccine was exposed to a temperature of 57.55 Fahrenheit (F) during a time frame of 8 hours and 30 minutes (product storage error). Multiple previous temperature excursions were reported.
headache; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 4, unknown manufacturer.), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3, unknown manufacturer.), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series complete but unknown manufacturer.), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 06Oct2022, outcome "recovered" (Oct2022). Therapeutic measures were taken as a result of headache.  Additional information: Facility type of vaccine was at pharmacy or drug store. There was no covid prior vaccination and not tested post vaccination. Other vaccine in four weeks was reported as No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 28-month-old male with no pertinent medical history and no drug reactions/allergies who in approximately May 2005, between 12 and 15-months of age, was vaccinated SC with a 0.5mL dose of Varivax. There was no concomitant medication. On 28-AUG-2006 the patient developed a low fever and vesicular lesions on his left thigh. Over the next week, the child developed hundreds more lesions (almost all of which were fluid filled). The lesions seemed to follow multiple dermatomes on the left thigh and buttock, with some lesions crossing midline. The physician felt that this was an atypical presentation of shingles. The patient was hospitalized and has not been released. The outcome was reported as recovering. No other information was available. There was no product quality complaint. Follow up information received from a healthcare worker indicated that the physician had no additional information to add to this report. The reporter considered the event to be an other important medical event. No additional information is expected.
Patient accompanied his brother to the brother's appointment today, he had not yet eaten today (morning appointment), while here, both brothers requested the meningococcal Group B vaccine. Patient was given the vaccine, he complimented the nurse who gave it, saying it barely hurt, but about 10-15 seconds after the injection (long enough to put the bandaid on the site), and patient stiffened his R arm involuntarily and lost his balance and awareness while sitting on the gurney thus falling backward. He was supported by the nurse and remained sitting. MD was called into room immediately. When MD arrived, patient appeared pale, was holding his R arm stiffly, was supported in a sitting position by the nurse, and was unresponsive to my questions for about 30 seconds, then he looked at me and asked 'What happened?", as his R arm started to relax. Radial pulse was slow, regular, not bounding, not particularly strong. Patient was moved by wheelchair to the treatment room where 10 L O2 were administered by mask, and patient was hooked up to a monitor which noted O2 sats at 100%, HR mid 40s, and adequate systolic BP. patient now fully alert, and lying on the gurney comfortably. Lungs clear to auscultation bilaterally and anteriorly, heart sinus tachycardia by auscultation and monitor, radial pulse regular, not thready or weak. Color was now returning to patient's face. Over the next 10 minutes, O2 was removed, O2 sats remained in the high 90s, and pulse came up to the 60s. Patient drinking water without difficulty. Patient gradually sitting on his own, dangled legs over gurney side, then was able to stand and walk without difficulty. MD discussed with patient and mother that it appears patient had a vasovagal reaction with seizure like activity (involuntary R arm tenseness). Before any further vaccines, patient should let the nurse know of this previous reaction, and he should be sure and eat before receiving vaccines.
who took the FLUZONE QUAD vaccination on Nov 18 2020. Patient is back in for 2nd dose of FLUZONE QUAD today on 12/15/2020 which is the 27 day instead of 28 days with no AE; Initial information received on 15-Dec-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9 month old infant patient who was on QUADRIVALENT INFLUENZA VACCINE (INFLUENZA QUADRIVAL A-B VACCINE) (FLUZONE QUADRIVALENT) (lot number and expiry date: not reported) for which who took the FLUZONE QUAD vaccination on Nov 18 2020 and was back in for the 2nd dose of FLUZONE QUAD today on 12/15/2020 which was the 27 day instead of 28 and wanted to know if it was acceptable to vaccinate on the 27th day (inappropriate schedule of product administration).  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.
Patient given vaccine at clinic and within 12 hours itching at injection site right arm and burning right side of face and neck.  Seen by doctor 72 hours later - no vesicles no resp sxs.
