chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got really tired like someone gave me a sleeping potion about 3:00 PM after vaccine and I went to bed and slept for a few hours and woke up at midnight, made dinner, and went back to sleep. Next morning I noticed I had a very swollen lymph node in my left armpit and it was also very painful, so that didn't go away and by the 2nd day both of my armpit lymph nodes were swollen and near my collar bone and I had sort of like a little bit of sense of pressure in my chest and I could still breathe but I wasn't able to go for a jog and couldn't put my arms down without increasing pain and the pain was traveling into my breasts and that's when I emailed my doctor and asked her what I could do and I did read that there was an increase occurrence with swollen lymph nodes. She had me try some Aleve and that helped only a little and she had me switch to Tylenol and it got better within 3-4 days, and it was resolved. Through this, I was very tired.
none. TC to reporter who states the AE is seizures which progressed to hypotonia, laryngomalacia, GERD, and laryngeal reflux.  01/29/2007 MR received documenting a 40 day hospital stay (8/23-10/02/2006) for new onset, intractable seizures beginning ~3 weeks following Pediarix vax. Infant began having seizures 8/16/2006 and was managed outside hospital prior to admission, but had been having increasingly frequent and more intense seizures which led to admission for video EEG monitoring on 08/23/2006.   Following admission, infant continued having daily seizures and infantile spasms.  Was treated with phenobarbital, Topamax, ACTH, and Keppra. Consults for Genetics, GI, Pediatric Pulmonary, and Otolaryngology. Additional DXs of Laryngomalacia and reflux. Infant was finally discharged on 10/02/2006 in order to seek a 2nd opinion from an epilepsy specialist.  Discharge DX: Intractable seizures. 02/26/2007 MR received from seizure specialist for several consultations beginning 10/02/2006 through 01/22/2007, including several Epilepsy Monitoring Unit stays for evaluation.  Multiple seizure types noted: Partial seizures within clusters of spasms manifest as tonic posturing of right or left thumb with mouth movements and eye deviation.  Infantile spasms occuring daily.  Axial Tonic seizures. Impressions:  Medically refracory epilepsy manifest by complex partial seizures and infantile spasms.  Laryngomalacia.  Feeding difficulties 2' to Laryngomalacia.Hypotonia.
The 9 year old patient received a full adult dose, 0.3mL, of the adult formulation of the Pfizer Covid-19 vaccine.
On 01/23/2018, we went in to a wellness check for and were prepared that it was time to start her on a vaccine schedule, she received her first round of PCV and IPV,and the only symptom she experienced that day was tiredness/sleepiness. About 3 days after the shots, patient woke up one evening throwing up.  It hadnt even occurred to me that she could still be having a reaction, so after watching her carefully, she was feeling better soon after so i wrote it off as it possibly being something she ate. Exactly 3 months later, the same story happened, except this time she didnt bounce back as quickly. She would wake up exhausted, lethargic, having diarrhea, vomitting, didnt want to eat for about 2-3 days, no interest in anything, crying, it just wasnt the same baby anymore. I took her in for an emergency appt, when her fever reached 102 fast, The dr on call did a few tests and sent us home, saying that the results were all negative and that it was possibly a reaction to the vaccine. She was sick like that for 3-4 weeks until completely better a month after.
Information has been received from an Immunization Officer concerning an unknown number of patients who, on unspecified dates might have received a dose of GARDASIL (dose, route and lot # not specified), which had been exposed to 11 degrees C for 137 hours. No adverse effects reported. This is one of five reports form the same source. The other linked reports are: 1211USA005919, 1211USA006714, 1211USA006715 and 1211USA006716. Attempts are being made to obtain additional identifying information to distinguish individual patients mentioned in this report. Additional information has been requested.
An after hour receiving vaccine booster my left arm at the injection site and left side of my chest and neck broke out into a very itchy bright red hot rash
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
lost hearing in her right ear; mouth sores diagnosed as oral shingles; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Feb2021 (Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 22Sep2020 (had lab work on Sep2020 because of surgery) and blood pressure. The patient had shingle's vaccine. Concomitant medication(s) included irbesartan (IRBESARTAN) taken for blood pressure, start and stop date were not reported. Five days after the first vaccine the patient got severe sores in her mouth and then she went to the doctor, they call it she could possibly have shingles or shingles in her mouth it appeared to be canker sore (later reported mouth sores diagnosed as oral shingles). Then five days later she woke up in the night and could not hear. She lost hearing in her right ear. Actually loss of hearing 2 days before the got her second vaccine and she talked to her doctor and doctor thought the patient still went ahead and had the second vaccine but she didn't want to put the patient on the Prednisone because that will weaken her immunity but then it didn't get better and she sent the patient to Ear, Nose and throat he told the patient if she has any hope to getting her hearing back she had to start this medicine but that's what the patient was concerned about. The patient took Prednisone on 12Mar2021 for the ear treatment. For the first 2 week she was taking 60 mg and then after 3 weeks, she took 2 tablets 40 mg and then the next week she took 10 mg for 2 days. The outcome of event mouth sores diagnosed as oral shingles was recovering, others was unknown.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 29-AUG-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L019297, expiration date 18-AUG-2017, 0.5 ml (route of administration was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 25 degrees Fahrenheit for 7 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Patient described feeling flushed.  We activated our rapid response and hooked the patient up to the monitor.   The patient was observed by our ED physician and observed for ~ 30 minutes.  All vitals were normal, the patient reported a Migraine for 1-2 days after.
