chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, burning sensation and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site swelling, burning sensation and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site swelling, burning sensation and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown deltoid. The reporter stated that the patient experienced pain, redness, and swelling at the SHINGRIX injection site which was described to the field representative as severe. The patient had burning with swelling and all of the side effects have since resolved.
Approximately 10 minutes after vaccine administration the patient told her mother she was dizzy while sitting in a chair outside the pharmacy. I, the pharmacist, ran to the scene and the patient was regaining consciousness as I approached. Her skin was red, and she was disoriented for a moment before asking what had happened. Her mother state she began shaking, and her head slumped as she fainted momentarily. EMS arrived and determined the patient was well enough for her mother to drive her home. The patient reported nervousness, and stated before vaccination that she had dizziness and fainting with Guardisil, but that it did not occur until 3 hours after administration while she was at home.
Patient stated as the injection was going in that the pain was sharper and different then he has ever had getting an IM injection. He stated that usually he notices some soreness a couple hours later but this pain was immediate and started just as the injection went in. Patient was instructed to call in the morning if the pain persisted.
admission after having an acute episode of chest tightness accompanied by SOB, found to have 2 mm inferior ST segment elevation on EKG in the ER.  He was emergently transferred where he was brought to the cath lab with finding of 99% heavily calcified mRCA lesion with thrombus noted to the rest of the RCA distal to the lesion.  ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
The amount drawn up and given was 0.5ml instead of the approved dose of 0.25ml.  Parent was contacted shortly after and a follow up call was made 2 days later. Patient experienced slight fever and fatigue on 11/13/22. Symptoms have resolved on 11/14/22 and no other symptoms have developed.
On the night of 01/04/2023, I started to experience some nasal drainage and had a slight fever. I had a lot of trouble sleeping that evening and when I woke up the next morning, I had a fever of 101.7. I did a home test, for Covid-19, and the test came back positive. I waited for the local clinic to open. I informed them that I tested positive and they prescribed PAXLOVID to me. I took PAXLOVID as prescribed and I feel that it helped me. My fever seemed to be gone in about 48 hours. The first day I really felt myself again though was 01/21/2023. I was sick for about two and a half weeks.
This spontaneous report was received from a physician refers to a 79 year old female patient. The patient has drug allergy with PRADAXA, LEVAQUIN, sulfa and tetracycline. The patient had no pertinent medical history. On 18-DEC-2012, the patient was vaccinated with a dose of 0.5 ml PNEUMOVAX23, (lot number was reported as H014196, expiration date 19-MAR-2014, route intramuscularly). Concomitant medications included hydrochlorothiazide, DYAZIDE, SYNTHROID, TOPROL, Vitamin D3, XARELTO and fish oil. On an unknown date, the patient could not sleep because of redness and pain at injection site after receiving a dose of PNEUMOVAX23. The patient was given an antibiotic as a treatment. On an unknown date, the patient recovered from the reported events. The patient sought medical attention (patient called the office). Additional information has been requested.
body aches, neck pain, malaise first couple of days following shot hot flash, purple face, bright red rash upper body on the forth day after shot one day temperature of 99.5 forth day fifth day filling out this form, better but not sure if this is over?
On 3/30/01 at 15:25, had a red, raised rash (patches) one on left upper anterior thigh and lower leg, left forearm and on each buttock. Clear runny nose. Seen by PA. HR-124; Resp-24; temperature 96.6 (Ax); O2 sat-95%. Observed for 1 hour, Rx'd with Benadryl susp. given to be filled. On 3/30/01, Pediatrician consulted by PA and told to go to ER if condition worsens. No respiratory distress (vital signs ok). Pt is to return on Monday. Called on 4/1/02 X 2 with no answer. Called on 4/1/01 at 15:00 and child is fine; rash is gone.
Information has been received from a physician concerning a 14 year old female who on 17-MAY-2007 was vaccinated with her first dose of Gardasil IM. The physician reported that the patient felt dizzy right after receiving the first dose of Gardasil IM. At the time of reporting the patient recovered from feeling dizzy and no further information was provided. Additional information has been requested.
immediate onset of funny taste in mouth, repeated cough, flushed feeling, jaw pain BP elevated to 160/80,. Hrt rate elevated to about 90, pt flushed.  lungs completely clear over next 10 minutes sx began to abate; completely resolved after 20 minutes, except bp still up c/w earlier in the office visit
Broke out in hives, unusually all over my lower body. Took cetirizine so I could sleep and get rid of the hives.  Began to have body aches all over. Began feeling cold.  During night woke up feeling hot. Feelings continued into next day. Extremely out of it, aches got worse.
