chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Colitis ulcerative aggravated; Lack of drug effect/humira not working; This is a solicited report based on the information received by Pfizer from AbbVie. (Manufacturer Control No: 21K-163-3957588-00). A contactable 62-year-old female consumer (patient) reported that:  Solicited report by a consumer of an adult female with events of non-serious ulcerative colitis flare up and humira not working with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced ulcerative colitis flare up and humira not working. PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 19Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 10May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of ulcerative colitis flare up with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of humira not working with humira (Adalimumab) was a reasonable possibility.  Change History: On 07Sep2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of "ulcerative colitis flare-up" was amended to "ulcerative colitis flare up". The event of "humira seems not to be working as well" was amended to "humira not working".  Humira Causality for events 1) Colitis ulcerative aggravated, 2) Lack of drug effect as per reporter (Drug/Vaccine): No reasonable possibility  COVID-19 Vaccine Causality for events 1) Colitis ulcerative aggravated, 2) Lack of drug effect as per reporter (Drug/Vaccine): Not Reported.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Colitis Ulcerative and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.
This spontaneous report as received from a certified medical assistant refers to an 18 year old female patient. The patient was vaccinated with a first dose of GARDASIL 0.5 ml intramuscularly sometime last summer (in 2012) and present to the office on 17-MAY-2013 for a second dose 0.5 ml intramuscularly (lot # not reported). No adverse effects reported. The patient did not seek medical attention. Additional information has been requested.
Woke up at 1am the night of flu vaccine with sweats, fever, chills, headache, and feeling left arm, chest, shoulder feeling swollen.  Eyes "crusty". Initially felt panicky, told himself to breathe slowly, and chest symptoms subsided.  He took Tylenol 650mg ii for HA.  He did not seek treatment, felt tired the next day, fine the day after.
Ten hours after I got the shot I got violent chills and fever(100.4), muscle aches all over. My quad muscles are still a little achy and weak. It lasted 36 hours and then I felt my Vestibular Migraines. I was dizzier than usual. Under my left armpit was very painful reaching toward my left breast. The area of the shot was not painful. I also had dizziness chest pains under my right clavicle immediately after I got the shot. The chest pain went away for three days and then it came back.  It was like an extreme muscle ache. It was a dull and intermittent pain. I was referred to a Respiratory clinic and I still had a low grade fever.  My left arm was stiff two weeks before the shot and  three days after the shot my  left shoulder was frozen. I had an appointment with my Orthopedist and she confirmed an encapsulated shoulder problem.  At present after three weeks my shoulder is still frozen and my armpit is still a little painful. The chest pains are less frequent.
BOTH ARMS WERE TURNING BROWN AND BLOTCHY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced both arms were turning brown and blotchy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both arms were turning brown and blotchy. This report was non-serious.
An approximately 4 inch x 2 inch warm, itchy, red raised red welt appeared at site of injection 7 days after dose given.   I was evaluated at a local acute care facility, and prescribed a methylprednisolone taper.  Other than some brief right arm discomfort, no other symptoms were noted.
