chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hoarse voice approx 2 1/2 hrs after shot was given (7:30PM Thurs 8/10/06). Friday evening ,Sat morning severe stinging pain on a few patches of hives which developed into blisters behind right shoulder, on neck and chest. Advised to put hydrocortisone cream for the next two weeks w/scabbing in those areas.
rash at injection site, radiating down to elbow, very hot feeling at injection site with some swelling, patient took Benadryl and reported the rash to pharmacy on 6/7/19 , rash has subsided to some extent, still itchy
I have contracted tinnitus 5 days after my first shot. I never had this condition before. It has made it very hard for me to fall asleep and I?m having a lot of problems with sleep now.
Muscle stiffness and inflammation, swelling like, soreness at the elbow;felt like my muscles in both right and left elbows were tightening up and it was worse in the left arm;also heat, burning sensa in the front of my chest and across my back shoulder blades, along with needle like pricking sensations all over my body, in my feet, in my arms and in the muscles of my thighs; it was so bad I went to the doctor and she prescribed 10 day supply of steroid, which I started to take but did not finish because I didn't want to rely on that. My hands and feet looked to me swollen and I went to a family doctor; she didn't think I was inflamed, but blood drawn showed inflammation. Blood was drawn twice and it showed an incre
Information has been received from a nurse practitioner concerning a 21 year old female with acne who in June 2007, was vaccinated with the first dose of Gardasil, 0.5 ml, IM. Concomitant therapy included BENZACLIN. In June 2007, the patient experienced a yellow milky discharge soon after the vaccination on the injection site. She also developed some very itchy rash on legs two to three weeks later. The patient eventually recovered from these symptoms on an unspecified date. on 10-SEP-2007, the patient was vaccinated with the second dose of Gardasil (lot# 658560/1062U). On approximately 24-SEP-2007 "two weeks after the second dose", the patient developed an itchy rash which started on both of her arms and spread to her legs. The patient also had some pilonidal cysts or skin infections on her body. Unspecified medical attention was sought. On an unspecified date, a complete blood count and serum ICG were performed which the results were normal. The patient's itchy rash arms and legs and pilonidal cysts or skin infections on her body persisted. No product quality complaint was involved. Additional information has been requested.
pt recv vax 26APR99 & on awakening 27APR approx 6AM noticed red dime sized area @ inj site lt arm;by noon Tuesday area approx greater size, warm to touch, stinging & itching;looks bruised;swelling around inj site;
"Rash" 1 day after MMR. Parent consulted primary care provider at pediatric clinic and was advised to use Benadryl. Presented to our facility on day 3 with diffuse edema, erythema, heat to the anterior right thigh. Immunization qualified LVN on our staff advised that it appeared injection was not given subcutaneously. Patient was prescribed oral and topical steroids by our facility's physician assistant.
3/7/05 10 AM VACCINATION 2:30 PM HOARSENESS, THROAT PAIN AND DIFFICULTY TO SWALLOW DEVELOPED 3:30 CHEST PAIN AND WHEEZINESS DEVELOPED, RESTED 3/8/05 REPORT TO THIS RECORDER, STILL HAS THROAT PAIN, DIFFICULTY SWALLOWING-THOUGH EASING. REMAINS WITH MIDSTERNAL CHEST PAIN AND WHEEZING WHICH INCREASES WITH ACTIVITY.BP=124/84.  NO LOCAL REACTION NOTED AT SITE OF VACCINATION. WILL FOLLOW CLOSELY FOR FURTHER EVENTS.
Developed immediate dizziness and in the course of a few minutes developed numb sensation in lips and mouth, within 2-3 hours developed wheezing requiring albuterol at home medical treatment
The patient was administered expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number-00578878) and transmitted to Sanofi on 27-Apr-2021.  This case involves a three month old female patient who was administered a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot Number:U6395AA, Expiration Date: 24-Apr-2021; Lot Number: UJ162AB, Expiration Date : 24-Apr-2021) via intramuscular route in unknown administration site for prophylactic vaccination on 27-Apr-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated the expiration date was read incorrectly. The reporter wanted to know if the vaccine was still valid and what needed to be done going forward. Also, the reporter mentioned they came to the health department for the vaccines and this was the only one she has had.  At the time of report, no adverse event was reported.  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 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.
