chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad headache after vax then 1 day  later received the Shringrex vaccine. Dr advised her that it was okay to receive Shringrex vaccine even though just received the Moderna vaccine a day before. After Shringrex vax, headache became worse, started to feel fatigued. Whole body felt like it was burning from the inside out, felt like it was on fire, excessive amount of sweating.
Severe and sudden onset of dizziness.  Able to get to sofa and lie down for ~5-10 minutes and dizziness went away.  Occurred two more times within 30 minutes.  Laid flat in bed both times for ~10 minutes.  Dizziness resolved after that and slight chills set in then low-grade headache a few hours later.  All symptoms resolved by ~8pm.
6/3  61 YOF with hx of HTN, HLD, DM, hx of Covid 19, CAD presented to ER with n/v, abd pain and myalgias for 2 days.
2 days after vaccination, patient developed 10/10 pain, and arm swelling. Entire hand and part of lower arm was also so swollen that he could not make a fist. Pain was worst in 3rd and 4th left fingers. Patient is a farmer and did use are for his normal heavy work after vaccination. Patient also developed numbness in 1st-4th fingers in hand, worse in 3rd-4th fingers most consistent with carpal tunnel
7 days after vaccine patient started to get itchiness, redness and bumps around vaccination site around 2 inches in diameter.  She reported these adverse events 9 days after vaccination because still present.  She was advised to use over the counter Benadryl and steroid cream to the rash area and report to her physician if not improving or getting worse over the next 24-48 hours.
This spontaneous report was received from a consumer, regarding a female patient of unknown age. No patient's medical history, drug reactions, allergies or concurrent conditions were reported. On unknown date, the patient was vaccinated with VARIVAX and PROQUAD (frequency, strength, route of administration, dosage number, lot number and expiration date for both vaccines were not provided) as prophylaxis. On unknown date, the primary reporter stated that her niece was administered one dose of VARIVAX and one dose of PROQUAD. No adverse effects were reported. The outcome of extra dose administered was unknown.
Patient is a previously healthy 4-month-old male born via spontaneous vaginal delivery following uncomplicated pregnancy who developed stereotypic events concerning for seizure approximately 2-3 weeks ago. These events consisted of oral motor movements followed by loss of tone and lethargy and were occurring 3-4 times per day. Reassuringly however patient has a normal neurologic examination today and has not had an episode of these movements for the past week. Given his typical development and normal neurologic examination I am less concerned that this is a manifestation of a seizure disorder however these events were fairly stereotypical and performing an EEG would be a simple way to further investigate this. If his EEG has a focal abnormality, I would consider at that time further neural imaging (MRI of the brain without contrast). At this time, I am hesitant to order an MRI of the brain as I believe it would need to be performed under sedation and given that the episodes have stopped I think the clinical scenario does not merit this level of investigation at this time.
This spontaneous report as received from a consumer refers to himself, a male patient of unknown age. No medical history, concurrent condition and concomitant medications were reported. On an unknown date in February-2018 the patient was vaccinated with RECOMBIVAX HB, dose/frequency: vaccine dose, intramuscularly for prevention of Hepatitis B. On an unknown date in February-2018, approximately 5 days after receiving the vaccine injection, the patient experienced fatigue. The patient did not sought medical attention and no treatment was given for the adverse event. The outcome of fatigue was reported as not recovered/not resolved. Causality assessment was not provided. No product quality complaint was present.
