chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 14 January 2010 from a health care professional. A 38 year old female patient with allergies to penicillin and sulfa developed right eye swelling, lip swelling, and generalized itching 30 minutes after she received a first dose of FLUZONE (lot U3253AA) which was administered on 16 September 2009 in the right arm. The patient had received prior doses of influenza via nasal route of administration, but had never received an injection of the influenza vaccine. The patient was seen by an emergency room physician and was treated with BENADRYL, DECADRON, and MEDROL dose pack. After completing the steroid dose pack she began having hives, lip swelling, and itching again. The patient was treated with steroids for two more weeks. The patient reported having an allergic reaction to shellfish one week prior to vaccination. Concomitant therapy included CYMBALTA. Recovery status was unknown. List of Documents held by Sender: none.
Narrative: as described in events, do not believe death related to vaccine/booster. had received 3 doses of Moderna covid vaccine/booster previously with no reaction
Information has been received from a physician concerning a 32 year old female patient with no pertinent medical history and no known drug reactions or allergies who in June 2009, was vaccinated subcutaneously with a dose of 0.5 ml of MMR II "in another country". There were no concomitant medications. According to the physician her titers were checked when she came to region and her mumps titer was negative. The physician gave her another dose of MMR II on 17-SEP-2009. The physician reported that later it was found that the patient was pregnant at the time of administration. LMP: 28-AUG-2009. EDD: 10-JUN-2010. The patient sought medical attention by an office visit. Additional information has been requested.
This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of oral, ROTATEQ (Lot # L000433 Expiration date: 09-JUL-2016 and K013861 Expiration date: 18-MAR-2016), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC)) was involved. This is one of several reports received from the same source. Additional information has been requested.
Seizures, several of them lasting a few seconds at a time for a course of a couple days.
Redness around site of injection greater than a quarter size - patient went to urgent care and received a prescription for antibiotic.
Ringing in ears, ears popping.  Brain fog , headache, pressure in head.  Trouble sleeping
Patient complained of numbness and tingling to neck and lower face. Patient received first dose of Moderna vaccine. Patient has multiple severe allergic reactions and knows the signs and symptoms. She believed anxiety may have contributed to her situation. Patient received medical attention and vital signs were within normal range.
has tested positive; has tested positive; runny nose; aches and pains; teeth hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "aches and pains"; RHINORRHOEA (non-serious) with onset Apr2022, outcome "unknown", described as "runny nose"; TEETHING (non-serious) with onset Apr2022, outcome "unknown", described as "teeth hurting"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 17Apr2022, outcome "unknown" and all described as "has tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Positive.  Clinical Course: She received her booster dose last Monday and she has tested positive for COVID infection yesterday. She has contacted her HCP and the receptionist has scheduled her for Monoclonal infusion. Her concern was that, she has gotten the booster dose, she has the infection and she would like to know if its beneficial for her to receive the monoclonal infusion too would her body's Antibody level become too much. She has an option for Monoclonal antibody and Paxlovid but she does not know which she should take given that she and her husband both tested positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200591780 Same reporter/ drug/ event for different patients.;US-PFIZER INC-202200591781 Same reporter/ drug/ event for different patients.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 9:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 42.73 for dose administered on 27-Oct-2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 22-Oct-2021 with temperature 39-43 degrees Fahrenheit from 11:00 AM to 05:00 PM and on 27-Oct-2021 with temperature 41 degrees Fahrenheit from 8:00 AM to 09:00 AM. This vial was moved to fridge on 29-Sep-2021 and beyond use date for the vial was reported as 29-Oct-2021. Product moved to clinic on 22-Oct-2021 and again on 27-Oct-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Student was quiet and sitting down when he received TDAP and Menveo injections. About 1 minute later, student stood up and was walking to the door when his head shook once and his eyes rolled back and he turned pale and fainted. He was caught by his mother and did not hit his head nor any other part of his body. Mom and nurse eased student to laying position on the ground. Student woke up after about 5-7 seconds and was talking regular. Student then said he had felt dizzy right before he passed out. Student's color returned after about 1 minute and he continued to rest on floor for about 5 minutes. During the 5 minutes, he was talking and laughing as he had before, and he mentioned that he had not eaten breakfast that day. Student stood up and sat in the chair for several minutes. He drank water and ate a lemon cookie. After sitting for about 10 minutes, student got up and walked outside with his mother at his side. Student was acting as he had previously and said he felt much better. Mom agreed to stay with the student for the afternoon and said she would take him to the doctor if he had any more concerning symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of malaise 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 malaise, nausea, chills and headache. On an unknown date, the outcome of the malaise, nausea, chills and headache were unknown. It was unknown if the reporter considered the malaise, nausea, chills and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The pharmacist called to report that almost all of the patients he vaccinated with SHINGRIX reported malaise, headache, nausea, chills lasting for 3 to 4 hours after administration. The pharmacist did not want to report a particular case. He called questioning the contents of the adjuvant.