I have a complex history of a rare form of Chronic ITP and while I still wouldn't change getting vaccinated, my platelets dropped to a dangerously low level about a week after receiving the first dose of the COVID Pfizer vaccine. They dropped to 44k, but I presume they may have been even lower before I had my blood drawn because I had uncontrollable nose bleeds and bleeding. My Chronic ITP had been in remission and at "safe" levels since May 2014 and so my doctor and I both presume the COVID vaccine triggered my platelets to drop. I wanted to sure you were aware this could occur for people with a history of platelet blood disorders.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. On an unknown date in 2014 (reported as after 24-NOV-2014), the patients were vaccinated with doses of improperly stored ROTATEQ (lot#, expiry date, dose, frequency unspecified). No adverse events were reported. No PQC involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L044475, expiration date 12-MAY-2017). The excursion temperature was 33.8 degree Fahrenheit. The excursion time frames were 1 hour 59 minutes and 1 hour and 43 minutes. The temperature was back in range. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of "gave half of vaccine" was received from a nurse concerning a seven-year-old male. The nurse forgot to remove the clip and administered half of the pre-filled FLUMIST syringe. The patient was re-vaccinated at a later date. There was no adverse event associated with this medication error at the time of the report, nor on 30-Oct-2008; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information received 30-Oct-2008 and incorporated into the above narrative: No adverse event occurred and the patient was re-vaccinated.
Moderate side effects: at hour 12, onset of nausea in muscles/body/head/eyes, pain, insomnia, chills/shaking. Acute side effects passed after 36 hours, but deep fatigue and brain fog persisted. After 4 days, symptoms of RA flare set in.
Severe uterine cramping, not able to sleep, shortness of breath, low and fluctuating blood pressure
rash; swelling of her face; given 3 doses of a Shingles vaccine; This case was reported by a pharmacist and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknwon date) and Shingles vaccine (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced rash, facial swelling and extra dose administered. On an unknown date, the outcome of the rash, facial swelling and extra dose administered were unknown.   It was unknown if the reporter considered the rash and facial swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comments:  The patient was inadvertently given 3 doses of a Shingles vaccine and within days, developed a rash and swelling of her face. The reporter asked about data or studies on the effects of 3 doses of the vaccine and potential side effects of this. Additional Supportive Information: The patient received 3 doses of a Shingles vaccine, which led to extra dose administered.
Thrombosis of the superficial vein in the right lateral chest wall (Mondor's disease).   Symptomatic treatment with NSAIDs and warm compresses.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 5:58 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 5:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was unknown whether patient was ever diagnosed with Covid-19. The information about acute illnesses, chronic or long standing health conditions, information about other medications(prescription, OTC, dietary supplements or herbal remedies) at the time of vaccination or at time of reporting were unknown. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
vomiting; distended stomach; sleeplessness; diarrhea; fatigue; 9 lbs of weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US086466.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomiting"; GASTRIC DILATATION (non-serious), outcome "unknown", described as "distended stomach"; INSOMNIA (non-serious), outcome "unknown", described as "sleeplessness"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "9 lbs of weight loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated two weeks after his covid vaccine, he had a distended stomach along with vomiting sleeplessness which has now progressed to diarrhea and fatigue. Illness has resulted in 9 lbs of weight loss.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizzy; headache; achy; red, painful and swollen at injection site (this one lasted 3 days); tired
This was a booster to two doses of Pfizer.  Patient appeared to possibly be having an allergic reaction  to the vaccine.  She developed a flushed, red area on her left cheek.  HCP came from the clinic and assessed patient.  Patient was given famotidine 40mg po x1.  She declined benadryl due to potential drowsiness adverse effect.  Patient called this morning stating she was ok and didn't have any other issues.
My whole body is sore is that normal; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (My whole body is sore is that normal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (My whole body is sore is that normal). At the time of the report, MYALGIA (My whole body is sore is that normal) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.   Reporter did not allow further contact
11 y.o. male inadvertently administered Pfizer covid vaccine adult dose instead of Pfizer 5-11 covid vaccine. Patient had no adverse effects from vaccination.
Knee pain that then transferred to the hips. Next day it transferred to my shoulders. Then continued to the elbow and wrists. Every day it is in a different joint. I have had to miss work because I am unable to walk and or move at times
mouth turned numb Narrative: Two hours after administration of the firs Moderna, employee reports she had numbness in her mouth, tongue, and jaw.
Rash from shoulder to elbow then itching over most of body continuing until today 01/16/2015. No other symptoms.
On 1/15/2021 awoke to 11x11cm area of painful erythema at injection site, and feverish to touch. Erythema and pain starting to resolve on 1/20/2021, but still visible redness around the injection site.