Expired vaccine given to the patient with no reported adverse event; Initial information received on 23-Aug-2021 regarding an unsolicited valid non-serious case from a consumer/non healthcare professional via Media information (under reference 00735381).  This case involves a patient (unknown age and gender) who received an expired dose of MENINGOCOCCAL VACCINE (MENACTRA) [expired product administered].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENACTRA (lot number and expiration date: not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was reported "What if an expired vaccine was given to a patient."  At time of reporting, the outcome was unknown for the reported event.   There will be no information on batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
While the Pneumovax vaccine was being administered, there was immediate excruciating pain lateral and anterior to the injection site (which was an IM injection in L Deltoid). The burning and stinging pain was felt primarily in the axillary region at the anterior fold, not at the site of the injection. Thinking the pain would pass and that it may have been expected, I went forward with the discharge immediately after the injection under the assumption it would clear up on it's own. It did not. When I arrived home my left upper arm and axillary area became even more sore and the burning sensation and tenderness increased. At this time an area of redness began to appear at the axillary area where the pain was felt during the injection. Again, this was not at the direct point of the injection, but lateral and at axillary region. Knowing that some tenderness is to be expected, I just watched the site. On 7/5/2012, the site became more inflamed and the area of induration, heat, and redness began to increase, I continued to watch it until today, 7/6/12. This morning, 7/6/12, I contacted Dr. at 10:30 am and left message and then again later in the afternoon when he was able to talk. He directed me to go immediately to the ER. I arrived at the ER around 2:30/3pm and was seen by Dr. who refused to document what was happening to me as a reaction to the  vaccine. She stated that she did not believe it was related to the vaccine and stated that she thought it was shingles. I explained to her that I am a Nurse Practitioner and know the difference between shingles and an acute reaction to a vaccination.  I suggested that thrombophlebitis be ruled out, as I was also taking Dysteda and the pain came on fairly quickly. If thrombosis was ruled out, then cellulitis would be good differential.  She became upset when I questioned her diagnosis of shingles. After contesting the diagnosis, she agreed to have a venous Doppler which was negative, and then gave me Augmentin 875 mg one tablet by mouth twice daily for five days. She stated "Rash" on discharge. And denied up until discharge that my soreness, inflammation, induration, and warmth were a reaction to vaccine. I photo documented the site from the night I got home until the ER visit, yet she ignored this information. Now it is 9:29 PM 7/6/12, I have had one dose of Augmentin. The area of induration is confluent, indurated, red and growing, and pain is progressively working its way up my shoulder. This has been a very upsetting experience. I am not concerned with blaming anyone. I am a proponent of vaccinations, but when an adverse event occurs, it is important to document and follow up, which this hospital and physician refused to do. Normally, a CBC would be drawn and the area circled with a surgical marker. This was just a disappointing experience. I will f/u as symptoms progress or heal.
Information has been received from a physician concerning a 16 year old female who on 31-AUG-2007 was vaccinated with a first dose of Gardasil.  Illness at time of vaccination included headache.  There was no concomitant medication.  Fifteen minutes after receiving the first dose of Gardasil she still had a pretty bad headache.  No hospitalization or medical treatment was required.  Additional information has been requested.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a 35 year old male. 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: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
The patient is a 3yo female with a history of eczema and asthmatic bronchitis who developed an epidermal inclusion cyst attributed to vaccine. The cyst to her R thigh professed over a 6 month period after receipt of dose #1 and 2 of HAVRIX, dose #4 PEDVAX Hib PRP-OMP and dose #4 of INFANRIX. Surgeons note states pathology report: 'Right lateral thigh mass-benign reactive tissue with granuloma annulare pattern. Persistent itchy subcutaneous nodules may arise after childhood vaccination secondary to a histiocytic reaction to aluminum, and additive used to hasten the immune response. Deep granuloma annulare-like infiltrates, are one describe histologic pattern.' Aluminum patch testing performed by allergy demonstrated Weak positive results to aluminum hydroxide.
Fever, chills, migraine, nausea, vomiting, excessive sweating, dizziness, exhaustion, soreness on site, large red knot on site, aches.
having a hard time breathing; Started out with the need to constantly clear my throat and then became full on wheezing and coughing; Started out with the need to constantly clear my throat and then became full on wheezing and coughing; This is a spontaneous report from a contactable consumer (patient herself). A 33-years-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186; Expiration Date: unknown) intramuscular, administered in Arm Left on 11Aug2021 09:00 (at age of as 33-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on 11Aug2021 09:30 (about 30mins after) receiving the shot patient started having a hard time breathing. Started out with the need to constantly clear throat and then became full on wheezing and coughing. The adverse event resulted in emergency room visit/department or urgent care. Therapeutic measures were taken as a result of adverse events as patient was checked multiple times within 2 hours. Was told to take inhaler before bed that night. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was recovered on an unspecified date in Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
After administering IMZ, patient leaned over and fell to the ground while on his way to post IMZ waiting area chair.  He fell and was unaware of what had happened.  911 was called and RPh followed instructions.  Patient was speaking to me, but was unaware that he just received IMZ.  After 911 came, patient declined further assistance and was advised by EMS to drink water and sit.
