chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11/20/08 fever up to 101.7; seizures.  12/26/08 MR received for DOS 11/20-21/2008 with DX: Febrile illness, possible seizure. Recent vaccination. Pt presented fever, decreased po intake and an episode of jerking of the whole body lasting ~ 5 min. On arrival T=100.0"F.  Some diarrhea x 1 week. No further episodes during o/n observation.
Pt recvd 2 doses of Engerix-B & exp no events following 1st dose but 4 days p/2nd inject exp severe dizziness, nausea, h/a, & ringing ears; treated w/Antivert & sx resolved;
I woke up unable to move my toes on my left foot. They were paralyzed. I couln't move them up or down, and I couldn't wiggle individual toes. I tried the right foot; it was OK. I went back to the left foot and still couldn't move the toes. I tried moving the ankle. After circling the ankle a couple of times, the toes finally moved. The total time was about 30 seconds; however, I don't know how long they were paralyzed before I woke up.
patient reported to the doctor that a rash developed a day or two after receiving her 1st dose of moderna.  Patient said that the rash was red and itched for a week or two.
Was seen on 4/4/01 for PE. She had continuation of symptoms. The ARNP decided it may be related to Hep-B received on 4/3/01. She complained of severe headache right after getting vaccine and it increased. Complaining of nausea, shaky, swelling of throat and tongue which hurt and tired. Lasted 32 hours and went away. Treated with Advil. Feels fine today, 4/5/01.
Arthritis flare up, Neck tight and sore, overall body ache, flu -like symptoms, lasted 48hrs
This spontaneous report as received from a pharmacist via a field representative refers to a female patient of unknown age. The pertinent medical history was unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous. The concomitant medications were unspecified. On an unknown date the patient developed cellulitis at injection site. It was reported that on an unknown date, the patient was seen at an unspecified emergency room as she developed a rash that was very painful. The pharmacist reported that it seems like the rash was going to be shingles. The outcome of the events was unknown. The causality was unknown. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of mobility decreased in a adult female patient who received FLULAVAL QUADRIVALENT (batch number H33J2, expiry date May 2016). In 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced mobility decreased, pain in arm, weakness and swelling. On an unknown date, the outcome of the mobility decreased, pain in arm, weakness and swelling were unknown. It was unknown if the reporter considered the mobility decreased, pain in arm, weakness and swelling to be related to FLULAVAL QUADRIVALENT. Additional details provided were as follows: The healthcare professional reported that, there were 2 patients (for other patient see case US2015GSK159505) who received FLULAVAL QUADRIVALENT and experienced the events. These reports could be a duplicate of a previous cases reported. However, according to the patient identifiers provided in both these case, no duplicate reports has been identified. An unspecified time after vaccination, the patient in this concerned case experienced left upper arm pain, swollen, weakness and was unable to lift left arm. The patient received physical therapy as a treatment.
Ringing in the ears?Tinnitus developed a few days later. Over the past year?I have seen an ENT Dr who then recommended an Audiology Program.  I am currently in Phase 3 of that program. I also had an MRI done of my head/brain to ensure there were no other issues.
Patient received a 3rd Moderna covid vaccine 1 week after receiving their second covid vaccine. (Thye were supposed to be scheduled for a flu vaccine and were scheduled wrong. The nurse then gave the wrong vaccine.  Patient, to date, has not suffered any adverse effects from above.
Information has been received from a physician concerning a female patient who was vaccinated IM with 0.65 ml dose of Zostavax (Merck). It was reported that the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Additional information has been received from the medical assistant who stated that they had "no patients who have had a reaction". Additional information has been requested.
This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient. A 31-year-old male patient received bnt162b2 (BNT162B2) on 23Nov2021 as dose 3 (booster), single (Lot number: FH8028), at the age of 31 years, in left arm for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Anatomical Location: Left Arm), administration date: 20Jan2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EM9809; Anatomical Location: Left Arm), administration date: 10Feb2021, when the patient was 31 years old, for COVID-19 immunisation. The following information was reported: RAYNAUD'S PHENOMENON (non-serious) with onset 01Dec2021, outcome "recovered with sequelae", described as "Raynaud's Disease". Therapeutic measures were not taken as a result of RAYNAUD'S PHENOMENON. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.
Severe MUSCLE pain.   Started in both shoulders, progressed to both thighs.  All around muscle tightness.  Trouble sleeping, getting up from chair, bed, toilet.    Muscle weakness (loss of strength).    Having this problem for 2-MONTHS.  Taking IBUPROFEN & prescription METHOCARBAMOL 500mg.   Both seem to lessen pain.
no adverse event; Indicate at which point in the process the medication error occurred? Storage in clinical practice/Temperature excursion - vaccine not viable according to manufacturer; This spontaneous report was received from a nurse, and refers to an 11-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant vaccination included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP). Historical vaccines included:  diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP); influenza vaccine; hepatitis a vaccine inact (manufacturer unknown), Hepatitis B Vaccine (Recombinant)(manufacturer unknown); polio vaccine; measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5),tetanus vaccine toxoid (PENTACEL); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), rotavirus vaccine live reassort oral 5v (ROTATEQ), and varicella vaccine (manufacturer unknown).  On 22-JUN-2023, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, dose 1, lot #W004648, expiration date: 06-OCT-2024, on the right arm administered for prophylaxis (strength, exact dose, and route of administration were not provided) following a temperature excursion, it was stated that a data logger was invloived. No adverse events occurred.    This is one of several cases of the same patient.