PATIENT WAS FASTING. SHE FAINTED AFTER 5 MINS OF THE SHOTS ADMININSTED WE HAD HER LAY ON BACK AND PAGED MANAGEMENT FOR CODE WHITE.SHE FELT BETTER AFTER 15 MINS SHE REGAINDED CONSIOUS AFTER 8 MINS AFTER SHE LAYED ON HER BACK
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017 (strength, dose number, anatomical locations and route of administration were not reported). Concomitant therapies were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has bee requested.
Patient reported that the vaccine triggered a bad psoriasis flare in her upper extremities, back, and legs. Flare was worse than she has ever had before and in locations that the psoriasis was never previously present. The flare occurred after administering Humira 5 days post vaccination.
The morning after the hepatitis B vaccine my baby woke up with left eyelid ptosis.  It resolved throughout the day.  Then the following morning, my baby awoke with right eyelid ptosis.  This too slowly resolved throughout the day.
Immediately after the shot, I felt very shakey.  It improved in about 15-20 so  I starting driving home.   While driving, I felt like I was developing a big lump in my throat and I started coughing.  My throat became extremely itchy.   As i reached home, my entire face and head became itchy.  Lump and itchiness in my throat continued.  Drinking cold liquids helped the lump some, eating was difficult but not entirely impossible.  Breathing was ok, but the itching was intense.  The next morning I had a slightly raised rash all over my back that was also itchy.  Benedryl didn't seem to help.  Issues last about 3 days.
Information has been received from a pharmacist concerning a 29 year old female patient with no allergies or medical history reported who on 14-OCT-2006 at a pharmacy was vaccinated with a 0.5ml SC dose of Pneumovax 23 (lot # 651399/0486F). Secondary concomitant vaccination on 14-OCt-2006 included influenza virus vaccine (unspecified) (manufacturer unknown). Several hours later, on 14-OCT-2006 the patient experienced tenderness, warmth, swelling and redness at injection site and soreness of whole arm with movement. The patient was treated with TYLENOL and BENADRYL. She saw the doctor on 15-OCT-2006 when she also had a fever (103 degrees Fahrenheit) and chills. The doctor ordered prednisone and SEPTRA DS. The patient was referred to an infectious disease specialist. As of 17-OCT-2006 the patient had not yet recovered. Additional information has been requested.
I was sick; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: Unknown) 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: ILLNESS (non-serious), outcome "unknown", described as "I was sick". Patient had an appointment yesterday for second shot of the Covid-19 and was not able to get there. Patient was sick and could not get there.   No follow-up attempts are possible. No further information is expected.
1/12/22  24 yr/o male who presents to the ED with fever, nonproductive cough, mild sinus headache, clear rhinorrhea, loss of appetite and myalgias.  Symptoms started 10 days ago as allergy type symptoms with evaluation by PCP by telemedicine the next day and 7 days ago outpatient COVID/flu swab which was negative.  He was treated with Flonase, Tylenol and Claritin.  He felt better and went back to work 5 days ago for 1 day.  He then developed recurrent symptoms 3 days ago but worsening with the addition of fever, loss of appetite and myalgias in addition to his clear rhinorrhea, postnasal drip and nonproductive cough.  He denies any nausea, vomiting, diarrhea, dizziness, chest pain, palpitations or dyspnea. 1/12/22 Review of Systems  Constitutional: Positive for activity change, appetite change, fatigue and fever. Negative for chills and diaphoresis.  HENT: Positive for hearing loss (chronic), congestion, rhinorrhea and postnasal drip. Negative for ear pain, nosebleeds, sore throat, trouble swallowing, neck pain, neck stiffness, voice change, sinus pressure and tinnitus.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough. Negative for chest tightness and shortness of breath.   Cardiovascular: Negative for chest pain, palpitations and leg swelling.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and hematuria.  Musculoskeletal: Positive for myalgias. Negative for gait problem.  Skin: Negative for wound.  Neurological: Positive for headaches. Negative for dizziness, tingling, syncope and weakness.  Psychiatric/Behavioral: Negative for confusion.   Discharge instructions include:   Follow up with PCP  for further evaluation and management.  Take your medications as prescribed. Rest. Drink plenty of fluids. Return to work 4 days Recommend regular diet with small frequent meals to ensure adequate calorie intake
have shingles now, had the vaccine/suspected vaccination failure; shingles, in hosp 5 days; in hosp 5 days for pain control; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization) and pain (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles vaccine and it was 4th time getting it in hospitalization for 5 days for pain control before they knew it was shingles. The patient had shingles at the time of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.