chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Follow-up information provided additional events, product details, lab results and patient demographics. This case was considered medically important. Information regarding Hib-Titer was received from an attorney regarding a 5-year-old male patient who experienced autism, neurological damage, mental incapacity, mild hearing impairment, learning disability, mixed receptive expressive language disorder, mercury poisoning and developmental disability. The patient received the fourth dose on 15-Jul-1996. The patient also received a dose of M.M.R. Vax on 15-Jul-1996. Medical records received from an attorney, alleged that on an unspecified dates, the patient having received a dose of Hib, along with other childhood vaccines, experienced autism on 18-Oct-2000. The patient also experienced neurological damage, mental incapacity, mild hearing impairment, learning disability, mixed receptive expressive language disorder, mercury poisoning and developmental disability on an unspecified date. The patient's outcome was unknown. No additional information was available at the time of this report. DNA test fragile X (results: negative) and hair metal test (results: Arsenic 0.048 ug/g (normal: <0.666), Lead 0.53ug/g (normal: <1.0), Mercury 0.89ug/g (normal: <0.40), Tin 0.37ug/g (normal: <0.30), were done on an unspecified date.
Started last night red on face, gave Tylenol woke up with eyes swollen, states feels warm to touch, mom instructed to give dose of Benadryl and call in 1 hour for status check.
pt signed vaccine form and confirmed with 2 employees she wanted polio vaccine and checked box that she was requesting vaccine , however she did not want an immunization, just reporting to be safe, no bad vaccine reaction , she wanted prolia medicine to be injected no vaccination
In September I had three mensural period with in few days and i am continue to bleeding. Today I started passing big blood clots and seems like it is not going to stop anytime soon.
Diffuse erythema, inflammation, itchy, warm to touch x 9 days - being treated with oral antihistamines and antibiotics for cellulitis. Started tx today.
12 days p/vax pt came down w/fever 104, cough (strangling), vomited from coughing so hard;rash on trunk;coughed for over 1month;
PT RECEIVED PFIZER COVID BIVALENT IN CLINIC.   PT TOLERATED WELL. ADVISED HER TO WAIT IN THE WAITING AREA FOR ATLEAST 15 MIN AND REPORT ANY DISCOMFORT/REACTION. PATIENT AND MOTHER RETURN TO IMMS ROOM AFTER 15 MIN STATING THAT SHE IMMEDIATELY BEGAN EXPERIENCING NUMBNESS AND TINGLING TO LEFT ARM AFTER INJECTION. SHE STATES THAT THE TINGLING GRADUALLY MOVED DOWN THE ARM AND REMAINS IN HER FINGERS ALONG WITH A DULLNESS/NUMBNESS STATING THAT HER ARM FEELS HEAVY. ICE PACK IMMEDIATLEY APPLIED TO THE SITE, INJECTION SITE SHOWS NO SIGNS OF REDNESS OR SWELLING, VITAL SIGNS NORMAL.  PROVIDER CALLED TO PT FOR FURTHER EVALUATION.  CLEARED TO GO HOME, MONITOR AND BE SEEN IN ER IF SYMPTOMS WORSENED.  MOTHER STATES THAT SHE REMAINED VERY FATIGUED BUT PAIN AND TIGNLING SUBSIDED.  THE NEXT MORNING PT WOKE UP AT HOME, FELT VERY LETHARGIC AND HAD SOME VISION CONCERNS.  MOTHER HAD HER SIT DOWN AND DRINK SOME WATER AND PT FELL OUT OF CHAIR INTO FLOOR, ARMS FOLDED UP AND INWARD AND EYES ROLLED BACK IN HEAD, MOTHER UNSURE OF HOW LONG THIS LASTED BUT EMS WAS CALLED AND PT TRANSFERRED TO ER AT THAT TIME.
Information has been received from a nurse, via a company representative, concerning a female patient (age not specified) who in March 2008 ("within the past week"), was vaccinated with the first dose of Gardasil (lot # not reported).  On the same day of vaccination, the patient developed an injection site reaction described by the patient's mother as swollen and red from the shoulder to the elbow, with a blister at the injection site.  The mother called the physician's office, and the physician told her to discontinue the series.  Subsequently, the patient recovered from the events (duration not specified).  Additional information has been requested.
