chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 13-SEP-2022 Reporter's Comments: The nurse reported that a patient received Infanrix expired dose. The reporter did not consent to follow-up. Additional supportive Information: The patient received expire dose which lead to expired vaccine used.
Case number PHEH2014US018028, is an initial spontaneous report received from a nurse on 05 Sep 2014. This report refers to a 63 year old female patient. Her medical history and concomitant medication was not reported. It was reported that patient was administered FLUVIRIN (batch number: 145223) vaccine that was stored below 36 degree F but not for frozen. No adverse reaction was reported. No further information was provided.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US2022AMR156058.  A patient (no qualifiers provided) received 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; influenza vaccine (FLU VACCINE VII), as single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COVID-19", start date: Jul2020 (unspecified if ongoing), notes: COVID 19 on Jul2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: This report concern an individual patient or several patients was reported as Individual Patient. The patient also got vaccinated in left arm, and it did not hurt, in Sep, and after 2 months the 2nd dose. They just applied to patient, the new one from COVID and derivatives, from Pfizer, and the one from Flu, yes it hurt, and had the symptoms of both for 3 days. (COVID 19 on Jul2020).  The lot number for [BNT162b2], was not provided and will be requested during follow up.
On May 11, 2021 I noticed my right eye was slightly bigger than my left eye - from May through June, 2021 the eye bulge became more pronounced and I was experiencing increased heart rate and palpitations. I suspected my autoimmune thyroid disease (Graves disease) was triggered and I was also experiencing symptoms of Thyroid Eye Disease. Since July 2021 I have been on anti-thyroid medication and beta blockers and the Thyroid Eye Disease has progressed.
High Fever got at 2nd and 3rd Day, Body Pain for  4 days, Chills for 3 days, Tiredness still , Headache is continuously in mild way.
2-3 cm area that is erythematous and that's quite hot. Apparently  a localized reaction to the shots.
Fainting. Within a minute or there about of injection limbs felt like pins and needles. Patient felt very hot, lost vision, and profuse sweating. These symptoms have never been recorded during previous vaccinations.
On 3/15/2021 pt had redness below where injection given then on 3/16 (5 days after vaccine) had itchiness and hive on that arm then on face and red eyelid redness and facial puffiness (no lip/tongue swelling, no shortness of breath, no chest tightness, no wheezing, no lightheadedness)
I started with the chills around 9:30/10am. I never noticed that I had a fever or anything, but I had terrible night sweats . I woke up at 4am to use the restroom and while I don?t remember what happened exactly,  I remember waking up  to my husband running to me asking if I was ok. I was in pain from hitting my face (maybe on the toilet, the windowsill or the floor.. there was blood everywhere). I don?t  know if I was standing up to flush or if it happened while I was sitting down. I had trouble walking immediately after and felt nauseated, but about ten minutes later (after resting on the floor), I felt better and went to bed.
Bell's Palsy; Persistent headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:00 (at the age of 61years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 06Mar2021 12:00 (at the age of 61years) for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced Bell's Palsy 10 days later. It was further reported that the patient had a persistent headache from date of second vaccine to now (pending clarification), including onset of Bell's Palsy. The onset date of adverse events was 07Apr2021 (11:00 AM) (as reported). The adverse events resulted in Emergency room/department or urgent care. The patient was treated with steroids and anti-viral. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
I had a persistent mild headache all day as well as moderate fatigue starting around 2pm EST.
Chills, fever lasting 36 hours, muscle aches lasting over 48 hours. Similar effects after first dose on 8/10 but shorter duration. Though these are listed as side affects, I have never suffered  from side affects after an inoculation before so I thought it was worth reporting.