Within an hour of vaccine severe muscle ache in shoulders, radiating to neck and head with bilateral ear pain and bilateral anckle pain.
fainted; Information has been received from a physician via a company representative referring to a 17-year-old male patient. There were no patient's pertinent medical history, concurrent conditions nor concomitant therapies.  On 09-NOV-2019, the patient received a second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot# and expiration date were not reported) and a dose of influenza virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported), both for prophylaxis.  On the same day, the patient fainted(syncope). The patient was in the physician's office. The patient came around after a few minutes. The patient was given juice and was observed and was fine. There were no lab diagnostics/studies performed. The causality assessment was not provided by the reporter.  Upon internal review, the event of fainted was determined to be medically significant.
The patient is a 44-year-old male that after receiving the vaccine (IM) in the left-deltoid muscle (13:20) proceeded to walk to the observation room where the Paramedic noticed him pale and having difficulty walking (13:21). The patient requested a chair to sit down and the Paramedic assisted the patient to do so. The patient expressed verbally to the Paramedic having a difficulty with needles and subsequently the patient lost consciousness while on the chair but maintaining a pulse and a hoarse respiration (snoring). Thereafter the patient was placed on a medical code in supine position with an immediate clearing of hoarse respiration. Evaluation by the Paramedic revealed an intact HEENT, (continued on page 2)...
Extreme malaise with loss of apatite for 16 hours beginning the morning after vaccine, no further tiredness the second day after vaccine. Red, painful rash around injection site going up and down the arm; painful to touch all rash, not just at injection site; lasting five days.
Information has been received from a certified medical assistant concerning an adult female patient who on an unknown date was vaccinated with a dose of PNEUMOVAX (Lot #660717/0224X).  Subsequently, the patient experienced tenderness and heat at injection site.  At the time of reporting the patient was recovering.  The certified medical assistant reported that the last year they never received any adverse reaction complaints and this year they had already received five complaints.  The reporter has requested a lot check.  In follow up the medical assistant reported that the patient was vaccinated on 14-OCT-2008.  In October 2008, the patient experienced a sore arm.  Subsequently, the patient recovered from the sore arm.  The medical assistant still administered additional patients using lot # 660717/0224X.  However, she now administered it in the patient's hips instead of arms.  No adverse events have been reported after she changed injection sites.  A standard lot check investigation was performed.  All in process quality checks for the lot number 660717/0224X was satisfactory.  The lot number 660717/0224X met the requirements of the agency and was released.  This in one of several reports provided by the same source.   Additional information has been requested.
Had TDAP-BOOSTRIX - was standing approximately 5 min later at check out counter and had syncopal episode - falling to floor regained consciousness in 1-2 min - completely recovered - 5-10 min without sequelae.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 03-AUG-2017 the patient was vaccinated with one improperly stored dose of VARIVAX (dose and route were not reported), lot # N001527 with expiration date 13-JAN-2019, and sterile diluent (MERCK STERILE DILUENT) (dose, route, lot# and expiration date were not reported) for prophylaxis.  The vaccines were exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. Data logger was involved. There was no previous temperature excursion.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 71-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced severe reaction at injection site - redness, swelling, and blisters. Therapeutic measures were taken as a result of the severe reaction at injection site - redness, swelling, and blisters and included treatment with an unspecified steroid. The clinical outcome of the events, severe reaction at injection site - redness, swelling, and blisters, was recovered on an unknown date. Follow-up (12Mar2015): Follow-up attempts completed. No further information expected.
Pt. reportedly developed tingling in arm after Trumenba vaccine and has been hospitalized for seizure activity and now requires physical rehabilitation.  Was prevously vaccinated with Bexsero x 5 years ago.  Still currently hospitalized.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), on 03Oct2021 as dose 3 (booster), single (Lot number: 301308A) at the age of 45 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pleva" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 05Sep2023 to 09Sep2023.
