chrisvoncsefalvay/vaers-outcomes huggingface dataset:
60 year old male female was administered with Fluzone High-Dose/no AE; 60 year old male female was administered with Fluzone High-Dose/no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA274328 (same reporter).  This case involves a 60 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route.  It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age) and overdose (overdose).  It was unknown whether adverse event was noted or not.  Information on the batch number was requested.  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.  List of documents held by sender: none.
Muscle aches, chills, fatigue, headache, pain at injection site, redness and swelling at injection site
an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; an employee who received the first dose of the Covid 19 vaccine, has tested positive for Covid 19 today; This is a spontaneous report from a contactable other HCP and a nurse. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), 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. The patient employee who received the first dose of the COVID 19 vaccine, has tested positive for COVID 19 today, 07Jan2021. The outcome of the event was unknown. The reporter would like to know if the patient can get the second COVID-19 vaccine.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported event.
This spontaneous report as received  from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced an adverse event. No treatment information was reported. The outcome of the adverse event was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Tiredness, mild fever 98.9,headache, diarrhea, sore joints, sore muscles
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 47 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
8 days after MMR and varicella vaccine, he developed seizures and had status epilepticus.  Follow up on 01/09/04: "Please add fever and cold symptoms for one-day prior to onset of seizures.  In ER was treated with IV Ativan x3 and Rocephin.  Intubated." The hospital discharge summary and medical records received on 3/3/04 state ataxia and vomiting. 60-day follow up on 03/23/04: "It is unknown if pt recovered from adverse events.  The pt has transferred from my care." Follow up 01/25/05: Patient has been transfered to the care of another physician, request will be forwarded to the new doctor. Recovery status unknown.
DIZZINESS; VERY COLD; LACK OF APPETITE; WEAKNESS; VERY TIRED; SERIOUS HEADACHE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced very cold. On 16-MAR-2021, the subject experienced lack of appetite. On 16-MAR-2021, the subject experienced weakness. On 16-MAR-2021, the subject experienced very tired. On 16-MAR-2021, the subject experienced serious headache. On 16-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious headache, very tired, very cold, dizziness, weakness, pain at injection site, and lack of appetite. This report was non-serious.
I went out of town for an anniversary trip to a high altitude area. I had two glasses of wine the night before the next morning I had two cups of coffee. We went on a hike trail and I noticed that I was getting out of breath quickly so we decided to go back and around 11AM is when my smart watch notified me that I was in Afib. I went to the fire department for a consult and then they decided that I should go to the emergency room because I was in active Afib. Me and my wife decided to drive back home to my home town and I went to the emergency room there and I ended up spending 24 hours in the emergency room. I had a little bit of a sore arm and slight fatigue immediately after the vaccine but after 24 hours I bounced back. The medications that I am on now because of the Afib are apixaban 5mg, ELIQUIS 5mg, metoprolol 25mg. I had an angiogram scheduled in two weeks.
After the second dose of the vaccine, I experienced flu like symptoms including aches in my body and most specifically in my joints; After the second dose of the vaccine, I experienced flu like symptoms including aches in my body and most specifically in my joints; After the second dose of the vaccine, I experienced flu like symptoms including aches in my body and most specifically in my joints; I also experienced extreme swelling in my lymph nodes in the left armpit, the same arm as the injection; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 10:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 17:00, after the second dose of the vaccine, the patient experienced flu like symptoms including aches in her body and most specifically in her joints and also experienced extreme swelling in her lymph nodes in the left armpit, the same arm as the injection. This was still persisting three days after the vaccine while all other symptoms resided after two days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events after the second dose of the vaccine, she experienced flu like symptoms including aches in her body and most specifically in her joints was recovered on 15Apr2021. The clinical outcome of the event extreme swelling in her lymph nodes in the left armpit, the same arm as the injection was recovering at this time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
6/25 This 27y.o. G1P0000 at 39w0d by 6 5/7 wk US presents to Triage with c/o SROM 0530 AM & ctxs. No VB.. Fetal movement normal. Desires KNBC. Induced labor, birthed baby boy
On 4/24/00, the pt experienced cellulitis and an abscess at the injection site. She was seen by a physician. The pt was hospitalized for eleven days. The cellulitis and abscess at the injection site were considered significant medical event. The reporter indicated she did not know exactly why the pt was injected with the vax, since she had a history of at least five previous episodes of arm abscesses.
Patient received FLUAD in right arm and PNEUMOVAX in left arm. A day later she developed a fever that was brought down with ibuprofen, however her left arm is swollen and sore still.