Information has been received from a consumer concerning consumer's son a 3 year old male who on 08-MAR-2006 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (reported as 0914L). Subsequently the patient experienced itchy Varicella like rash around the injection site ever since. The rash flares up and becomes worse when the child is sick with a cold or other illness. The patient sought medical attention, was referred to a dermatologist, and an unspecified steroid cream (manufacturer unknown) was prescribed, but it did not help. At the time of reporting, the patient had not recovered. Follow up information was received from a pediatrician who reported that the now 3 years old male returned with his parents for localized pruritic dermatitis at site of immunization 31 months ago, in May 2006. the pediatrician stated that the vaccine was OMPC, and the reaction was probably an Arthus reaction. An Arthus reaction began the day of immunization but should not last longer than a few weeks. The pruritis has perpetuated itself by his scratching and eczema. The pediatrician recommended keeping the site under clothes at all times in hopes that he would forget about it. The family had a nice routine for eczema. When the patient bathed, soap was avoided and a EUCERIN product similar to CETAPHIL was substituted. AVENO lotion was applied several times per day. DESONIDE cream was used briefly for flares of skin rash. The trial of ACYCLOVIR did not make a difference. Laboratory test performed in last month (November 2008) were normal except for serum IgE 126 IU/ml. On exam on 16-DEC-2008, the right thigh dermatitis was quiescent. The patient had some nasal and eye drainage. TMs and pharynx were normal. The pediatrician thought that the family was coping rather well with his rashes and recommended that follow up on a PRN basis. Additional information has been requested.
PATIENT REPORTS PAIN AND REDNESS AT INJECTION SITE THE NIGHT AFTER ADMINISTRATION. TODAY THE UPPER ARM IS STILL RED, BUT NO LONGER PAINFUL.
This spontaneous report as received from a physician refers to a coworker, an adult patient of unknown age and gender. No medical history and current conditions were provided. On an unknown date the patient was vaccinated with two doses of hepatitis B vaccine (manufacturer unknown), intramuscular injection (lot number and expiration date were not provided). There was not concomitant medication reported. On an unknown date the patient was told need hepatitis B vaccine (manufacturer unknown) intradermal since he/she had two series of RECOMBIVAX HB intramuscular and the hepatitis B surface antibody was negative reported as "did not show immunity in blood work". The reporter did not assess the relatedness of B vaccine (manufacturer unknown) intramuscular injection with the hepatitis B surface antibody negative. Additional information has been requested.
MAY 13 -2nd booster given at 11:10 am at Pharmacy.  By 2 pm right ear hearing impaired.  By 7:15 pm total loss of hearing rights ear.   Tuesday. May 17 visited ENT did hearing test.  Right ear no hearing and left impaired.
Slight headache overnight after 1st dose on 3/8.   Adverse reaction after 2nd dose on 3/29 at  3:30 that afternoon. I started seeing ?floaters? in my right eye only. Floating dark strings, dots, squiggles in my peripheral vision. Took my blood pressure and it was elevated at 168/93. I immediately took an additional 25 mg of losartin and called my eye doctor and was told to come in the next morning for an eye exam.  My blood pressure lowered to normal over the next few hours. I felt tired and restless overnight.  The next evening 3/30 after my eye dr appt, I developed a very severe headache, first in the front area of my head, then finally on the left side of my head.  Overnight the pain in the left side of my head increases and I experienced nausea, body aches and fatigue. The floaters in my right eye remained the same. No floaters or problems with my right eye.
Pt recv vax on 11/9/98; 5 hr later pt exp flushing, nausea & vomiting
Pregnant patient and Nursing 1 yr old received the first dose; meternal exposure during Breast feeding; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient and Nursing 1 yr old received the first dose) and MATERNAL EXPOSURE DURING BREAST FEEDING (meternal exposure during Breast feeding) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Miscarriage of pregnancy.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 20-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient and Nursing 1 yr old received the first dose) and MATERNAL EXPOSURE DURING BREAST FEEDING (meternal exposure during Breast feeding). On 20-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient and Nursing 1 yr old received the first dose) and MATERNAL EXPOSURE DURING BREAST FEEDING (meternal exposure during Breast feeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114448 (Patient Link).
Rash noted at on right thigh by mother that began yesterday morning 7/16/2020
vaccine received on 3/16; shortly after midnight on 3/24, I began to notice pain at the injection site, redness, swelling - symptoms align with reports of "covid arm" or "moderna arm" - delayed-type hypersensitivity reaction; expected pain at injection site on 3/16 and 3/17 that resolved by 3/18 but returned with redness and swelling on 3/24
Patient came to pharmacy and showed his arm was swollen, red, and warm to the touch.  He stated that he went to the doctor to have them look at it.
