chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; I tested negative on Day 8, and just re-tested positive again on Day 14.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EW6202), on 19Apr2021 as dose 2, single (Lot number: EW0151) and on 26Oct2021 at 15:45 as dose 3 (booster), single (Lot number: FH8020) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "mild asthma" (unspecified if ongoing), notes: Mild asthma; "history of chronic bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "recovering", described as "I tested negative on Day 8, and just re-tested positive again on Day 14."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: I tested negative on Day 8; (Aug2022) Positive, notes: just re-tested positive again on Day 14. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient took antiviral product Paxlovid for covid-19 treatment starting from 17Aug2022 till 22Aug2022. She was prescribed and took Paxlovid for COVID-19 on Day 1, one day after original symptoms onset. She tested negative on Day 8, and just re-tested positive again on Day 14. Symptoms have improved slowly but persisted since original onset. For Other medication in 2 weeks product was Tylenol/Advil with start date 16Aug2022, stop date was 30Aug2022.  No follow-up attempts are possible. No further information is expected.
Engerix-B pediatric administered to adult; Engerix-B pediatric administered to adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult male patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 24th January 2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 µg. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: The nurse reported that during an audit they found that the Engerix-B pediatric doses were administered to the 5 or 6 adult patients. The vaccine administration facility was the same as the primary reporter. The reporter consented to follow up.  Additional Supportive Information: The adult patient was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. This case had been linked with US2022158095 by same reporter for different patient.; Sender's Comments:  US-GSK-US2022158095:Same reporter US-GSK-US2022158096:Same reporter - Deleted US-GSK-US2022158133:Same reporter - Deleted
hx of t105 last 2 days p/vax;hx given by mom;also poor feeding & not sleeping well
Got shot on Feb. 28, 2020, and the day after I received the shot, about 23 hours later, I had a fever, eyes got very tired, had a headache.  By March 1, I felt a little better and the fever, eyes and headache were gone.  A few weeks later I started getting headaches but mainly when I am laying down in bed.  When I get up, it seems to get better.  I have not had headaches before.  Had a sore arm after the shot.  Took tynenol.  Sore arm lasted about 4 -5 days.
This spontaneous report as received from a male pharmacist of unknown age who was the patient. Pharmacist states he got splashed with live ZOSTAVAX on his skin and in his left eye. Pharmacist stated this occurred 10minutes ago, and his left eye was itchy. The pharmacist hung up the phone so that he could flush his eye with water. It was unknown if the patient sought medical attention. Unknown if this occurred while he was administering the vaccine; unknown if a client received less than a standard dose of live ZOSTAVAX. At the time if report, the outcome of patient was unknown. Additional information has been requested.
Nausea, fever, chills, vomiting, body aches, headache for 2 days. Aches continued for 4 days. Covid arm rash began on day of shot and continues for 8 days. Arm very sore for 8 days.
103.5F Fever couldn't break fever for 17 hours. Still at 101.7F. Fuzzy, irritable, not wanting to eat or drink
Pt exp redness, soreness & a swollen area 3 inches in diameter @ injec site p/receiving Td;
ABOUT 11 HOURS AFTER receiving the above vaccines developed numbness and weakness of legs with abnormal gait.  went to ED where had labs and imaging done and given IVF bolus.  after receiving IV fluids symptoms improved greatly
Day 1- extreme fatigue, extreme muscle aches,slight head ache, injection site soreness.,fever of 99.01,sore throat,cough
a 12 years old patient received TENIVAC instead of ADACEL/ No AE; Initial information received on 12-Apr-2021 regarding an unsolicited valid non-serious case received from a nurse via (Reference number: 00557053).  This case involves a 12 years old male patient who received a 0.5 ml first dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] batch number: U6265AA, Frequency: once, Strength: Standard, Expiry date: 19-Apr-2021 via intramuscular route in the left deltoid on 10-Apr-2021 for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered).  The patient's past vaccination included Diphtheria, Tetanus, and Acellular Pertussis (DTAP) for which patient had completed five doses.  The patient's medical history, medical treatments and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (latency: same day).  Potential Product Technique Complain: No. Caller with question on whether dose of ADACEL needs to be administered.   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 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.
After I got the shingles; Made me so sick; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and sickness. On an unknown date, the outcome of the shingles and sickness were unknown.   It was unknown if the reporter considered the shingles and sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got one Shingles shot and need 2nd shot.  The patient stated he/she got the shingles. Made so sick. The follow-up would not possible as no contact details were available.
