chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant and refers to 69 patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # L035878, expiration date 11-AUG-2018 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 1 degree Celsius for 1 hour and 15 minutes and of 10 degrees Celsius for 30 minutes. No previous excursion were reported. The temperature excursions were detected by a data logger. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient experienced itching of the face and eyes with redness. Vital signs stable. Patient improved. Went home in stable condition. Patient advised to follow up with primary care physician before returning for second dose.
Immediately p/DTP inject infant stopped breathing, turned cyanotic, began breathing on own w/o CPR; very pale & listless when pt left clinic site; was transported to hosp by ambulance;
This spontaneous report as received from a physician via a company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an unspecified dose of GARDASIL (route, lot number and expiration date not reported). Concomitant vaccinations included MENACTRA and Tdap (manufacturer unknown). The physician stated that the unspecified number of patients on an unknown date experienced fainting when GARDASIL was administered with MENACTRA and Tdap (manufacturer unknown). The outcomes of the events were unknown. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown demographics. The patient's current conditions or medical history were not reported. On 21-JAN-2014, the patient was vaccinated with the first dose of GARDASIL 0.5 ml intramuscular (lot number and expiration date were not reported). The patient may had an unspecified reaction after receiving the vaccine. On 25-MAR-2014, the patient was vaccinated with the second dose of GARDASIL 0.5 ml intramuscular (lot number and expiration date were not reported). On 25-MAR-2014, after receiving her second dose of GARDASIL the patient developed chills, headache and possible fever. At the time of the report the patient was not recovered from the chills, fever, and possible fever. Outcome for unspecified reaction was unknown. The patient did not sought medical attention for the event experienced after the first dose of GARDASIL. The patient visit the office for medical attention for the events experienced after the second dose of GARDASIL. Additional information has been requested.
p/vax pt started screaming during vax & was inconsolable during remaining time in clinic;child broke out in a cephalo-caudle rash;rash described as starting bumps;pt began crying;had staring daze x 5min;
Sore arm (expected, within an hour) Moderate to severe chills, 14 hours after vaccine Moderate to severe joint and muscle pain, 14 hours after vaccine. Joint/muscle pain still persists 45 hours after vaccine.
vaccine running down on patient's arm; did not receive a full dose; vaccine running down on patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of exposure via skin contact in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th September 2021, the patient received the 1st dose of Shingrix .5 ml. On 5th September 2021, unknown after receiving Shingrix, the patient experienced exposure via skin contact, accidental underdose and inadvertent exposure to vaccine. On an unknown date, the outcome of the exposure via skin contact, accidental underdose and inadvertent exposure to vaccine were unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The reporter stated that while administering the Shingrix vaccine to the patient, some of vaccine was running down on patient's arm, which led to exposure via skin contact, inadvertent exposure to vaccine and accidental underdose. The reporter's concern was that the patient did not receive a full dose of Shingrix. The reporter consented to follow up.
The morning of 6/5/2020 I awoke with fever (100.5 degrees), dizziness, significant fatigue, and loss of vision (pre-fainting) when I got up from bed. My arm at the injection site was also sore all night and into today. I rested and/or slept in bed most of 6/5/2020; my fever went down (99.5 in the afternoon) with a single dose of acetaminophen, but lightheadedness and significant fatigue persisted through the day and into the night. On 6/6/2020 (today), I awoke with some lightheadedness; went to take a shower and nearly fainted in the shower from lightheadedness, dizziness, and loss of vision (including the visual sensation of waves of dim light when my eyes remained closed) for about 10 minutes. I returned to bed, rested most of today, and felt somewhat better in the afternoon. Lightheadedness is gone; fatigue is less than yesterday (about 75% less). But this a.m. I awoke to find itchy hives near my bellybutton and across my lower back, with a few on either side of my hips. It might be related to the vaccine; or it might be a result of a mountain hike I took on Thursday. I don't know. I did not take any pain or fever medication today; my temperature was normal this morning.