This child received her 3rd Hep-B vaccine on 12/12/00 about 14:30. At 02:00, on 12/15/00, the parents were awakened by the child's cry. They found her limp, unresponsive and gasping for breath. The parents called 911 and started CPR. The child was pronounced dead at the hospital. The parents came in on 12/19/00 and voiced their concern that the death may have been related to the Hep-B vaccine.  Follow up information- Report 2001000092-1 describes the death of a 22 year old female who received an injection of hepatitis B vaccine (Engerix-B). The vaccinee was reported to be ab active, healthy child with no known acute or chronic medical conditions. She had no known allergies. There was no history of substance abuse and no family history of stroke, heart diesease, or sudden death. Her height and weight were not known, but she was described as "small for her age". There were no concurrent medications. the vaccinee received her first injection of Engerix B (lot ENG2205A2) on June 01, 2000 and her second injection of Engerix B (lot # ENG3141A2) on July 6, 2000. She had no adverse experiences following receipt of these two injections. She received her third injections of Engerix B on Dec 12, 2000. After receiving the third injection, she reportedly took one tablet of acetaminophen (Tylenol) to prevent local soreness. She was well until approximately 02:00 on Dec 15, 2000, when her parents were awakened by the child's cry. They found her lying in bed limp, unresponsive to verbal stimuli, and gasping for breath. Her eyes were half open. The vaccinee then stopped breathing. Her parents began cardiopulmonary resuscitation and summoned emergency medical personnel. The vacinee was transported by ambulance to the local hospital, where she was pronounced dead on arrival. An autopsy reportedly did not reveal a cause of death, although toxicology results were pending as of Feb 26, 2001. The vaccine provider considers the death to be unrelated to Engerix B administation. The most recent information, received on March 2, 2001, indicated that the childs parents voiced their concern that the death may have been related to the hepatitis B vaccine. The reportr stated that the vaccinee's 13 year old brother received three injections of Engerix B on the same dates, and from the same lots, as his sister. The brother had no adverse experience following receipt or any of the injections. He continued to be well as of Jan 04, 2001.
Besides significant pain in the injection site,  a rash broke out on my neck but not at the injection site.  I have no history for developing rashes int he past.  Symptoms bean within 24 hours of injection and are continuing 72 hours later.  I will try a Benedryl tomorrow.
this child came through a Covid vaccine clinic. the parents intentionally put the incorrect date of birth on the consent form of the child, so he could be vaccinated sooner.  the parents were educated on how dangerous and inappropriate this was. no adverse reactions to report from father, who verified, that he was deceitful when putting his sons date of birth on form.
Possible seizure activity on 2/1/00. She has since been seen and examined and dx'd as having had a behavioral type occurance. A follow up report received 8/1/2000 adds: Child was not actually known to have a seizure. Mother reports that she fell over and couldn't crawl as usual. She put the baby to bed for a nap - when she awoke 2 hours later, all was normal. Seen by neurologist - EEG done, WNL. No more incidences. Child did not have a fever at the time she presented symptoms. Follow up needed.
Fever tired whole body ache red rash injection site upset stomach  nausea very sick no energy
Patient  walked about 30 feet away from where vaccines were given and passed out, hitting his head on the wall and scuffing his left knee.
New information was received in patient details, medical history, and event outcomes. Information regarding PREVNAR 13 was received from a physician regarding a male patient who experienced soreness in the leg, didn't want to walk or put weight on it. The patient received a dose in 2010. The patient experienced soreness in the leg, didn't want to walk or put weight on it on an unknown date in 2010, after administration of PREVNAR 13. The patient returned to the doctor's office on 16 Sep 2010. Diagnostic tests and treatments were not reported. The outcome of all events is recovered. No additional information was available at the time of this report. See Related Case: US WYE H1764310, same source (non expedited event).
The patient was last seen at approximately 3:00pm.  He was alert and responsive.  He offered no complaints.  At 4:32pm the RN went into his room and found him unresponsive, absent of vital signs.  CPR was immediately initiated and (!! was activated.  911 EMS responded at 4:45p and continued CPR. Th patient was prounced dead at 5:09pm.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 63-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "HNT" (unspecified if ongoing); "HLP" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "OSA on CPAP" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient received Paxlovid for COVID 19 treatment. Treatment start date is 16Jun2022 and treatment stop date is 21Jun2022, indication for treatment of COVID 19.route of administration Oral.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received the shot on 7/13/18 and got this reaction 3 days later on 7/16/18. Her got swollen legs and ankles/ also got rash on stomach and arms. Called doctor who gave her a steroid shot which resolved the issue.
He has a quarter dollar size read circle around where the vaccine was injected. It is warm to the touch and swollen
started having a  dry cough almost within 5 minutes of the injection. proceded to have throat tightness and some shortness of breath. while in the store i tooll 75 mg of benadryl. this caused the symptoms to stablize but not go away.  took additional 50 mg benadryl 1 hour later. needed benadryl 50 mg every four hours for 24 hours. was still having throat tightness and shortness of breath. requiring albuterol about every 4-6 hours. called primary care that started me on prednisone taper. completed that and symptoms slowly resolved with prednisone over 4 days. however i have continue to have a headache since that day
Sore arm for 3 days, fever for 3 days starting 12 hours after dose, severe vomiting for 1 day starting 12 hours after, severe headache for 3 days starting 12 hours after.
