chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received a Hepatitis B shot (second series) and developed a severe rash on trunk, arms, legs. I was examined by the doctor on 8/15- she prescribe steroids and Benadryl.  I asked her to fill out this form and she said it was not a requirement.  I feel that the severe reaction I had needs to be prevented from happening again and it is important that this data is shared with other provides in order to prevent if from happening again.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2022 at 7:39 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Mar-2022 at 7:39 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Vaccine administration time 07:39:33. No treatment information was provided. The patient was administered second booster dose that went into 2 to 8 Celsius thaw state on or above 24-Dec -2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. This case was linked to MOD-2022-542869 (Patient Link).
Second dose administered outside of 42-day window. Pt reports he did not receive an email telling him to sign up for second dose.
I awoke with a terrible headache and vomited for several hours.; vomited for several hours; I was dizzy; unable to eat with a lingering headache all weekend; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 16:30 (at the age of 39-years-old) as a single dose for covid-19 immunization. Medical history included asthma, hypertension, hypersensitivity, allergies with aspirin, burlap. Concomitant medication(s) in two weeks included mefenamic acid (ADVIL [MEFENAMIC ACID]). The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Mar2021, Saturday, 4 days after vaccination, the patient awoke with a terrible headache and vomited for several hours. She was dizzy, unable to eat with a lingering headache all weekend. The patient did not receive any treatment. Outcome of the event was recovered on Mar2021, at the time of this report. No follow-up attempt are possible. Information about lot/batch number cannot be obtained.
Started with chills and muscle aches 12 hours after vaccination, then fever. Fever spiked up to 104 with rigors for around 3 hours. Finally came down to 102 with Tylenol and Naproxen but persisted throughout the next 20 hours , Tylenol was used throughout that time . Friday morning woke feeling improved but very weak, temp was down to 100.8 and continued to go down to WNL by 7pm on Friday night. By Saturday I was feeing normal but continued to have hot and cold episodes which are unusual for me.
Patient received Dtap vaccine 12/20/12 at approx 2:15pm. Parent reports early evening, hard lump developed at injection site and later evening erythema surrounded lump approx 2 inches in diameter. Reported 12/21/12 am to pediatrician. Borders marked with pen per RN advice. No oozing from site or drainage or fever present. Mom instructed to use warm compresses & light massage to knot area and return for appt if redness enlarged or fever or oozing developed.
Dizzy, sweaty, lightheaded, thirsty. Subsequently resolved with juice.  30 minutes later developed a feeling of pins and needles in legs/arms (this is a typical migraine presentation).
Service member received SPV on 12/4/10. Had contact with girlfriend on 12/10/10 (states he had bandaid on site). Girlfriend noticed lesion (L) calf 12/17/10. 12/28/10 sample sent for vaccinia testing ((+) orthopoxvirus).
swollen arm at injection site; soreness in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm at injection site) and VACCINATION SITE SWELLING (swollen arm at injection site) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm at injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen arm at injection site). At the time of the report, VACCINATION SITE PAIN (soreness in arm at injection site) and VACCINATION SITE SWELLING (swollen arm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.
Approximately seven minutes after the vaccine was given, the patient fainted and had a seizure. The paramedics came and took her to the hospital. Patient was still sweating, unsteady, yawning, and kept her eyes closed as they were examining her and when she left in the ambulance.
Received quarter size red raised welt on leg where varivax was given, 2 day day history, treatment with antibiotic and cortizone. ? reaction or cellulitis.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 31-MAY-2014 the patient was vaccinated with first expired dose of ZOSTAVAX (vial, dose 0.65 ml, subcutaneous, (lot # was not specified), expiry date 08-MAY-2014). No adverse effects were reported. No PQC was involved. Additional information is not expected.
Local soreness, redness, knot, swelling  Body aches, chills, chest pain, elevated heart rate
expired daptacel was administered with no reported adverse event; Initial information received on 09-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (Nurse).  This case involves a 2 months old female patient who was administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2023, the patient received 0.5 ml dose of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with no reported adverse event (expired product administered) (latency : same day) (Suspension for injection) (Frequency = once), (Strength = standard) (lot C5893AA) via intramuscular route in left quadricep for immunization.  Action taken: Not applicable.  Outcome: Unknown  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.
I had a severe headache (8/10). I also had a fever and chills (101.3 F). I felt very fatigued and weak as well. I have gotten a flu shot every year for about 5 years now and I have never gotten this severe of symptoms.
had the 2 shot shingles vaccine and I still got it!/ suspected vaccination failure; have it / just the skin. i am auto immune and stressed/ have it on my nose up to the corner of my eye; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included autoimmune disorder and stress.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine and an unknown time after starting Valtrex, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient was auto-immune and stressed. The patient had 2 shots of Shingles vaccine and still got shingles. The patient had shingles on his/her nose up to the corner of eye. The patient stated that the ophthalmologist said that his/her eye was not affected, just the skin around it. This case was considered as suspected vaccination failure case, because details regarding laboratory confirmation of shingles and time to onset were unknown. The follow-up would not be possible as no contact details were available.
