chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion due to the refrigerator door being left opened on 21SEP2022. Caller reporting PENTACEL, ACTHIB, IPOL, MENQUADFI, and TENIVAC at a high of 47F out of range for 20 minutes with no reported adverse event; administered IPOL post excursion with no reported adverse event; Initial information received on 11-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case is linked to cases 2022SA422151(CLUSTER), 2022SA421782(CLUSTER), 2022SA422546(CLUSTER), 2022SA422846(CLUSTER), 2022SA419841(CLUSTER), 2022SA422655(CLUSTER) and 2022SA422419(CLUSTER).  This case involves a 10 years old male patient who received IPV (VERO) [IPOL] after temperature excursion at a high of 47 F (Fahrenheit) out of range for 20 minutes with no reported adverse event .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   A temperature excursion due to the refrigerator door being left opened on 21-Sep-2022. Pentacel, Acthib, Ipol, Menquadfi, and Tenivac at a high of 47F out of range for 20 minutes with no reported adverse Event  (product storage error) (unknown latency).  On 26-Sep-2022, patient received 0.5 ml total dose of suspect IPV (VERO) (lot V1A022M, exp date: 17-Feb-2024, strength: standard ) via intramuscular route in the right deltoid for immunization post excursion with no reported adverse event (poor quality product administered).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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.
No additional AE reported; an expired PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a consumer referring to a patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.      On 01-FEB-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T009744, at a dose of 0.5 milliliter for prophylaxis (route of administration not reported). The vaccine had expired on 28-JAN-2022 (expired product administered). The vaccine had no prior temperature excursions. No additional adverse events reported.
My 2 month old was administered the DTAP-IPV/Hib (Pentacel). She cried as usual and got over it relatively quickly. However, later that night, several hours later, she started screaming uncontrollably as if something was terribly wrong. I had never seen her or any baby scream like this. It was like a different child. No matter what I did, I could not console her. She acted lie she was trying to go to sleep and would drift off, but it didn't last long before she was screaming again.  Her leg was swollen and red as well. After a couple of hours of trying to calm her, I called the pediatrician's office. Over the screaming, I explained what was happening and they told me it was "normal"! I was shocked. I couldn't believe that if this was a typical reaction, why it would be administered. (My 3 year old had received all recommended vaccines and no reactions like this) Something seemed terribly wrong with her. After getting off the phone, I felt no better, but she eventually fell asleep and stopped the screaming. About a week later, she developed thrush and it persisted for about 3 months. We tried all the prescripts for this, but eventually, the only thing that worked was to give her regular probiotics daily. The doctor still insists that she didn't have a reaction and that they almost never have reactions to the vaccines. I have no idea whether there was permanent damage, but I hope and pray not.
Vaccine was administered outside of storage recommendations. patient returned on 6/5/21 to re-vaccinate
Spinal pain, headache, muscle pain, stiffness. Light headed, pain: light headedness began about 1 hour after vaccines given. No tx. Pt stated he was flat on his back in bed for three days; very stiff and sore.
creatinine went up; creatinine went up; This is a spontaneous report from a contactable consumer reporting for her mother from a Pfizer-sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The reporter stated that, the patient had kidney problems. Her creatinine went up after taking the vaccine. She was asking if her mother should still take the 2nd dose of the vaccine? The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Pt had redness and swollen on left arm. Pt came to pharmacy today 10/1/18. Pt is doing ok, just little pain. Pt has been taking TYLENOL for the pain. Advised pt to take IBU or TYLENOL and put ice.
My arm hurting; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jun2022 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "My arm hurting"; PAIN (non-serious), outcome "unknown".  Additional information: This report was not related to a study or programme.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 12 year old (reported as 11 year old) female patient who was vaccinated with two doses of MMR II (lot #s not reported) respectively on 16-JUN-1998 and 25-OCT-2001.  On 30-DEC-2009 the patient developed mumps and was diagnosed with mumps.  She was afebrile and had left parotitis.  On 30-DEC-2009 the first blood work was performed.  IgM was <1:10 (normal range <1:10), IgG was 1.91 (normal range > 1.10), serum amylase was 65.  At the time of this report, the patient's outcome was unknown.  Additional information has been requested.
redness of arm; swelling of arm; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 min after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: redness of arm) and swelling arm (Verbatim: swelling of arm). The outcome of the erythema of extremities and swelling arm were resolved (duration 5 days).   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     It was unknown if the company considered the erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was a GlaxoSmithKline representative who was reporting on behalf of an HCP (doctor). He reported that the patient experienced swelling and redness of the arm right above the elbow for 4 to 5 days.  The reporter consented to follow up.
