chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my underarms have been swollen; It was difficult to put my arm down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 37-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jan2021 (Lot number: EL4264, Expiration Date: May2021) at the age of 37 years 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: SWELLING (non-serious) with onset Feb2021, outcome "not recovered", described as "my underarms have been swollen"; LIMB DISCOMFORT (non-serious) with onset Feb2021, outcome "not recovered", described as "It was difficult to put my arm down". The events "my underarms have been swollen" and "it was difficult to put my arm down" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, limb discomfort.  Additional information: immediately following R under arm swell to the point. It was difficult to put her arm down. It went down a little never completely   No follow-up attempts are possible. No further information is expected.
The adverse event was tightening  of chest, dizziness, shortness of breath, increased blood pressure, hot flashes, and a slight headache. I don't know if the vaccine is the cause or not but I cannot rule it out.
Pt called today and informed pharmacist that she's been having pain in one of her legs whenever she puts pressure on it or perform heavy duty use of that particular leg. She noticed the pain/weakness the day after vaccine administration.
Caller's husband received the second dose on 17MAR2021 and tested positive for the Covid virus on 25MAR2021; Caller's husband received the second dose on 17MAR2021 and tested positive for the Covid virus on 25MAR2021; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is one of two reports.  A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose on 17Mar2021 and tested positive on 25Mar2021. The patient did not experience any symptoms with the COVID virus. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515627 same reporter/drug, different patient, similar events
pt recvd vax & 6 hrs p/vax went into convuls & was hospitalized for observation; next day had another sx which lasted approx 15 mins; on both occasions temp was 101;
30APR97 mom called in AM to say pt had rash from head to genitals;red raised spots lt leg w/redness & swelling @ immun site;mom advised to take pt to MD was running low grade fever; & cranky;mom called back 3:30 MD said it was a rxn;
Pt received MCV4 and Tdap 8/3/15 and 8/4/15 the injection site became irritated, and swollen. It is painful to lift left arm, and feels warm. 8/5/15 patient's palms on both hands became very itchy, swollen, with redness.
Acute onset crying, grunting respiration, fever, distress.  11/30/06 Received medical records from PCP which reveal patient in good health on day of vax.  Returned to office after waking from nap crying & shaking & grunting with each breath.  PCP felt it was probable immunization reaction & after about 2 hours of observation in the office was sent home.  Symptoms returned & worsened at home & was admitted to hospital for additional management & observation.  Temp on admit was 103 & patient had faint lacy macular rash over her arms, legs & torso.  CXR & abdominal films were WNL./ss 12/8/06 Received medical records from hospital which reveal patient admitted to hospital 11/9/06 with acute grunting & fever, rule out sepsis or intussusception.  Continued to improve while hospitalized & was d/c to home on 11/11/06.  No d/c summary included with records & no final dx available.
THROWING UP; NOT EATING; NAUSEOUS; FEVER; This spontaneous report received from a consumer concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included skin tags under patient's arm, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 11-MAR-2021 08:15 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced throwing up. On 11-MAR-2021, the subject experienced not eating. On 11-MAR-2021, the subject experienced nauseous. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 96.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nauseous, throwing up, not eating, and fever. This report was non-serious.
Client c/o lightheadedness after receiving vaccine. Fire Rescue at scene to assess patient.  All vitals stable, patient began to feel better.  Per Fire Rescue, no further evaluation needed.  Client released home at 4:22pm.
This is a serious spontaneous case initially received from other health professional on 07-Feb-2019, concerning a 27-year-old, adult female patient. On an unspecified date in Sep-2017, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On an unspecified date in Sep-2017, eight hours after vaccination, the patient lost feeling in one of her legs which doctor had put down to a pinched nerve from her time in the gym. On an unspecified date in Sep-2018, 3 days later, the patient was unable to walk. The patient was left paralysed from the waist down. The patient was taken to the hospital and was finally diagnosed with Guillain-Barre Syndrome (GBS). The outcome of the event was not reported.; Reporter's Comments: A 27-year-old, female patient experienced lost feeling in one of her legs, 8 hours after administration of INN Flu Vaccine which was finally diagnosed as Guillain-Barre Syndrome. The case meets level 4 of Brighton Collaboration criteria of diagnostic certainty. Considering the plausible temporal relationship between vaccination and reported event, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the event of Guillain-Barre Syndrome as possibly related to suspect vaccine. The event of pinched nerve was assessed as not related to suspect vaccine as the clinical course suggests that the reported time in the gym as a more plausible explanation for the event. The company assessed the case as serious (medically significant).
sensorineural hearing loss, unilateral of the right ear; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 21-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered right ear fullness with no hearing. The patient was diagnosed with sensorineural hearing loss, unilateral, of the right ear. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event to be disability. Upon internal review, the event of sensorineural hearing loss was determined to be medically significant.
