chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke in AM, hard crying for few mins then calmed down & went to sleep; couple of hrs later could not fully arouse pt; no fever, breathing good, good color; PM went to MD transported to hosp emergency; CAT Scan-hemorrage; lt-sided paralysis;
no AE reported; The product was administered on 06 MAY 2021 and expired on 04 MAY 2021.; Information has been received from a medical assistant , referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-MAY-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R020949, expiration date on 04-MAY-2021, 0.5 milligram (administration route and anatomical location were not reported) for prophylaxis.   The reporter confirmed that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  vaccine did not had any temperature excursion. No additional adverse event (AE) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R020949; expirationdate: 04-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Patient started experiencing chest tightness last night on 1/25/2019 mostly exercise induced. Today she is experiencing sore throat and chest tightness. The symptoms are not worsening and slightly better.
High fever of 102F and macular papular rash on trunk and face. Some scattered to extremities.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included dialysis.  Subjects had previously received Recombivax and did not respond to therapy.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis B antibodies.  At the time of reporting the outcome of the event was unspecified.  The nurse reported that this occurred in a total of eight patients.  GSK case numbers are A0638778 and A0638780A through A0638786A.
Pain at right deltoid, right shoulder, right neck. Ecchymosis at site, hot to touch, increased bleeding at site. No anticoagulant meds or bleeding disorders.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's pertinent medical history was not reported. It was reported that on 28-NOV-2014 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (Lot # reported as H016919 and expiry date reported as 10-SEP-2014) of dose 0.5 ml via subcutaneous route. No adverse experience reported. Product quality complaint was reported as no. the outcome of the event was unknown. Additional information has been requested.
Woke up at 4am next day to use the bathroom and was too dizzy to walk.   Remained in bed all the next day.  Walls appeared wavy, couldn't move her head.  The 2nd day was better, but couldn't stand to take a shower to day 3 post vaccine.
Information has been received from a 28 year old female with  no known drug allergies who on 6/25/02 was vaccinated with a dose of MMR II. On 7/2/02, the pt developed a sunburn like rash on her face and left arm. At the time of this report, the pt did not seek medical attention. Additional info has been requested.
Hospitalized 12/1/2021; COVID-19 positive 12/1/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider: MD Admission Date: 12/1/2021 Discharge Date: Dec 3, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: Patient is a 63-year-old female past medical history significant for obesity, diabetes, insulin resistance, hypothyroidism and known pulmonary hypertension presents to the hospital on 12/1 due to dyspnea, chills, decreased appetite, nonproductive cough, headache diarrhea, nausea and vomiting.  Patient was tested positive for COVID-19, with chest x-ray showing focal opacities in the right lower lobe and right middle lobe representing pneumonia.  Her symptoms started around 11/27.  Patient was started on remdesivir and Decadron.  Decadron was interrupted as patient got better and got discharged on 12/03.  Will however try to complete 10 day course of dexamethasone.  Patient was started on antibiotics with suspicion for concomitant bacterial pneumonia however clinically this was felt to be less likely and hence were discontinued.  Patient was requested to resume her insulin regimen as she was doing before.  She states that hypoglycemic events are not frequent.  I asked her to call PCP if her blood sugars are persistently elevated especially getting discharged on dexamethasone.  However it has to be noted that patient's insulin needs were much lower than what she actually takes at home.  She was evaluated for possible need for home oxygen on the day of discharge, but did not need any.
Patient came in to get her first Covid vaccine.   She could not recall ever getting a vaccine before and seemed anxious.   Fifteen minutes after her vaccine I went over to check on her.   She appeared to be disoriented sitting in her chair in the lobby.   She was not responsive for a couple minutes.   We laid her down flat on the floor and gave her some cold water .   She was very hot, sweaty, tachycardic and said she just had a weird dream.   The paramedics came and said she experienced a psychogenic reaction secondary to first-time vaccine injection.   Patient declined going to the hospital.
Mom called just over 2 1/2 hrs after administration stating pt had hives, throat felt like it was closing.  Advised to call 911.
10:00 am - headache, pressure on frontal lobe 2:00 pm - headache excruciating, weakness in legs, nausea 2:35 pm - blood pressure 198/97 2:40 pm - severe headache  3:00 pm - muscular aches all over body, overwhelming weakness 3:40 pm - vomited, had to pull over while driving home  3:50 pm - somewhat relieved after vomiting, arrived home stayed in car (parked) for over one hour to allow headache and weakness to subside 5 pm - entered apartment, took blood pressure, 137/77 5 pm - temperature normal (98.0 F) 5-9 pm - muscle weakness, headache.
