chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up with an alarm in my head; Strong metallic taste in my mouth; Off balance; Heart started pounding really hard at normal rate; Chest hurts; This spontaneous case was reported by a patient and describes the occurrence of EXPLODING HEAD SYNDROME (Woke up with an alarm in my head), DYSGEUSIA (Strong metallic taste in my mouth), BALANCE DISORDER (Off balance), HEART RATE ABNORMAL (Heart started pounding really hard at normal rate) and CHEST PAIN (Chest hurts) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced EXPLODING HEAD SYNDROME (Woke up with an alarm in my head), DYSGEUSIA (Strong metallic taste in my mouth), BALANCE DISORDER (Off balance), HEART RATE ABNORMAL (Heart started pounding really hard at normal rate) and CHEST PAIN (Chest hurts). On 02-Feb-2021, EXPLODING HEAD SYNDROME (Woke up with an alarm in my head), DYSGEUSIA (Strong metallic taste in my mouth), BALANCE DISORDER (Off balance), HEART RATE ABNORMAL (Heart started pounding really hard at normal rate) and CHEST PAIN (Chest hurts) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. No treatment information was provided   Reporter did not allow further contact
I have got contracted COVID; I have got contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "I have got contracted COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: No just an antigen test, they had PCR test this morning but we don't have those results. The antigen test were positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: Vaccination Facility details, consumer stated, withheld got at Pfizer. Withheld got it at town Withheld. Patient treatment received was reported as Tylenol.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200158065 same AE/drug, different patient
Patient fainted about 5 minutes after administration of vaccine while shopping in the warehouse with her grandmother.  Patient came around quickly, paramedics were called and arrived, but patient left on her own accord.  She was not transported by the paramedic.
patient developed tingly lips palms and itchy throat. Given PO diphenhydramine and felt better
6 inch swelling, pain, reddness at site of injection (left deltoid area). Also whole left arm swollen. Pt to ice area use analgesic, call MD if fever.
Tiredness; very painful arm, sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Apr2021 14:30 (Lot number: EW0164) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: she just takes anxiety and depression medications but she would rather leave them out of this report; "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (She says her reaction was that she got the full-on flu for about 2 weeks), for immunization, reaction(s): "flu". The following information was reported: FATIGUE (non-serious) with onset 18Apr2021, outcome "recovered" (20Apr2021), described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 18Apr2021, outcome "recovered" (20Apr2021), described as "very painful arm, sore arm".  Additional information: For the first dose of the vaccine she reports that it was just a very painful arm and tiredness: no other symptoms. She says the sore arm lasted about 3 days from 18Apr2021 to 20Apr2021 and that she recovered completely from it. For the tiredness she says it occurred from 18Apr2021 immediately after the shot, subsided on 20Apr2021, and that she recovered completely from it. She says she remembered being very tired on 19Apr2021. She said for medications she just takes anxiety and depression medications, but she would rather leave them out of this report. No further medication information provided. No prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. The caller denies being sick at the time of vaccinations.  No follow-up attempts are possible. No further information is expected.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Diagnosed with Covid 19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Diagnosed with Covid 19) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Diagnosed with Covid 19). At the time of the report, COVID-19 (Diagnosed with Covid 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: No specific follow-up information recorded.
Patient is a 43 year old army reservist. He states that he received "lots of shots" in December 2002 and January 2003 in preparation for deployment. He recalls awakening one morning in January (1-2 days after the shots) with severe pains in both knees " I couldn't move, the aching was real bad" (6/10 on pain scale). After about 5-10 minutes he was able to seek medical assistance. He had x-rays taken and he was told he had "degenerative arthritis". The pains persisted and on February 26th he received "cortisone shots in both knees that didn't help" and Celebrex that gave some relief. He is especially concerned when going up or down steps and reports falling on one occasion and injuring his right shoulder "when my knees gave out on me. " He also reports an increase in the severity (5-6/10) and frequency (3-4/week) on his "migraine headaches since getting the shots". He describes a "throbbing, constant pain in the right temple" with intermittent "sharp knife-like pains that moves across to my right eye and forehead" associated with "watering of my eyes" photosensitivity and periodically seeing "wiggly lines". He denies aura, nausea, vomiting or paresthesia. He took Excedrin migraine and Midrin for a while and is currently using Imitrex. Additionally he complains of fatigue "feeling tired all the time"; "muscle cramps in my lower back, thighs and right wrist"; problems sleeping-both falling asleep and "wakes during the night" for which he takes Benadryl that "helps" and "memory problems".
