chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bloody noses, one required trip to ER because I was unable to stop the bleeding after 40 minutes. I have had multiple episodes since; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Nov2021 17:30 (Lot number: FH8028) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gluten sensitivity" (unspecified if ongoing); "Known allergies: Tetracycline" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 26Oct2021. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EN5318, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 02Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL3302, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 12Jan2021, for COVID-19 Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 20Nov2021 05:00, outcome "recovering", described as "Bloody noses, one required trip to ER because I was unable to stop the bleeding after 40 minutes. I have had multiple episodes since". The event "bloody noses, one required trip to er because i was unable to stop the bleeding after 40 minutes. i have had multiple episodes since" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of epistaxis.   Follow-up attempts are completed. No further information is expected.
pt cam e in today with rash/redness at site of injection. around injection site is red/black and blue and sore.  Pt said she was feeling lightheaded/dizzy at after receiving injection and reaction showed up following morning. Pt took 2 benadryl night after injection, just 1 dose.
things tasting funny and they tasted odd; Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6205 and expiration date not reported) via an unspecified route of administration at right arm on 27Feb2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included ongoing diabetic (adult onset). Concomitant medications included Metformin at a dose of 500 mg, 2x/day, for several years for diabetic (does not think this would cause a funny taste). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date not reported) via an unspecified route of administration at right arm on 30Jan2021 as a single dose for COVID-19 immunisation. On 27Feb2021, on the same day of vaccination, patient experienced the taste of food that was odd and was not normal and Sore arm (started right away after the vaccine). Patient was treated with tylenol or ibuprofen, whatever was in the medicine cabinet. Patient was not visited to emergency room or physicians office due to events. Outcome for the event things tasting funny and they tasted odd was recovered (reported as lasted about 1 day and went away) and sore arm was unknown (lasted several days).  No follow-up attempts are needed. No further information is expected.
Received his first dose of VAXELIS at 4 months/patient received Hepatitis B at birth.; The baby missed his vaccinations at TWO months old; This non-serious spontaneous safety report with reference number #2022SA024585 was received by a partner on 25-JAN-2022 and forwarded to regulatory authority on 27-JAN-2022 from a health care professional.  The causal relationship between Vaxelis and the reported events "received his first dose of VAXELIS at 4 months/patient received Hepatitis B at birth" and "the baby missed his vaccinations at two months old" was assessed as not applicable due to the nature of the event.  Further information is expected.
LARGE RED SPOT ON FOREHEAD GREW TO SIZE OF A PLUM AND REMAINED FOR ABOUT A WEEK.  AT IT'S CORE WAS A LARGE, BADLY BURST BLOOD VESSEL.  I WAS ON PLAVIX FOR BRAIN ANEURYSM AT THE TIME.  WAS NOT ON IT FOR THE SECOND SHOT AND IT DID NOT HAPPEN THEN.
Within 5 min got a tickle in throat that led to coughing and asthma tightness and dizziness. Took my Ventolin inhaler and my chest opened up. I continued to feel more and more dizzy and found myself finding it hard to speak. Felt very buzzy, like my body was feeling waves of tingles. My head started hurting and neck. This progressed at the vaccination site for a while. I don?t know at what time they suggested N ambulance take me to the ER. By the time I was in ambulance my head and neck were hurting very had. I was having trouble talking and any body movement felt like I was moving through mud. Very tingly and heavy feeling.  I felt very drowsy and my eyes stayed closed. At the hospital they gave me an anti nausea, Benadryl and some migraine pain medicine. I think it was about a half hour or more I started being able to open my eyes again and see straight.  The pain in my head and neck calmed down. I think I arrived at the ER around 3:45/4 and I was discharged at 7:45. I continued to have head and neck pain, body aches. My shooter and arm wheee shot was is very very sore. I slept ok but woke many times with my heart racing and feeling that buzzing sensation again like I was high. I?ve taken Advil for pain. Been resting all day today. Still having a bad headache and neck pain. Feeling very drowsy. Eyes hurting. I feel like I?m slowly coming out of whatever happened but still feeling like I?ve been hit by a truck.
