chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had bronchitis; became sick; suspected vaccination failure; had the flu that last lasted 1.5 months; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included antibiotics nos for bronchitis.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient started antibiotics nos at an unknown dose and frequency. On 20th December 2019, less than 2 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced bronchitis and feeling unwell. The action taken with antibiotics nos was unknown. On an unknown date, the outcome of the vaccination failure and feeling unwell were unknown and the outcome of the influenza and bronchitis were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza, bronchitis and feeling unwell to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by patient herself. The patient received an unknown manufacturer of the flu vaccine,  The patient become sick and had the flu that lasted 1.5 months and   the patient had bronchitis and had to take antibiotics.  This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. The reporter did not consent to follow up.
I am fully vaccinated with 3 pfizer shots and 1 Moderna bivalent booster; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "I am fully vaccinated with 3 pfizer shots and 1 Moderna bivalent booster". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: The patient was fully vaccinated with 3 Pfizer shots and 1 Moderna bivalent booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PC from mom 7Feb91, child has rash on hands & arms, rash is blister-like T goes up to 103 controlled /w Tylenol has runny nose. Mom states she noticed 2 spots on her hands before the shots were given.
Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast).  The pharmacist reported that, several years ago, the pt subsequently developed hives and had trouble breathing after being vaccinated. Medical attention was not sought. Subsequently, the pt recovered from the hives and trouble breathing. No further information is available.
Extremely light-headed for 4 hours starting about 30mins after receiving vax; heart palpitations roughly 5hrs after vax lasting about 30mins on and off
Pneumococcal polysaccharide vaccine. Swelling, heat, hard knot, pain, couldn't lift arm to shoulder level. The swelling was from injection site-left side, down arm, just above elbow and up to shoulder to clavicle. Treatment: cold compresses & ibuprofen.
Blood clot, swelling noticed a few hours aftee vaccine.  Probably coincidence but felt it should be reported. Im not sure if the doctor she saw for blood clot knew she got the vaccine. It was a different clinic.
Patient called today, He stated that 18 hours after his dose of Janssen he had a nose bleed that lasted 8 hours and expeled 2 large blood clots from his nostils.  I asked if he had seen a physician and he had only called his friend who was a PA. I encouraged him to contact his physician and inform him/her of the situation.
Child was seen "shaking with eyes rolling up in head" by parents who then rushed child to Emergency Room. Upon arrival child's temp was 104.5 degrees F, but no other symptoms. Mother states that child was not ill upon awakening, but did continue to have fever for 2 days. Parents were told child had a febrile seizure probably from a virus as blood tests, chest x-ray, and EKG were normal and her temp had risen so high so quickly. No further treatment was given except for antipyrectics. No previous hx of seizures.
Swollen Lymph nodes in left arm 1 week later and persist 1 month later
20 minutes after receiving shot I was driving home and became light headed and dizzy, felt like I wanted to faint, difficulty taking a deep breath, nauseated, shaky and heart rate was 125. Chewed a Claritin, drank 20 ounces of water quickly and feeling subsided within 10 minutes. Next day I developed nerve pain over the right side of my upper and lower teeth, severe headache and neck pains, pain over my right eye socket lasting 6 hours. I would have headaches waking me from sleep on and off with pulsations of my heart beat in my right ear. April 4th I felt faint at work-experiencing the same symptoms I did after receiving my vaccine. April 7th I had an MRI brain and experienced a vasovagal near syncopal event while in the scanner. April 12th I went to ED for tachycardia. I was diagnosed with palpitations. PCP ordered Event Monitor for two weeks. I was having auditory and visual hallucination, difficulty thinking, brain fog, headaches, neck and back pain,  nerve pains to my feet with burning sensations, Neve pains to my face and teeth, muscle aches, body aches, nausea, diarrhea, anorexia, anxiety, tremors, pulsations in my brain, vertigo, feeling of bugs crawling on my skin, muscle weakness, fatigue, double vision, blurred vision, disassociation, insomnia. I was diagnosed with POTS May 18th. Started on a beta blocker May 29th.
02/08/2021 I got the vaccine, and got home, and in the evening, I had an alert on my watch that I had an Afib episode, This lasted until morning, saw DR next day. Beta blocker treatment, Afib went away. Echo ordered, echo normal, saw cardiologist Feb 18th, had another EKG. April 2nd, noticed Afib on watch again. I took a beta blocker and it went away and I have not had any sense.
Shingle outbreak; A spontaneous report was received from a pharmacist concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingle outbreak.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient experienced shingle outbreak. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, shingle outbreak considered unknown.
