chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got both shots / shingles again/ suspected vaccination failure; shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles over all left side of head and face).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got both Shingles shots and got shingles again. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for shingles were not provided.
Pneumococcal vaccine RD-SQ 10/15/2001. Complained of Redness at site. High fever 103 degrees. Tx Tylenol, cool compress. Referred to family practice.
91y.o. male referred for abnormal troponin and ECG.   He is known to our practice through management of permanent atrial fibrillation with multiple strokes during previous hospital admissions.  As noted previously, the patient is not on anticoagulation at the recommendation of his oncologist in the setting of mild dysplastic syndrome requiring serial blood transfusions, gait instability with falls, recent piriformis hematoma, and epistaxis.  He has currently been in the hospital since 7/19, currently in the inpatient rehab unit, and has only been out of the hospital for around 48 hours total ever since 6/26.  For the past few days the patient has been experiencing fluctuating mental status with significant lethargy and variable blood pressure values requiring multiple RRT calls.  Symptoms have been attributed to anemia, and the patient is now back to mental status after receiving blood transfusion.  During one of the RRT evaluations, ECG was noted to be mildly abnormal.  Follow-up troponin was minimally elevated 0.05, which then trended down.  Because the troponin elevation ECG changes, cardiology consult was requested.  The patient, confirmed by his wife, was not having any chest discomfort, dyspnea, or palpitations.
"44 yo woman with COVID infection in December, DM2, HTN, FSGS, obesity, sleep apnea, amenorrhea, and h/o allergy to shellfish and iodine with anaphylaxis.  After her first dose of the vaccine she immediately noticed flushing of her face and later that day noticed that she had a rash on her face.  She did not report this reaction prior to the second dose of vaccine, but she did tell her vaccinator afterwards and so she was escorted to the treatment area for observation immediately after.  Within a few minutes she was complaining of trouble breathing due to a sense of constriction and congestion in her throat, no wheezing, no itching.  She began to notice that her voice sounded different in that it was more raspy.  She visibly appeared to be working hard at breathing, although it was difficult to discern to what degree this symptom was due to her obesity.  Her O2 sat was 98-100% throughout and her BP and pulse were stable, if slightly hypertensive.  Her lung exam was CTAB. Due to the progression of her symptoms to voice changes, she was immediately administered an EPI-pen.  Within a moment or two, she noted relief in her throat constriction and her voice returned to normal.  She was observed to have decreased work of breathing and appeared much more comfortable.  She was then given 50 mg of benadryl orally.   She noted a racing heartbeat with the EPI-pen but no chest pain.   She agreed to be monitored for a return of symptoms for an extended period of time and she was informed that she would need someone to drive her home today and stay with her.   At 1515 pm she continued to be free of symptoms and at that time her vital signs were 138/83, 90, 100% on RA.  Her family came to pick her up and she was instructed to call 911 if symptoms return."
sudden onset of confusion, mild but noticeable; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 24Apr2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 03Apr2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Apr2021 at 22:00, the patient experienced sudden onset of confusion, mild but noticeable and sudden enough that the patient believe it could be from the vaccine. She was sitting at home reading and looked up and was confused to find herself in her own home and then it happened about 5 more times within the hour. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event sudden onset of confusion, mild but noticeable was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment(24-APR-2021): This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added.  No follow-up attempts are needed. No further information is expected.
Patient reported feeling dizzy and short of breath within 30 minutes of vaccination.  Patient transported to ER by EMS.
Seizures started in a week of shot and quit talking. Rx'd Phenobarbital, clonazepam, Vigabatrin and Keppra and now delayed in all areas. Treatment-S/P PT and OT therapy and Ketogenic Diet. DX: Epilepsy; Neurological disorders. An annual report received 8/18/2003 adds: Pt has seizures (10-20) daily, nonverbal and delayed in all areas. Thanks for wanting an update on him. We would like to see more research on children's vaccination and a parents list that are going through the daily struggles like us.