This spontaneous report was received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant medication included DILUENT MRK INJ. On 11-DEC-2018, the patient was vaccinated with an improperly stored dose of varicella VARIVAX injection, lot# N035937 (expiration date: 18-DEC-2019) for prophylaxis (anatomical location, route and dosage details were not reported) (product storage error). The vaccine was reconstituted using properly stored DILUENT MRK INJ, lot# R002209 (expiration date: 03-JAN-2020). Between 10-DEC-2018 to 21-DEC-2018, the vaccine underwent multiple temperature excursions from -14 degree Celsius (C) to -10 degree C for 90 minutes of time frame. The patient did not experience any adverse effects. The call was because of a "data logger". No previous temperature excursion was reported. No product quality complaint (PQC) was involved.
After receving the 3rd additional dose of Moderna patient presented to emergency department with syncope.  Patient was discharged next day.
FLUTTER LIKE PRESSURE; MUSCLE SPASM AND FLUTTER SPASM; PAIN IN THE CENTER OF CHEST; FLU-LIKE SYMPTOMS (CHILLS, FEVER); PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hole in heart, hypertensive, chronic migraine, and murmurs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included paracetamol. On 23-MAR-2021, the subject experienced pain in left arm. On 24-MAR-2021, the subject experienced flu-like symptoms (chills, fever). On 25-MAR-2021, the subject experienced flutter like pressure. On 25-MAR-2021, the subject experienced muscle spasm and flutter spasm. On 25-MAR-2021, the subject experienced pain in the center of chest. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Negative negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasm and flutter spasm, flu-like symptoms (chills, fever), pain in the center of chest, and pain in left arm, and the outcome of flutter like pressure was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
urticaria on chest, trunk, legs, back;bright red papular rash on arms appearing approx 10min p/vax;IgE medicated type I urticarial rxn;lt skin irritable/red;
Patient developed difficulty breathing one week after vaccination but did not seek treatment until 2 weeks after vaccination. She was evaluated with a CT scan that revealed multiple pulmonary emboli. An MRI was performed on the brain to determine whether a stroke had occurred, which was determined to be negative for stroke. Patient was not hospitalized but started on Eliquis immediately (10mg bid x 7 days, then 5mg bid thereafter). She has had many other tests to determine the cause of the PEs including pulmonary exams, stress tests, asthma exams, but no cause has been  determined.
Expired Havrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received HAV (Havrix) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis.   On 08-MAR-2023, the patient received Havrix. On 08-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 8-Mar-2023 A technician called in to report the administration of an expired Havrix dose to 2 patients. The reporter asked if she had to call back the patients in order to re-vaccinate them. Both patients had same initials. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used. The case was linked with case US2023036774, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023036774:Same reporter
Sore arm, sore and swollen arm at the injection site; Sore arm, sore and swollen arm at the injection site; This is a spontaneous report from a Pfizer sponsored program, received from a contactable consumer (patient). The consumer reported similar events for two patients. This is the first of two reports.   A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number was not reported), dose 1, via an unspecified route of administration, administered in arm on 29Jun2021 (age at vaccination: 63-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took flu shot. On an unknown date, the patient had sore arm, sore and swollen arm at the injection site after her Pfizer Covid-19 Vaccine. The outcome for the events was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.
Mother states pt's arm became red and warm to touch at injection site on the evening of 11-14-07. Mother states a large red, warm area on his (R) arm was present in the am on 11/15/07, mother also noted and rash around the red area and took pt to the ER-the ER gave the pt Benadryl and sent home Mother states today 11-19-07 that the swelling, redness and heat is gone.
death Narrative: not thought to be associated with the covid vaccine, had clear other reasons for demise
30APR97 pt reported fever of 101;inj site on rt arm became blistered & weepy;arm also became swollen to elbow & above inj site to arm pit;arm red @ swollen area;13MAY & 14MAY pt became ill w/vomit & diarrhea;pt called MD;
February 10,2021 (about 1030PM) Diarrhea, stomach ache/cramps last through the night and until the next morning.  Thursday morning  up about 05:00AM - sick at stomach, mild headache, body ached all over, freezing cold,  temperature 98.3F, fatigued, slept most all day.  Able to eat granola bar, hot tea-with sugar, (Normally do not take any thing in hot tea or coffee but was craving something sweet. Drank lot of cold water.  Friday morning, sick at stomach, mild headache, body aches all over, freezing cold, Temperature 98.xF, fatigued, again slept a lot of the day.  Ate a home made waffle for breakfast with syrup (Still Craving Sweets), black coffee, (continuation section),
Brief dizzy spell while working from home (staring at computer screen), followed about an hour later (5:30pm) by fever symptoms. Rested in bed and drank water starting at 7:00pm, and took 200mg Ibuprofen at about 8pm. Symptoms had ended by 4:00am.