APPROX 2 HRS P/VAX GIVEN, CHILD BEGAN TO BREAK OUT IN PALE RED MACULAR RASH BEGINNING ON HEAD THEN DISAPPEARING THERE BUT SPREADING TO TRUNK-NOT ON EXTREMITIES.
Woke up to bad stomach pain almost like IBS; Liquid diarrhea; Gut pain; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history includef high blood pressure (Hbp). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 at 01:00, the patient woke up to bad stomach pain almost like IBS, liquid diarrhea and gut pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bad stomach pain, liquid diarrhea and gut pain was not resolved at the time of this report. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax 1FEB93; pt was sick on 5FEB93; 19FEB93 pertussis smear & culture neg; hospitalized 21FEB-23FEB; 5MAR93 bronchoscopy-pertussis culture pos;
he had his vaccination at 2:18, sat down in observation and after one minute, he lost consciousness, caught by father, and began having tremors. Woke up after 30 seconds - 1 minute. Helped to wheelchair. Skin was pale, but pt. was alert and oriented x 3, he reported blurry vision prior to incident. Observed on cot for 30 minutes. Given water, vital signs checked, wnl. Pt. left with father, escorted in wheelchair.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-044885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-044885:First dose case
Information has been received from a consumer concerning her 4 year old male relative who in 1998 was vaccinated with a dose of varicella vaccine. Subsequently, in approximately 2001, the pt developed chicken pox after being exposed t another child at day camp who had also been vaccinated with varicella vaccine. The pt recovered completely from chicken pox. It was noted that the pt's brother subsequently developed chicken pox after being exposed to the pt. It was not reported if the pt sought medical attention. No further info was provided. Additional info has been requested.
within 15 minutes started feeling nauseous, bad headache minutes after. Got dizzier, brain fog.  At home later progressed to fever, chills, sore throat.  The next day the SOB returned, chest pain/pressure Now almost 2wks later still feeling very short of breath
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; PAIN IN THE ARM; This spontaneous report received from a patient concerned a 76 year old white and hispanic or latino female. 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: 1805022, expiry: UNKNOWN) dose was not reported,1 total, administered to left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date patient experienced pain in the arm after vaccination. On 17-AUG-2021, the patient was performed with SARS cov2 AB IGG spike semi QN test which was found to be negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the arm and confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210905663. This report was associated with product quality complaint number 90000192051.; Sender's Comments: V0: 20210905692-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I woke up 2:00am felt extremely dizzy on the way to the restroom. I had to lay on the floor upon me getting up I passed out. I went to ER had several tests done to rule stroke and anything cardiac related. I started feeling better when I left the ER.
pt recv vax 15JAN97 & 20JAN97 pt devel more than 300 vesicular lesions;24JAN97 pt was very sick w/a fever of 104 & full blown chickenpox;pt also exp some problem breathing;x-ray negative & pt otherwise healthy;lethargic & exp nausea;
Serious pain in the arm where the vaccine was injected. Could not even lift my arm. Extreme muscle pain in my neck and shoulders all night long; in bed writhing in pain all thru the night. Constant headache all night long (I never get headaches) Nausea Generally ill feeling with low energy  (I have never experienced adverse symptoms from any other vaccine taken previously).
Dementia; This case was reported by a consumer via (GSK Patient Assistance Program) patient support programs and described the occurrence of dementia in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dementia (serious criteria GSK medically significant). On an unknown date, the outcome of the dementia was not recovered/not resolved.   The reporter considered the dementia to be unrelated to Shingrix.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient's spouse called because the patient got denied and mentioned that the patient had dementia (no further details provided).  The reporter did not provide batch number/ lot number and expiry date. Unable to ask questions because the reporter did not want to respond, was mad about denial reasons and hung up call. The reporter did not consent to follow up.
pt broke out w/red whelps all over body;had a fever of 102.5 that could not be broke;was seen in hosp ER & was given DPH;
night of shot my hands turned red and i took an Allegra, 2:00 Am on the 10th started to have  fever, chills, body aches, couldn't lift my head.  i rested and slept that day and took Tylenol. felt better yesterday rested and today still fee little out of it
The patient was very nervous for the injection. Mom held her during the injection.  The injection went without any event, however a little while after the shot, maybe 5-10 minutes the patient felt dizzy and passed out for a split second.  Mom and I were standing next to her talking at the time so we caught her.  She regained consciousness immediately.  I gave her a sprite and an ice pack and had her sit down.  I did not elevate her legs or lay her down because she was feeling much better.  I contacted our supervisors regarding the incident.  We advised mom to take her to get checked at the urgent care but mom declined.  I called a few hours later to check up on her and she was doing fine. Mom believes it was just nerves.
