chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen and red left Arm, itchy left arm, tingling and swelling of lips. Applied ice pack to arm and took 2 benedryl tablets. Initial symptom of itchiness and arm swelling presented approximately 5-10 minutes post injection.
By The afternoon following my son receiving his second Dtap and first polio vaccines, his mood had changed to one of significant agitation and anger, which was out of the ordinary. His consistently peaceful sleep pattern was disrupted, and now, 2.5 years later, I am aware that he has not had one night of sleep since those shots during which he hasn't had a night terror type outburst, or several. He had a seizure after the shots as well, only it was about a week after. He exhibits rage and sensory problems, and is constantly covering his ears. He hits his head on the floor very hard and will hit himself with objects. He also seems to have little ability to resist the urge to hit me or my husband, but seems to know he's not supposed to do that. He is very smart in many ways, but I wonder how this will effect his entire life.
First vaccine given 3/5/2021 second 3/26/2021 booster given 8/24/2021.  Early 2021 weakness began then the below new symptoms started in September 2021. No definitive diagnosis given.  Ataxia Sudden decrease in vision Orthostatic Hypotension Weakness Unable to walk/bed bound Confusion Cognitive issues Loss of bladder and bowel control A-fib
Fever, chills, headache and lightheadedness sore arm at site of injection.
Within one hour of receiving vaccine developed itchy skin rash on both upper arms, which spread to her neck and back. Developed throat tightness and shortness of breath w/cough. Has history of asthma and allergy to shellfish. Pulse: 96; Resp: 16; BP: 118/78; Pulse Dx 99%.
Progressive motor and sensory deficits starting about 1 week after vaccination. Developed LE paresthesias, followed by foot drop, followed by LE paralysis, and then progressing to upper extremity paralysis. Multiple brain, brainstem, and spinal cord lesions that are non-contiguous. Workup has been negative to date. Case referred to department of health and CDC.
Patient got dizzy and hyperventilated (nervous, as friend experienced adverse reaction). Gave water and resolved.
Pt recvd 3 doses of Engerix-B 6FEB91 & 6MAR91 & 2SEP91 & it was determined that pt did not seroconvert; Reporter indicated that pt was to recvd 4th dose of vax 11JAN92 w/a f/u lab titer 1 mo later to check for seroconversion;
Patient received PEDVAXHIB to left deltoid and PREVNAR 13 to right deltoid. About 2 minutes after vaccines given, patient felt dizzy and fell.
C/O chills, headache, fever 102.6 degrees F, lethargic, diarrhea times 1. Headache with 1st flu shot. Denies nausea and vomiting. Brother c/o viral infection 1 wk ago. 12/16/05 Pt getting better fever broke.
Swelling, heat, erythema left upper arm from shoulder to elbow; urticaria.
Starting in December, after the third vaccine, I started waking up at night with a racing heart. It happens several times a night and 3-4 times a week.   When I heard about other people having heart issues I decided to report it.   I haven't been able to get to my primary care doctor or a cardiologist, yet.
Booster dose after J&J Provider documentation:  She mentions some irregularity of her menses after the booster shot. She has had two menses this month.  2/28 and 3/21
Employee states after leaving work and going home she vomited a few times throughout the night. Employee also states she has had blurred vision.
expired vaccine is stored and then administered; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that on 29-Oct-2021 vial placed in refrigerator. No temperature excursion and no adverse event was reported. No treatment information was reported.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses  of LIQUID PEDVAXHIB (lot # L051122, expiration date: 12-OCT-2018, lot # M001814, expiration date: 15-OCT-2018, lot # M006710, expiration date 06-DEC-2018 intramuscularly (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.4 degrees Celsius for 1 hour 17 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
BP 105/70, P 70, OX 99%.  5 minutes after vaccine was given the patient c/o dizziness.  Was assisted with EMT to observation room.  Stable after a few minutes.  Left home with mother. Client's second set of vitals taken while standing stable.  Denies additional issues.  Refuses to go to hospital.  Went home with mother.  Assisted to exit by EMT.