Client experienced syncope, dizziness as she walked out of the clinic area into the hallway; as her legs weakened, she hit her head to the wall and was caught and supported by a nurse as she slumped to the floor. Client was non-verbal for about 5 seconds and assisted to  a chair, vital signs were taken - BP 80/56, pulse 66, cold compress to forehead, feet elevated; slow verbal responses but awake, rested for approximately 15 minutes alert after this period, no complaint of headache or other discomfort. Mother reports child had not eaten except for a poptart in the morning.
had vaccine at 0140,  went home had supper.  At 0515 started with the chills & shaking.  Shaking continued with full body involvement.  No temp.  No diaphoresis. Went to bed.   Vomited x1.  Slept for a while-  next arm felt weak all over legs ached.
Progressing ataxia with onset approximately 11/08. Severe gross motor and fine motor impairment noted.  6/15/09 Received PCP medical records for 11/19/07-04/2009. FINAL DX: ataxia, hypertonia, tremors Records reveal when patient seen 11/19 experienced progressive walking abnormality, falls, irritability, balance difficulty, leg pain, weight loss, shaking, confusion, rhinorrhea, speech regression x 3 wks.  Parent reported symptoms had been present prior to flu vaccine.  Developed fatigue, back pain, excessive sleeping, otitis media w/effusion.  Neuro -ophtho consult done 12/07 dx w/seizure disorder; normal optic nerves & retina; normal hyperopis.  RTC 10/08 w/cough, decreased appetite, nasal congestion/drainage, fever, chills, shaking, falls, unsteady gait.  Dx w/viral URI, gait disturbance.  Referred to Neuro & Ophtho.  Dx w/nystagmus thought to be neurological rather than optho in origin.  Referred to genetics & eval of 4/09 revealed amino acid deficiencies.  9/29/09 Neurology consult records received DOS 12/30/08 to 6/18/09. Assessment: Progressive ataxia. Patient presents with abnormal gait, stumbling and falling. Ataxia, shaking of legs and arms, shaking speech. Gaze jerk nystagmus. Truncal ataxia. Intention tremor, tremor in speech.
For both dose 1 and dose 2, I started to feel fatigued approx 12 hours post vaccination. I woke the next day with fever (100.7) and body aches. Symptoms resolved with in 36 hours.  I tested positive for COVID 11/19/2020.
48 hours after vaccination given, patient brought to clinic with redness to left upper arm, erythema with mild induration. No fever and normal movement.
Pretty sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR069301).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself/herself. The age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient got sick after 2nd shot of Shingles vaccine. The reporter had a feeling how he or she was going to feel after his or her 2nd COVID vaccine next week. For the tolerence of dose 1 refer case US2021AMR069301, reported by same reporter for same patient; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR069301:
Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a seven years old male patient who was administered expired TENIVAC and administered expired TENIVAC to make up for his 5th missed dose of DTaP series. This is actual medication error case due to expired vaccine used and wrong vaccine administered. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of Varicella Vaccine for Immunisation; and a dose of IPOL for Immunisation. On 07-Aug-2018, the patient received a dose of suspect 0.5 ml TENIVAC lot U5280AA, exp date: 16-March-2018 via intramuscular route in the left thigh to make up for his 5th missed dose of DTaP series. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: not applicable. 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 sender: none.
Coma then death due to herpes simplex 1.  My wife was in a coma on 7/27/21 then died 8/6/21
Miscarriage after receiving 2nd Covid vaccine during first trimester, confirmed at doctors office by bloodwork. Estimated due date June 1, 2022.