Severe headache and inability to respond verbally or cognitively to questioning. Disorientation and inability to recall time. Unable to complete sentences when queried by EMT personnel and security personnel called to attend episode. Unable to write name when asked by attending personnel. Unable to communicate, but able to comply with instructions given by attending personnel. EMT personnel arrived within 30 minutes and monitored blood pressure -- approximately 190/100.  Post-event, unable to sequence numbers (telephone or addresses), unable to use computer key board (lack of spatial awareness), continuous head ache for three months. Visited local physician the day after the event, and started treatment for elevated blood pressure.
Site red and bruised with bump. Pt directed to use cool and warm compresses to the site. Also instructed to take Tylenol for pain. Follow up in office.
This spontaneous report as received from a physician via company representative, refers to a 11 year old male patient without concurrent conditions or pertinent medical history. On 09-MAR-2015 the patient was vaccinated with the first dose of GARDASIL injection, lot # K006960, expiration date in February 2017. (Dosage and route were not reported). Concomitant therapies included Tdap (unspecified), tetanus toxoid (manufacturer unknown) administered on the same date. The physician informed that on 09-MAR-2015, the patient experienced a pallor, reported as "turned white" and had clonic movements. Also stated that the patient did not have a full syncope. The patient was told to lie down and was given water, after that he was able to walk out of the office 5 minutes after the events. It was unspecified if the patient will continue the therapy with GARDASIL. There were not laboratories diagnostic performed. The outcome of pallor was unknown while the outcome of tonic clonic movements was recovered on 09-MAR-2015. Additional information has been requested.
03/05/06 10 am shot given, symptoms came about 5pm, water drain from eyes, no itching, symptoms subsided approx 4-5 hours later. No problem this morning 03-06-08
CD30-positive lymphoproliferative disorder; This is a literature report.  A male patient in his 70's received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "primary cutaneous anaplastic large cell lymphoma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHOPROLIFERATIVE DISORDER (medically significant), outcome "recovering", described as "CD30-positive lymphoproliferative disorder". The patient underwent the following laboratory tests and procedures: T-cell receptor gene rearrangement test: Positive. Reaction for dose 1: Tumor - onset of 2 days from dose 1. Patient had lesions on Axilla. Diagnosis: CD30-positive lymphoproliferative disorder. Patient had no therapy/treatment and was near complete remission. No reaction for dose 2.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt reported to vaccination site Appx. 1 hour after receiving IM version of Flu Vaccine.  Pt Complaint of redness to back and arms and feeling itchy.  Airway was patent, pt speaking in full sentences, no scratchy throat reported or hoarseness.  PT. Declined receiving Benadryl, she stated Benadryl usually raises her heart rate.  Pt also stated had medical appointment in a couple of hours.  Medical director contacted, pt referred to Primary Care Doctor for evaluation.  Pt. seen by PCM at the hospital and discharged with consult to allergist.
Tingling lips; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8727) via an unspecified route of administration in the arm left on 30Mar2021 at 14:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive other medications within two weeks of vaccination. The patient had no allergies to food, drug or any other medications. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021 at 16:00, the patient experienced tingling lips and tingling tongue. No therapeutic measures were taken as the result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tingling lips and tingling tongue was unknown.  No follow-up attempts are needed. No further information is expected.
6DEC95 5PM pt recvd phone call from grandma;stating pt was crying cont,hands were blue,legs shaking&appeared to be having diff breathing;was told to go to ER;7DEC95 recvd call from mom stating took pt to ER&was told had a rxn;fever 1
Patient c/o palpitations, flushing, heart-racing and butterflies in her stomach. Fire-Rescue performed vitals: BP-134/73 P:87 sitting and BP: 154/70 P-87 standing. EKG presents a normal sinus rhythm. The patient signed a refusal for transport with the Fire-Rescue crew and drove away shortly after.