Starting 4 hours after vaccines given, patient developed hyperactivity, was walking aimlessly in circles, felt like he was going to die (became paranoid), and could not sleep for 2 consecutive days/nights and also had local pain/swelling/erythema at injection site and developed facial flushing.  This all resolved in 2-3 days.  Complicating the incident is that the patient had just started Strattera (for ADHD) 2 days prior to these vaccines.  After the reaction, he stopped the Strattera and has not had any of the medication since.
big rump that is warm to the touch; Headache; Pain at the site of injection; A spontaneous report was received from a consumer concerning a female patient of 52 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced headache,vaccination site pain and big rump that is warm to the touch. The patients medical history was not provided.No relevant Concomitant medications were reported.  On 13 feb 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 031M20A) vaccine in the left arm for prophylaxis of COVID-19 infection. On 13-feb-2021,couple of hours later,patient experienced headache,vaccination site pain.  On 20-feb-2021,patient experienced big rump that is warm to the touch. No Treatment information for the event was provided. Action taken with second dose of mRNA-1273 in response to the event was not reported. The outcome for the events headache,vaccination site pain and big rump that is warm to the touch was not provided.
The patient is a 21yo acdu usmc HM who scheduled this appointment to discuss adverse effect of the Pfizer covid-19 vaccine on 9/16/21. I called and spoke with the patient. He states he received the first dose of the Pfizer vaccine on 9/7/21. On 9/9/21, he started having a metallic taste in his mouth when he ate an egg or meat, now he has that taste with all protein and fatty foods but not with carbohydrates. He states he s chewing gum with mint after meals. He denies fevers, angioedema or aphthous ulcers in the mouth. He has no other concerns.
Patient transferred from outlying hospital with severe ARDS secondary to COVID pneumonia on 3/9/21.  Patient had been admitted to outlying hospital since 3/5/21.  Patient was residing at a nursing home prior to hospitalization. Patient had received both COVID vaccines prior to admission but not yet considered fully vaccinated due to timing. Patient had a very complicated hospital stay and required mechanical ventilation.  Patient was treated with antibiotics, steroids, remdesivir and convalescent plasma.  Patient ultimately improved and was discharged to a rehab facility.
One day post vax the pt developed an injection site reaction characterized by an area of redness measuring 2 inches by 1 inch and a lump at the site of injection.
Time line for my Covid-19: Began aching and low grade fevers approximately 2/17/21.  Husband started with a cold on 2/3/21 so cancelled his scheduled Covid shot.  He entered hospital on 2/22/21.  I had infusion on 2/24/21.  I had bad chills, fever, loss of bladder control in night, diarrhea next day but better in two days. Husband died 3/22/21.  I did have hair loss for about a week, then it stopped.  My doctor thought I should have at least one shot.  Waited until July 23rd, had first Pfizer shot. Reactions from 1st shot were achiness and low grade fever.  Arm was sore.  It lasted about 36 hours.  I decided to get the second shot on 8/13/21.  Reactions follow:  Friday evening & overnight: Fever of 100.5 Degrees, extremely sore muscles, pounding headache, loss of bladder control when going to toilet. Felt better during day hours. Saturday overnight:  Night sweating severe enough to soak pj's and sheets. Sunday: ate breakfast, tasted weird like some chemicals, stomach began to hurt.  I had taken my blood pressure medicine before breakfast and thought that was the problem.  But later at church, I had diarrhea then felt better.  Still a little disoriented.  On 8/16, I traveled to another state to see my sister.  We went to 3 different cities.  On 8/18 I began breaking out with what I thought were bug bites from a swarm on my left arm and back of neck.  Blisters began to form.  However, my sister had no bug bites. The injection sight had nothing in that area and my arm was never sore.  However it kept increasing the next day to my right arm, both hands and more blisters began forming.  At that time I thought it might be hives.  I returned home 8/20 and I researched side effects from Covid shots since it continued getting worse and found out hives, blisters, etc. were a side effect from 3 to 14 days after a shot.  By Sunday 8/22 it began on my face, hip area and on legs.  it was severe enough to go to the emergency room that afternoon.