Severe chills the night of the shot, teeth chattering, couldn't get warm;  next afternoon, chills resumed mid afternoon.  Decided to get into bed to warm up.   Walking up the stairs and holding both rails - left and right - I blacked out, fell forward and hit my mouth on the edge of one stair, and my ribs on the edge of another stair.   Lots of blood,, chipped a tooth, lots of swelling in my mouth, deep laceration on my face and very sore ribs.   Saw doctor the next day.   No stitches required and ribs are bruised only.  I will need dental work done to repair my teeth.
Patient fall unconcious on the chair for couple of second and felt nauseated.  moved patient to the floor laying on the back and feet elevated. Called 911 for paramedics.
This spontaneous report was received from a medical assistant concerning a 12 years old male patient, who on 29-JUL-2012 was vaccinated with the second dose of VARIVAX (Merck) subcutaneously (dose not reported) (lot # 671083/0826AA, exp. 02-JUN-2013). No concomitant medications involved. On 29-JUL-2012 (also reported as on 28-JUL-2012) the patient developed 101 degree fever, as well as pain, redness and blisters around the injection site. The reporter mentioned the patient's first dose of VARIVAX (Merck) was on 16-JUL-2001 and he was unaware of any adverse symptoms after this dose was administered. No treatment was given for the events. No diagnostic laboratory studies were performed. The patient sought medical attention via office visit. Additional information is not expected.
Within 5 hours, I had fever and chills. Fever to 101.5, muscle aches all over, headache and weakness, these symptoms lasted for 24 hours and then resolved.
After receiving the vaccine I passed out. Waited the 15 minutes then got into my vehicle. At that time my entire body felt as though it was on fire and I broke out in hives. Had trouble breathing. Went home, took Benadryl and waited it out. Breathing went away a few minutes later but hives stayed for 3 days. My arm was swollen and tender the next day and stayed swollen for 4 days.
Day after vaccine, had:  nausea - took Dramamine vomiting chills / cold headache - took excederin and rizatriptan joint and muscle pain all over body  Adverse reaction lasted 36 hours.
Initial case was received on 11 May 2010 from a healthcare professional. A 50 year old male patient received an injection (route and site not reported) of ADACEL (sanofi pasteur Inc., lot number U3049CA, sanofi pasteur Ltd. lot number C3258) on 25 March 2010. The patient had no illness at the time of the vaccination and no other vaccinations were given within the 4 weeks prior. His medical history included seasonal allergic rhinitis. He had no other pre-existing medical conditions and no concomitant medications. The patient called the doctor's office on 08 April 2010 to report experiencing wheezing on exertion which started on 31 March 2010. He also experienced tightness in chest and arm soreness at injection site on unspecified dates. The patient was seen in the office on 09 April 2010 and had an unspecified work-up done to rule out medical conditions. The results of the work-up and the outcome of the events were not reported. Documents held by sender: None.
Received ZOSTAVAX on 6-19-12 - pt started to have severe chills and body aches. No documented fever. Then developed a rash and warmth, shingles type eruption to area of inj. site.
On about 10/29 I started feeling more tired than usual, but no fever, pain, or other.  Then I developed signs of UTI (increased urinary urgency with significant leaking, frequent urination) but not really painful.  Since my MD does not like to give antibiotics for UTI with out fever, I have increased the amount of cranberry capsules and fluids I take and have started feeling much better.  Today I had no leaking, or urinary urgency and was able to go much longer between trips to bathroom.
pt recvd vax & pain in back in rt arm & then devel pins & needles sensation about 2 wks p/inj;nothing significant on neuro exam
Staff was delegated to assist with flu vaccine and inadvertently gave Tdap. Flu was given after vaccine error occurred.