02/11/22 presents to ED for "COVID Pneumonia". PMHx of "dementia, cardiac sarcoidosis on chronic prednisone, chronic CHF, CAD, hypertension, hyperlipidemia, PE"
after about a week maybe a rash showed up on my right forearm and since then I have had it spread to also to my left forearm now it has spread past my elbows and to separate patches on the front of each. Thank you
Mother reports that child has abdominal pain and vomiting issues. She suspects that this is due to HPV vaccine. Last dose given 9/21/16.
Pt brought to EMS room due to cough and chest tightness, FNP @ bedside zyrtec 10mg by mouth given @ 955, repeat dose @ 1015am. BP: 148/58, pulse 85, pulse ox 99% @ 1020, verbal orders for benadryl 50mg by mouth given, patient dischared to care of son in no distress, she reported chest tightness had improved and cough had dissipated.
Acute respiratory failure with hypoxia; COVID-19 virus infection; Pneumonia due to COVID-19 virus
Nightmares, headache, fever 102.1 F, severe joint pain (7 / 10), shaking chills
The lot number for the first dose of vaccine that was taken on 12/17/2021 is: EK5730, And the lot number for the second vaccine that was taken on 01/07/2021 is: EL3248. I started experiencing heart palpitations about mid April, and I started experiencing shortness of breath
Started with pain and redness one day after the injection. Redness spread and began itching and hurting. Went to urgent care who prescribed prednisone and cephalexin which only helped temporarily. Went to ER next day when redness was spreading up and down the arm. The gave me antibiotics, BENADRYL and a steroid interveinously and prescribed new antibiotics. They stated the reaction is allergic and that I have celulitis.
rash in the area, it is red; A barely perceptible/slight swelling; The reaction is localized; Every time she extended the arm it would hurt; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (rash in the area, it is red), SWELLING (A barely perceptible/slight swelling), SKIN REACTION (The reaction is localized) and PAIN IN EXTREMITY (Every time she extended the arm it would hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced PAIN IN EXTREMITY (Every time she extended the arm it would hurt). On 17-Aug-2021, the patient experienced RASH ERYTHEMATOUS (rash in the area, it is red), SWELLING (A barely perceptible/slight swelling) and SKIN REACTION (The reaction is localized). In August 2021, PAIN IN EXTREMITY (Every time she extended the arm it would hurt) had resolved. At the time of the report, RASH ERYTHEMATOUS (rash in the area, it is red), SWELLING (A barely perceptible/slight swelling) and SKIN REACTION (The reaction is localized) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
flushing , rash to face and chest. small bumps on the lips and tip of tongue. Improving symptoms with claritin and benadryl taken by the patient prior to arrival to the ER.
pt transferred to Hospital from PCP; pt was to receive IV infusion of Regeneron (for positive COVID test) but was dyspneic and O2 sats in the 70s on RA; was transferred from Hospital to another Hospital and found to have COVID pneumonia; placed on NRB mask and eventually BiPAP; given steroids and inhalers; no remdisivir due to renal function; pt's condition deteriorated in spite of treatments; was placed on comfort care measures when pt experienced hypotension and she passed away in the hospital
Low grade fever and R eyelid swelling. No respiratory distress, no other rashes present.
Patient diagnosed with Varicella, received Varivax on 6-16-1997.