Positive in-home antigen (Name withheld) 16Jun2022; Positive in-home antigen (Name withheld) 16Jun2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 2, single (Lot number: EL0140) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Oct2021 at 11:00 as dose 3 (booster), single (Lot number: 012F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. There were no known allergies reported. Patient took Paxlovid for COVID 19, treatment was started on 16Jun2022 and Stopped on was 20Jun2022, Lot number as 1916517A. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Jun2022, outcome "not recovered" and all described as "Positive in-home antigen (Name withheld) 16Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative, notes: Negative test 23Jun2022; (16Jun2022) Positive, notes: Positive in-home antigen (name withheld). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not take other medication in 2 weeks. Reporter stated that Possible rebound after Paxlovid. Original symptoms started evening of 14Jun2022. Positive in-home antigen test (Name withheld) on 16Jun2022. Paxlovid Started in the evening of 16Jun2022. Negative test on 23Jun2022. On 29Jun2022, deeper cough/phlegm was started, Heavy congestion, Complete loss of taste/smell on 05Jul2022.
Leg pain and then death.  Reported severe pain in leg on same day of short.  Continued pain through June 13 reported to daughter, advised to seek medical attention.  Reported hip pain, bilateral to urgent care on June 20, 2022.  Patient died unattended death approximately June 20, body discovered July 4, 2022
12:10 Became pale, clammy. Asked for glass water. Then c/o numbness around (L) side of lip, and (L) side of face. Approx 5-10 minutes after giving vaccine. 12:14 pm BENADRYL 25 mg PO given 911 called. Sent to ER with paramedics-ambulance 12:39 pm.
I went to the pharmacy to get my 3rd COVID-19 shot and waited my 15 minutes. I was fine went home. About a month ago I noticed that my ear was very clogged and I went to see my doctor. I had some wax but my hearing is still very foggy. It is getting better but it is not completely normal.
Skin reaction after 2nd vaccine (red/purple color, hot, hard skin)  102 degree fever, chills, body aches for 48 hours after 2nd vaccine
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756496A, A0756498A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers : AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches received (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Info has been received from a physician concerning a 12 month old male, with no medical history, who in August 2005, was vaccinated with a dose of MMRII. In August 2005, the pt experienced an elevated fever that was greater than 103F. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested.
9/19/19 (R) arm swollen at immunization site & rash temp-normal per mother Spoke with Dr. office 9/20/19 child okay went to school.
Patient is having soreness and pain that radiates down her arm to her elbow and fingers. She is still reporting soreness that is disturbing her sleep. Followed up with patient on 6/17/21 and patient is still experiencing pain and side effects. Muscle soreness is the primary complaint. Patient did not disclose other medications that she is on. Patient is seeing oncologist  for a previously diagnosed stage 3 vaginal cancer. Patient signed a consent form assuming responsibility for follow up regarding side effects with her doctor.
This was the Johnson and Johnson shot I received.   Normal symptoms of tiredness, soreness occurred immediately.  Within 3 days I developed chronic stomach pain and GI problems.  Bloody stool has been going on now for 3 months.  I weigh 145 lbs and have lost 40 lbs. currently at 105 lbs.  Doctors haven't been able to diagnose my situation even after several blood tests, colonoscopies and biopsy's.  I was a perfectly healthy 26 year old with no family issues of GI problems or other complications.  I now can barely stand for a few minutes at a time.  Doctors think I have either Chrons, or Ulcerative Colitis, but the biopsy's are inconclusive.
pt recvd vax @ 3PM & had sz @ 3AM 22JUN94; rushed to ER & discharged 830PM; referred to epilepsy clinic;
Within 10 minutes of receiving 1st vaccine client exhibited signs of SOB, sweating all over, tingling in both arms from the elbow down to fingers, then syncope for app 1 minute. Received shot at 1:30 PM BP @ 1:50 PM was 81/50 P-68@99%. BP@ 2:08PM 68/43 P-65@99%. Given bottle of water and 2 pieces  of bite  size  chocolate (milky way). Was AVO X3 before leaving with sister to stay the night.  If any other symptoms arrive will go to ER.
Information has been received from a physician concerning an 84 year old female with hypertension, gastroesophageal reflux disease, hypothyroidism and drug allergies to penicillin, cephalosporin, sulfa drugs, morphine, codeine, iodine, phenobarbital and latex, who on 29-AUG-2007 was vaccinated SC with a 0.65 mL dose of ZOSTAVAX(Oka/Merck) (lot# 657675/06180). Concomitant drug therapy included BENICAR HCT, NEXIUM, SYNTHROID, SULAR and DYAZIDE. On 01-SEP-2007, the patient experienced hives. The patient was treated with BENADRYL. Subsequently the patient recovered. There was no product quality complaint. Additional information has been requested.
After the first shot on Nov. 13th., he said he saw black and white spots, felt hot and dehydrated.  After the second shot at 9:00 a.m. Dec. 15th, he reported having a swollen throat.  He woke up the next morning at 6:00 with hives(itchy splotches that caused his eyelids to swell) all over his body and had a fever of 100.2.
Vertigo symptoms for 5 days; Body and joint aches; Body and joint aches; Temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Apr2022 as dose 4 (booster), single (Lot number: Fk9893) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLOFT. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), PAIN (non-serious) all with onset 23Apr2022, outcome "recovered with sequelae" (Apr2022) and all described as "Body and joint aches"; PYREXIA (non-serious) with onset 23Apr2022, outcome "recovered with sequelae" (Apr2022), described as "Temperature"; VERTIGO (non-serious) with onset 23Apr2022, outcome "recovered with sequelae" (28Apr2022), described as "Vertigo symptoms for 5 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vertigo, arthralgia, pain, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.