Day 2 fever; chills; Body aches; Headache; Super tired; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 16Mar2021 at 0.3ml single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Relevant medical history and concomitant medications were unknown. it was unknown if the patient was tested for COVID-19 prior or since the vaccination. On 17Mar2021 the patient experienced fever, chills, body aches, headaches and super tired. It was unknown whether a treatment was received. The events resolved on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd flu vax on 12OCT92; pt exp sl nausea that noc; 37 pts seen @ this dialysis center recvd vax from this lot; 32 had no adverse events; 2 pts had minor reactions the day of vax;
I quit smoking about two weeks before the first dose of the vaccine. I was having a little trouble breathing. My breathing started to get worse during the few weeks after the first dose of my vaccine. I saw my doctor two weeks after the vaccine. My doctor said I was wheezing and I was given an inhaler. My breathing has been progressively worse over the last six months. I had some flu-like symptoms after the vaccine. I just got some heart testing done recently.
The following morning after waking up, I could feel a little discomfort under my left arm pit. Saw in the mirror that it was extremely swollen as well as my left breast. I was not in any significant pain but it was uncomfortable when my arm is straight down be my side or when laying down. I've taken Advil daily since which has now been 13 days and the swelling still remains.
This spontaneous report as received from a pharmacist refers to a patient of unspecified demographics. On 08-APR-2014, the patient was vaccinated with ZOSTAVAX, dose and frequency were unspecified, (lot number J011550, expiry date 19-DEC-2014) that had been improperly stored. No adverse effects reported. The outcome of patient was administered ZOSTAVAX that had been improperly stored was unknown. No product quality complaint was involved. No further information provided. Additional information has been requested.
Developed nausea with vomiting X 1 and a bout of diarrhea.  Mild soreness at injection.  Today feels nauseated.
Information has been received from the authors in a literature article concerning a 18 year old female patient who was vaccinated with PCV23 (manufacturer unknown) and had received PCV23 (manufacturer unknown) 5 years earlier. Concomitant vaccines included meningococcal vaccine. The 18 year old female with sickle cell disease type hemoglobin SS SCD presented to the adolescent clinic with severe pain and swelling of the left deltoid 1 day after administration of PPSV23. The area surrounding the injection site was mildly warm with red and edematous tenderness from midclavicular to upper humerus. The patient received ibuprofen for pain and was evaluated during the office visit. The patient was not admitted to the hospital. This is one of several reports from the same literature (1506USA012954, 1506USA013115, 1506USA013112 and 1506USA013113). Additional information has been requested.
chills - 0730 body ache, headache - 1000 headache significantly worse - 1110
The day after injection, a sore and reddened area developed about an inch or two from injection site. Hot to touch and very sensitive.
My adverse event started on 11/01/2022 in the evening. All of a sudden I developed vertigo. I also vomited  for the whole day and everything looked vertical. My right ear was screeching. I went to my doctor's office and she prescribed medication which didn't help much. She said nothing was there. I felt like my left ear needs to be opened up to see where was going on in there. I was referred  to an ENT.  He gave me 3 series of Steroids  injection in my right ear. He also  send me for MRA , I was diagnosed with brain aneurysm. I was referred to a Neurosurgeon  they said the aneurysm wasn't life threatening .  They did Cranial angiogram where It was  showed it was outside my brain.   I have 16% of hearing on my right as of now. They said it's permanent hearing loss. I will be doing follow up once every year to see if the aneurysm grows or not. I have to live with this hearing loss for rest of my life.
Since 24 hours after injection moderate to sever itching  and tingling. left upper arm and upper back.  Currently using hydrocortisone cream 2 to 3 times a day to lessen itching. Continuous day and night.  No issues before injections.   I am a retired RN.  No redness noted at injection site.  Or anywhere.
SEVERE NAUSEA, HEADACHE, SORE INJECTION SITE. NAUSEA PERSISTED UNTIL EVENING AFTER PEPTO BISMO TABLETS; HEADACHE UNTIL FOLLOWING DAY. BASICALLY PASSED OUT FOR 24 HOURS EXCEPT FOR NAUSEA.
Fever on 5/10/01 and 5/11/01. Temperature max 104.3F. Swelling and induration, redness, tenderness at injection site about 6cm with lump and pruritus. Treated with Benadryl IV, Augmentin, Tylenol and Motrin and ice packs/hot packs.