STARTED DEVELOPING ITCHING AND RASH WITIN 24 HOURS.  CONTINUES ON AND OFF AND INCREASINGLY BECOMES WORSE.  SENSITIVE TO TOUCH; SWELLING AROUND ARMPITS AND SWELLING AT INJECTIONS SITE.  HIVES IN BACK OF THE NECK, INNER GROIN, STOMACH.  REACTION OCCURS AT PREVIOUS INJECTION SITE WHEN CURRENT SHOT IS GIVEN.  SYMPTOMS ARE STILL DISTRESSING PATIENT. SYMPTOMS HAVE BEEN CONSISTANT SINCE SHOT #2 ON AN IRRADIC BASIS.    PT. USED BENADRYL CREME TO PROVIDE TEMP. RELIEF. DOCTOR RECOMMENDED CONTINUING TO USE BENADRYL CREME AND RECOMMENDED PT. TO DISCONTINUE ANTHRAX SERIES
TESTED + FOR COVID 9-26,   WENT TO er 10-08 FOR DYSPNEA, LOSS OF SENSE OF TASTE AND SMELL,  WEAKNESS AND WAS ADMITTED 10-9 WITH COPD EXACERBATION,  DIASTOLIC HEART FAILURE, COVID, ACUTE KIDNEY INJURY , DECEASED 11-3-23 IN THE HOSPITAL
Dizzy; Weak; Throat are swollen; Oxygen levels dropped to 91%-92%/While she was flying her oxygen dropped; Heart rate was 141/heartrate was 106-110; Face swollen; Body ache; Eyes started swelling up; A spontaneous report was received from a consumer who is a 28-years-old female  patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events eyes swelling up, oxygen levels dropped to 91%-92%/ while she was flying her oxygen dropped, heartrate was 141/ heartrate was 106-110, face and throat are swollen, body aches/pain, dizziness and weakness.  The patient's medical history was not provided. Concomitant medications reported were propofol, benadryl and oxygen for drug use for unknown indication.  On 02-Feb-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection.  On 02-Feb-2021 , the patient experienced the events eyes started swelling up, oxygen levels dropped to 91%-92%, heartrate was 141, face and throat are swollen, body aches, had pain, while the patient was flying her oxygen dropped, the patient takes propofol 10mg to reduce heartrate  but did not work as well as it normally does was around 110, her oxygen saturation was 96% when she landed, heartrate was 106-110.   On 03-Feb-2021, the patient took some benadryl to help with side effects. She was still dizzy and weak.  Treatment details included Benadryl and Propofol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events oxygen levels dropped to 91%-92% was considered resolved on 03 Feb 2021.  The outcome of events, eyes started swelling up was unknown, heartrate was 141,face and throat are swollen ,body aches had pain ,while she was flying her oxygen dropped, her oxygen saturation was 96% when she landed, heartrate was 106-110, dizziness, weakness was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
2nd Moderna shot given 5/31/21 at 12:49 pm. By 1:00  pharmacy tech saw that pt. had a large, red, swollen area surrounding inj site. Pt. complained of dizziness and extremely itchy upper arm. Pt reported no difficulty breathing. Had pt lower her head while staying seated. 1:00 pm bp 131/92 pulse 76. Pt then reported increasing dizziness. Had pt. lie on floor with lower legs up resting on chair. 1:05 pm bp 142/102 pulse73. Pt's alertness was decreased compared to before shot. Called 911 around this time. 1:10 pm bp 148/101 pulse 76. Still no difficulty breathing  when asked. Then at 1:12 pm pt. complained of being cold throughout whole body. 1:14 pm pt. started to perspire. Pt. was brought a light blanket and covered. 1:15 pm pt. started to shiver. Ambulance personnel arrived, assessed pt. and transported her to e.d. shortly thereafter.
Information has been received from a physician's office manager, that a female patient on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and meningococcal vaccine (manufacturer unspecified). It was indicated that after receiving the vaccine, the patient had fainted. Medical treatment and current patient status was not reported. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2009. Follow-up indicated that the health care provider believed it was dut to other factors that had caused the patient to have fainted, and not feel that the varicella virus vaccine live (Merck) was a factor. Current patient status was not reported. Additional information is not expected.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patients were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product. This case was one of the 7 cases, reported by the same reporter.
Received the 1st dose while having COVID; A spontaneous report was received from a healthcare professional concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events received the 1st dose while having covid/ SARS-CoV-2 test positive.  The patient's medical history was not provided. Concomitant medications reported were Metoprolol, Levothyroxine, Wellbutrin used for unknown indication.  On 6 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 6 Jan 2021, the patient received the first dose of mRNA-1273  while having covid.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   On 6 Jan 2021 the outcome of event(s), received the 1st dose while having covid was resolved.