Information has been received from a physician concerning a 3 and a half year old male with unknown pertinent medical history and unknown drug reactions/allergies, who on 14-APR-2004 was vaccinated with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck), (lot number not provided). The physician stated that the patient came with shingles on approximately 20-SEP-2007. No history of chicken pox was noted. No further information is provided. No lab diagnostics studies were performed. The outcome was reported as recovering. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
1-23-06 Immunization given.  Child has cough, temp 98.4; 1-24-06 Temp 103.5-99.7, decreased appetite; 1-25-06 Temp 103, positive flu test, pharyngitis, urine culture negative on 1/26/06, Bronchitis -treatment-1-25-06 Rocephin
no adverse event; improperly stored dose was administered; This spontaneous report was received from a nurse and refers to a 12-month-old patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 01-FEB-2021, the patient was vaccinated with a improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot# T013205, expiry date 03-DEC-2021 (route of administration was not reported) for prophylaxis.  The vaccine underwent temperature excursion of 48 (not further specified) for 24 hours and 45 minutes. There were no previous temperature excursions. The call was because of digital data logger. No adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity). At the time of the report, IMMUNE SYSTEM DISORDER (Caller says one person was a TV host that said its been a year sine they had the Bivalent and she showed zero immunity) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.   Details regarding AE could not be collected fully. Treatment information was not provided.   Reporter did not allow further contact
the evening of the vaccine, I experienced soreness at the injection site. That night, I had fever, chills, and muscle aches which were all expected. A couple of days after the vaccine, I had dizziness and nausea followed by a headache. about 3 weeks after the vaccine I experienced increased dizziness, nausea and ringing in my ears accompanied by earache in my right ear. I visited my doctor, after an incident in which I was so dizzy I almost fainted while driving. My doctor ordered tests endoscopy and colonoscopy but results did not indicate a reason for the dizziness and nausea. I was then (March 2021) referred to an ENT who reported seeing similar symptoms in other patients following the 2nd dose of the covid vaccine. He did some test and noted I had an inner ear imbalance. He gave me a steroid to help with what he described as my immune system attacking my inner ear. He stated my symptoms would last 2-4 months. It is now July and it appears that I have bouts of dizziness and nausea. Hearing tests were also conducted due to the ringing and no hearing loss detected.
Pt recvd 3 doses of Engerix-B 1NOV90, 6DEC90 & 30APR91 & 9SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Client received 1st dose of Moderna vaccine at 9:55 am. The client who was learning disabled, became extremely anxious, rocking and hyper-ventilating at approximately 10:10 AM. She had two events that may have been seizures, each lasted approximately 5 seconds. Vitals taken at 10:12 were BP 130/74, O2 98%, HR 102. 911 was called at 10:15 am. When the paramedics arrived, they knew the client by name and transported her to Hospital. Client's PCP was called and a message was left. PCP called back and confirmed message was received.
PT REPORTED PAIN AT INJECTION SITE STARTING THE NIGHT OF VACCINATION AND INJECTION SITE REACTION HAS GOTTEN WORSE IN THE PAST 2 DAYS (REDNESS, SWELLING AND ITCHING)
This case was reported by a pharmacist and described the occurrence of local reaction at injection site in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLULAVAL. At an unspecified time after vaccination with FLULAVAL, the subject experienced local reaction at injection site (golf ball sized indurations to distal injection). It was swollen and hard at the injection site. At the time of reporting the outcome of the events was unspecified. Product complaint was also noted. It was reported that 6 subjects adverse events following administration with FLULAVAL. The vaccines were given from two vials with same lot number. The vaccines were administered by the staff of a nursing home. The director of nursing reported the adverse events to the pharmacist. It was noted that the facility would be shutting down on 16 October 2011. Linked cases Include A0947071A, A0947174A, A0947175A, A0947176A and A0947177A. Follow-up received from the reporting pharmacist on 18 October 2011: On 23 September 2011 the subject received a dose of FLULAVAL (0.5 ml). Later the same day, the subject experienced injection site induration and swelling at injection site. At the time of reporting, the events were resolved. The pharmacist confirmed that the events were not considered serious. FLULAVAL was identified as the suspect product, but a causality assessment was not provided. The pharmacist reported that the facility that administered the vaccine had reported the event to the CDC and returned any unused vials to pharmacy. According to product complaint investigation results by GSK quality assurance/Biologicals on 31 October 2011, the product complaint was assessed to be unsubstantiated.
approximately 5 minutes after vaccine administration, reported headache and nausea.  Brief chest discomfort.  No respiratory symptoms, REsolved after 30 minutes and discharged to home.
Woke Friday am with no control over my bladder and violent shaking of my legs with pain radiating from my hips. Fever of 100.9.Couldn't move my legs or sit up and eventually fell to the floor on my back.  Spent over an hour using my elbows to scoot across floor. Hit head 3 times and passed out for awhile. Got help and went to the ER.  CT showed no concussion. Pain reliever helped and after several hours was discharged with instructions to use a walker. Used walker for 2 days and then cane. Still have leg pain on occasion and now the Vertigo is worse. Also had reaction to first vaccine but just high fever, 101.4 and aches.