Six hours later I was dizzy and out of breathe. I fainted on the stairs. I slept until 3am the next morning and I woke up with chills. I had a temp of 102. I had muscle and body ache. It was bad, I took Tylenol and Ibuprofen. It only soothed the pain a little. I had a fever that climbed to 104. I felt like my bones was being drilled and started hallucinating for two days. I was hallucinating until the 4th day the fever started to break, I was gushed in sweat. It was like a cloud was shifted and I started getting better.
The night after being administered the vaccine, the patient experimented hives and rash in several parts of the body. He took BENADRYL 50 mg that night. This symptom lasted approximately 2 days.
Patient was pale, felt nauseated, and had numbness and tingling in right arm after injection of Flu vaccine.  Had vasoconstriction to limb.  Limb cool to touch, mottling noted.
12/6/05:started feeling extremely tired, headache; removed Bandaid entire area underneath was red; 12/7/05: noticed "scratch marks" approx 2-3" away from site; 12/8/05: stayed home from work for rest; 12/9/05: Contacted VAERS, was advised to see to see a doctor; Contacted 122 MDG, sent to Dupont ER for immediate treatment.
Patient has seizure onset on 8th day (after 4 month vaccine). He is diagnosed with seizure disorder based on EEG. There is positive family history of seizure. Not sure if any relation.
Daughter received varicella vaccine 4/5/03. Father came down with disease 4/29/03. Missed 9 days work 4/21-5/7/03.
I had extreme headache and could not focus  I got dizzy and fainted and lots consciousness. I ended up  lose muscle control and urinated .   Afterwards, I could not speak  well.  I continued to have massive  headaches
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B and 012020A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Patients received expired vaccine which was stored in the refrigerator beyond 30 days.
pain at injection site from an hour after vaccination, slowly faded over the course of 3-4 days. chills, muscle aches, low-grade fever, small, occasional joint pains, tiredness. all of these flu symptoms started around 11pm (minor) and progressed to their worst by midnight, lasting in fluctuating severity until Sunday, May 23rd.
Patient had minor swelling at the injection site, followed by a headache. A rash developed the same day as the vaccine below the injection site. The rash has been there for one weeks time as of today and is slowly getting more itchy and spreading slightly.Patient came in with concern because the rash was spreading and getting itchier.
This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. In May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. The patient was treated with Antiviral for systemic use. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In mid-May, the patient received 2nd dose of SHINGRIX, 2 months after 1st dose. During 2nd week of June, the patient experienced shingles. The physician of the patient stated that she did not think it was related to the receipt of SHINGRIX.
Fever, rash began 4/2/06. Parent took child to ER. Dx vaccine reaction. No TX, D/C.
This is in follow-up to report (s) previously submitted on 11/14/2008. Information has been received from a healthcare worker concerning a 17 year old female with asthma who on 27 Aug 2008 was vaccinated with the first dose of GARDASIL intramuscularly. On 23-Oct-2008, the patient was vaccinated with the second dose of GARDASIL intramuscularly concomitant therapy included unspecified oral contraceptives. It was reported that one day after receiving her second dose, on 24-Oct-2008, the patient experienced an asthma attack. Prior to this, it had been 4 years since this patient had experienced an asthma attack. She was treated with an unspecified asthma inhaler. The patient also developed redness, swelling pain and warmth at the injection site after both of her immunization with GARDASIL. All these symptoms were greater after the second dose than the first dose. The onset date of these symptoms was unspecified. At the time of the report, the patient was recovering. The patient sought medical attention, by phone call. Follow up information received on 30-DEC-2009 stated that the patient's mom called and said that the patient has a reaction to the injection, her arm was swollen/warm to touch and she had an asthma attack. Patient has not had an attack for four years wasn't sure if it was related or not. Inhaler made patient feel better. Additional information is not expected.
The pt experienced febrile seizures, he vomited, was unresponsive and his hands and feet appeared to be turning what the Mother called purple and that he began to start to twitch in all extremities. She called the ER triage line and was told her son may be having a seizure and to bring him to the ER. The pt have a fever of 101. Mom stated he appeared to be in a daze as well.