While eating lunch, tongue started burning and tingling with odd taste in mouth.  The bitter taste, almost like soap, and the tingling sensation lasted until bedtime that evening.  All ingedients in lunch have been tolerated before, had eaten from this same batch of vegetables and meat the day before with no issues.  Per advisement of physician in my work office, i took 50mg Benadryl when i got home.  Ate from the same batch of food 2 days later and no odd taste or tingling sensation.
This case was reported by a nurse via other manufacturer and described the occurrence of therapy non-responder in a patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B. Additional details were provided as follows: The nurse reported that an unspecified patient was non-responder after receiving an unspecified number of ENGERIX B on unspecified dates. No further information was provided.
A serious, study report of right lower lobe pneumonia was received from an investigator, concerning a four-year-old female subject number 1-08-02946 enrolled in a study. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject had a history of fever and cough for approximately five days prior to hospitalization but was otherwise a healthy patient. She was not taking any concomitant medications. The subject received FLUMIST on 10-Oct-2008. The subject was admitted to the hospital on 18-Nov-2008. On admission, her chest X-ray was consistent with right lower lobe pneumonia. WBC was 13,300 with 63% neutrophils. A blood culture was sterile. She had an uncomplicated hospital course and was discharged on cefdinir twice a day to complete a ten-day course. The subject was seen again on 22-Nov-2008 in the emergency room (ER) for subjective fever and back pain. Physical examination was unremarkable and the subject was not in respiratory distress. Repeat chest x-ray was without significant change. Her rapid flu test was negative. She was sent home on ibuprofen for pain. The subject's final diagnosis was right lower lobe pneumonia. The subject was discharged from the hospital on 19-Nov-2009, but the outcome of the event was not reported. The investigator assessed the event as not related to FLUMIST.
Moderna COVID -19 Vaccine EUA 2-3 days after vaccine injection site on left arm felt pain and hardness. 11 days passed hardness is gone but having mild red and itch around the injection area. The second dose had been scheduled on 3/27 which is 20 days away from now. Should I take the second dose?
Fever of 102.5 that came down with ibuprofen. Pain. Malaise. Area of 7 cm x 5.5 cm of erythema, induration and tenderness at injection site extending below site. Initiated cephalexin today.
Information has been received from a nurse practitioner, concerning a 13 year old female patient, who on 20-APR-2011 was vaccinated intramuscularly, with her first dose of GARDASIL (lot # and dose not reported). Nurse practitioner stated that patient had seizures four days later, on 24-APR-2011, and was admitted to the hospital. An electroencephalogram (EEG) was performed and confirmed the seizure. On an unknown date patient recovered from the event. Additional information has been requested.
Had herpes; This is a spontaneous report from Pfizer. A contactable consumer reported for a male patient of an unspecified age who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had herpes. The outcome of event was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL  9 (lot # reported as L0245711, expiration date 08-MAY-2017, exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient called a few hours after receiving pfizer covid vaccine from their house reporting that they were developing itchy hives on their skin on body. informed patient to take 50mg of benadryl at once and repeat dose again in 4-6 hours and if hives do not subside by then to go to a walk-in or emergency care clinic for treatment.
Metallic taste in mouth, shoulder/neck stiffness, headache and went flush. Returned to normal within two hours
About a month ago in early June, I was getting up and my right ankle was weak and I almost fell.  I had difficulties walking for a few days.  This was followed by intermittent bouts of sharp pain in said area, accompanied by weakness.    It started in the feet and has now crept up to the area between my elbow and wrist (and occasionally joints in my finger).  It feels like sharp arthritic pain (of which I do not suffer from) and it shifts from bottom of leg to elbow to wrist all in the right hand side of my body.   I also felt tingles all over my body for an extended period of time months after having received the vaccination.  This symptom has gradually subsided but now it feels that the tingles are localized and occur intermittently.  But for now it's sharp localized pain in ankle/knee and arm (pain ranges from wrist to elbow) in the right side of my body.  I am going to call tomorrow to set up an appointment with my general practitioner.
On 2/13/06 received DTaP vac. ON 2/14/06 at site of the injection has developed a large red welt aporx. 4"x5". Developed a fever and vomiting. Also my son has same symptoms both got vac. same day. 2/17 redness is down however son has developed a fever. Doctor has prescribe antibiotics and anti-inflammatory med.
6/7/03 Severe vomiting 2 days after DTaP. Staring and somnolence; no fever. Flushing after vomiting. Taken to ER--suppository.
Student received flu vaccine without a parent-signed consent.   I called the student's mother and notified her that her daughter had received a flu vaccine during our flu outreach, and that we did not have a signed consent for her.  Mom confirmed that she did not complete or return a consent.  I let her know that due to this incident we would be taking measures to avoid such situations in the future, as well as providing additional training to our school health staff.  I offered her our sincerest apologies.  Parent expressed understanding and stated that she did not receive a consent, but had she gotten one she would have signed her daughter up.