FLUZONE HD vaccine from last year, which expired on 30-Jun-2021 was given with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via  Medical Information  (Reference number- 00829584) and transmitted to Sanofi on 27-Oct-2021 in a specific country.  This case involves an 88-year-old female patient who vaccinated with expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from last year [Batch number: UJ515AA and expiry date: 30-Jun-2021] (expired product administered).  The patient, medical treatment(s), vaccination(s), and family history were not provided.  No other concomitant vaccines were reported.    On 26-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ515AA and expiry date: 30-Jun-2021] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the the same day].  At time of reporting, the outcome was unknown for the event.  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 the 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 FELL PRIOR TO COMING INTO STORE OUT OF CAR AND GOT A BLOODY ELBOW.  INSIDE PATIENT HAD RECEIVED VACCINE AND WAITED HIS 15 MINUTES. HE WAS ASKED IF HE WAS DOING OK AND HE SAID IM FINE. HE WAS TALKING AND RESPONIVE WHILE IN THE STORE. HIS CARE GIVER SAID HE WAS FINE. FROM THE TIME HE LEFT THE STORE HIS CAREGIVER SAID SHE NEEDED HELP TO GET HIM IN HIS CAR HE FELL FROM HIS WHEELCHAIR AGAIN AND HE WAS STIFF AND NOT TALKING. PATIENT WAS TAKEN TO medical facility
No s&s until 12:45 am when I woke up with extreme shaking all over my body that would not stop. I felt a low fever, that was 99-100F. The shaking would not slow down for about 2 hours, Then it began to decrease very slowly. This event left me in bed exhausted for 2 days. I am blood type A+.
Information has been received from a physician concerning a female (age not reported) who on approximately 03-NOV-2006 ("last week") was vaccinated with Pneumovax 23.  Concomitant medication was not reported.  On approximately 03-NOV-2006 ("last week"), patient received the Pneumovax 23 vaccine.  The patient was fine when she left the physician's office but later that evening, the patient had a local reaction at the injection site.  The patient's skin was red, warm, swollen, puffy and itchy.  The area of redness was approximately the size of a baseball in circumference.  Subsequently on an unspecified date, the patient recovered from injection site skin was red, warm, swollen, puffy and itchy. Additional information has been requested.
An attorney alleged that a male received 3 separate doses of Acel-Imune and Hib-Titer vaccines sometime between 9/29/97 and 12/1/99. He was subsequently, dx'd with mercury poisoning and neurological injuries, including "disintegrative" (or "regressive," "late-onset," or "degenerative") autism. As of the date of this report, no further information was available.
Sore shoulder; general malaise for the next two days; strange smelling urine; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 18:30(at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 20:30 the patient experienced sore shoulder, general malaise for the next two days with strange smelling urine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events.  The clinical outcome of the event shoulder soreness, malaise and urine odour abnormal was recovered on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Pt. was administered GARDASIL vaccination on 9/30/10. Approximately around Thanksgiving pt.'s 1st symptoms were legs & arms tingling & hurting. Pt. received her 2nd GARDASIL vaccination on 12/10/10 and reported her whole body hurt. She reports having swollen glands, joint pain, tiredness, chills, leg pain, SOB, chest pain, aching muscles, muscle weakness, & stomach ache. Pt. had several doctor appointments in December who stated it may be caused by the vaccine. Pt. reports she is fine now.
Within 24-48 hours of 1st Shingrix shot, started having sharp, piercing, hyper-sensitive pain in my rib cage starting in the back left upper part of rib cage moving all the way around to my left breast.  Ultra-sensitive to touch, burning, pulsating pain at times -- felt like someone kicked me in the ribs or had a collapsed lung.  To-date, still have the pain precluding me from sleeping well at night.  Today, woke up with painful itchy red raised bumps mid range on side of left ribs.
Tingling in fingers all the time. Bursitis in left and right hip joints. More prominent in the right hip joint. Makes it difficult to walk. Developed a very bad cataract in the right eye. So blurry that I cannot read. Bladder or kidney stones. Altered mouth chemistry resulting in cavities. Impact on hormone levels.
2 days p/vax pt had episodes of tonic clonic movements of the head & upper extremities lasting only a few seconds, which occurred as pt was falling asleep; this recurred the following morning but not since; no fever;