Information has been received from a consumer concerning her daughter a 16 year old female with a history of mild infrequent palpitations who on 16-AUG-2007 was vaccinated IM with the first dose of Gardasil vaccine (Lot # not provided). Concomitant therapy included montelukast sodium (MDS), Yaz and albuterol. On approximately 30-AUG-2007 "two to three weeks" post vaccination the patient experienced an increase in frequency and intensity of her heart palpitations. The patient's mother reported at that time of this report that her daughter's increase in heart palpitations persisted. At the time of this report the patient was under care of her pediatrician. Additional information has been requested.  This is in follow-up to report(s) previously submitted on 11/14/2007.  Initial and follow up information have been received from a consumer and a health care provider concerning her daughter a 16 year old daughter with a history of mild infrequent palpitations who on 16-AUG-2007 was vaccinated IM with the first dose of GARDASIL (Lot # 658554/0928U).  Concomitant therapy included montelukast sodium (MSD), YAZ and albuterol.  On approximately 30-AUG-2007 "two to three weeks" post vaccination the patient experienced an increase in frequency and intensity of her heart palpitations.  The patient's mother reported at that time of this report that her daughter's increase in heart palpitations persisted.  At the time of this report the patient was under the care of her pediatrician.  Follow up information received from a health care provider stated that the patient was diagnosed with tachycardia by her primary care physician.  On 17-OCT-2007 the patient was vaccinated IM with the second dose of GARDASIL (Lot #658563/1063U).  Additional information has been requested.
This spontaneous report was received from a pharmacist regarding an 84 year old male patient. Pertinent medical history was reported as none. Patient had drug reactions/allergies to sulfa. On 11-JUL-2017, the patient was vaccinated with PNEUMOVAX 23, lot# M038216, expiry date: 31-JUL-2018, intramuscular for prophylaxis. Concomitant medications included blood pressure medicine, loratadine, pantoprazole, iron supplements and antibiotics in the past. On 11-JUL-2017, after few hours of vaccination, the patient experienced swelling in the bicep are in the arm in which injection was given. No treatment was given for the event. The patient sought medical attention by visiting the pharmacy. Outcome of the event was reported as not recovered. Causality of the event was not reported. Additional information has been requested.
I passed out driving 60mph on the highway. I awoke stopped in the middle lane not really understanding what was going on. Sweat was gushing down my head. Luckily nobody was injured. I start to feel better around 4:30pm
Several pts exp pain after vax;  Pain persisted for 3-4 minutes after inj.
six days after vaccination the patient had myoclonus of the left eyelid, inflammation, and pain that has not abated.  she has a follow-up scheduled w/ her PCP to address
PATIENT WAS GIVEN PFIZER COVID 19 VACCINE FOR 11 AND UP AND PATIENT WAS 10YRS AND 10 MONTHES OLD. NO ADVERSE REACTION WAS NOTED.
Per patient's Daughter the patient developed blood clots in his small intestine on 4/13/2021 and died 4/22/21 with physicians unable to explain how or why he developed these clots while on apixaban. She requested his case be reported and reviewed in hopes it helps make the vaccines safer if that was what caused the clots.
Patient came into clinic with mild redness bilaterally on arms as seen by nurse. Patient was wearing gloves brought from home the whole visit. Patient received covid-19 booster vaccination. Patient noticed redness on arms and sweating hands while waiting 15 minute period after vaccination. Patient removed gloves noticing more redness on palms of hands and then washed hands and arms in sink. Nurse offered benedryl, patient declined. Nurse monitored patient for a total of one hour after vaccination. Redness improved significantly bilaterally.  LVN
Headache, pain in joint, painful menstrual periods, sleep difficulties, spasm, rash, rheumatoid arthritis, fatigue, problems to swallow food and severe eye pain.
Arm red from shoulder to elbow. Wrap around arm. Swollen up. So painful could not move arm for five days. Dizziness and weakness still today. I took BENADRYL and hot pack on arm. I took pain med.
Covid-19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose
severe allergy reaction with hives. Treated by doctor with inyection and cream .Two weeks later I still have hives.
While driving home from Pharmacy after getting my Flu shot I started seeing squiggly lights which is indicative of an upcoming Migraine headache.  I haven't had a migraine headache in over 10 years.  The squiggly lights got larger and obstructed my field of view.  As soon as I got home I found my prescription from my neurologist.  I took one tablet of: BUTALB-APAP-CAF50-325.
Post COVID Rehabilitation; Post COVID Rehabilitation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Post COVID Rehabilitation". Clinical course: The patient was attributing ongoing GI and neurologic symptoms to the Pfizer COVID-vaccine received in Dec2020-Jan2021 (as reported) timeframe, for which the patient was continuing to seek care.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had bad headache one week after taking Pfizer covid vaccine. 3 days later went to ER due to severe headache and high blood pressure. was diagnosed with Shingles in ER.