Received Varivax #2 on 5-7-2008.  On 5-9-2008 mom called the afterhours triage nurse, was told to take patient to ER.  Mom took him to ER since his Right arm was red, raised, swollen, hot to touch. At the ER mom states she was told it was an allegic reaction to the varivax immunization.  Pt given benedryl 25mg and told to repeat every 6 hours as needed.  Also told to apply cold or hot compresses. Told to return to ER is arm gets a red streak. Per mom, on %-12-2008 when she call the office, she stated the redness is gone.  what is left is the hard area where the injection was given.  the hard area is "less hard" than it was.  It is now only quarter size. Presently mom has stopped benedryl, had been giving at night only.  suggest continue few more nights, and call prn.Agreed to make a vaers report.
DENIES ANY ADVERSE ADVENT.  NO PROBLEMS AFTER VACCINES WERE GIVEN.
Developed symptoms of pain and numbness within 2 hours after receiving vaccine, and still complains of these symptoms as well as limited mobility.
Normal motor and language development up until January 2023 New left side hemiplegia in January 2023 (upper and lower extremity on the left only) Brain MRI in February 2023 revealing diffuse white matter changes/abnormalities and inflammation Received 5 days IV steroids, 2 days IVIG (8 day inpatient stay) in February 2023 Repeat MRI revealing same white matter abnormality distribution but a little less contrast enhancement Minimal to no clinical improvement  Received 3 days IV steroids in July 2023 for ongoing hemiparesis  Will have repeat brain MRI on 9/22/2023 No firm diagnosis given. working dx is clinically isolated syndrome however given ongoing clinical and brain abnormalities this dx doesn't quite fit either
recevied expired a dtap vaccine/ no AE;Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and physician via call center via Medical Information (Reference number- 00708519).  This case involves a 4-year-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  The patient's past medical history, medical treatments, vaccinations, concomitant vaccination and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), PROQUAD; HEPATITIS A VACCINE; and PNEUMOCOCCAL 13 VALENT VACCINE for prophylactic vaccination.  On 03-Aug-2021, the patient received a third dose of 0.5mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (diluent lot number: U6842BA, powder lot number: UJ335AA and expiry date: 05-Jul-2021) via intramuscular route in the right arm for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  It was reported that, "I gave a dtap vaccine but it expired last month. Does the person have to come and redo it?."  At the time of reporting, 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.
Slight numbness in tongue that lasted several hours beginning within 10 minutes of vaccine along with dizziness; experienced fatigue, nausea, tinnitus, blurry vision in right eye, elevated heart rate, buzzing sensation in back of head, stabbing pains in stomach followed by profuse watery diarrhea.  Dizziness and nausea still unabated seven days following vaccination.
Itchy bumps behind the knee and in the chest / Could have been a rash; This case was reported by a physician via call center representative and described the occurrence of itchy rash in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 45N34, expiry date 21st January 2022) and (batch number 4RR52, expiry date 7th December 2021) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced itchy bumps behind the knee and in the chest.  The bumps were resolved in 2 days.  The reporter provided the batch numbers and expiration dates of the adjuvant and lyophilized component.  The reporter mentioned about bumps it could have been a rash. The reporter consented to follow up.
Unable to move my arm, unable to take shirt off by myself. Severe pain took ibuprofen but didn't help much.
Patient received first dose of Pfizer at her doctor's office, but unfortunately it was missed and we administered Moderna for the scond dose.
Hard, red and swollen area at site, 1.5 in and 1 in treated 3 days after im w/KEFLEX for cellulitis.
15 minutes after MMR and VZV administered, orange size red splotches appeared at injection site. child had not ever eaten egg yolks. no other allergies noted.child was alert and playful, abdomen became whelped and splotches around neck appeared.
Erythema and induration started 24 hours, post vax, increasing to 3" X 3" by 72 hours. Plus itching which was relieved with ice and Benadryl.
This spontaneous report was received from a registered nurse refers to a patient of unknown age. On 09-MAY-2014, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml, intramuscular, Exp date 09-MAR-2014. On 09-MAY-2014, the patient was administered expired PNEUMOVAX 23. No adverse effects reported. Additional information has been requested.
The patient experienced recurrent syncopal events at home within 24 hours of receiving his 3rd dose of the Pfizer-BioNTech mRNA COVID-19 vaccine and was found to have complete heart block requiring CPR and temporary pacing. He was transported to our hospital, where a temporary pacemaker was placed. A coronary angiogram showed normal coronary arteries. Further evaluation here, including echocardiography, cardiac MRI, cardiac PET/CT, and endomyocardial biopsy was consistent with lymphocytic myocarditis. Multiple laboratory assays for possible viral etiologies of myocarditis were negative.