Flu like symptoms, low grade fever, soreness, fatigue, general malaise, redness, swelling.
Flublok QIV given to a 15 year old male with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who reported INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]given to a 15 year old male with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 27-Oct-2022 or 28-oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE pre-filled syringe (strength, dose,lot number not reported) via cutaneous route in unknown administration site for flu immunization.  On 27-Oct-2022 or 28-oct-2022,  the patient reported a non-serious event  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (flublok qiv) given to a 15 year old male with no reported adverse event (product administered to patient of inappropriate age).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Client reports she felt pain in shoulder area immediately upon administration.  Stated she's had previous flu vaccinations and never experienced this sensation before.  Reports she continued to feel pain and noted that when movement and range of motion was initiated, an increase in pain was experienced and consequently limited her range of motion from then on.  Client states she has not seen a HCP and has not had any testing or treatment.  As of 11/14/2019, she continues to have pain with arm movement but states it is a bit less.
Vaccine was given today at 4:30 pm. The parents were notified to observe for possible adverse reaction. No adverse reactions were reported from the parents.
her arm is warm, red, and swollen (patient stated it's about the size of a dollar bill) and that it's been happening since Monday.
The client reports that her arm swelled up at the site of injection to the size of a tennis ball. The site was red, painful, she was nauseous  and in general she did not feel well. She reports that she was taking regular doses of BENADRYL, but she reports no trouble breathing or rash occurring. The client did not seek medical care or call the pharmacy when the reaction occurred. The incident was discovered by the pharmacy when call the client to get her second dose of SHINGRIX.
I was shaking a lot; chills; a low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I was shaking a lot), CHILLS (chills) and PYREXIA (a low grade temperature) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced TREMOR (I was shaking a lot), CHILLS (chills) and PYREXIA (a low grade temperature). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (I was shaking a lot), CHILLS (chills) and PYREXIA (a low grade temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   This case was linked to MOD-2021-407226, MOD-2021-407239 (Patient Link).
T78.40XA ALLERGIC REACTION, INIT 4/8/2023 HYPERCALCEMIA OF MALIGNANCY
Onset of red warm swollen patch on left arm below DTAP and IPV immunization sites within 24 hours.  Rash progressed over left arm to cover entire arm with irregular patches of blue gray color and 1st generalized arm edema within 4 days.  No itch, fever, mucosal lesions.
I started losing my hairs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FP7136) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "I started losing my hairs".  Additional information: The patient received the first dose on 14Apr, within 2 days she started losing her hairs and when she got second dose of it, it was almost all completely fallen out and right about quarter to a 3rd of hairs that was it. The patient stated that it increased hair loss and she had lost about almost well over half the 3 quarters of her hair from this. She had not changed any products that she used prior to this. It started falling out about 2 days after receiving the first Covid shot.
Administered injection 09:05. At 09:15 mom noticed red rash from chin to all parts of the body and legs. No respiratory or itchy-resolves in 10 minutes. Dr gave BENADRYL before he can chew it up was gone.
pt recv vax & c/o chills, malaise-t100.4, Bp 108.70, P96;
Information has been received from a health professional concerning a 9 year old white male who on 08AUG2003 was vaccinated in the left arm with a first dose of varicella virus vaccine live. The pt's mom called the drs office to report that the pt subsequently developed 30 lesions on his body . Subsequently, the pt recovered. Additional info. has been requested.