throwing up; iron deficiency; get itchy; like having the flu on steroids for a week; Polycythemia rubra vera; tired all the time; sick; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, on 22Apr2021 as dose 1, single (Lot number: EW0162) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 22Apr2021, outcome "recovered" (Apr2021), described as "sick"; FATIGUE (non-serious) with onset Jun2021, outcome "not recovered", described as "tired all the time"; POLYCYTHAEMIA VERA (medically significant) with onset Jul2021, outcome "not recovered", described as "Polycythemia rubra vera"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; IRON DEFICIENCY (non-serious), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "get itchy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "like having the flu on steroids for a week". The events "polycythemia rubra vera", "tired all the time", "throwing up", "iron deficiency", "get itchy" and "sick" required physician office visit. Patient believes he got cancer from the Pfizer COVID Vaccine.  Had bloodwork done in Jan2021, got the Pfizer COVID Vaccine in Apr2021 and May2021, then had bloodwork in Jul2021 and diagnosed with Polycythemia Rubra Vera causing high red blood cell count, all blood counts are out of whack, and iron deficiency. Has all sorts of medical problems. Clarified other medical problems were prior to the Pfizer COVID Vaccine doses. Polycythemia rubra vera causes him to be tired all the time and get itchy. Clarified being tired all the time started before being diagnosed with Polycythemia rubra vera. Attempted to clarify outcome. Got sick for a week with both jabs.  Only supposed to get sick with one of the jabs but got sick with both. Caused him to be violently ill, throwing up, like having the flu on steroids for a week. The patient underwent the following laboratory tests and procedures: Blood iron: (unspecified date) Unknown results, notes: all blood counts are out of whack, and iron deficiency; Blood test: (unspecified date) Unknown results, notes: all blood counts are out of whack, and iron deficiency; (Jan2021) Unknown results, notes: Had bloodwork done in Jan2021, got the Pfizer COVID Vaccine in Apr2021 and May2021; (Jul2021) Unknown results, notes: Had bloodwork done in Jan2021, got the Pfizer COVID Vaccine in Apr2021 and May2021; Red blood cell count: (unspecified date) High, notes: causing high red blood cell count. Therapeutic measures were taken as a result of polycythaemia vera, fatigue, vomiting, iron deficiency, pruritus, illness. Treatment: Put on baby aspirin, 81mg once a day by mouth, pill form.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337144 same product/patient/event, different dose;
On 2/24/06 at approximately 12pm pt reports having stomach pain, pale and blue around lips, could not move arms and legs and was having trouble catching his breath, his significant other called SHC instructed to call 911 pt reports paramedics came to house, no fever, low BP (exact reading unknown). Pt refused to go to ED pt reported this episode subsided after 3 hours.
I had arm pain. My arm was heavy. I could not lift it, I got chills and a high fever of 102 and joint pain. I took Tylenol. The fever lasted about 5 days.
My menstrual cycle has been incredibly irregular. I have been having breakthrough bleeding and extremely heavy clotting which I have never had before. I have been bleeding for 25 days straight at the time of reporting this, and my clots are getting bigger and the bleeding is getting heavier.
This case was reported by a pharmacist via call center representative and described the occurrence of stinging in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced stinging. On an unknown date, the outcome of the stinging was unknown. The reporter considered the stinging to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient did not require any intervention, hospitalization, emergency room or physician visit, and the symptoms were not considered life threatening or disabling. For tolerance to next dose, refer case US2018102505.
pt recvd vax & 10 minutes p/vax exp dec BP, inc pulse, tightness in chest, color pale & clammy skin;
The patient had no adverse event.  The timing of  this dose is not within guidelines.  It should have been a minimum of 4 months from 3rd dose.
mouth broke out with cold sores; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (mouth broke out with cold sores), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (mouth broke out with cold sores), CHILLS (chills) and PYREXIA (fever). At the time of the report, ORAL HERPES (mouth broke out with cold sores), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The following day after vaccination developed low grade fever, irritability, significant vomiting and mild diarrhea for 2 days.
Within first 10 minutes after injection, patient was rubbing her arm and noted increasing pain. She also  noted swelling. She had on long sleeves, so she pulled her arm out and there was a large area of swelling noted in the right upper arm, measuring 10 cm x 10 cm. No erythema or heat noted.  Ice applied for 10 minutes, no further swelling noted. Denied difficulty swallowing, breathing. No rash noted. This all occured while she was still in the clinic.