pt states redness @ site where MMR was given; area approx 5 1/2 x 6cm slightly raised red area on arm; pt first noticed day p/vax
No adverse event. This was a medication error: patient inadvertently received Moderna off-label prior to her 18th birthday
Fever of  102 for 12 hours , maxing out at 103.4 F  Pain  and swelling in arm pit
Severe symptoms ? red skin/hives from neck to elbows, swollen tongue and throat, dizzy and rapid hearbeat  I got the vaccine at 4:09PM on 1/14 at School.  At about 4:15PM I began to feel very shaky, heart was racing/rapid heart beat and very dizzy.  From here the details are somewhat blurry till after the ambulance arrived and I received the EPI ? PEN. I walked over to a volunteer, I held her arm, I felt like I was too dizzy to stand so I asked to sit down.  She walked me back to my car where I sat down and a wheelchair came. Some one arrived and took my blood pressure. My throat and tongue became swollen and it was very difficult to swallow.  The volunteer kept asking me questions and then the ambulance arrived.  Once in the ambulance, they gave me an EPI-PEN, steroids, Benadryl and IV.  They took me to the ER where I was monitored for several hours.
Intermittent vertigo, wavy sensation in her head, eyes felt wobbly, nausea.
Coughing up brown stuff. Runny nose, ear ache. Loss of appetite. Confusion/hallucinations. Fever. Tx; rest and fluids.
Awoke AM of 21AUG92 w/blisters @ inject site, chills & flu-like sx; duration 3 days; 24SEp92 dose #2 onset of fever of 103 on PM of 24SEP92; flu-like sx; nausea & vomiting, dizziness; duration 48 hrs;
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th April 2019, 7 days after receiving Shingrix, the patient experienced shingles. On 7th June 2019, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated his brother in law received the Shingrix and developed shingles 1 week later. The reporter did not provide any further details on this event.  The reporter asked if it was a live vaccine.  The reporter asked if any new studies have been done on the outcome of having only the first vaccination. The date of birth or medical doctor information was not given.
Arm red swollen and whelped at injection site along with body aches,fever &chills. Lasted a couple of days, then symptoms reappeared two weeks later and lasted 3-4 more days. The redness on arm was approximately 1/3 of upper arm. Very tender and itchy
One day after the vaccine, I had a horrible sore throat, body aches, joint pain, lymph node swelling under left axilla and left side of throat. Also runny nose, Fatigue and headaches. This only lasted 1 day. I felt better on day 3, after the vaccine.
Engerix-B was administered, had expired on 09May2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number unknown, expiry date 9th May 2022) for prophylaxis.   On 24th May 2022, the patient received Engerix B. On 24th May 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    Additional Information: GSK Receipt Date: 24-May-2022 Reporter's Comments: HCP reported a dose of Engerix-B was administered on 24th May 2022 that had expired on 9th May 2022. Chat was abandoned after attempting to collect demographics.  Additional Supportive Information: The patient received dose of Engerix B vaccine on 24th May 2022, which was already expired on 9th May 2022.
1-14-11: Experienced a febrile seizure, stopped breathing x sev. secs. Called 911 & tx by ambulance to Clinic.
enlarged lymph node on the left side of neck; The initial case was missing the following minimum criteria: no specific adverse event. Upon receipt of follow-up information on 27Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 2, single (Lot number: EK9231) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "never smoked" (ongoing); "have not drunk alcohol", start date: 1975 (ongoing), notes: have not drunk alcohol since 1975; "never used illegal recreational drugs" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EL1284, Anatomical Location of Administration: right arm), administration date: 23Dec2020, when the patient was 66-year-old, for Covid-19 immunization, reaction(s): "enlarged lymph node on the left side of neck". The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jan2021, outcome "not recovered", described as "enlarged lymph node on the left side of neck".  Additional information: It started with an enlargement lymph node on the left side of neck. It would reduce in size but never go away completely, enlarging each time she got another vaccine for covid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300101142 Same patient and similar event, different vaccine doses;
PATIENT'S REPRESENTATIVE REPORTED HIVES, HOT FLASHES, AND SWEATING PALMS/FEET APPROXIMATELY 3 TO 5 HOURS AFTER VACCINATION. THERE WAS NO INJECTION SITE REACTION AND NO FEVER. PATIENT ONLY REPORTED A TYLENOL ALLERGY. THEY DID NOT TAKE ANY MEDICATIONS TO TREAT SYMPTOMS. PHARMACIST FOLLOWED UP WITH PATIENT SEVERAL HOURS LATER AND HE REPORTED HE WAS FEELING MUCH BETTER AND WASN'T CONCERNED. I ADVISED HIM TO FOLLOW-UP WITH ME IF ANY ADDITIONAL TREATMENT WAS NECESSARY.
menstrual cycle delayed, and took 6 months to return to normal. abnormal heart palpitations for weeks after getting the shot.  Muscle ache in legs/fatigued for weeks after getting the shot.