Fever pain at injection site, chills Narrative:  per supervisor report: "received 2nd injection on Tuesday 2/23/21 experiencing fever, chills, arm pain"  Other Relevant History:
Information has been received from a Registered Nurse concerning a current 20 year old female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (Lot # unknown). The nurse reported that a patient  said that 3 or 4 weeks after receiving the first dose of GARDASIL she started having joint pain on her wrists and ankles. The first dose of GARDASIL was administered by a different facility and this patient was new to the clinic. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. Follow up information has been received from a registered nurse via medical records, concerning a 20 year old female student patient with no illness at the time of vaccination or no known drug allergies who in approximately August 2010, received the first dose of GARDASIL. The patient stated that on 20-AUG-2010, she developed pain in her wrist, finger and ankles which started after the first dose of GARDASIL. On an unspecified date the patient was prescribed with NAPROSYN and minocycline hydrochloride. On 24-SEP-2010, the patient's labs were within normal limits except for mean corpuscular volume 79.1, mean corpuscular hemoglobin 26.0. The patient's serum rheumatoid factor test was <20 and serum antinuclear antibodies test was negative. On 01-OCT-2010, the patient had a follow up with her physician, it was reported that all symptoms had resolved, her exam of wrist and arm were remarkable. The patient had good response to NAPROSYN with no side effects. The patient was diagnosed with arthralgia (hand and finger) and joint pain. There was no no need of further work up unless her symptoms recurred. The patient was prescribed with NAPROSYN PRN. There were no new concerns. No further information is expected.
Sore left arm; Fatigue; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), FATIGUE (Fatigue) and CHILLS (Chills). On 09-Mar-2021, PAIN IN EXTREMITY (Sore left arm) had resolved. At the time of the report, FATIGUE (Fatigue) and CHILLS (Chills) had not resolved.            The Action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable.  Concomitant medication used were not provided.  No treatment information was provided.     This case was linked to MOD-2021-039122 (Patient Link).
urinary track infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (urinary track infection) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced URINARY TRACT INFECTION (urinary track infection). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) ongoing from 24-Feb-2021 for UTI, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (urinary track infection) outcome was unknown.            Concomitant product use was not reported.  Treatment product use was not reported.  Follow up email received on 01Jul2021 from the reporter states that there was no remarkable connection of urinary tract infection to Moderna vaccine   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Correspondence follow up email attached: casuality updated
Information has been received concerning a pt who on 05/10/00 was vaccinated with first dose of varicella vaccine. On 06/16/00, the pt developed a chickenpox rash. the reporter is unsure of number of lesions, however she describes a good rash. the pt sought unspecified medical attention was sought and on an unspecified date the pt recovered.
Suspected vaccination failure; believe I have suffered VZV Opthm / had a more severe outbreak of herpes zoster which included infection of my. Eye; have chronic herpes zoster in my trigeminal nerve; believe I have suffered VZV Opthm / believe I had Vz; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), herpes zoster infection neurological (serious criteria GSK medically significant) and varicella zoster. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, herpes zoster infection neurological and varicella zoster were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster infection neurological and varicella zoster to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient was being treated for an immune deficiency. The patient also asked should he/she get shingles vaccine if he/she has an immune problem. The patient stated that after receiving the Shingrix vaccine, he/she had a more severe outbreak of herpes zoster which included infection of his/her eye. The patient also had chronic herpes zoster in his/her trigeminal nerve and any amount of stress causes an outbreak of varicella zoster virus.  The patient believe he/she had suffered from ophthalmic herpes zoster. The patient also believe he/she had varicella zoster. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for Herpes zoster and time to onset were unknown.
4 bumps to forehead. Family wants this even documented. not urticarial. No facial swelling. no difficulty breathing. Injection site WNL
Saturday, Marth 5th -- day after vaccination.  Upon awakening, extreme pain head-to-toe, in muscles and joints.  Severe headache (very rare for me), Hands could barely move (like severe arthritis),  Slightly elevated temperature (98.9 when my normal is 97.8).  Overall symptoms faded slightly and then returned to full strength two or three times during the day.  Unable to eat (not nauseous, just not hungry) and only drank water.  No bowel movement and very little urination during the day.  By about 18:00, headache was gone and pain was receding .  Around 21:00 started getting very cold and could not seem to get warm.  Started shaking severely from cold.  Put on sweat suit, turned on bed heater, and added blankets, then went to bed around 22:00.    Woke up Sunday morning (March 7th feeling absolutely perfect!  None of the previous day's pain was present, no temperature, no limits to hand/finger movement, and was very hungry.  Ate a normal size breakfast with no problems, urination was normal,   It was like the reaction had never happened, but my wife assured me that it had.   Other than slight constipation, I have no had any problems since.
feeling slightly ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "chest tightness", "difficulty breathing", "almost fainted ". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling slightly ill".  Additional information: The consumer was concerned because her daughter (patient) had chest tightness, difficulty breathing, and almost fainted with her first shot. She went ahead and got her second shot anyway and only had "normal reactions" like feeling slightly ill. She was concerned if there are boosters because she has not heard of anyone else having these effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.