chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High Risk HPV; cervical dysplasia; Interchange of Vaccine Products; GARDASIL-9 administrations: Dose 1: 30-JAN-2016; Dose 2: 29-DEC-2016; Dose 3: 03-JUL-2017; This spontaneous report was received from a physician (who was also the patient's parent) and refers to a 22-year-old female patient. No information regarding the patient's medical history, concurrent conditions was provided. She had penicillin allergy. Her concomitant medication included unspecified birth control.  On an unknown date in approximately 2005 (reported as 16 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscularly (formulation, dose, anatomical location, lot # and expiration date were not reported) for prevention.  On 30-JAN-2016, 29-DEC-2016 and 03-JUL-2017, she was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, once, vial, intramuscularly (anatomical location was not reported) for prevention. Lot numbers and expiration dates of this doses were: lot # L011846, expiration date reported as 17-JUN-2017, but upon internal validation process, it was established as 16-JUN-2017, lot # L011846, expiration date reported as 05-JUN-2019 and # L011846, expiration date reported as 29-JUL-2017, but upon internal validation process, it was established as 28-JUL-2017. It could not be determined which lot numbers were administered on what dates.  On an unknown date in January 2021 (reported as 4 months ago), the patient was diagnosed with high risk human papillomavirus (HPV) infection and moderate cervical dysplasia. She sought medical attention and had loop electrosurgical excision procedure (LEEP) performed as a treatment for the events. It was unknown if any laboratory diagnostics or studies were performed. At the reporting time, she did not recovered from the events.  The causality assessment between the events and the suspect vaccines was not provided.
consumer reports that 2 children exp adverse event following 1st DTP @ 2months of age;exp drowsiness w/in 24 hrs of immun; event occurred in 1993; rx'd w/APAP;  pt also on apnea monitor;
Twelve hours after vaccine, woke at 2 am due to violent vomiting. Vomiting was nonstop and could not even keep a sip of water down. Began vomiting large amounts of bile. The vomiting did not stop until 11am after I took one dose of Zolfran. Following that, I slept all rest of that day (4/17) into next day. That next day, felt very shaky/dizzy with chills. Ate for first time since vomiting episode (toast and scrambled egg) and proceeded to have diarrhea for rest day. The GI symptoms finally subsided on 4/19 but still tired and somewhat shaky.
The same night (5/19) I received the Moderna vaccine (5 hrs later), I experienced itching at the site. Eleven days later (5/30), more itching, redness, raised round circle around the site, the size of a lime. As of today (6/3) continuing to be very itchy at times. The red circle is getting larger, the size of a grapefruit, warm to the touch, somewhat hard, and swollen. NOTE: The vaccine was administered at pharmacy
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site redness, myalgia, gastrointestinal disturbance, headache, shivering, fever, fatigue and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, however it could be adult as per package insert of SHINGRIX. The age at vaccination was not reported. A healthcare provider who had administered 202 total doses of SHINGRIX reports that approximately 10 patients had reported having all adverse events that were listed in the prescribing information. Some reported a sore arm lasting 4 to 5 days, but all other reactions resolved within 1 to 3 days. There were no reports of any serious adverse events or any symptoms not noted in the prescribing information. The healthcare provider did not want to report a particular patient's experience. The incidence of adverse events came up casually while discussing an unrelated question. She feels that because what the patients experienced were common side effects and not alarming, she did not want to report them individually.
Pt states rash with itchy began week of Oct 20th. Pustule forming over weekend of 10-25-08 - 10-26-08. Itchy t/o body but rash contained to waist area. Pustules starting to scab over as of Mon 10-27-08. Pt checked on per phone call on 10-29-08. Done well takes Benadryl 25mg PO if its to help with itchy as directed by nurse on 10-27-08. Able to go on with life & "not bothering much at all."
Shortly after recieving the vaccination i expierenced the usual symptoms (fatigue, sore arm, etc). After a few days i noticed i had a lump inferior to the mid clavicle area. I assumed it to by a lymph node, and waited 4 weeks to see if it went away. When it did not go away I made an appt w/ my Dr. He ordered an ultrasound. It took almost three weeks to get an appt for ultrasound. They confirmed it was a 1.4cm lymph node, possible reactive. The report stated they could not rule out malignancy and suggested further test. My provider ordered a chest X-ray which came back negative for lung effusion or masses. However, once again the report said it could not rule out soft tissue tumors or malignancy. Im not awaiting a surgical consult for biopsy. Ive had this lymph node for nearly 3 months.