Transient synovitis of the right hip with a high ESR and normal CBC other than high platelets.
Headache, Myalgia, Fever, left arm soreness, fatigue Narrative:
Child felt fine on Friday and Saturday; on Sunday began fever of 101.7 up to 103.5 with cough.  Tried to get into see the Dr. but no appointments were available.  13yr old sibling starting to get ill.  11/10/09 Medical records received for DOS 11/06/09. ED visit  DX: Viral syndrome. Presented in ED w/one day flu-like sx, sore throat , hot. Diffuse myalgia. HA. D/C home. Follow up with PCP.
About five hours after the second dosage or the oral, typhoid vaccine, I woke up with a fever, which continued over the next 17 hours, reaching 103F. I also had a headache, body aches, tremors, a sore throat, and experienced stomach pain.
SKIN DISORDER; SWOLLEN LEFT LEGS; ANKLE SWELLING; LEFT BREAST WAS BIGGER THAN IT WAS BEFORE; LEFT ARM SWOLLEN; ITCHY SPOTS ON HEAD; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, and other pre-existing medical conditions included: The patient had no known allergies and relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (subcutaneous, batch number: 1152570, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced skin disorder, swollen left legs, ankle swelling, left breast was bigger than it was before, left arm swollen, and itchy spots on head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient recovered from skin disorder on JUL-2021, and swollen left legs, and ankle swelling on 26-JUL-2021, had not recovered from left arm swollen, and itchy spots on head, and the outcome of left breast was bigger than it was before was not reported. This report was non-serious.
Cough; Chest congestion; Heavy head; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), CHEST DISCOMFORT (Chest congestion), HEAD DISCOMFORT (Heavy head), FATIGUE (Tiredness) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced COUGH (Cough), CHEST DISCOMFORT (Chest congestion), HEAD DISCOMFORT (Heavy head), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, COUGH (Cough), CHEST DISCOMFORT (Chest congestion), HEAD DISCOMFORT (Heavy head), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.    Reporter did not allow further contact
Body aches, dizziness, 102 fever, shortness of breath, confusion, fatigue.
This hit me like a sledgehammer.  I've never had an adverse reaction to any vaccine or any shot after 20 years in and 20 more working for Federal Govt.  I had Fever, chills, headache, tiredness, lack of energy, etc.  All symptoms described by CDC.  Started on 21 Nov until abating starting on 2 Dec.  Used over-the-counter medicine like Advil, Ibuprofen, and Tylenol to counter symptoms.   Went to ER on 29 Nov and they ran a battery of tests; referred to and went to my Family Practice doc on 1 Dec who ran more tests.   They did not prescribe any medication and recommended continued use of over the counter medicine.
pressure behind neck, then tingling pressure on left arm, & left leg started hurting then I could not walk. That evening my back began to hurt. I took tylenol & it went away.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (lot # K016966 expiry date: 10-MAY-2017, lot # L040460 expiry date: 27-MAY-2017 and lot M018810 expiry date: 28-MAY-2018) for prophylaxis, which was exposed to a temperature of 54.08 F for 198 hours and to 30.4 F for 333 hours (incorrect product storage). The temperatures were logged with a data logger, and there were no prior excursions. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA006420: US-009507513-1612USA006419.
At about 10 minutes after administration, patient felt a bit lightheaded. She was given apple juice and was able to bring her mask down from her face and lightheaded feeling quickly resolved.  BP 148/83 p 74.
Raised red mark at sight of injection, chills, fever, anxiety, lots of bowel movements and urination, muscle aches, can?t sleep,  can?t eat
Product administered when stored in freezer beyond the 21 days that Pfizer has data to support.