This case was reported by a other health professional via sales rep and described the occurrence of rash in a 16-year-old male patient who received BEXSERO. Co-suspect products included Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Human Papilloma virus 9 valent. In October 2017, the patient received BEXSERO, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Human Papilloma Virus 9 Valent. In October 2017, less than a month after receiving BEXSERO, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and Human Papilloma Virus 9 Valent, the patient experienced rash. In October 2017, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to BEXSERO and Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 15 or 16 years old. The healthcare professional reported that the event was regarding BEXSERO in combination with human papillomavirus vaccine (HPV-9) and meningococcal vaccine (MCV-4). The patient experienced a rash on his arm. It was unknown if the reporter considered the rash to be related to HPV 9 vaccine. The healthcare professional did report this to GSK in October 2017 as well.
Pt had a syncope episode lasted app 10 sec. Pt was placed on the exam table, provided with orange juice and glucose tabs. Pt mother was in the room with pt. VS sign were taken and document in EMR . Pt was able to walk out without  any help, was AAo x 3 upon leaving office.
Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days.  Patient cannot remember if this occurred after the 1st, 2nd, or both doses.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (172250). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) 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, Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days. Patient cannot remember if this occurred after the 1st, 2nd, or both doses.), administration date: 14Apr2021, for covid 19 immunization, reaction(s): "Patient experienced a sore arm at injection". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week, approx. 3-5 days. The patient cannot remember if this occurred after the 1st, 2nd, or both doses." Additional information: [COVID-19 Pfizer Vaccine/approx. May2021 (approx. 4-5 weeks after 1st dose)] Patient experienced a sore arm at injection site post-vaccination; soreness lasted less than a week/approx. 3-5 days. Patient cannot remember if this occurred after 1st, 2nd, or both doses. Reporter consider that event was caused by suspect product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101748709 same patient, different dose.
Follow up received from the physician provided information regarding serotyping. Information regarding Prevnar was received from a physician regarding a 26 month old male patient who developed pneumococcal bacteremia. At 24 months of age, the patient received the fourth dose on 7/16/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 7/16/04. Dose regimen was 1 dose. Concomitant medications were not reported. On 8/24/04, a 26 month old male patient developed pneumococcal bacteremia and was hospitalized. He was discharged from the hospital on 8/26/04. The reporter indicated that the patient has recovered. The reporter indicated that he has been unable to obtain serotype information for this patient. The reporter stated that the hospital worked with the local health department to forward isolates to the CDC. However, whenever the reporter calls the local health department, they have no information to provide him. The reporter indicated that this patient has returned to his office several times for infectious illnesses. The patient was worked up for immune deficiencies, however, nothing was found. No additional information was available at the time of this report.
Severe fatigue headache, body aches, coughing, nausua , light headedness, extreme tiredness depression
Itching at the injection site with a rash that started to form around injection site. Patient started Clobetasol propionate 0.05% cream on 2/2/2021 as prescribed by dermatologist after the same reaction occurred after the first dose on 1/5/2021. Patient will continue the cream for a few more days and if the event does not resolve will go back to dermatologist. The cream worked within 4 days after first injection. First injection was on left arm and reported to VAERS.
Erythematous raised rash on entire skin surface.  On the right lateral upper thigh, there are two larger patches of erythema about the size of a clementine.
Symptom onset of 5/1/2021 with loss of taste, loss of smell & runny nose. Tested positive via PCR on 5/3/2021.
Incident 1:  Evening of March 15, noticed itching at top of anus.  This progressed to intense itching of the scrotum and testes as well as swelling.  Antihistamine (Fexofenadine) oral was taken and symptoms resolved over a couple of hours.  Morning of March 16 noticed swelling near penile head which was not painful which resolved over the course of the day.  Incident 2:  4/14/2021 evening, noticed itching of left buttock - clear soft swelling which could be seen as a raised area; antihistamine treatment led to resolution.  Incident 3:  4/20/21 morning.  Eating breakfast and noticed left side of mouth especially tongue was numb/swollen, progressed to where had difficuty pronouncing words and was quite scary; took antihistamine and resolved over a couple of hours.  Seemed as though it was borderline anaphylaxis but did not progress to throat tightening or difficulty breathing.
Patient was given a single DTaP instead of KINRIX, our clinic is out of stock on IPV so patient was sent down the street for IPV vaccine.