The equipment provided in the ancillary kit leaked at the hub during injection causing vaccine to run down recipients arm. After reviewing with medical director, the decision was made to repeat the dose immediately in the other arm.The equipment was Magellan 3mL syringe with 25G x 1" needle.
PATIENT STATES THAT ALMOST IMMEDIATELY SHE DEVELOPED A FEVER AND CHILLS BUT IT DID NOT SUBSIDE AND THEN SHE BEGAN TO HAVE CHEST PAIN AND ITCHING - STILL NOT WELL AT TIME OF REPORT
Patient said shortly after leaving the pharmacy she started feeling shortness of breath, and her arm began to swell and become red/heated, didn't seek medical attention, received shot on 10/19/19. returned to the pharmacy on 10/21 saying she wanted us to be aware of reaction she experienced. The reaction she said had significantly improved however, still red and swollen. Told her she should go to her dr to get it checked out and said she would on her way out. Patient also stated that she has appointment on  Wednesday with her provider and will bring it up to him then.
Headache, injection arm swelling, injection arm pain making it difficult to move arm, runny nose, and tiredness. All symptoms started around 5 hours after injection and became severe for the next 8 hours. By 10:30 am the next morning all symptoms were gone after taking one dose of Advil. No symptoms returned once Advil wore off.
"Received the shingles vaccine on Wednesday, 7-17-19, and have  been suffering from all the symptoms associated with the vaccine every day  since then.  I have had swelling at injection site, body aches, chills, and  fever.  The highest fever (101.5) was this afternoon (7/22/2019).
pt recvd vax & devel h/a which became progressively severe flushing-sweats/chills, anxiety, general sense not being well-shaky;rx DPH
Refused to eat, slight temperature, increased sleepiness. The next day, the pt developed clicking of tongue, and stopped breathing.
I developed a 2? diameter area of raised bumps on my lower forearm, between elbow and wrist, underneath side of forearm.  Maybe 40 mini bumps in all. Similar to tall pimples or mini blisters, maybe 1/16 inch tall.  It was an itchy rash that lasted for a month or so.  I received my second dose of the vaccine three weeks after the first dose and had no adverse affects from the second dose.  The rash area has scarred now with dark marks on area on forearm.  No other after affects.
The ped covid vaccine (10 mcg) rather than the baby covid vaccine (3 mcg) was given. She was 2 months from her 5 yr birthday and the nurse mistakenly chose the vaccine for 5 and over rather than the vaccine for 6 months to 5 years. There were no reported side effects or ill effects.
23 year old white female received first dose of Pfizer vaccination today, March 26, 2021 at 1328.Lot# ER 8732. Vaccine given in left deltoid. She complaints of lightheadedness to RN @ 1335. She states " I have anxiety when having blood drawn". Denies any past medical history and NKDA. Assisted to floor and legs elevated. Vital signs obtained; blood pressure 120/70, pulse 71, 02 saturation 99% on room air, respirations 18, even and unlabored. After consuming water, stated "I feel better". Assisted off floor into sitting position and another set of vital obtained. Blood pressure 124/74, pulse 76, 02 saturation 97%, respirations 18, even and unlabored. awake, alert, oriented to time, place, and situation. Discharged from facility at 1400 in stable condition.
The next day after the 2nd pfizer covid vaccine Sunday November 7th, 2021, I had chills and minor body aches. Then on Monday November 8th I started having chest pain, the pain and discomfort continued to Tuesday November 9th, The chest pain was increasing and stated sweating and felling nauseated so i went to an urgent care, they did an EKG and it came back negative so they called an ambulance and i was transferred to Hospital. At the Hospital they completed 2 other EKGs and all came back abnormal, so they checked for troponin level and it came back 18. The cardiologist suggested that a cardiac Cath is necessary to rule out heart attack. the cardiac Cath came back negative, but the cardiac MRI confirmed myocarditis. The diagnosis was myocarditis after all the test and finding by the cardiologist..