Initial report received from an investigator on 21 December 2009 under the reference number FUF14. A 73-year-old female subject experienced chest pain 106 days after receiving a second dose of study product H1N1 (30 mcg HA, Group 3), lot number UD12416 on 27 August 2009. The subject experienced sweating and chest pain under her rib cage (both sides) on 11 December 2009. The subject went to the emergency room (dates not provided) and was admitted to the hospital for heart catheterization that was normal. The subject was diagnosed with air pockets in the abdomen after an abdominal ultrasound, and was started on PROTONIX. The subject is to have a follow-up ultrasound in 6 months. Hospitalization dates were not provided. The subject recovered from the chest pain 4 days after onset. The subject remained in the study trial. According to the investigator, the event of chest pain was not related to the study product. The unblinding information for this study was received on 25 October 2009. Follow-up information was received 05 January 2010 from the investigator. The subject, who had a past medical history of hypertension, had previously received a first dose of study vaccine on 06 August 2009. The event diagnosis was amended by the investigator to non-cardiac chest pain which began 09 December 2009 and ended 11 December 2009 (previously reported as chest pain with a start date of 11 December 2009 and stop date of 15 December 2009), which changed the event latency from 106 days to 104 days post vaccination. The investigator clarified that the subject had experienced two separate episodes of chest pain; one episode on 09 December 2009 and a second episode on 11 December 2009; the patient was hospitalized on 11 December 2009 following the second episode. Diagnostic tests included an abdominal ultrasound on 09 December 2009 which revealed air pockets present. On 14 December 2009, a left heart catheterization was performed which showed normal function. Following the ultrasound and heart catheterization, the subject was diagnosed with non-cardiac chest pain. On 15 December 2009, the subject was discharged and scheduled for a six month follow-up ultrasound. The subject recovered from the event on 11 December 2009 (previously reported as 15 December 2009). According to the investigator, the event of non-cardiac chest pain was not related to the study vaccine or concomitant medications. Documents held by sender: None.
Patient called the evening after (11/14/19) administration with complaints of left sided numbness and pain from her shoulder down to her foot. She stated it has started earlier in the day and that she had been taking Advil to try to cope with the pain. I told her that some arm pain was expected and that she should maintain awareness about her side effects over the evening and that I would follow up with her the following day. Friday, 11/15/19 around 5 pm she stated that all of her side effects were gone and that she was feeling much better. The patient called on Monday morning, 11/18/19, with complains of total left arm weakness, blurry/distorted vision and leg numbness/tingling. She stated these new symptoms had started Sunday evening. I told the patient to seek medical care for precautionary measures at this time.
Patient developed rash on left arm initially within 24 hours of receiving the injection.  Rash progressed to right arm, abdomen, back, and bilateral lower extremities.  Rash was red and itchy.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age.  No information was provided regarding the patient´s (pt´s) concomitant medications, concurrent conditions or medical history.  In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location and lot # were not provided) by a health care provider as recommended for the long-term prevention of shingles and zoster related conditions.  Subsequently, on an unspecified date, the pt was treated by a health care provider for shingles.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The pt had not recovered from shingles.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt received two vaccines on 9/24/15. The 2nd vaccine caused mild raised bruising within seconds of admin. Pt reported easy bruising and previous sensitivity. Pt's health was good upon leaving the site.
Other complications following immunization, not elsewhere classified, initial encounter on 2018-11-29.
On Monday, December 19, 2022, I had an angina attack while clearing the snow from my driveway. The attack lasted about 15 minutes. On Thursday, December 22, 2022, my doctor advised me to go to the emergency room. At about 09:30AM that day, the emergency room performed and EKG and a blood test for enzymes. The blood test showed heightened levels of enzymes and that I had previously experienced some form of distress. The cardiologist recommended a heart catheter procedure. I was taken into the Cath lab at about 03:00PM. They discovered an 85% blockage in my right coronary artery at which time they implanted a stent. I spent the night in the hospital for observation. After an Echo test and blood test on Friday, December 23, 2022, I was discharged from the hospital. They prescribed blood thinners.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unspecified date, the patient was vaccinated an improperly stored dose of LIQUID PEDVAXHIB (strength, dose, route of administration and anatomical location were not reported) lot # N014944 and expiration date: 06-MAR-2020, indicated for prophylaxis.     No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Celsius to 25 degrees Celsius (8.8 degrees Celsius) for 5 hours and 15 minutes on unspecified dates. There were no previous excursions reported. Medical Assistant was not sure why the refrigerator went out of range. This is one of several reports received from the same reporter (MARRS#: 1808USA004222).; Sender's Comments: US-009507513-1808USA004222:
Vaccination given at 1120.  At 1146 patient reported itchiness to throat and having trouble swallowing saliva.  IM Benedryl 50mg given at 1150.  Patient left with husband  at 1215.  Denied SOA and Swollen throat at that time.  Patient refused For EMS to be called but agreed to seek treatment at hospital.  Report called to nurse at ER.
Migraine, body aches, fatigue, fever, chills, loss of appetite, lightheadedness/dizziness, nausea, dehydration