Patient was to receive the Pfizer updated bivalent booster but the vaccine was given without the diluent. Patient received a concentrated dose of the booster; 0.2ml was administered. Parent, who also works in the pharmacy, called later that evening to report she remembered not diluting the vial before she told the technician to draw up 0.2ml for the dose. I advised her to monitor for any allergic reactions and educated her on possible adverse reactions that could occur. No adverse reactions were reported as of two days post vaccination.
Pain in arm where I go the vaccination. Shivering and very cold all night. Muscle tense and sore throughout the night, aching this morning across upper body. Feel out of sorts.
PT received 2nd dose Pfizer at 1617, c/o gradual onset headache7/10 and dizziness at 1635. PT was transferred to WC, then to cot. Reported feeling better lying down. No LOC noted. VS at 1637: BP 102/70 laying, HR 76, SPO2 99% on RA. No s/s respiratory distress. 1640: 120/54 BP laying, HR 72, SPo2 99% RA. PT was provided cold compress at 1644, accepted and drank juice. PT denies nausea and reports she ate lunch and had fluids last at 1300. VS at 1643: BP 108/62, HR 74, SPO2 99% RA.  1647: BP sitting is 124/78, HR 83, SPO2 99% RA, RR 18.  Reports HA is 5/10 at 1649. PT reports she had no problems, SE after first dose. At 1651, PT stood without difficulty, verbalized that he head felt 'good' and pain was 2/10. Denies dizziness, reports that she feels 'back to normal. VS at 1651: BP 164/84 standing, HR 92, SPO2 99% RA. 1655: BP 140/86 sitting, HR 72, SPO2 99%. Standing BP at 1655 is 128/64. PT reports that she is back to baseline, denies further headache, dizziness, walks a short distance at 1700 with no difficulty. PT educated on vasovagal reaction, verbalized understanding. Exited facility with  mother at 1702.
Bivalent Covid vaccine administered to patient 8 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Headache with fogginess that turns into nausea.  Flushed feeling in face.  L breast is more full and sore.  Headaches come and go and feel like a vice on the top and side of my head that then lets go.  Intensifies in afternoon typically or first thing in morning.
Headache; soreness to the injection site; This is a spontaneous report from a contactable nurse. A 55-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular on 21Dec2020 07:30 at single dose on her left arm for covid-19 immunization. Medical history included hypertension. No allergies to medications, food, or other products. Concomitant medication was received within 2 weeks of vaccination included lisinopril. The patient experienced headache and soreness to the injection site on 21Dec2020 10:00. Treatment included Tylenol 500mg. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Dec2020.  No follow-up attempts are possible. No further information is expected.
Post flu shot - expressed chest pain. Physician called & instructed to call 911 & transport to hospital. Hospital unknown.
This report from study was reported via Pregnancy Registry (initial receipt 19-Aug-2015), concerns a neonatal patient. The patient's mother had a medical history of anemia, neurological conditions (migraines from 1991 until 2000 which had resolved), headaches, nausea, constipation, heartburn, low iron, and infertility and was pregnant via IVF (In Vitro Fertilisation). The mother's concomitant medications included prenatal vitamins, estradiol, progesterone injection in oil, progesterone vaginal insert, ondansetron for nausea, paracetamol for headaches, docusate for constipation, iron for low iron, diphenhydramine for sleep and ranitidine for heartburn. The patient's mother drank tea and drank wine between 08-Feb-2013 and 27-Feb-2013 and then again between 06-Jun-2013 until 09-Nov-2013. The mother had an ultrasound on the 06-Aug-2013 saw mild ventriculomegaly. On the 14-Aug-2013, the patient's mother had an ultrasound which saw stable mild ventriculomegaly and was also seen on the 22-Aug-2013 during an MRI (Magnetic Resonance Imaging). On the 02-Oct-2013, the patient received the AFLURIA vaccine (batch number 'R55601') via the mother (intra-uterine) 1 shot 1 day. The patient was born at 39.1 weeks with a birth weight of 3990.0 grams, and Apgars of 0 at one and five minutes. On an unspecified date, the baby was diagnosed with neonatal left MCA (middle cerebral artery) stroke per the pediatric neurology medical record. The baby was seen for follow-up on the 10-Dec-2013. As of the 14-Jan-2014, the baby was off seizure medications. Testing had showed that she was 25% behind in gross motor skills. She was recommended physical therapy when child is older. Neurology will continue to follow up. Outcome was unknown. Reporter comments: The reporter stated that the events were a congenital anomaly.