I have been feeling really bad; large rash all the way around; I have flu like symptom; area is red and inflamed and it feels heat. The whole area feels hot and red/arm where I got the injection is swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 12:00 as dose 1, 0.3 ml single (Lot number: HG9498) at the age of 76 years intramuscular, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 21Oct2023, outcome "unknown", described as "I have been feeling really bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset 21Oct2023, outcome "unknown", described as "I have flu like symptom"; VACCINATION SITE INFLAMMATION (non-serious) with onset 21Oct2023, outcome "unknown", described as "area is red and inflamed and it feels heat. The whole area feels hot and red/arm where I got the injection is swallowing"; RASH (non-serious) with onset 21Oct2023, outcome "unknown", described as "large rash all the way around". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site inflammation. The patient was treating it with Aloe. Additional information: Consumer stated, "I got the Pfizer vaccine on Friday and for the past three days I have been feeling really bad. My arm where I got the injection was swelling with a large rash all the way around; The area is red and inflamed and it feels heat. The whole area feels hot and red. I have flu like symptom for the last three days." The patient was wondering if this was normal and if that will continue to happen. The patient just treated it with like Aloe because it's, the area was red and inflamed and it felt heat. The whole area felt hot and red.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Pt w/ chest pain concerning for pericarditis. Ordering ESR/ CRP and echo
redness and swelling on the injection site; redness and swelling on the injection site; tired for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness and swelling on the injection site), VACCINATION SITE SWELLING (redness and swelling on the injection site) and FATIGUE (tired for 3-4 days) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006M20A and 040A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pneumonia vaccine (he had reactions to other vaccines (Pneumonia vaccine) prior years,) and FLU. Past adverse reactions to the above products included No adverse event with FLU; and Reaction to previous exposure to any vaccine with Pneumonia vaccine. Concurrent medical conditions included Blood pressure high (High Blood Pressure for 3 years and controlled with Ramipril 3 years ago,). Concomitant products included RAMIPRIL for Blood pressure high, METOPROLOL, CLOPIDOGREL BISULFATE (PLAVIX) from 14-Jun-2022 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) and INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling on the injection site), VACCINATION SITE SWELLING (redness and swelling on the injection site) and FATIGUE (tired for 3-4 days). In March 2021, FATIGUE (tired for 3-4 days) had resolved. In November 2021, VACCINATION SITE ERYTHEMA (redness and swelling on the injection site) and VACCINATION SITE SWELLING (redness and swelling on the injection site) had resolved. Not Provided          It was reported that, after the first primary shot, the patient had redness and swelling on the injection site, and she was tired for 3-4 days. After the 2nd primary shot, she had redness and swelling (red Lump) on injection site and a little tired for 3-4 days. After the first Monovalent booster, she had redness and swelling on injection site for 1-2 days.  No treatment medications were reported.   This case was linked to MOD-2022-691336 (Patient Link).
This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 2 patients of 10-14 years old with unknown gender were vaccinated with VAQTA (2 doses) (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of several reports from the same source. Additional information has been requested.
patient received a dose of Menactra that was expired by two days/no AE; Initial information was received on 06-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 year old female patient who was vaccinated with 0.5 ml once dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that was expired by two days (batch number U6219BA and expiry date 16-Jun-2020) via intramuscular route at the left deltoid on 18-Jun-2020 for prophylactic vaccination (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE (HPV VACCINE) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  At the time of report 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 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.
Patient received a monolent Pfizer Covid 19 vaccine on 11/17/22, after having received Janssen on 03/13/2021 and a Janssen Booster on 12/23/2021.
Had vaccine on 1/4. On 1/7, redness developed around vaccine site. It's sore, itchy, bruised and warm to the touch but not raised. Pt marked site on 1/7 AM and on 1/8, it's still the same size.
probable vaccine related myelitis ( seen by neurologist and physiatrist) , burning pain in legs, heaviness, difficulty walking, banding around back of spine to front, spascity, constipation, urinary frequency,   Physiatrist seen an neuro exam was abnormal suggesting a myelitis ( I did not tell him I had the covid vaccination, which was an error on my part)  Seen four days later by neurologist neuro exam essentially normal except for my hyperreflexia (since transverse myelitis 2003).   No MRI done ( as I didn't contact him in a timely manner ) by the visit most of symptoms have resolved.
Shaking; Dizziness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), DIZZINESS (Dizziness) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced TREMOR (Shaking) and DIZZINESS (Dizziness). The patient was treated with NAPROXEN SODIUM (ALEVE) for Chills, at a dose of 1 dosage form. At the time of the report, TREMOR (Shaking), DIZZINESS (Dizziness) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
seizure; fainted; Initial information received on 19-Sep-2022 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 17 years old male patient who had seizure and fainted after receiving vaccines BEXSERO and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 15-Aug-2022, the patient received an unknown booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength was unknown, lot U7294AC and expiry date was unknown) via intramuscular route in unknown administration site for Prophylactic vaccination. On an unknown date, the patient received an unknown booster dose of suspect BEXSERO not produced by Sanofi Pasteur (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 15-Aug-2022 the patient developed a serious event of seizure and fainted (syncope) (Latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE and (unknown latency) following the administration of BEXSERO.   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Recovered / Resolved on 15-Aug-2022 for both events.  Seriousness criteria: Medically significant for both events.; Sender's Comments: Sanofi company comment dated 23-Sep-2022: This case involves a 17 years old male patient who had seizure and fainted after receiving vaccines BEXSERO and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. The time to onset is compatible with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Very bad head ache.  Achy and tired for 1.5 days.  Vomited twice the day after vaccine.  Lost of hearing, ringing, and noise in R. ear.  All have subsided, except the the hearing loss.  I can not even hear someone talking on the phone.  The noise and the ringing have gone, but I truly cannot hear except very very faint sounds.