Boostrix administered on 2/27/2006.  Started with fever the day after up to 103. Fever lasted ~2 days.  on 3/1/06 fever was improving but started with gross hematuria in the evening.  Seen by nephrologist on 3/2/2006 and felt to have acute glomerulonephritis.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 21-year-old female patient who experienced large swelling in arm for a week from shoulder to elbow, mild weakness in left arm, tingling in fingers and flu like symptoms, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On 06-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1810 expiry date: 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious large swelling in arm for a week from shoulder to elbow 6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious mild weakness in left arm 6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious tingling in fingers 6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious flu like symptoms6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab data.) Final diagnosis was flu like symptoms, tingling in fingers, and mild weakness in left arm and large swelling in arm for a week from shoulder to elbow. 600 mg of Ibuprofen was received as corrective treatment. The patient outcome is reported as Unknown for large swelling in arm for a week from shoulder to elbow, as Unknown for mild weakness in left arm, as Unknown for flu like symptoms and as recovered/resolved on an unknown date for tingling in fingers. Follow-up information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. Patient age and event outcome was updated. Documents held by sender: none.
Pt reports swollen arm and redness in the site where injected with Prevnar 13 vaccine (LD).  No other reactions reported - called pt's spouse on 10/29/15 and he reports swelling has gone down and is not as red - pt appears to be acting normally otherwise.
Heaviness in legs within 5 min of giving. Both legs have remained numb x 24 hours. 12/16/09 Pediatric records received for DOS 11/05/09. Pt. had vaccine 1 day ago and presented with h/o arm and leg numbness just following vaccination. Today c/o legs feeling heavy and stiff and pain in right knee. Neuro exam normal. Neurology referral done. Assessment: unspecified idiopathic peripheral neuropathy 12/21/09 Neurology consult records received for DOS 11/06/09. Neuro exam normal. Pt. walking and jogging normally. Assessment: unusual response after vaccination, possible genomic disorder
Starting on the day after my shot I was completely fatigued and unmotivated. This continued for four full days afterwards before easing off on the fifth day, and gone by the sixth.  During this time I also had some confusion and difficulty comprehending reading and verbal explanations. Unsure what day it was. I found myself misspeaking words with the wrong meanings. I also was confused if I had completed tasks such as going for a scheduled unrelated blood test, taking my car in for maintenance, etc, and could not recall if I had done these things or if they still needed done.   I would stay awake no more than a few hours, 5 at most, then sleep for 8-10 hours. This went on until the fifth day.
Felt groggy; unfocused after first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 23Mar2021 22:00, outcome "recovered", described as "Felt groggy"; DISTURBANCE IN ATTENTION (non-serious) with onset 23Mar2021 22:00, outcome "recovered", described as "unfocused after first shot". Therapeutic measures were not taken as a result of somnolence, disturbance in attention.  Additional information:  It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine: and within 2 weeks of vaccination. It was unknown if  the patient diagnosed with COVID-19 Prior to vaccination. Since the vaccination, it was unknown if the patient been tested for COVID-19. Allergies to medications, food, or other products: Unknown. Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines: I became aware of the event the evening of 23Mar2021  approximately 10:00PM. If it is convenient, could you kindly provide the contact info for the person who is reporting to you: Response: I do not have his contact information. this was a comment on social media. All I know is he lives in (With held).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11/5/08 Late night or early 11/6.  Chest and back pain, pressure in chest, shortness of breath.  Sides of neck had odd sensation, like "bubbles going up", began shortly after with a bad headache at the back of the head.  Ankles painful, left arm where shot given painful down to elbow.  Made sure high blood pressure meds were taken.  Also took med for relaxation.  The next morning still had HA, soreness all over, fatigue and difficulty breathing.  Went to cardiologist on 11/7/08.
Pt reported sweating and palpitations vitals: 128/72, 83, 20. Pt given water.  Pt stable and released from the vaccination site.
Severe congestion, cough, dramatic behavior change--19 month old great sleeper who was wide awake and screaming for 3-4 hours straight and then on/off through night.  Patient was struggling to walk, used the wall to keep himself upright.  Often went and stood in corner of room and leaned against the wall with head (never done this before).  Appeared to be delirious.