Pt came into observation area at 11:04 am, after 15mins, Pt left observation area on route home.  Pt came back at 11:22am with rash to b/l upper extremities and upper back.  Vitals obtained and 25mg PO Benadryl administered.  Pt has no compliant of shortness of breath and chest pain.  Pt vitals obtained 3 more times.  Pt rash spread to right breast and lower back.  Benadryl 25mg PO administered again, vitals reobtained.  Pt has no further complaints at this time of shortness of breath or chest pain.  Pt reports that she took Buspar prior to arriving to facility for Covid vaccine and cipro antibiotic for urinary tract infection.  Pt vitals reobtained at 12pm and no further interventions needed at the time.   Pt reports NO shortness of breath or chest pain.  Pt assessed an noted with no respiratory distress.  Pt left facility at 12:05pm in route home with family at side.  Last set of vitals noted to be BP 135/70 , HR 100, RR 17, temp 97.9, o2 sat 100% on room air.
Sat required 15 minutes on site. Left facility and shopping on way home with my husband, when checking out felt light headed, dizzy - if I would pass out. Once home ate something as had only small breakfast - symptoms passed.  Gavie it no more thought until talking with a co-worker. She experienced same thing along with another co-worker
I received my second injection of the Pfizer vaccine for COVID-19 on 4/7/2021. I was diagnosed with ductal carcinoma in situ in the left breast on 11/19/2021. I am convinced that there is a connection between the vaccine and the cancer. On 1/26/2022, I had a lumpectomy, through which all of the cancer was successfully excised, and radiation therapy. I am currently on tamoxifen.
After administering the Vaxneuvance vaccine, I went to engage the safety on the needle and the syringe broke and the needle came off. I was able to completely engage the safety, so nobody was injured.
Patient was admitted to facility on 10/09/2021 with positive COVID-19 test. Patient stated she had been fully vaccinated. Patient is a resident and I was unable to look up vaccination information. Patient expired 12/09/2021. Document will not allow me to enter patient death date in section 21
At approx. 1530 pt. reported feeling tired, soreness at injection site radiating up to and to the back of the left shoulder.  Also c/o tingling in throat, face feels stretched, along with pain in neck  with itchiness.  Given water to drink,  BP 152/99, P 101, R 24, SpO2 100%.  At 1545 Pt. reports all symptoms have gone.  BP 134/87, P 87, SpO2 98%.
Exposure probably on 5/21, then fatigue, sore throat, runny nose set in on 5/23, but no fever Breakthrough infection with COVID-19 established  by + home antigen test on 5/25
Beginning in mid-December, I began to experienced increased heart rate and occasional breathlessness. I have a little soreness in my chest. I saw a doctor today and had a few tests and was referred to a cardiologists for additional testing.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history, concomitant therapy and concurrent conditions were not reported. In August 2016 (also reported as 26-AUG-2016 to 30-AUG-2016), the patients were vaccinated with VAQTA (Lot number, expiration date, concentration, dose, frequency and route of administration were not provided), which was improperly stored, this excursion was detected due to a digital data logger, it was also reported that VAQTA was exposed to a temperature of 35 Fahrenheit degrees for 32 hours. No adverse effects were reported. Additional information has been requested.
Persistent tachycardia, heart racing, pounding heartbeat and palpitations Brain fog Memory issues Lightheadedness Shortness of breath Sweating
Patient presents to the ED for evaluation of SOB and subsequently tested positive for COVID-19 on  6/20/22 via PCR.  This meets criteria for vaccine breakthrough case review.
12 days after SC VZV vaccine injection into (R) triceps patient developed low grade fever which then resolved, then redness, swelling, tenderness (5 cm) over injection site.
Information has been received from a registered nurse concerning a 74 year old male who on 21-Mar-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 26-Mar-2007 the patient presented with shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information received from the registered nurse indicated that the patient recovered on an unspecified date. Additional information is not expected.
PRIOR TO THE VACCINE, PATIENT WAS NERVOUS AND SCARED OF THE NEEDLE. I ASKED THE PATIENT WHICH ARM THEY WANTED THE VACCINE IN, AND PROCEDED TO ADMINISTER THE VACCINE, AFTER CLEANING THE INJECTION SITE (RIGHT DELTOID). THE PATIENT MADE JERK MOVEMENT (DID NOT STAY STILL) UPON THE INJECTION OF THE VACCINE, LET OUT A VERY LOUD SCREAM, CLAIMED TO SEE STARS AND CLAIMED TO HAVE EXPERIENCED "THE MOST PAINFUL VACCINE MOMENT OF HER LIFE." SHE NOTICED A TINGLING SENSATION IN HER ARM IMMEDIATELY.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of VAQTA lot # M039202, expiration date: 11-MAR-2018 (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA003299: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA002262.