Began having pain in left arm evening that vaccines were given. Developed fever of 99.5 degrees with sweats and chills. Temperature the day after the vaccine was 100.4 degrees and pain in the left arm from elbow to shoulder. Pain is rated at a "7" on a scale of 1-10. There is no redness. Mother reports "looks a little swollen compared to right arm." Mom believes arm is warmer than right arm. Provider spoke with Mom and advised ADVIL for sx control and to continue to monitor. This was added as an allergy on patient's medication list.
Initial misuse report received from a health care professional on 25 September 2013. The cases were received on 22 March 2014 at GPV. FLUZONE Intradermal was ran down from vaccine administrator's arm because patient pulled away. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Woke up the following day (1/29/2021) with extreme vertigo. I have a history of vertigo, last episode 4 or 5 years ago. This episode lasted 5 hours; Exhaustion and slept for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EZ9264), via an unspecified route of administration on right arm on 28Jan2021 at 15:45 at the age of 69 year old at a single dose for COVID-19 immunisation at the hospital. Medical history included coronary artery disease, vertigo (I have a history of vertigo, last episode 4 or 5 years ago). Allergies to medications, food, or other products was dilantin, streptokinase. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient previously took dilantin, streptokinase and experienced allergies. It was reported that patient woke up the following day (29Jan2021, 09:00 AM) with extreme vertigo. This episode lasted 5 hours. Following that, about an hour after she arose, she had exhaustion and slept for 4 hours. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the event vertigo aggravated on 29Jan2021 14:00 and recovered from exhaustion on an unspecified date in Jan2021.
Moderna Vaccine: fever (101.6 Deg. F) starting early next morning, soreness of arm (a few hours after injection), Headache (minimal)
I have had 2. I have developed heart anything?s,  and sfter gettin the Moderna booster on December 29,2021, I hemmoraged on January 9,2022 and was taken to the hospital
Started with aches in my arms and fingers, then whole body, shivers, 101.6 fever and a pain in my head that was like a stabbing pain.  I took Advil, slept for over 12 hours (normally and 6/7 hour sleeper). Woke up slightly better, still ache and shivers but headache has almost gone and temperature is normal.
Case number PHEH2014UD016323, is an initial spontaneous report from a physician received on 13 Aug 2014. This report refers to a 37-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with the first dose of RABAVERT (batch number: 52011A) on 01 Aug 2014 and experienced flu-like symptoms (see case: PHHY2014US102563). She was vaccinated with second dose of RABAVERT (batch number: 52011A) on 04 Aug 2014 and third dose of RABAVERT (batch number: 52011A) on 08 Aug 2014 respectively. On 09 Aug 2014, 24 hours after the third dose of RABAVERT was administered, she experienced delayed type II hypersensitivity reactions to RABAVERT in the form of a localized rash, joint, and back pain. The physician insisted the rash was a representative of delayed type II hypersensitivity reaction to RABAVERT. The outcome of the events was unknown. Seriousness and causality was not reported.
Initial information received from a Nurse on 13-Dec-2018 and additional information received also from a Nurse on same date. This case involves a 3 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy received. On 25-Sep-2018, the patient received a 0.5 ml first dose and 0.25 ml second dose on 26-Nov-2018 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number UT625JA/UT625UA (expiry date: 30-Jun-2019) via intramuscular route in the right thigh. It was a case of actual medication error due to vaccine underdose and inappropriate schedule of vaccine administered. It was reported that patient actually got a full dose of 0.5 ml in September and then 2 months later got the 0.25 ml dose. As recommended, doses should be administered 2 weeks apart. It was unknown whether patient experienced any adverse event. Documents held by sender: none.
Appr 5-10 mins following immun-pt broke out in urticaria "hivey" type rash;  Rash started on face then to trunk & arms; referred to MD; by time seen by MD rash had almost disappeared x/on face; MD stated no more Pertussis; No meds ordered;
Patient and parent informed staff their school required them to show proof of vaccination for MMR and Varicella. We did not have proof. Parent and patient agreed to MMR and VARICELLA vaccine, however staff inadvertently administered PROQUAD.
Severe headache, fever of 101.2°F, chills, fatigue, muscle aches, nausea. Headache and fever were treated with 500mg acetaminophen and 25mg diphenhydramine. Symptoms have lessened but are lingering on date of this form submission (3/26/2021)
Lip-chewing; slurring; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PYRIDOSTIGMINE; PREDNISONE; AZITHROMYCIN [AZITHROMYCIN DIHYDRATE]. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary immunization, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Primary immunization, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (1st booster , manufacturer unknown), for COVID-19 immunization. The following information was reported: COMPULSIVE LIP BITING (non-serious), outcome "unknown", described as "Lip-chewing"; DYSARTHRIA (non-serious), outcome "unknown", described as "slurring". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 siblings in family dx w/varicella FEB97;14 days later pt was dx w/chickenpox-also had varivax vax 25OCT95;temp & over 130 lesions & an office visit;
pt recv vax 1MAY97 & on 3MAY97 devel temp-extreme irritability-refusal to eat on 4MAY97;devel temp of 104-105;3-4 palpable lesions on abd & groin;mom gave ibuprofen;dx varivax rxn & otitis;prescribed amoxil;