On 7/16/21 patient  received second dose of Covid-19 at approximately 10:00 AM.  At around 5:00 PM patient starting feeling hot and cold which slowly progressed to where he felt like he had the normal flu around 8:00 PM.  About 15 minutes later he experienced slight tingling in hands, progressed to almost full body tingling sensation, most powerful in hands and feet.  It was at its most powerful around 10:00 PM and he considered going to the hospital but did not.  The tingling sensation subsided around midnight 12:00 AM.  When he woke up on 7/17/21 he felt better and has been feeling better ever since.  None of the symptoms have returned as of 7/18/21.  Patient will follow up with his doctor.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, route of administration, lot # and expiration date were not reported). On the same day, the patient passed out and had seizure like symptoms for a few minutes after receiving the GARDASIL 9. The patient received unspecified medical attention because she was in the office at the time of the events. The outcome of the events was reported as recovered (date unspecified). The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of passing out and seizure like symptoms were considered to be medically significant. Additional information has been requested.
At 5 am I noticed that my arm was very itchy. It was warm by 8am, and throughout the day it began to swell slightly and turn red. At 9pm arm is sore, swollen and red near the injection site.
The patient experienced no symptoms; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.       On 07-APR-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) injection administered by subcutaneous route as prophylaxis (dosage regimen, strength, and anatomical location were not reported; lot number and expiration date were unknown by the reporter) (product storage error). The patient experienced no symptoms. It was unknown if the sterile diluent (MERCK STERILE DILUENT) used for administration was stored properly.      The vaccine underwent a temperature excursion of -14.3 degrees Celcius for 12 minutes, with a previous unspecified temperature excursion as captured by a data logger.
Severe angioedema- lost control of bladder function , swelling in hands and feet, discolored. Gained 6lb of access weight while in the hospital. Skin burning, rash on chest.
This is a spontaneous report received from a non-contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot no: EM9809) via an unspecified route on her left arm on 19Mar2021, at 14:00 as a dose2, single for COVID-19 immunisation (at the age of 32-Years-old). The patient did not have any medical history. Patient did not have any allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EM9808) via an unspecified route of administration on her left arm on 26Feb2021, as a dose 1, single for COVID-19 immunisation (vaccinated at 32years old). On 19Mar2021, after approximately 6.5 hours following second vaccination the patient had sudden and acute back pain. The patient stated that the pain was located primarily on left side in the middle back, although there were some sharp pains on the right side (middle) and left lower back, sharp pains would come and go intermittently, multiple times in the first 24 hours and then about twice a day for the following three days, pain was lingered on day 4 though that was mostly a sore ache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of acute back pain was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.  DSU Amendment (02July2021): This follow-up report is being submitted to amend previously reported information included 1. Patient country added in patient tab 2. Relevant Med History "None" deleted since Historical Vaccine captured 3. "a contactable patient" updated as "a non-contactable patient" in narrative.
10 days after vaccine - developed erythematous papules all over trunk, face, fever.
Other complications following immunization, not elsewhere classified, initial encounter on 2022-04-21.
This case was reported by a nurse and described the occurrence of injection sit cellulitis in a 4 year female pt who received Infanrix. The nurse reported that "at least" 6 other pts experienced cellulitis at the injection site following the administration of Infanrix "from 2 lot numbers"; however, pt identifiers were not provided for these additional pts. In each case, injection site cellulitis and with injection site swelling occurred following administration of the 4th or 5th dose of Infanrix. On 8/16/04, the pt received the 4th dose of Infanrix in the right leg. This dose of Infanrix was either from lot DTPA622A2 or DTPA598B2. Approximately 3 days after the administration of Infanrix, on 8/19/04, the pt experienced swelling at the injection site. The pt was seen by a physician who made the dx of injection site cellulitis. The event was ongoing at the time of initial reporting. The nurse considered the events to probably be related to vaccination with Infanrix.