Sitting on couch, attempting to reposition myself, starting having horrible nerve pain in right upper arm where flu shot was given. Went to pcp next day and was dx with injection nerve injury. Was given a shot of cortisone in my shoulder and it was better for about 6 weeks then had to go back to doctor d/t increased pain. Was given a steroid taper this visit. Continue to have sporadic pain to area.
Super tired; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 29Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing outbreaks on lip (oral herpes) began having outbreaks on her lip when she was 39. The patient had a family history of Fib (atrial fibrillation) from an unknown date reported that her mother has a fib but it's not genetic. Concomitant medication included valaciclovir hydrochloride taken for oral herpes from an unspecified start date and ongoing. On 29Mar2021, the patient experienced sore arm for 2 days and on 30Mar2021 experienced super tired. The reporter considered the events as medically significant. The patient underwent lab tests and procedures which included covid-19 screening: negative and X-ray: normal both on Apr2021. The outcome of the event sore arm was recovered on 31Mar2021 while for the event super tired was recovered on 30Mar2021.
pt t101 R in PM of 25JAN94; cried 3-4 hrs during the noc (inconsolable) listless all day on 26JAN94; lt thigh red & edematous; fully recovered on 27JAN94;
Body aches; headache; nausea; elevated temperature; This is a spontaneous report from a contactable consumer (Patient). A 23-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Feb2021 12:00 PM (at the age of 23-year-old) as dose 2, single administered in right arm for COVID-19 immunisation. The patient's medical history was reported as none and had no known allergies. Concomitant medication included LORYNA for birth control, start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) on 28Jan2021 at 2:30 PM, as single dose in right arm for covid-19 immunisation. The patient did not receive other vaccine in four weeks. On 18Feb2021 at 16:00, the patient experienced body aches, headache, nausea, and had elevated temperature. The patient underwent lab tests and procedures which included elevated body temperature on 18Feb2021. The patient had no COVID-19 prior vaccination and was not tested for COVID post vaccination. The patient received treatment with Tylenol. The clinical outcome of events was resolving at the time of report. No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Immediately after needle removed from arm patient had convulsive syncopal episode which lasted under 1 minute. Patient was monitored for approximately 45 minutes following and allowed to leave the clinic once he felt well and vitals were stable.
My period is very regular, but it started 15 days earlier than normal. (13 days after receiving my 1st dose)    This is the first time this has ever happened to me. It was worrisome.   The period lasted the same number of days it normally does, but the flow was lighter.
Shingles; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In February 2020, between 1 and 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shngrix a little over 2 months before the date of reporting. In the last week from the date of reporting, patient had shingles before getting 2nd dose. The patient was asking whether he/she need to wait a year and get both shots again and if he/she need to get 2nd dose after shingles clear up within 6 months of 1st dose.
12/30, evening, child showed mom his arm, at site of injection, he had a bump that protruded 1/4cm, diameter also 1/4cm. & it was pointed. It was firm, yet it could be depressed & would pop back out. On 1/1, developed hives, gone by 1/4. 60 day follow-up dated 9/26/00 provided no additional data.
Arm started aching immediately after being vaccinated. About an hour and a half after getting the vaccine my nose started running and I threw up three times.
Around 9 am the next day I had a slight fever at 101 and I felt less energy and more exhausted and my lymph node  got swollen under the same arm I got vaccinated and that same arm. I was in pain as well as my back and whole body. That lasted for 3-4 days and the swelling was finally gone after one week. I took Excedrin to help control the fever. The under arm swelling lasted for a whole week and also the injection sight pain.