High fever 102.3  - around 200am first  and seondnight  -  received vaccine on 2-4-2021  - On 2-5-2021 ran  temp of 100.5 all day
Information has been received from a woman's in a dr's office concerning a pt (demographics unspecified) who was vaccinated with a first and second dose of varicella virus vaccine (site unknown). Subsequently, the pt did not seroconvert. The pt sought unspecified medical attention. Additional information has been requested.
Information has been received from an employee at a physician's office concerning a couple of patients who was vaccinated with GARDASIL. The patients experienced "headaches, wheezing, dizziness and joint pains" after vaccination. It was stated that the vaccine was not administered at the office therefore she could not provide additional information. This is one of several reports from the same source. Additional information has been requested.
vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration". Patient reported no adverse reactions.
This spontaneous case reported by a consumer, describes the occurrence of taste disorder (bad taste in her mouth 1 day later), oral hypesthesia (lips felt jittery and numb) and oral paresthesia (lips felt jittery and numb) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 008C21A) for COVID-19 immunization. Concurrent medical conditions included abnormal blood pressure and cholesterol. On May 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; .5 milliliter. On May 14, 2021, patient experienced taste disorder (bad taste in her mouth 1 day later), oral hypesthesia (lips felt jittery and numb) and oral paresthesia (lips felt jittery and numb). The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency; and rubbing alcohol (isopropanol), at an unspecified dose and frequency, for adverse event. At the time of the report, taste disorder (bad taste in her mouth 1 day later), oral hypesthesia (lips felt jittery and numb) and oral paresthesia (lips felt jittery and numb) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications included medicine for blood pressure and cholesterol.
Patient reports having a 3 inch long, 3 inch wide rash above her left ankle that appeared about 2 days after the first vaccine. She states it was itchy and sore to touch. She used iodine and alcohol as a "home remedy" for treatment. She states it subsided after a few days and reappeared for a day on 3-29-21. She received her second dose on 3-31-21 and has had no issue but is monitoring. Advised patient to reach out to her PCP if it occurs again so he can evaluate cause and how to treat. Patient "saw a similar report on the news of a similar side effect and wanted to report".
Pt R/cd ZOSTAVAX on 8/19/14, 8/20/14 early AM noticed mouth swelling progressing to neck edema, hoarseness and throat swelling (dysphagia).
Injection on 05/30/02. 05/31/02, required office visit to check site, 4" x 3" area left leg with redness and swelling. Treated with Motrin and ice.
This spontaneous report was received from a pharmacist concerning a 50-year-old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication or drug reaction/allergy. On approximately 23-MAR-2017 (two weeks ago), the patient was vaccinated with bcg live (BCG VACCINE USP) intramuscular as prophylaxis (dose, lot number, and expiration date were not reported). On 05-APR-2017, the patient was vaccinated with VARIVAX as prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient did not seek medical attention and no adverse event was reported. No further information was provided. Additional information has been requested.
felt extreme fatigue, "couldn't move", no meds taken, but called out the next day 1/22.
Sore arm for 4 days Muscle aches Chills Redness at site of injection for over two weeks
pt to ED after recent hospitalization for COVID AND NSTEMI; had been dc'd to home with O2 supplementation; to ED with c/o increasing SOB, persistent confusion, increased O2 requirements; pt is positive for COVID in ED; treated with decadron and remdesivir; NRB mask; pt became more confused, agitated and combative; pulling O2 mask off and O2 sats decreasing; nurse found pt to be unresponsive and CPR was started and continued for 15 minutes; pt's family decided to stop compressions and make pt a DNI; pt died in the hospital
2 cold sores back to back since / cold sores since first shot; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd November 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself.  The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received the 1st dose of Shingles vaccine and had 2 cold sores back to back since vaccination.
Pt had a syncopal event w/ associated dizziness and lightheadedness.   Vitals: 108/95,67,17 Placed in Trendelenburg position for recovery.  Pt stabilized and left in the care of mother.
1OCT91 recvd Engerix-B vax w/o reaction; 1NOV91 recvd 2nd Engerix-B vax & 2 days later devel a sl raised warm reddened area 4 cm out from inject site; resolved in 2 days w/o tx;
pt recv vax 10JUL96 & on 5DEC97 pt devel varicella that consisted of 22 to 25 lesions that were located mostly on trunk;9DEC97 pt devel a stomach virus that included vomiting;
Patient states he felt tingling sensation down right arm after Japanese Encephalitis vaccine. Patient was administered vaccine in the same arm.