Patient was under the age of 18 at time of vaccination. No adverse results were reported by patient.
stroke after booster; This serious case was reported by a consumer via interactive digital media and described the occurrence of stroke in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced stroke (Verbatim: stroke after booster) (serious criteria GSK medically significant). The outcome of the stroke was not reported.   It was unknown if the reporter considered the stroke to be related to Shingles vaccine.     It was unknown if the company considered the stroke to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the consumer interactive digital media. The patient had  one had a stroke the day after booster. The follow-up could not be possible as no contact details were available. This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR066269:Same reporter US-GSK-US2023AMR066213:Same reporter
No adverse events; Administered a dose of improperly stored proquad; This spontaneous report was received from a nurse referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, drug reaction/allergy and concomitant medication were not reported. On 28-APR-2020 the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product storage error) subcutaneously (dose, frequency were not reported) lot # S023651, expiry date: 26-JAN-2021, for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of minus 8.1 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
a 75 y.o. male with past medical history significant for DM type 2, COPD on 3L NC at baseline, CAD with stent, and hypertension who presented to ED with increased shortness of breath for about 3 weeks
Pfizer 2/23/21 and 3/16/21. Positive on 1/24/22
A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time;; Overdose; No reaction noted; This spontaneous safety report, with reference number 2023SA238061, was received by the partner on 03-AUG-2023 and forwarded to UBC on 04-AUG-2023, from a health care professional.  Due to the nature of the event, the causality between the events "A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time and Overdose" and Vaxelis was not applicable.  Further information is expected.  Significant Follow-up information was received by the partner on 15-AUG-2022 and forwarded to company on the same day, from a physician. The case is maintained as non-serious.  Due to the nature of the event, the causality between the events "A clinic supervisor reports that they had a patient on 31Jul2023 who was accidentally administered with ACTHIB and VAXELIS at the same time and Overdose, Overdose, and No reaction noted" and Vaxelis was not applicable.  No further information is expected.
I was required to get my flu and covid immunizations prior to employment. I received my Flu Vaccine on January 03, 2022 administered by Nurse. I have been experiencing extreme pain at the injection site and tried to alleviate it with pain reliever and ice/hot pack. The pain has not subsided and I was now experiencing tingling, numbness and weakness in my left arm. I went back on January 24, 2022 and spoke to a Nurse. I told her of my problems and she referred me and told me to fill out paper work. I have attached that incident report to this email. The following two days she was out due to illness and never did a physical assessment on me. On Thursday January 27,2022 she returned my call to report that based on a technicality of my start date January 10, 2022 she was not able to do anything for me and referred me. I called several times with no response  and left a detailed message with call back number.  I have been to the Urgent Care on January 27, 2022 and was prescribed prednisone with no progress. I have an appointment with my PCP on February 04, 2022.
My arm is with pain for this month; I can't hold up very painful; I am with pain in my two arms; 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), administration date 02Aug2021 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "My arm is with pain for this month; I can't hold up very painful; I am with pain in my two arms".  Follow-up attempts are completed. No further information is expected.
Diarrhea, Nausea, Extremely low energy for the course of a day and a half.
Shot felt like rubbing alcohol burning at site. Instantly dizzy, flushed, rapid heart rate, nausea. Went from Healthy to Flu symptoms over night. Was very sick in 48 hrs, stayed very sick for 3 weeks.