Patient indicated on consent form that she has not received a COVID vaccine previously and acknowledged before vaccine also. But once the claim was run through insurance we discovered that she had already received two doses of Moderna elsewhere
Patient developed left-sided chest pressure occuring after going to bed 4/08/03.  It lasted 30 seconds and resolved spontaneously.  She had two more similar episodes, and became short of breath the third time.  She went to the ER, where she had two more episodes of chest discomfort, and then symptoms resolved entirely.  EKG and CXR at the ER were within normal limits.  No blood work was done. She had experienced abdominal cramping and diarrhea that evening before she developed the chest pain.  I saw her the afternoon of April 9, and she had been symptom-free throughout the day (no GI symptoms or chest pain).  Vital signs when I saw her were:  bp 120/72, pulse 76, resp. 16-20, and temp 98.  A repeat EKG was again completely within normal limits.  She denied prior cardiac history, although she has several cardiac risk factors (tobacco use, high cholesterol).  An outpatient stress echocardiogram was ordered for further evaluation, and is pending.
This case was reported by a nurse and described the occurrence of an injection site reaction in a 5 year old male pt who received DTAP (Infanrix) for prophylaxis. On 07/21/03, the pt received the 5th dose of Infanrix (Lot# DTPA592B9) in the left arm.  On the same date, he also received an injection of IPV in the left arm, and an injection of MMRII in the right arm. On 07/22/03, 1 day post-immunization, the parents noticed that the pt had developed an injection site reaction characterized by an area of swelling and redness that was the "size of a grapefruit".  On 07/23/03, the pt was seen by the physician, who administered Benadryl and prescribed applications of ice. The outcomes of the events were unknown.
Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of VAQTA lots # M031695, M022556, M036459, M032492 and M022924 with expiration dates 26-MAY-2017, 26-MAY-2017, 18-JAN-2018, 02-MAR-2018 and 24-JAN-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. The doses of VAQTA were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
(L) upper arm erythematous macular spot after 24 hours. Placed on Keflex.
Approx midnight of 9/26/12 pts arm swollen she went to hospital at 4am 9/27. She received f/u and pneumonia in left arm- this was the swollen arm. Pt felt cold and clammy.
Local itching after administration of vaccine with minutes (1-5  minutes). Itching resolved quickly 5-10 minutes. Flu like symptoms 1-2 days after vaccine administrations.
At about 5:30pm on the following day of the vaccine injection, a headache began and Tylenol was administered. Headache went away by 7:00pm; at about 8pm- 9pm a stomach ache began and ended.  At 10:45pm, chills and a fever occurred. Tylenol was administered, and at 1:45 am on 12/15/201, Motrin was administered.
Patient returned to ER with seizures, fever. Had possible history of seizures from 1 month ago. Not related to immunization. Respiratory distress, intubated. Sent to hospital.
store excursion, reported to moderna.  vaccine had been in refrigerator over 30 days
COVID19 type itchy rash at the injection site; COVID19 type rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (COVID19 type itchy rash at the injection site) and VACCINATION SITE RASH (COVID19 type rash at the injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATENOLOL, PRAVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (COVID19 type itchy rash at the injection site) and VACCINATION SITE RASH (COVID19 type rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (COVID19 type itchy rash at the injection site) and VACCINATION SITE RASH (COVID19 type rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Red, warm area at injection site (Rt) upper arm, warm to touch, itches, size of an egg.
6 months later / shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient for self. The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. When the vaccine became available, patient was one of the first in line. About 6- months later, the patient  developed Shingles on his/her tail bone. The patient thank God for the vaccine. It kept the infection from being more than a small nuisance. The patient rarely recommend any vaccine but highly recommend this vaccine. The patient's mother had a horrible case of shingles. The nerve damage was pretty horrendous. This case was considered as suspected vaccination failure as details regarding vaccination schedule was unknown at the time of reporting.
Initial information received on 20-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old male patient who was vaccinated with DAPTACEL instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was also a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event was occurred or not following the vaccination. 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 Directive 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. List of documents held by the sender: None.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in August 2014 (reported as since 14-AUG-2014) the patient was vaccinated with at least one dose of improperly stored VARIVAX (lot number, expiration date, dose and route were not reported). No concomitant medications were reported. On an unknown date in August 2014, (reported as "within two days of dose"), the patient complained of injection site pain. The outcome of injection site pain was not reported. The relatedness between injection site pain and VARIVAX was not reported. This one of several reports received from the same reporter. Additional information has been requested.
Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included Walker user.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2.5 ml. On 05-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL). On 05-Nov-2021, ACCIDENTAL OVERDOSE (Pharmacist inadvertently gave two patients booster shots at 2.5 mL instead of 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.