Left deltoid area of arm swollen, red, rash. Lower left arm has itchy bumps around 5. Patient's arm hurts to touch.
Nausea immediately for over 48 hours Diarrhea for over 48 hours Feeling that I'm not getting air even with deep breaths Feet burning on bottom
29AUG inflammation/induration to lt thigh, t99.3; given APAP; hold further doses of DTP;
Information has been received from a physician's assistant concerning a 4 year old healthy male who on 12/09/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # not available). There were no concomitant medications. On 12/10/03 the pt developed swelling from shoulder to elbow in the injection arm. No other information was available. Unspecified medical attention was sought. There was no product quality complaint.  There were no lab diagnostic studies performed. Additional information has been requested.
Patient C/O wheezing, sneezing, watery eyes, difficulty breathing and hives aproximately 5 hours post vaccine administration. Went to ER and reports he was given Pepcid, Benadryl and steroids. Discharged home 4 hours later. Given a 5 day course of Prednisone 20mg PO. Reported to work 5/6 without any signs or symptoms. States he feels "great".
Pt came to ER with difficulty breathing and cough onset 1 week ago.  Patient admitted to ICU.
Erythema multiform - treatment 5 days oral steroids 1/2 tsp one daily
Patient received Sinovac 04/03/21 and 05/01/21 Then received Pfizer 08/29/21 and 10/02/21. Patient did not disclose previous Sinovac doses
Within 1/2 hr of receiving injection pt complained of face itching.  Within 1 hour face and neck burning red and itchy. Given Benadryl at school. Slept several hours, still complaining of itching when she woke up.  Resolved without further treatment.
2 -3 hrs after vaccine - fever, HA took a day ADVIL. 3-4 hrs post - okay. 2-3 days felt better. 97 Developed oral redness/rash - spreading shoulder -> elbow wide/flat hot to temperature.
Information has been received from a physician concerning a 17 year old male with BACTRIM allergy and no pertinent medical history who on 29-APR-2011 was vaccinated in the right upper arm with the first dose of GARDASIL, 0.5 mL intramuscularly (Lot number 666987/1016Z). Concomitant vaccination administered on the same day included a dose of hepatitis A vaccine (manufacturer unknown) in the left arm. The physician reported that 8 days later, on 07-MAY-2011, the entire right arm from shoulder to hand became very swollen and red. The patient was seen in the office on 13-MAY-2011 with swelling, redness with venous distension, no open areas were noted. The palm was more red than the arm. The arm was 3 cm larger than left arm. He was afebrile and denied pain. No axillary or cervical adenopathy was noted. There were no other complaints other than swelling. The erythema of arm was mild, there was no warmth. The physician did not feel that this was cellulitis or venous thrombosis, and was unsure if it was related to GARDASIL due to the date of onset. No treatment for the adverse event was given, laboratory diagnostics studies were not performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 173 doses were given from LOT 070H21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow up received with no new clinically significant information
vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022; The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022; Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date), PRODUCT STORAGE ERROR (vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy  gave Moderna Covid-19 vaccine past its beyond use date), PRODUCT STORAGE ERROR (vaccine was placed in the refrigerator on 24JAN2022, administered on 2mar2022) and PRODUCT EXPIRATION DATE ISSUE (The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The Pharmacy gave Moderna Covid-19 vaccine past its beyond use date to 21 patients. Lot Number 030H21B Expiration date 23MAR2022. The Pharmacist wrote an expiration date of 24MAR2022 on the Moderna Covid-19 vaccine instead of 24FEB2022. The Moderna Covid-19 vaccine was transferred from the Freezer to the Refrigerator on 24JAN2022. Pharmacist did not know which dose the patient received the invalid dose on. The Pharmacist did not know which arm the patient received the Moderna Covid-19 vaccine in. The Pharmacist did not have any other adverse events or side effects to report.   No treatment medication was reported.