T 101.2  x 24 hours developed on 7/30/21, treated with tylenol.  developed a rash, small red raised bumps on 7/31/21. Rash first developed on face, stomach and back, now appears on bilateral arms and legs also. Treating itching with calamine lotion to affected area as well as Aveeno oatmeal baths. Developed an occasional non-productive cough on 8/1/21.
light-headed; muscle weakness; fever; This is a spontaneous report from a patient. A 35-year-old male patient at same age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 26Jan2021 05:00 PM on left arm at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Jan2021 on left arm for covid-19 immunisation. The patient experienced light-headed, muscle weakness, and fever, all on 26Jan2021. The outcomes of events were not recovered. Treatment were not received. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Information about lot and batch number was requested.
Glandular swelling in neck, underarms and behind knees. Axillary temp.-around 104 degrees F, according to mother. Rash on stomach, back, head, arms and legs.
Fever 100.4 11/22, cough from 11/24 till present, brown sputum with streaks of blood for four a.m.'s following vaccine, severe sore throat upon a.m. awakening from time of vaccine till present, upper abdominal discomfort on right and left sides on 11/22, diarrhea on 11/22, runny nose from 11/24 till present, severe nausea on 11/22, headache on 11/22, feeling of mailaise on 11/22, chest tightness, heartburn.
Symptoms: & cardiopulmonary arrest Treatment: EPINEPHRINE 8 MG Unknown during code
Pericarditis; The initial version of the case was processed as Invalid due to Unidentifiable reporter, but now upon the follow-up the case contains all the necessary information required for the case to be valid.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown". The event "pericarditis" required emergency room visit.  Clinical course: Ended up in the emergency room on Wednesday night diagnosed with Pericarditis after taking the 2nd Pfizer shot. The Doctor said this is now common after the Pfizer shot. Especially with teenage boys and young males.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Temp up 103.7. Very fatigued, tired, laying around. Very poor diet and activity for several days.
Myalgias tachycardia dyspnea mild chest pain headache dizziness and vertigo fever (after Aleve 400mg and Tylenol) was 102.
This is a spontaneous report from a contactable consumer reporting for herself. This female patient of unknown age and race/ethnicity received in Feb2018 (about 2.5 weeks as of 26Feb2018) a single dose of PREVNAR 13 in the left arm for immunization. Medical history and concomitant medications were not reported. Patient received in the past a flu shot for immunization. It was reported that patient was experiencing severe arm pain started 2 days after vaccination (Feb2018) that has not improved or gone away. Patient described the pain as terrible anytime she puts pressure on it, such as sitting at the kitchen table (not hurt if there is no pressure on it). Additionally patient reported having trouble turning her head and neck to the left and not being able to drive. Patient stated that prior to vaccination with PREVENAR 13, she got a flu shot in the same arm on an unknown date and it did not hurt at all.  She has been to multiple physicians and they are unsure what to do. They advised her that they do not think it was related to the vaccine but she thought that it was. She tried treating it with pain killers and creams but nothing was working for the pain. Outcome was not recovered. Information on the batch number has been requested.
The patient was playing with his 9 year old daughter. The daughter touched the vaccine site and touched her neck. About 6 days after the exposre, she had 3 itchy papules on the back of her neck -- two of them have small (pinpoint) vessicles. She is otherwise fine. She was sent home with instructions to not touch the wound site, limit exposure with anything that touches the site, and will stay home from school until the lesions go away. The local public health department was contacted -- they requested a culture of the site.
slept excessively 48 hrs post vax p/crying 45 mins 1st was very fussy x 2 wks p/shot; site of shot-nl;
Sore throat; Fatigue; She felt sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 23 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; MALAISE (non-serious), outcome "unknown", described as "She felt sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient asked if she could delay her 2nd dose schedule that was supposedly tomorrow. Stated she felt sick and fatigue after her 1st dose and tested negative from covid-19 virus and was supposed to get the second dose of the Pfizer-BioNTech Covid-19 Vaccine today and then because she was sick with past 3 days with fatigue and sore throat. She wanted to know if she could get the second dose. So basically, she was fatigue and Sore throat she was sick for the past 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & exp a flare-up of MS; MD reports that pt has been treated in the past for many yrs for MS & last October;
After 2 weeks of receiving FLUVIRIN, pt complained about pain in his arm where the vaccine was administered. Pt described as a numbing sensation, however he could move his arm. When asked if he took any pain meds, he said he took Aspirin for a few days. However the numbing sensation continued. MD was contacted.