On July 14, 2022 I tested positive for COVID-19. I took a rapid test at home on July 14, 2022.  I did a tele visit with my doctor. My Dr. told me to isolate and said that my symptoms as mild.
Swollen Lips; Swollen eyes; Sicker than a dog; Rash around the injection site; Chills; Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen Lips), EYE SWELLING (Swollen eyes), ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site), CHILLS (Chills) and VACCINATION SITE PAIN (Sore at injection site). On 12-Feb-2021, the patient experienced LIP SWELLING (Swollen Lips) and EYE SWELLING (Swollen eyes). On 11-Feb-2021, ILLNESS (Sicker than a dog), VACCINATION SITE RASH (Rash around the injection site) and CHILLS (Chills) had resolved. At the time of the report, LIP SWELLING (Swollen Lips), EYE SWELLING (Swollen eyes) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
A patient fainted about five minutes after receiving his COVID vaccine. He came to the pharmacy counter to tell a pharmacy technician that he wasn't feeling well. He then began to hold on to the counter and lower himself to the ground because he felt like he was going to faint. The pharmacist went to assist the patient immediately. He was unresponsive lying on the ground for a few seconds, but quickly became responsive again. EMS arrived to assess the patient. He was determined to be okay and was not transported to the hospital.
SORE MUSCLES IN BOTH ARMS WHERE RECEIVED THE SHOTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: blood pressure. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced sore muscles in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore muscles in both arms where received the shots was not reported. This report was non-serious.
Moderate to severe localized reaction right arm anterior half armpit to two inches below elbow- Red, hot, swollen itchy, tender
Sore on lt arm @ site of DTP vax, scabbed area approx size of quarter surrounded by approx 1/4" redness-area not warm, no drainage, no fever- home treatment w/h202 & ATB
Resident expired on 12/1/2022 at 1405. .  Resident began having respiratory issues on the morning of 12/01/2022.  Oxygen was applied.  Breathing treatment's given.  Chest x-ray performed and flu swab also performed.  Resident was a DNR,   12/1/2022 05:00  Called to resident's room. Resident coughing and having difficulty breathing. O2 sats 88%  Inhaler administered. O2 started at 2 liters. Breathing treatment administered.  O2 sats up to 95% Temp- 100.2 P- 98 B/P- 100/60. R- 20.   12/1/2022 09:58   Resident resting in bed at this time. No s/s of adverse reaction to covid booster. Resident denies pain/discomfort to the site. Resident remains afebrile at this time.  12/1/2022 12:02 Signee called to resident's room by CNA stating family wanted to see the nurse. Signee entered room and family states "He just sounds gunky." Resident noted to have a productive cough. Stridor noted to BIL lungs. O2 94% via nasal cannula. T 99.1. Resident noted to have chills. Breathing treatment administered. Dr. notified. New order received to obtain CXR and swab resident for the flu. Resident aware and agreeable.   12/1/2022 16:05  Entered residents' room to check on him and noted resident to be in respiratory distress. . Resident suction by staff related to resident has coughed  up secretions/phlegm.   No visible signs of life noted.  Resident is a DNR.  Time of death is 4:05 pm. Family remains at bedside and Dr. notified of residents passing and gave order to release body to funeral home of choice.
Patient felt flushed nausea, and headache within 5 minutes of administering. Recovered with continued headache after 25 min observation.
Severe muscle weakness and complete loss of muscle tone. Diagnosed with PMR (Polymyalgia Rheumatica) and put on a Prednisone taper. Loss of 2 months at work 50% chance of reoccurrence.
same day as vax pt devel pain in lt buttock & lt hip that gradually decreased over several days.
Red patch 2 1/2 x 2 inches suddenly appeared at vaccination site There is no itching, swelling or or fever at the site I have no other symptoms  This occurred 2 weeks after vaccination
Severe migraine (worst of my life) beginning 1 week after first injection, vomiting, diarrhea, fever of 102 orally, chills, severe body aches which lasted for approximately 7 to 10 days post first injection.   Since injection to presently, experiencing debilitating fatigue and somnolence, arthralgias in hands and feet every morning, peripheral swelling, migraines 2-3 times a week
Patient reports increased inflammation, back and joint pain. Patient treated with Toradol injection and Tylenol/ ibuprofen from PCP.
Mother reported that her son had a nosebleed on Wed 7-30-08 and had never had one before; Mother reported small amount of blood; Mother also reported left arm swelling to elbow; Mother reported no change in level activity
Localized redness, rash, fatigue, fever, chills, nausea, vomiting.
Information has been received from a consumer concerning her daughter who on 03-MAY-2007, 10-JUL-2007 and 15-NOV-2007 was vaccinated with first, second and third dose, respectively of GARDASIL (dose, route and lot numbers not reported). The consumer reported that her daughter was sick just about the entire freshman year at college. "She was not herself". It was noted that she did not display as severe symptoms as her sister (WAES 0910USA00170). It was not specified if the patient sought medical attention. This is one of two reports from the same source. Additional information has been requested.