I lost my voice, my face tingled, my eyes Got puffy, itchy,  and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing.  I took two Benadryl; about 45 minutes later my breathing improved.  I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.
headache, diarrhea,  very bad aches and pains, very high blood pressure, difficulty breathing.  Symptoms lasted 2-3 weeks.
diagnosis of shingles; blisters in her mouth; cold sores in her mouth; cold sores/ were painful; skin became painful on the right arm where she received the injection; painful/ axilla,; painful/ flank; painful/ breast; painful/ back; developed blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2020, the patient received the 1st dose of Shingrix. On 15th September 2020, 2 days after receiving Shingrix, the patient experienced shingles, blistering of mouth, cold sore mouth and pain. In September 2020, the patient experienced skin pain, axillary pain, flank pain, breast pain, back pain and blister. On an unknown date, the outcome of the shingles and skin pain were unknown and the outcome of the blistering of mouth, cold sore mouth and blister were recovered/resolved and the outcome of the pain, axillary pain, flank pain, breast pain and back pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, blistering of mouth, cold sore mouth, pain, skin pain, axillary pain, flank pain, breast pain, back pain and blister to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that got the 1st dose of Shingrix on her right arm. The patient stated that 2 days after vaccination, developed cold sores in mouth that were painful. The patient said that after the blisters in mouth resolved, her skin became painful on the right arm where she received the injection, as well as her axilla, flank, breast and part of her back. Following the pain on her skin listed, she also developed blisters, which had since resolved, but the pain remains till the time of reporting. The patient had 2 virtual visits and was given the diagnosis of shingles. The reporter consented to follow up.
patient stated that he was feeling lightheaded and dizzy. gave him a bottle of water and put some icepacks on his neck to cool him off and stood by him for 5 minutes , after that he felt better
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 07-FEB-2014 the patient was accidentially vaccinated with PNEUMOVAX23 (lot #, expiration date unspeciifed), 0.5 ml, one shot, intramuscular when the patient was supposed to instead receive (Oka/Merck) VARIVAX. No product quality complaint (PQC) was involved because the mistake involved "only user error, and there was no confusion due to any kind of product defect or packaging defect". No adverse effects were reported.
otherwise healthy child received fourth Dtap (daptacel) and comvax- hep B/Hib and developed urticarial rash on body within 24 hrs- erythema multiforme. no mucosal involvement. no fever but uncomfortable and a large target lesion surrounding vaccine site as well as throughout body.
From 6/12/14-6/23/14-spitting up small amounts of vomit and assumed it was a result of reflux. From 6/24/14-6/26/14-frequent vomiting. Noticed loss of language around this time.
sensitivity to cold; feeling chilled; short of breath (SOB) with minimal exertion; This is spontaneous report from a non-contactable nurse reported for herself. A 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) intramuscular in the left arm on 08Jan2021 12:00 at single dose for Covid-19 immunization in a hospital. Medical history included COPD, hypothyroidism and allergies to penicillin (PCN). The patient was not pregnant. The patient has no COVID prior vaccination. Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), montelukast sodium (SINGULAIR), oxybutynin, and azelastine; all from unspecified date for unspecified indication. The patient previously took Celebrex and experienced allergies. Historical vaccine included first dose of BNT162B2 intramuscular in the left arm on 20Dec2020 09:15 (61 years old) at single dose for Covid-19 immunization in a hospital. The patient has no other vaccine in four weeks. On 08Jan2021 15:45, the patient experienced sensitivity to cold, or feeling chilled for 48 hours post dose, short of breath (SOB) with minimal exertion for 72 hours post dose. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not COVID tested post vaccination. The patient did not received treatment due to the events. The outcome of the events sensitivity to cold, or feeling chilled, short of breath (SOB) with minimal exertion was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2013, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016 (reported as later in 2016), the patient was treated for herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
Transfered for DVT/pulmonary embolism. Tested positive with unknown symptom date.
Information has been received from a physician and a school nurse concerning a 7 year old male who on 10-OCT-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was also noted that the child was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 22-AUG-2003. A school nurse reported to the physician that between 24-MAR-2005 and 09MAY-2005, the child developed a "more severe case" of chickenpox, noted to be breakthrough with 50 to 250 lesions. Unspecified medical attention was sought. The outcome was recovered. A product quality complaint was not involved. No additional information is expected.