shortness of breath; Weakness; This is the spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number- EL9267) via an unspecified route of administration in arm left on 23Feb2021 01:30 PM (age at vaccination was 60 years) as dose 1, single for COVID-19 immunisation. The patient's medical history included ongoing asthma, she had asthma in the past but she had outgrown it. When she would get sinuses or a minor infection she would have little issue then. She used to have trouble breathing before but not like this. She never took any medication for the asthma, she is not on any medications or nebulizer treatments. The patient's concomitant medications were not reported. She did take vitamins and protein before the vaccine for a few days because thats what she read, She work in organic gardening and so she takes mostly organic stuff. She did not take other products. The patient stated that she got her first Pfizer Covid- 19 dose last 23Feb2021 and the next day she experienced weakness and shortness of breath on 24Feb2021 on 06:00 AM. The breathing was worse, but the weakness was not as bad, the weakness was better, it was like she could not do anything. It was reported that she was still having side effects. She read up a lot about the vaccine. she read that side effect usually last the first 2-3 days, but this is her 6th day, was it normal. When this all first began, when she heard about the shot, she heard that its suppose to be in the second shot that there would be side effects not the first. She does land scaping so she was pretty active and yesterday(28Feb2021) all she did was cuttings, she didnt do digging or anything but still got worn out and yesterday was the 5th day. It's like she just cant catch her breath. She did not take Tylenol, because she read that she was not suppose to. The outcome of weakness was resolving and for shortness of breath was not resolved.  No follow-up attempts were possible. No further information was expected.
Extremely swollen lymph nodes along left side of neck  Abnormal Period, missed one completely and then spotted for a month.
Patient was injected with Pc and HIB at 2:30pm on November 4, 2008. After injections administered, patient screamed and cried for 5 hours straight. Patient was inconsolable. Patient would not eat or sleep. I (patients mother) contacted doctor. They suggested applying a warm pack to the injection site or a warm bath. After the bath, patient calmed down but still showed signs of pain/distress. In the morning of November 5th, patient threw up multiple times. As of now, 10:10pm central time, Patient is fussy but is sleeping and eating. Doctor advised me to file this information with the CDC.
I have dystonia in my right leg that's since spread to my left leg. I have ongoing migraines and visual disturbances. These have been the primary issues I've been experiencing.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from Other health professional (Medical assistant). This case involves a 6 months old female patient who received vaccines Hepatitis B vaccine, PENTACEL and ACT-HIB. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13 given on 26-Sep-2018. On 26-Sep-2018, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE lot UI903AA, expiry date 21-Nov-2018 via unknown route in the right thigh. On 26-Sep-2018, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. The patient was ordered for injection of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported. It was an actual medication error due to extra dose administered and wrong vaccine administered. It was reported that 6-month old who received double the dose of HIB vaccine, PENTACEL and ACTHIB. They were ordered for Hep B which has not yet been given. The patient did not experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
About 4-5 hrs after receiving IPV & HIB pt awoke from nap fussy & very pale vomited x1 - stool x 2 paleness resolved after 30min. Was seen back in MD office with NL exam & vitals. Temp was 99.6 (R).
11/13/2020 - had the first of two Shingrix vaccinations 11/20/2020 - noted burning pain in my trunk 11/21-23/2020 - experienced severe back and hip pain. Took Advil, with no relief 11/24/2020 - consulted with my physician. I have long suffered from lower back pain and believed this to be consistent with past symptoms. 11/25/2020 - began a course of Methyprednisolone-4 mg dose pack for back and hip pain. The muscular pain subsided, but some burning sensation remained.  12/1/2020 - rash appeared 12/2/2020 - began valacyclovir 1 g tablets (21 tablets total) 12/10/2020 - all symptoms gone except mild itching
10/04 unstable walking. 10/05 went to family doctor as walking. 10/06 taken to ER not able to stand and was admitted to hospital. 10/07 diagnosed with GBS and transferred to another hospital.
High fever, ranging from 103-105 for roughly 24 hours; moderate fever of 100-102 for subsequent 24 hours; Difficulty sleeping; extreme fussiness. High fever and other symptoms responded to Acetaminophen temporarily; re-administration also effective; high fever remitted after about 24 hours; moderate fever remitted after about 48 hours.
10 min post dose, I experienced a lump in my throat and tingling in my face as if I was about to break out in hives. I took an antihistamine (Zyrtec) when I got home about 20 min post dose.
10 mins after vaccine administration became very dizzy and 10 sec. loss of consciousness, then nauseated  with dry heaving. VSS: 142/86-86 O2 sat 97%. Administered Ondansetron 4mg x 2 at 4:30pm, with some relief, Continued complaint of dizzy feeling nad nausea declined ED eval. Administered 500ml of  NS,   VS at 545pm: O2 sat 100% pulse 80 BP 153/99  discharged home with Zofran 4mg  2 4hours as needed