10-7-14 Chiropractor appt at 9:00am. Felt baby more. 11:15am OB-GYN appt: no fetal heart tones. Admitted to hospital and induced at 37 weeks. Delivered still born on 10-8-14 at 2:00am.
pt started with persistent cough , airway swelling and difficulty swallowing. IM benadryl 25 mg given and 0.3 mg Epi via Epi auto injector 911 called pt transported to ED
STARTED FEELING THE EFFECTS  INSTANTLY; RUNNING A 100 DEGREE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced started feeling the effects instantly, and running a 100 degree fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 DEGREE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the started feeling the effects instantly and running a 100 degree fever was not reported. This report was non-serious.
She is a health care worker.  She presented with her CDC card.  There was no indication she had received the Bivalent Booster.  She filled out the paperwork for consent.  At time of injection prior to injections she was asked if she had received a Bivalent she stated no.  When charting this information into patients Chart there was no indication she had received a Bivalent booster.  However when nursing facility was charting in their system they found out on Oct 2022 she did in fact receive a bivalent booster and notified us of this.   NO adverse reaction-no symptoms, no signs, no treatment, no reaction
Headache, Myalgia, Fever & ErythemaMultiform Narrative: L arm still sore, red with lump/swelling x 3 days. instructed to see a MD asap
Clients mother call to Health Department on 03/30/09, received 1st HPV 07/29/08 at Health department, no adverse reactions after this vaccine.  Received 2nd HPV 09/30/08 at other Health Department.  Reports 1-2 weeks after 2nd dose, daughter experiencing "blackout spells and severe headaches."  Reports client had 1st seizure on 03/29/09.  Has appointment with PCP this week. 4/2/09-records received for DOS 4/1/09-office visit after near syncope for past 6 months, usually can tell when they are coming on becomes lightheaded and roaring sensation in ears with occasional nausea. occurring about every other week. Headaches occurring weekly. Almost blakced out and had tremors muscles in arms and legs felt tight. Tired afterwards. Episodes began after gardasil vaccine and depoprovera, Assessment: near syncopal episodes. R/O possible seizure disorder. Episode of hyperventilation due to anxiety syndrome.  4/16/09-records received 4/1/09-C/O near syncope for past 6 months lightheaded and roaring sensation in ears and nauseated feeling with them. Headaches weekly. Tremors. Blackout spells and tired. Started depoprovera. Episode of hyperventilation due to anxiety syndrome. 4/8/09-office visit for blackout and near fainting episodes-Assessment:vasovagal event with convulsive syncope followed by hyperventilation syndrome. Prone to syncope and presyncope.
Rash all over body; redness at injection site; Slight Headache; Allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd August 2019, the patient received the 1st dose of Shingrix. On 24th August 2019, 1 days after receiving Shingrix, the patient experienced generalized rash, injection site erythema, headache and allergic reaction. On an unknown date, the outcome of the generalized rash and injection site erythema were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the allergic reaction was unknown.   The reporter considered the generalized rash, injection site erythema, headache and allergic reaction to be possibly related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix on left arm. On 24th August 2019. the patient woke up with a slight headache and a rash all over her body. The patient also has redness at the injection site. The patient went to see her physician on 28th August 2019 regarding the rash and the doctor gave her a steroid injection and some other medications to take. The patient stated that her physician thinks it was an allergic reaction to the vaccine. The reporter was consented to follow up Emergency room (ER) visit was required. The patient did not provide any additional details.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 73 years, in left arm 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), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt recv vax on 4/26/99; on 1/1/99 pt exp sciatic-like pain in legs, weak legs
This spontaneous report as received from a nurse via a poison center refers to a 2 week old female patient. The patient's medical history included neonatal jaundice. On 20-JAN-2014 the patient was vaccinated with a dose of VAQTA one dose, injection route, once by accidental (lot number and expiration date were not reported). There was no concomitant medication or past drugs. The vaccine was not supposed to be provided to the patient. She had not received any other vaccines. No adverse reactions were observed 20 minutes post injection. No laboratory date was available. As of 20-JAN-2014 the patient would not continue to be given VAQTA accidentally. The outcome was unknown but was without adverse reactions at the time of the report. Additional information is not expected.
Received an adult Havrix which was also the patient's 3rd dose, got 2 doses back in 2009; Received an adult Havrix which was also the patient's 3rd dose, got 2 doses back in 2009; Received an adult Havrix which was also the patient's 3rd dose, got 2 doses back in 2009; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HAV (Havrix 1440 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 adult (received 2 doses back in 2009).   On 19th July 2022, the patient received the 3rd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 19th July 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, drug dose administration interval too long and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose, drug dose administration interval too long and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Jul-2022 Reporter's comment: The 14 years old patient received an adult of Havrix which was also the patient's 3rd dose. The consent to follow-up was given via postal. Lot number and expiry date was not available at the time of the call.  Additional Supportive Information: The 14 year patient received Havrix 1440 adult as 3rd dose and got 2 doses back in 2009, which led to lengthening of the vaccine schedule, overdose and inappropriate age at vaccine administration.
Large red, warm to touch area surrounding the injection site. Ice applied and BENADRYL cream, advised to use BENADRYL po that night.