Onset of vitiligo on perineum. No family history . No previous personal history. Vitiligo confirmed by three doctors.
Automatic twitching and muscle spasms. Arm is still sore but is getting better Anxiety, nauseas
7 days after 1st dose I experienced blood in my urine for 2 days. 2 days after my 2nd dose I experienced blood in my urine for 2 days.
This is a spontaneous report from a Pfizer-sponsored program, by a contactable female consumer (patient). A female patient, of unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection), via an unspecified route on Mar 19, 2021, single dose for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unknown date, patient experienced headache, fever, chills, body aches and nausea. She asked if this was normal. It told to her 'yes' some people experience this. The outcome of the events: unknown. No follow up attempts possible. Information about batch/lot number cannot be obtained.
pt recvd vax over last 5yrs & was found to be a non-responder p/9th dose;3rd series was completed in 1994;
diagnosed with degenerative mitral regurgitation; I have had a tightness and pain in my chest since a week after my first dose; I have had a tightness and pain in my chest since a week after my first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Batch/Lot number: unknown), 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: CHEST DISCOMFORT (disability), CHEST PAIN (disability) all with onset 2021, outcome "not recovered" and all described as "I have had a tightness and pain in my chest since a week after my first dose"; MITRAL VALVE INCOMPETENCE (disability, medically significant) with onset 2021, outcome "not recovered", described as "diagnosed with degenerative mitral regurgitation". The events "diagnosed with degenerative mitral regurgitation" and "i have had a tightness and pain in my chest since a week after my first dose" required physician office visit. The patient underwent the following laboratory tests and procedures: Cardiac function test: (unspecified date) generative mitral regurgitation; SARS-CoV-2 test: (May2022) Negative. It was unknown if therapeutic measures were taken as a result of mitral valve incompetence, chest discomfort, chest pain.  Adverse event: Consumer have had a tightness and pain in his chest since a week after his first dose of the Pfizer covid vaccine. He finally got into a cardiologist where they ran tests and he was diagnosed with degenerative mitral regurgitation. The doctor confirmed he did not have it prior to getting the vaccine as he had many tests done on his heart in years prior due to service and it has always came back normal until this. AE resulted in: Doctor or other healthcare professional office/clinic visit, Disability or permanent damage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was also given Proquad (MMR-V) LT, SC, Merck Co. No reaction on 10-23-19  Patient is a 4 y.o female that had concerns including Rash (from where she had injections on Wed.). Assessment/Plan Comments: Reaction to vaccines / I will check with the vaccine manufacture and file a adverse event report since these were all from the same supplier and did not react to the MMR vaccine from Merck. Ice; Benadryl if progressing. Tylenol OK
get the shots, got shingles/suspected vaccination failure; Shingles; Hurt; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: get the shots, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Hurt). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that it was horrible to receive the shingles vaccine. The reporter stated that they had a two doses plan and receive it even if you had shingles.  The patient reported that it does not hurt as bad if you receive the vaccine because he/she know he/she experienced shingles after received vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Information has been received from a consumer concerning a patient with post herpetic neuralgia and a history of shingles who was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed "a few prickles" "a few days." The patient outcome was not reported. Additional information has been requested.
Extensive swelling and itching at site if injection, on 5th day after vaccination, lasting 3 days
Only the liquid component  used; Only the liquid component  used; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA759A, expiry date 30th November 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comments: A health care professional reported that patient might received a partial dose of Menveo with only the liquid component. The reporter consented to follow up. Additional Supportive Information: The patient received partial dose of Menveo with only liquid component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2022193713, reported by same reporter.; Sender's Comments:  US-GSK-US2022193713:same reporter
Began with weakness of March 24th and stroke- like symptoms despite a clear CT Scan and EKG. Trouble walking or staying awake. Heart stopped on March 28th. Deceased.
pt recvd vax; exp gen swelling of head lymph nodes & stomach; to MD who felt rxn to DTAP;