This spontaneous report was received from a female nurse of unknown age reporting on herself with antibiotics allergy and allergy to bee sting. The patient's medical history included herpes zoster. In July 2013 (reported as last Wednesday or Friday), the patient was vaccinated with ZOSTAVAX 19400PFU (lot # not reported) subcutaneous (dose not reported). No other co suspects were reported. Concomitant therapies included many but were not reported). In July 2013, the patient experienced itching and "lump" around the injection site. The patient reported that she experienced arthralgia in both wrists. The patient did not take any treatment for it. The patient did not seek medical attention. Labs diagnostics were not performed.  The outcome of "lump" around the injection site, the patient experienced arthralgia in both wrists and the patient experienced itching was reported as recovered/resolved. Additional information has been requested.
pt recvd vax & exp generalized itching, cough, nausea, wheezing; tx Epi, oral DPH, Pred;
On 5/15/2023, I woke up with nasal congestion, runny nose, bilateral kidney pain, and muscle aches. On 5/16/2023, I had a fever, headache, and a really bad sore throat. On 5/17/2023, I developed laryngitis and lost my senses of taste and smell. On that day, I tested positive for COVID-19. On 5/19/2023, I went to the doctor, because I had terrible throat pain, complete laryngitis, and extremely painful swallowing. I also had big sores running down to the back of the throat. My doctor tested me for strep, and the result was negative, but she did tell me that she has been seeing terrible sore throats and strep with the current variant of COVID-19. She said this was different from the strains she had treated in the past. On that day, I began taking Paxlovid. By 5/22/2023, my sore throat was getting better.  By 5/23/2023, my throat felt normal again. I still have nasal congestion, but all the other symptoms are gone. I also had terrible fatigue, but I feel like I'm 90% better now.
Patient was confused as to which dose was being given. We administered his bivalent booster but he needed his second dose of his primary series.
Headache, Myalgia, NauseaVomiting, lightheaded, fatigue Narrative:
Vaccine site had 2 painful and itchy bumps appear. The next day they started merging into one bump and have a 2-3 inch red raised bump around them. Getting more itchy and painful by the day, and getting more firm.
Felt awful; No energy; Light headed; Rashes on leg; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt awful), ASTHENIA (No energy), DIZZINESS (Light headed), RASH (Rashes on leg) and NAUSEA (Nauseous) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced FEELING ABNORMAL (Felt awful), ASTHENIA (No energy), DIZZINESS (Light headed) and RASH (Rashes on leg). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 28-Jun-2021, NAUSEA (Nauseous) had resolved. On 01-Jul-2021, FEELING ABNORMAL (Felt awful), ASTHENIA (No energy), DIZZINESS (Light headed) and RASH (Rashes on leg) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.
Information has been received from a consumer concerning a 7 year old male who was vaccinated with a dose of MMR II on unspecified date. Soon after receiving MMR II the patient became withdrawn and was diagnosed with autism. No additional information was provided. The patient did not recover. The patient sought unspecified medical attention. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Pharmacist on duty selected DTaP rather than Tdap so age was not appropriate.   Discovery occurred by another pharmacist after the fact.  Contacted patient's guardian.  No adverse reaction occurred.  Per CDC guidelines, this still counts as a 12 year old dose and repeat immunization is not necessary.
June 5, 2007 - Meningitis shot.  November 9, 2007 - Symptoms appear, including weakness in arms only. Weakness gradually increased until patient was unable to raise her arms to put clothes on or button pants. She couldn't carry books at school, couldn't open doors, brush her teeth, put her hair up. No pain. No stomach or repiratory illness in over 10 months preceeding symptoms. Weakness had not progressed any other muscle groups before treatment was administered. Patient is in recovery process (regaining strenth). 12/21/07-records received for DOS 11/13/07-seen in clinic for C/O right greater than left shoulder weakness when she tries to raise her arm up. PE: abduction of 4/5 slightly more weak on right and 4/5 on left. Motor and sensory grossly intact. Seen in ER 11/14/07-presented with C/O weakness in shoulders after 25 minutes of exercise. No mucle tenderness. Weakness improves with rest. Weakness involves proximal UE not distal UE.  1/14/08-records received for DOS 12/6-12/8/07- DC DX: Atypical Guillain Barre. Presented to ED with C/O upper extremity weakness while practicing basketball. Unable to life arms up. Weakness greater on right than left. Few days later had problems with everyday activities. PE: decreased tone in upper arms. 1/15/2010 Patient is still progressing toward full recovery. Some weakness still present. NE Estimate 85% of full strength is where she stands.