Patient reported urticaria, she was noted to have erythematous hives upper and lower extremities and torso. Airway clear, respirations even and unlabored, HR 101. Patient administered 25mg PO Benadryl. Vital signs @ 5:58pm BP 152/98, HR 101, O2 sat 94%, Resp 22. Patient was then observed for 10 minutes , vitals then were 125/86, HR 101, O2 sat 94%, Resp 18. Additional Benadryl 25mg PO administered at 6:19pm. Patient reevaluated at 6:30pm- Improvement noted. Reassessment completed. Patient reports she is better and no longer itching all over. Hives improved. Patient was advised to follow up with her PCP as needed. Call 911 or report to nearest ER if emergency.  Patient left at 6:45pm.
Sore painful arm. Fatigue, drymouth, sick stomach feeling, listless, cannot concentrate.
Tested positive for COVID 8 days after first dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, the patient received first dose and 8 days later, she tested positive for COVID 19. The reporter wanted to know the appropriate place to report this. She wanted to know if it could be reported on the Safety website. She will have patient do it. She just wanted to make sure it was appropriate place. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine was provided. Client signed a consent form and on the form answered no to ever having received a Covid Vaccination.Fact sheet was reviewed and copy given. Vaccination of J&J given by nurse along with fact sheet and vaccination card Client waited 15" and no reaction.  On 5-11-21 when being entered in, it was noted that the client had received a first dose Moderna at another facility the same morning 5-10-21 unknown if adverse event  Attempted contact by e-mail  only phone number is friend  have not heard anything as yet.
On 2/5/2021 resident noted to be azotemic. Creatinine up to 3.8 and BUN in 80's. He was started on NS hydration. On 2/7/2021 he was noted without VS, per MD notes, possible VF arrest, renal failure; death unclear exact cause.
Patient described arm to have a large spot of swelling and pain. Said swollen spot had gotten bigger and was painful. Patient also stated that she had a bad headache. Directed patient to stay hydrated, use cool cloth/ice pack on arm, and to take Tylenol or Ibuprofen to help with pain and headache. When she called back and said those weren't helping we directed her to go to ER if she thought she needed to. She said she would try to hold out and see how she felt later.
Right thigh site, red, indurated, tender 2x3cm size x 7 days. Fever x 1 day. (7 day course) dx cellulitis Rx ? then post ? Keflex 250-3.5mL tid x 10 days.
Received Dtap + PREVNAR on 2-5-09 @ 16:30.  300/am 2-6-09 reported temp 104.7 continued running temp with no other symptoms for 3 days.  Day 4 developed a rash.
Patient received the Morerna vaccine and then received the Janssen vaccine for the second dose which is not in compliance with the EUA.
cramps; gas; diarrhea; headache; fever; chills; started to feel sick; This case was reported by a consumer via call center representative and described the occurrence of cramp in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included diverticulitis and renal stone. Concurrent medical conditions included constipation. Concomitant products included plantago ovata (Metamucil).   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cramp, gas, diarrhea, headache, fever, chills and sickness. On an unknown date, the outcome of the cramp, gas, diarrhea, headache, fever, chills and sickness were unknown.   It was unknown if the reporter considered the cramp, gas, diarrhea, headache, fever, chills and sickness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in her right arm and within 2 days started to feel sick with chills, fever, headache, diarrhea, gas, cramps.  The patient had a history of kidney stones and history of diverticulitis and she has to take Metamucil to help with her constipation. The reporter consented to follow up.
This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored GARDASIL (Lot number, dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Fever T max 103 12 hours after vaccine administration followed by febrile seizure x 1 episode. Admitted for observation.  12/2/08 Reviewed PCP medical records of 11/25/08 & vaccination records w/o lot numbers recorded.  Records reveal patient in good health on day of vaccination.  Included hospital labs of 11/26.
104F fever for about 12 hours along with severe fatigue, chills/sweats and brain fog.  Following the 104F, a high fever around 102 for the next 24 hours with more fatigue.
It was reported that a female patient (3 of 3) received a Fluzone SV vaccination. Reportedly the patient developed reaction of warmth, erythematous area around the injection site for 24+ hours after the injection, measuring > 5cm and up to 10cm. Further information is requested. From additional correspondence received on 03/06/2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and the responsible physician information were also provided.