ZOSTAVAX administered SC on 07/11/13. Patient developed a varicella-like rash on legs and back on 07/13/13 - confirmed on exam 07/15/13. No fevers.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On an unknown date an unspecified number of patients were vaccinated with GARDASIL (dose, lot and expiry date was unknown). The vaccine was exposed to 28 Fahrenheit for 15 days, an excursion that was found to be unsupported by in-house stability data. No adverse symptoms were reported. The nurse was unable to provide administration dates and well as lot and expiration dates for the vaccine involved. This is 3 of 3 reports by same reporter. Additional information has been requested.
1.5 days after vaccine, nausea x 1 day, area at vaccine site reddened, warm to touch, tender to touch, gradually worsened over days, 6 days from vaccine still very tender at injection site reddened 1 1/2" by 1" area.
Pt with c/o lightheadedness and burning sensation in chest 5 minutes post vaccination. Assisted to stretcher bed. BP 110/67 HR 85 RR 20 O2 sat 99% on room air. Water & electrolytes given for hydration. Pt stated burning sensation resolved prior to discharge and lightheadedness minimal. Ambulation on unit with no c/o. Discharged at 11:15 AM
Beginning on 3/17/2021, upon awakening around 6:50am, I experienced extreme dizziness when sitting up after lying flat on the bed.  I was so dizzy, that I could not stand up.  Since 3/17/2021, I am continuing to experience dizziness when I change position from standing to lying down,  from lying down to sitting up, and while moving my head around while doing household chores and shopping where I bend over and stand up.  The dizziness fades away once I remain in a static position.
Tested Positive for Covid19 on 07/08/2021.  Suspected Delta Variant  Had Covid19 Symptoms, including headache, body pains, Severe lower back pain, Loss of smell, Low oxygen levels (83%), persistent cough, fatigue- Lasted 10days Recovered, but persistent cough, mild headaches and mild fatigue
pt recv vax 15FEB95 & 24hrs later exp a rash all over body & face;pt refused to see a MD;no further details were provided;
Swollen Lymph Node (two days after vaccine), swollen arm (next morning),fatigue (next day), sore throat  (next day), headache (next morning), sharp back pain (next morning).  Warm compress, Tylenol. Symptoms continue.
received his first dose of Pfizer COVID19 vaccine and five days later tested positive for COVID; This is a spontaneous report from a contactable pharmacist. An 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received his first dose of Pfizer COVID19 vaccine and five days later tested positive for COVID. His doctor ordered monoclonal antibody infusion. He is doing much better after receiving the monoclonal antibodies. The reporter wanted to know if he has to wait 90 days to get the second dose of vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: The association between the event positive for COVID with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax 19DEC95 & 7MAY96 pt devel a chickenpox rash & broke out all over, according to pt mom pt was seen the following day in MD ofc & sx w/chickenpox;
08/29/22 presents to Birth Center Triage for "ctx".  PMHx of "Crohn's disease Bowel resection 2015"
0920 VAC. ;  0930:   AFTER VAC. SHOT- NAUSEA/VOMITING, "FOGGY FEELING"; 0930:  VS:   BP:  145/90, P:  89; T:  98.3 DEG. F; 02 SAT:  RA:  97%; 0948:  VS:  BP:  129/82, P:  85,  O2 SAT:  98 %R.A.
Moderna 4/6/2021 and 5/4/2021. Positive on 1/28/2022.
Heart racing,difficulty breathing, dizzy. It passed after about 15 minutes with no treatment.
Swelling around site and down left arm. Eventual hives, swelling continued into the next day, eventually patient diagnosed w/cellulitis.
mom phoned clinic 1245PM to report pt had sz in car on way home; described pt wiggling all over, hollering about 30 mins w/cal episode a/hollered again & stared, wiggling & kicking; reports has done this a/a few times w/petit mal sz;
4-5 days after vaccination was an onset of constant Dizziness, Head Pressure, Brain Fog lasting over 1 month
Erythematous, warm, firm 3cm area of skin and injection site left arm 2 days after immunization. Given Keflex and Benadryl.