This spontaneous report as received from an Immunization Coordinator and 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 unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD therapy type rHA (recombinant human albumin) with lot # M014304, expiration date 22-SEP-2017 and lot# M040141, expiration date 06-JAN-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluents (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.5 degrees Fahrenheit for 36 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009125.
2:05PM RASH TO BOTH CHEEKS NOTED, GREATER ON THE RT CHEEK.NO SOB OR DIFFICULTY SWALLOWING. BP 161/89, HR 76. A/O PINK, W/D, RESP REG WITH EASE. NO DISTRESS NOTED. 2:28 PM DECREASED RASH NOTED. BP 145/79, HR 65, R 20.  HUSBAND HERE TO DRIVE PT HOME. AMBULATORY - GAIT BRISK AND STEADY.
COVID vaccine breakthrough case Dose 1        Moderna     9/13/21     049C21A Dose 2         Moderna     10/11/21      020F
Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately 84 years of age, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
This spontaneous report refers to a 68 year old female patient with no medical history or drug allergies/reactions. On 15-OCT-2013 (reported as one month ago), the patient was vaccinated with ZOSTAVAX refrigerated vial lot # J004600 and expiry date 18-JUL-2014, standard dose (0.65 ml), subcutaneous injections for prevention of shingles. Concomitant therapies included unspecified medication for acid reflux, Synthyroid and Lipitor started around the time of vaccination. On an unknown date in October 2013 (reported as within 1 week of vaccination), the patient developed headaches that occurred every day, dizziness when she stand, lightheadedness, hoarseness and fast heart rate. The outcome of events was reported as resolving. No lab tests were performed. Motrin was given as treatment for events. The patient sought medical attention, by speaking to her physician. Additional information has been requested.
Information has been received from a licensed practical nurse and a nurse practitioner concerning a 23 year old female patient with no pertinent medical history or drug reactions who on 14-SEP-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 663452/0671Y). Concomitant therapy included NUVARING. On 15-SEP-2009 the patient fainted at lunchtime. Medical attention was sought via called the office. No laboratory diagnostics studies were performed. At the time of this report, the patient was recovering. Follow-up information has been received from the licensed practical nurse regarding the 23 year old female patient (105.4Lb and 63 inches) who on 14-SEP-2009 at 11:50 a.m. was vaccinated intramuscularly in the left deltoid with the first 0.5ml dose of GARDASIL (lot# 663452/0671Y). The licensed practical nurse reported that the patient had a granola bar for breakfast. One hour after lunch, the patient was sitting at computer desk and started to feel dizzy. Then the patient fainted at her work station. The patient did not hit the floor. She woke up and went home. It was reported that the patient did not had other symptoms since. Additional information is not expected.
Headache, Myalgia, SINUS COLD SYMPTOMS AND ROSY CHEEKS Narrative:
When mom was called, she stated that Pt had a tiny rash on her cheeks but it went away the next day. No other symptoms.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unspecified date since 25-JUN-2015, the unspecified number of patients were vaccinated with VAQTA (lot# K012457 and expiry date: 04-JUN-2017) (dose and frequency were unknown), which were exposed to temperatures outside of the recommended range on 25-JUN-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 9 week old patient of an unknown gender. On 15-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (lot # K007247 and expiry date 17-MAR-2016 or lot # K006805 and expiry date: 24-MAR-2016. No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Pt experienced (L) deltoid pain with no redness, edema, rash or fever immediately after receiving the flu shot. 3 weeks later, she remains with pain and weakness to (L) arm.
Arm was sore; Chills; vomited; Fever; headache; This is a spontaneous report from a contactable consumer. A 13-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 10Jun2021 at 16:15 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included headache, nausea, vomiting, COVID-9. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration on 19May2021 at (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 10Jun2021 at 16:30, the patient experienced arm was sore after receiving the vaccine. On 10Jun2021, the patient experienced about 12 hours after receipt of the vaccine, woke up with chills and vomited, about 2 hours later fever, headache, chills and vomited a second time. Patient reported that by 6pm on 11June, patient had no symptoms was feeling normal and eating regularly. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events arm was sore, chills and vomited, headache was recovered on 11Jun2021 at 18:00.  The lot number for BNT162b2 was not provided and will be requested during follow up
11/23/22 presents to ED for "shortness of breath". PMHx of "COPD, type 2 diabetes mellitus, hypertension, bilateral DVTs on Eliquis, ICH, SAH, hydrocephalus s/p VP shunt, PCA aneurysmal bleed s/p coiling (2021), and dementia"
11:00 PM Fussy, irritable, fever 101.6, seizures - stiffening of limbs and vacant look (witnessed by ER doctor ). Admitted to ICU on anticonvulsant therapy and monitored. Blood culture positive. Treated with Rocephin.
pruritic rash-onset 24 hr p/vax; no change in behavior, feeding; mild diarrhea;