Patient stated he had experienced usual side effects from the vaccines including fatigue, frequent urination (every hour) and blurred vision. Those symptoms only lasted 3 days after his first covid vaccine, but persisted since he received his second dose on 6/8. He denied having shortness of breath, irregular heart rate, hives or any other anaphylaxis reactions. No new medications or health conditions as he was aware of. He will continue monitor more symptoms and he has scheduled an appointment with his primary provider in couple weeks
felt like I was going to hit the floor; Lightheadedness/Dizziness; jerking/involuntary jerking, quenching, it was kind of weird; body jerking; feeling weird/felt like she was not herself/ she felt her body was trying to fight off something; heaviness in her legs; felt pain in her face; flinching; This is a spontaneous report from a contactable consumer(patient).  The 61-year-old female patient received first dose BNT162b2, via an unspecified route of administration on 04Mar2021 (Lot Number: EN6205) as single dose for CIVID-19 immunization.  Medical history included blood pressure issues from 2010 and ongoing, ongoing sinus issues which was diagnosed in 1973 or 1974, hypoglycaemia, reaction to tetanus shot several years ago. The patient's concomitant medications were not reported. She received postnasal drip started on 02 Mar2021 or 03 Mar2021 before the vaccine. She got the first Covid shot on 04 Mar2021. She wait 30 minutes because had reaction to tetanus shot several years ago. She had flinching, jerking and feeling weird 10 minutes after vaccine on 04 Mar2021. She and husband in holding area waiting. One time jerk so bad felt that she felt she had to lay down. She felt like she was not herself like she was out of body like there and she was not (AS REPORTED). She had a weird feeling after vaccine, she felt her body was trying to fight off something, felt like little bit out of body feeling, felt like she was going to hit the floor on unknown date. She felt lightheadness on 04 Mar2021. They checked her pulse and there was nothing with her heart rate. She does not know if it was an anxiety attack or not. She was nervous about getting the vaccine because it was so new. She felt this way for four days. On the fourth day that she felt she was coming around and on the fifth she felt herself. She has other underlying health issues and does not want the virus. She had heaviness in her legs, felt a pain in her face both on 04 Mar2021. The doctor wanted to rule out if she was having a stroke. She went to the ER, the ER kicked her out and did not find them. Her BP was 130/60 on 09Mar2021. They did blood work and an EKG(Electrocardiogram). They ruled out stroke. The doctor stated that the allergies could have made her feel dizzy but did not know about the twitching and jerking. She has lightheadness and dizziness because of other health reasons like sinuses, blood pressure and low blood sugar which these were before the vaccine. She had the normal EKG on 09 Mar 2021. There was unknown treatment received for events. Outcome of heaviness in her legs was recovered on 06Mar2021, of felt pain in her face, feeling weird, Dizziness was recovered on 07Mar2021, flinching, jerking was recovered on 04Mar2021, of felt like I was going to hit the floor was unknown. Case was assessed as serious.
pt came in for a flu shot but was accidently given a third covid vaccine . he is almost due for a booster. he got his first covid moderna vaccine on 04/05/21 , second one on 05/05/21 and got a pfeizer vaccine today 10/26/21.  pt felt fine and was happy that he got his third dose, he also said that he still wants the flu shot so we gave him a flu shot as well. when asked if we should report this to his primary, he said he did not have a primary doctor.
CONGESTED FOR 3 WEEKS, HEADACHES & FATIGUE FOR OTHER 2 MONTHS, NAUSEA AND DIARRHEA FOR 3 DAYS BODYACHES FOR 2 WEEKS, LOST TASTE & SMELL FOR A WEEK, LOST APPETITE FOR 1 WEEK
I went to the Clinic to get my 2nd shot of COVID. I waited 15 to go home left with no problem. That evening and the next day I had a sore arm but it went away. A year later I tested positive with COVID. I have Flu like symptoms, sore throat that persists and I feel weak, The sore throat is still my issue.
Information has been received from a physician concerning an adult female pt who on 9/19/99 was vaccinted with Hep B vaccine. Subsequently following vaccine, the pt experienced urticaria for about 3 days, which later subsided. The pt was presented to an allergist with symptoms. The allergist believed there was an association between the pt's urticaria and therapy with Hep B vaccine. Additional information has been requested.
I was informed that a close friends father was hospitalized with partial paralysis which was determined by healthcare professionals to be Guillain-Barre Syndrome a direct result from receiving the vaccine just 8 days prior.  When I asked which vaccine he took, I was informed that it was the J&J thus it is my duty to report this adverse event
A fever of 99 degrees came on around 7pm, 4/5/14.  Motrin was administered and baby was put to bed.  At 6:15 AM on 4/6/14, baby cried in crib briefly.  Mother went into babie's room, picked baby up and baby was limp and very red faced and hot.  Pajamas were removed and baby started a full body seizure in mother's arms.  Eyes were open, arms and legs were seizing and baby started to foam at mouth.  Paramedics were called.  Oxygen was administered.  Seizure lasted approximately 5-6 minutes.  Baby's temperature was 101.5 degrees when checked in the ambulance but paramedics said it was probably more like 103-104 during the seizure. In hospital, motrin and tylenol were administered. Blood was drawn to check for abnormalities and nothing was found.  Baby did not return to normal self in terms of behavior for several hours (4 hrs). Sent home from hospital after 6 hours total and continued to give motrin and tylenol for the next 24 hours. Area where the MMR shot was given on 3/27/14 (left thigh) became newly inflamed- swollen and red.  That lasted for 2 days and then returned to normal.  Baby had follow up visit with her pediatrician on 3/7/14.  It was determined by the Dr. at that time that she probably had a reaction to the MMR vaccine, which came on 10 days after it being administered.