Patient presented to emergency department on 4/3/21.  Patient had initial COVID-19 infection in November 2020 that was managed as an outpatient with no specific treatment at that time.  Patient reports symptoms at that time were cough, loss of sense of smell, taste.  Patient has since had multiple episodes of pneumonia/bronchitis requiring multiple course of steroids, antibiotics, and inhalers since initial COVID infection in November.  She had worsening symptoms the day prior to this admission. IIn the ED, patient had fever of 103F, chills, sweats, body aches, cough, sats dropped to 60s.  COVID-19 POC test done in ED on 4/3/21 was positive (both PCR tests performed on 4/5 were negative).  Chest Xray shows persistent ground glass opacities in both lungs that have worsened compared to February 2021.  Patient was treated this admission with convalescent plasma, remdesivir, antibiotics, oxygen and steroids.  Patient did improve and was discharged to home on 4/8/21.
Approx. 26 hours, post vax, pt had nausea, diarrhea, abdominal cramping and low-grade fever began. Seen by MD on 4/26/01 at 13:00. Rx'd Pepto-Bismol and had gradual and steady improvement. Completely "better" by 4/30/01. Only site of injection complaint was redness.
This spontaneous report as received from a healthcare worker, refers to an unspecified number of patients of unknown age and gender. On unspecified dates since 02-JAN-2015, the patients were administered an unspecified number of improperly stored doses of PEDVAXHIB (dose, route and lot numbers were not reported). This is one of several reports received from the same source. Additional information has been requested.
18 days after the vaccine I started having a miscarriage. The miscarriage was over 7 days later.
G40.909 EPILEPSY, UNSPECIFIED 6/19/2021 HX OF CEREBRAL VASCULAR ACCIDENT > 8 WKS. I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/14/2021 HX OF CEREBRAL VASCULAR ACCIDENT > 8 WKS. I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 5/19/2021 HX OF CEREBRAL VASCULAR ACCIDENT > 8 WKS. I82.409 ACUTE DVT, UNSPECIFIED VEIN 5/8/2021 HX OF CEREBRAL VASCULAR ACCIDENT > 8 WKS. R09.02 HYPOXIA 5/8/2021 HX OF CEREBRAL VASCULAR ACCIDENT > 8 WKS. G40.909 EPILEPSY, UNSPECIFIED 6/19/2021 HX OF STROKE I63.9 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 3/14/2021 HX OF STROKE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 5/19/2021 HX OF STROKE I82.409 ACUTE DVT, UNSPECIFIED VEIN 5/8/2021 HX OF STROKE R09.02 HYPOXIA 5/8/2021 HX OF STROKE
Patient reported having periodic chest pain after receiving the vaccine. His father took him to the pediatrician and he is being treated for bronchitis
Patient is 9 years old and was scheduled to receive the pediatric dose of 0.2ml but mistakenly recieved  the adult dose of 0.3ml of Pfizer Covid vaccine.  Not reportable adverse reaction has been reported as of this report.  Mom will continue to monitor and report to clinic for any concerns.
Patient was 28 weeks when given her TdaP vaccine.  Her EDD: 12.26.2021 No complications during this pregnancy.
Symptoms started the following day with a headache, body aches and chills for two days, then I started to get what I thought was hives behind my left ear. Within 24 hours, they had moved throughout my hair on the left side of my head. Very itchy. I called the pharmacist that had given me the injection and she said that she didn't think they were hives. She thinks it's shingles based on the explanation I gave her. She said they usually follow a nerve and the ones behind my ear are in a row  like she described. She told me to report this to you.
Received Daptacel and MMR vaccines over the left deltoid with development at 24 hours of severe swelling and redness and mild itching (about 7cm size).  Area spread to inner elbow area in another 24 hours. Child treated with Benadryl and Keflex.
Patient with 2 doses of Pfizer vaccine, last dose February of 2021.  Admitted through ED from facility with hypoxia and dyspnea found to have COVID pneumonia.  Continued to decompensate during stay, requested comfort measures only.  Died on 01/10/22 of COVID related complications.