Pt. recieved vaccine 12 hours past expiration. No adverse event. Pt. declined revaccination
The child was in the office for well check up. The pt was cleared by doctor as a well child. given 2 month immunizations. No reaction was noted at that time. Discharged to home with Mom and grandmother. Stated cause of death as SIDS.
I passed out going down stairs; woke up disoriented; weak; dizzy; bloody nose; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received her second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EM9810) at her left arm, at 11:00AM 17Feb2021, for Covid-19 immunization. The patient received her first injection (Lot number EL9765) on 27Jan2021 10:15AM at her left arm. The patient's medical history was not reported. The patient had no other vaccine in four weeks and had no other medications in two weeks. The patient was fine for 10 hours afterwards, went to bed, woke up disoriented weak and dizzy. She passed out going down stairs, came to on the floor at the bottom of the stairs, bloody nose, about an hour later passed out again in the kitchen and woke up on the floor. No warning either time, like light switch being turned off. The patient never had a reaction to anything before, never passed out before. She felt better at time of reporting. The adverse events happened at 07:00 AM 18Feb2021. The patient had not received any treatment for the events and not covered from the events. The patient had no Covid prior vaccination and Covid was not tested post vaccination.
Fully vaccinated, not boosted.   COVID infection breakthrough with inpatient hospital stay.   LOT NUMBER OF VACCINE 1 NOT DOCUMENTED
Initial report received from the patient's wife on 31-Aug-05.  A 52-year-old male patient had received for wound an injection of DECAVAC (lot unknown) on 28-Aug-05.  1 day later, he had "slow thinking", fatigue and memory problems.  As per the reporter, the patient has history of "gluten ataxia", allergies to codeine and emycin, diabetes and TBD.  The patient received many other medications (unspecified).  The patient's recovery status was not reported.  Follow-up information received on 17/Nov/2005.  This case is now medically confirmed.  As per responsible physician the patient was not seen in her office.  The patient has gluten ataxia-neuro symptoms which worsens by exposure to gluten.  His symptoms were worse for three days post immunization.  Lot number for DECAVAC was U1584BA and was administered in the left deltoid.  As per reporter the patient recovered.
Narrative:  Patient fully vaccinated for COVID-19 hospitalized for COVID-19 pneumonia. Admitted from LTC facility on 8/26/21 with COVID-19 positive status, increasing oxygen requirements, dry cough, generalized weakness, fever. Received supplemental oxygen, dexamethasone and remdesivir. Increased oxygen requirements in beginning of admission but weaned back to baseline (2L NC). Developed AKI during hospitalization; normalized by discharge. Altered mentation during hospitalization, at baseline upon discharge. Elevated blood sugars addressed during admission with insulin. Thought to be secondary to dexamethasone use and holding semaglutide therapy. Discharged back to care facility 9/7/21.
Large erythematous, indurated area at site of vaccination. Area about 5 cm diameter today, was larger on 6/19/07 per mom.
Left eye upper eyelid swelled shut upon awakening at 06:00 10/26/2005. Vaccine given approx 15:00 10/25/2005. Treated with warm compress and ibuprofen.
Patient passed-out twice after administration, then vomited. She felt very weak and tired until she vomited then she began to feel better. I talked to the patient about an hour later when she was at home and feeling better.
Information has been received from a physician concerning a patient who on 25-JUN-2012 was vaccinated with a 0.5mL dose of Hib conj vaccine (OMPC) and PENTACEL together. It was unknown if the patient was sought medical attention. No adverse effects reported. Follow up information has been received from the physician concerning the 9 weeks male patient, who was vaccinated with the first dose of PEDVAXHIB and PENTACEL. The patient was perfect, did not have symptoms. No further information is available.
the afternoon p/vax pt had a high pitched, inconsolable crying spell for 5hr;
Mild Fever, Weakness, Headache, Dizziness, Muscle aches and pains, Upset stomach, Swollen glands, Hip, leg  and neck pain, trouble walking due to weak muscles and pain.
Patient was given the wrong dose of COVID vaccine. She received 0.3 mLs instead of the recommeded 0.2 mLs. At the time of this report, she has NO side effects.
LOCALIZED REDNESS AND SWELLING AT SITE OF INJECTION WITH SMALL RED BUMPS. APPEARED A WEEK AFTER INJECTION. REACTION GETTING BETTER.