Patient was given COVID-19 vaccine and was in 15 mins observation period. Patient complaint of throat numbing, tongue was swelling and left eye was twitching. We called the rapid respond team of our clinic and Dr and his team did assessment. Patient was observed for 30 more minutes. Patient was authorized to go home. It turned out that it was a minor allergic reaction and patient is to report to emergency room if she doesn't get better when she gets home.
pt w/several year hx of febrile sz; last sz occurred 5SEP96 & lasted >30min;no focal signs of infect on exam;t104.1;
Information has been received from a registered nurse concerning a 45 month old male patient with no pertinent medical history and no allergies who on 06-AUG-2007 was vaccinated subcutaneously with a 0.5ml dose of PROQUAD (Merck) (lot# 658186/0789U).  There was no concomitant medication.  On 28-MAY-2010 the patient developed chickenpox.  The patient had a generalized itchy rash on his trunk, arms and legs.  The patient visited the office on 01-JUN-2010.  No treatment had been prescribed.  There were no laboratory diagnostics studies performed.  The nurse stated that the vesicles had already started to crust.  At the time of this report, the patient was recovering.  No further information is available.
This case was reported by a physician and described the occurrence f expired vaccine used in a 47-year-old male patient who received ENGERIX B (batch number K94NR, expiry date 8th June 2014). On 11th June 2014, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This case is one of the 2 cases reported by the same reporter for the same vaccine.
Pt. experienced on injection. Pt continued ongoing pain and swelling. Saw an M.D. who said that nothing could be done.
17MAR95 DT given rash around inj site per mom; 19MAR95 c/o pain both knees-would not walk or navigate stairs for most of day per mom;
Vaccine vial MAY have not been diluted prior to use, as a result the patient may have received a higher than approved dose. Parent/Caregiver was notified, no concerns or adverse effects noted. 2nd dose on 05/03/22 may have also been affected.
My son has swelling on the right sholder the size of a base ball warm to touch, red and sore can't move his arm and has a high fever 102.1
After administering vaccine the patient stated to feel sedation and a strange tingling in her legs. We watched the patient for approximately 30 minutes until she stated she felt a strange lump in her throat. We gave her 50 mg of diphenhydramine and called 911.  After their assessment and consultation with the patient she was released on her own accord.
Immediate lightheaded, dizzy and within 12 hours sore arm and fatigue. Within 24 hours severe back pain and severe fatigue interfering with daily activities, inability to work at job. Over the course of  5 days severe side and back pain radiating to lower back up through shoulder on left side wrapping to chest and stomach . After 10 days developed spinal pain, nerve and poking sensations, numbness and tingling in legs and ankles, stiff neck, loss of balance and coordination, dizziness, vertigo and insomnia. Visited ER and urgent care facilities.
Ringing in the right ear.  Ear Pain,  WORST HEAD ACHE I have ever had in my life.  The head ache has lasted over a week.  The ear pain has lasted over a week.  The ringing in the ear comes and goes.
Hives after ~48 hours on both arms.  Hives continue to spread after 72 hours covering 30% of back area and 25% of arms.  Benadryl 25 mg PO appears to be controlling the hives now.; This is a spontaneous report from a contactable consumer. A 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 20May2021 08:00 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunization. The patient has no medical history and concomitant medications. The patient has no known allergies. On 22May2021 at 08:00, the patient experienced hives after 48 hours on both arms. Hives continue to spread after 72 hours covering 30% of back area and 25% of arms. Benadryl 25 mg P.O appears to be controlling the hives now. The outcome of the events was recovering.
Raised, hardened, hot bump on arm 24 hrs post injection with pain and swelling
On 25JUL90 pt recvd vax & later exp diarrhea & T-102 w/ flu-like sx.
This spontaneous report as received from a pharmacist and the patient refers to a 57 year old male patient. Patient with allergic reaction to penicillin. No pertinent medical history was reported. On 11-JAN-2014 the patient was vaccinated with ZOSTAVAX (dose, lot number and expiration date not reported) subcutaneously (the patient thought). There was no concomitant medication reported. The patient reported that he was having a reaction to the ZOSTAVAX shot. On 12-JAN-2014, one day after getting the vaccine, his left arm (site of the injection) was sore. On 13-JAN-2014 two days after getting the shot, his arm was sorer and getting worse with each hour. His arm felt very hot and he had a red circle around the injection site and that had gotten bigger each day and a second red circle had appeared near the injection site. The pharmacist reported that the patient had inflammation, redness and pain at the injection site where he received ZOSTAVAX that was spreading on his arm and was not getting better. The patient sought for medical attention and talked to the pharmacist. No treatment was given for the events. The outcomes of the events were reported as not recovered. Additional information has been requested.