A FAMILY ASKED IF  THE MOM, DAD, AND THEIR TEENAGE BOY (AGE 17 AND 11 MONTHS) COULD GET THE COVID VACCINE AT OUR LOCATION.  WE LOOKED ON THE WEBSITE FOR THE AGE LIMITS, AND IT LISTED  AGES 16 AND UP COULD RECEIVE THE COVID VACCINE. WE PROCEDED TO GIVE THE VACCINE TO THE PARENTS AND THEIR SON ON MONDAY, APRIL 12, 2021. UPON FURTHER INVESTIGATION, WE FOUND THAT THE  AGE LIMIT FOR THE JOHNSON AND JOHNSON COVID VACCINE IS ACTUALLY 18 YEARS OLD. WE NOTIFIED THE PARENTS, AND TOLD THEM OF THE SIDE EFFECTS TO WATCH OUT FOR AND IF THEIR SON EXPERIENCED ANY OF THESE, TO IMMEDIATELY CONTACT HIS PCP. WE ALSO NOTIFIED THE PCP OF THE EVENT AND EXPLAINED WHAT HAPPENED.
Rash on right arm after second shot at first injection site. Burning. Hot.welted. soreness.off and on. Itchy too..its better now.  Does not itch anymore but still has redness.
1 hr after visit eyes swollen, rash on both wrists, wheezing (Hx of Asthma), HA, took 2 ASA for HA and Benadryl. Also tightness in throat. Better with in 15 minutes of Benadryl. Pt was on no allergy meds at this time.
CLIENT PRESENTED FOR HER SECOND DOSE WITH CLAIMS THAT SHE RECEIVED A PFIZER VACCINE FOR HER FIRST DOSE. STATE REGISTRY INDICATES FIRST DOSE WAS MODERNA ENTERED BY PHARMACY ON 9/14/2021 WITH MODERNA LOT #.   MODERNA VACCINE NOT AVAILABLE AT THIS MASS VACCINATION SITE. PFIZER VACCINE ADMINISTERED AS CLIENT'S SECOND DOSE OVER 28 DAYS LATER ON 10/22/2021.  NOT SURE IF THIS COUNTS AS AN ADMINISTRATION ERROR OR NOT SINCE IT IS UNKNOWN IF CLIENT COULD HAVE DRIVEN SOMEWHERE ELSE TO OBTAIN MODERNA VACCINE TO MATCH HER FIRST DOSE IN SERIES.  ASSUMING SHE COULD NOT, THEN MIXING MANUFACTURERS IN PRIMARY SERIES IS ACCEPTED ALTHOUGH NOT PREFERRED OR RECOMMENDED.
Initial misuse report received from a healthcare professional on 21 February 2014. The case was received on 21 March 2014 at agency. FLUZONE HD was inadvertently administered to patient under age 65 years. No adverse event was reported. List of documents held by sender: none.
PATIENT PRESENTED TO THE ED FOR LOW HEMOGLOBIN AS SEEN ON LABS DONE AT RHEUMATOLOGY CLINIC ON 05/09/2023. PT C/O INCREASED FATIGUE AND SOB WITH EXERTION OVER THE PAST FEW MONTHS.
Every time I eat I suffer from a sever headache, extreme dizziness and sleep for hours.  If I do not eat, there is no reaction
This spontaneous report as received from a pharmacist refers to a 86 year old male patient with no pertinent medical history and concurrent conditions. On 30-JUN-2014 the patient was vaccinated with ZOSTAVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The pharmacist reported that the patient presented to the pharmacist today on 03-JUL-2014, with a red, oval area around the injection site. This red area developed on an unspecified date. The outcome of red, oval area around the injection site was unknown. The patient sought medical attention. No treatment was given for adverse event. No lab diagnostics studies were performed. This is one of two reports from the same source (other case # 1407USA004360). Additional information has been requested.
Vaginal Spotting (Bleeding) after Second dose; This spontaneous case was reported by an other caregiver and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal Spotting (Bleeding) after Second dose) in an 80-year-old female 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) (Intramuscular) 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 09-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal Spotting (Bleeding) after Second dose). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal Spotting (Bleeding) after Second dose) outcome was unknown. Not Provided          No concomitant medications were provided No treatment medications were provided   Reporter did not allow further contact