Currently 7 months pregnant, received vaccine around 1pm and started having reaction around 4:30pm. I also had previous reaction during my last pregnancy (2 years ago).   Side effects: fever (101 at the highest, sore throat, dizziness, fatigue and standard sore arm)
after 2 weeks muscle twitches and Fasciculation started in eye, forehead, chin, feet and then all over body in few weeks. I thought it will go with time, but still it is persisting.   Note - same day my wife also took same vaccine in same facility. She is also facing these symptoms.   Please help & Guide
After getting a shot patient felt dizziness for 15 - 20 minutes. pulse 67, o2 sat 92. gave patient cold water. continuous monitoring for 30 minutes. gave salty snacks. checked for orthostatic hypotension. patient left after about 75 minutes. called back from home and was doing well
After the employee received the vaccinations she took the bus home and approximately 45 minutes later she became nauseous and began "dry heaving".
On Feb. 4, in the evening, the area about 3 inches below the injection site started to itch and was slightly reddened in an area about 3 inches across and 2 inches up and down.  These  symptoms continued about 8 days.  I did not seek medical attention, but did treat the itching with Cortizone 10 cream a couple of times per day for about 4 or 5 of the 8 days.
get shingles even after the vaccine/ Suspected vaccination failure; Shingles; patients were female and not yet 50; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: get shingles even after the vaccine/ Suspected vaccination failure) (serious criteria medically significant), shingles (Verbatim: Shingles) and inappropriate age at vaccine administration (Verbatim: patients were female and not yet 50). The outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     The company considered the vaccination failure and shingles to be possibly related to Shingrix.   Additional Information: Receipt date: 16-AUG-2023 The patient was in late 40s. The reporter asked if the vaccine itself could cause a case of Shingles. Reporter stated that she had three patients still get shingles even after the vaccine and discussed that might be a possibility at some point, but she indicated that she believed it might had been a result of the vaccine itself. The reporter discussed that the adverse events that include flu-like symptoms including myalgia, fatigue, headache, shivering and fever and when asked if these might had been the symptoms that the patient experienced, she stated no, and stated what they experienced, was indeed a case of shingles. Reporter discussed that the indication was for patients over 50 years. The reporter did consent to follow up. The patient below 50 years received Shingrix, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting. This case was 1 of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR112314:same reporter US-GSK-US2023AMR112313:same reporter
The patient received an expired vaccine. HepB vaccine expired 11/22/22 and was administered 12/21/2022. No adverse events occurred and no treatment was necessary
patient states she had severe swelling at the site the morning after receiving vaccine. Patient states she  has a red itchy patch at the injection site. Patient stated she has experienced several red itchy patches on her body since receiving the vaccine. She showed me a current red itchy patch of her left side.
a male patient who is over the age of 45 received the first dose; No additional AE reported.; This spontaneous report was received from a registered pharmacist and refers to a male patient who was over 45-years-old. The patient's concurrent conditions, medical history and concomitant therapies were not reported. There was no information regarding the patient's drug reactions or allergies.  On an unknown date, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, formulation, route and site of administration, lot #, expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA001661:
prolonged malaise, h/a, low grade temp, diarrhea, for 1wk;
PER MOTHER, REDNESS AND SWELLING AT INJECTION SITE WITH BLISTER LIKE LESIONS, AFEBRILE; SEEN BY MD ON 8/23/12. TX WITH ANTIBIOTICS AND DX WITH CELLULITIS.
Information has been received from a physician concerning a patient with no medical history who on 29-MAY-2007 was vaccinated with one 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot #657195/0366U). Concomitant vaccines administered included routine vaccinations for a one year visit. The patient developed a breakthrough case of chicken pox. Additional information has been requested.
A few days of heart palpitations - consistent through the day. And then blood pressure spiked. I was taking Blood pressure and the cuff detected an arrhythmia   and so I went to ER on the 12th. Cardiologist  dr visit was on 14th of January.  I was put on blood pressure medicine - a second one  (I was already on one) - Metoprolol ER Succinate. I had my second dose on January 15, 2021. After my second dose, I had pain in my upper part of my chest - left side - and it went away.
14 days p/immun devel fever & generalized rash over body; rash lasted 3 days; fever only 1st 12 hrs;
8/30/21 on HD, DM, previous AVR on coumadin, paroxysmal atrial fib, AICD. Presented to hospital after mechanical fall at home 9/13/21 pt transferred to hospital due to possible compression of nerve