chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was receiving her flu vaccine and Pfizer Comirnaty booster; patient was receiving her flu vaccine and Pfizer Comirnaty booster; Booster; Passed out; Vomited; This is a spontaneous report received from contactable reporter(s) (Other HCP) via Pfizer sales representative.  A 66 year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OFF LABEL USE (hospitalization, medically significant), PRODUCT USE ISSUE (hospitalization) all with onset 2021, outcome "unknown" and all described as "patient was receiving her flu vaccine and Pfizer Comirnaty booster"; IMMUNISATION (hospitalization) with onset 2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Passed out"; VOMITING (hospitalization) with onset 2021, outcome "unknown", described as "Vomited". After receiving the vaccinations, the patient vomited, passed out, and had to be sent to the hospital.   The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event passed out and vomiting cannot be completely excluded.The case will be reassessed if additional information becomes available.. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Lump, Itchy, Sore for 8 days, then weakness and pain of the arm and limited ability to stretch. Oongoing severly up to today.
got booster shot; bone crushing pain; knee meralgia; knee meralgia, it was really uncomfortable; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation; Bnt162b2 (dose 2, single), administration date: Mar2021, for COVID-19 immunisation, reaction(s): "tinnitus ringing of the ears". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "got booster shot"; BONE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "bone crushing pain"; MERALGIA PARAESTHETICA (non-serious) with onset 2021, outcome "recovered" (2021), described as "knee meralgia"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2021, outcome "recovered" (2021), described as "knee meralgia, it was really uncomfortable".  Additional information: It was reported that bone crushing pain and patient's knee meralgia was really uncomfortable was experienced for 36 hours. The patient reported that the third one (booster dose) was so "ridiculous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 2-3 sec later devel papular eruption @ arms-trunk;wheezing-adrenalin given transported to hosp
Wrong route of administration; big red swollen bump at injection site; big red swollen bump at injection site; big red swollen bump at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 23rd February 2019, less than a day after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site swelling, injection site erythema and injection site lump. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site lump were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site lump to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix subcutaneously, which led to incorrect route of vaccine administration. The patient developed a big red swollen bump at the injection site that went away after 3 days.  The pharmacist did not know the lot number or expiry date.  The dose was given at a different pharmacy.
R MCA acute ischemic stroke symptom onset 12/12 1115AM, was outside time windows for tPA upon arrival to our center Underwent IR for thrombectomy.  NIHSS 11, left sided weakness, facial droop, slurred speech
Woke up dizzy, upper arms hurt to the bone, by afternoon hurt to try to raise them. Has hurt ever since, dizzy everyday, general sick feeling, passed out in class on a dizzy spell.
Patient claims to have previous neurological conditions indicates he does not feel strength in the lower extremities and feels dizzy. It is taken s/v and it is instructed to remain seated resting initial patient who has no strength and is taken in a wheelchair to the vehicle of his mother.
Pt recvd mumps vax & several wks following vax pt devel pancreatitis; no further details were provided;
The first symptoms that I had were chills and a fever of 101 degrees. On the second day I had no fever, I tested positive that day as well. I developed cough and fatigue. Those symptoms stayed with me until 03/21/2023. The cough resolved to normal. The fatigue lasted through the 03/26/2023. I didn't take any medication for my symptoms. I did not seek medical care at all.
Severe swelling, continuing pain which has climbed from shoulder to neck. Trouble raising left arm to shoulder height. My nerve pain by shot.
Flu symptoms: Muscle aches, nauseous, fever of 101 F, itching. Rash started on 12/19/2011. Rash is on stomach, back and a little on both legs. Most symptoms resolved except rash.
25 doses of expired Moderna Covid-19 vaccine were administered to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received Moderna Covid-19 vaccine as booster dose. The vial was initially stored in the refrigerator on 29 Apr 2022 and 04 May 2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
Headache, chills, body aches, dizziness, nausea, and low grade fever.
This spontaneous report as received from a 18 year old female consumer with allergy to "SULFA" refers to herself. No concomitant medication were reported. On 17-DEC-2013 the patient was vaccinated with second shot of GARDASIL lot # J006850, intramuscular for prevention of HPV. On 17-JAN-2014, the patient experienced genital warts. Patient sough medical attention: on unknown date her physician used acid and another unknown substance that freezed the warts for removal. The outcome of genital warts was reported as not recovered. Lab diagnostic studies included pap smear (date and result unknown). The patient did not complete the series of GARDASIL. No adverse effects were reported with first dose of GARDASIL. Relatedness between genital warts and GARDASIL was not reported. Additional information is not expected.
COVID-19 Vaccine EUA; On April 22 around 6pm, I felt dizzy when I was eating. So, I stopped eating and got rest and that made me feel better. April 23  to April 28, the dizziness comes and goes during the day each day. Mostly, it comes when I eat, and I feel like my head are heavy sometimes. I seen a doctor about the dizziness on April 26 and he ordered a blood test for me, and the result came back normal. I felt better on April 30, less dizzy.
Patient seen at travel clinic & received 3 injections, Hep A, Typhoid & Yellow Fever, while lying down. 5 min passed & she felt fine. She walked to the cashier, stated she did not feel well & passed out. She was assessed by a physician, given cranberry juice & monitored by nursing before allowed to leave.
Muliple segmental and subsegmental low risk pulmonary embolisms presenting with dyspnea and hypoxia. Succesfully treated and patient on treatment with a DOAC
Informatin has been received from a physician's office concerning a 36 month old male patient who on 05-APR-1997 was vaccinated with on dose of VARIVAX vaccine. On 06-DEC-1997 the patient experienced chickenpox with "approximately 20 to 25 lesions". No further information is available.
The arm where the vaccine was injected is very itchy. The injection site is swollen, red and hard and is painful. It gets better with antihistamine (hydroxizine) and Tylenols.
p/vax pt had T102 next day;pt spiked T105 & had generalized sz;seen in ER & no focal findings;
No further adverse events; Doses administered during temperature excursion; This spontaneous report was received from a office manager (who was a clinical manager and also a medical assistant) and refers to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 18-MAR-2022, improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) syringe (lot#U018309 and expiration date:08-JAN-2023) (dose, route of administration and anatomical location were not provided) was administered to the patient for prophylaxis (product storage error). No additional adverse event was reported.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA007589: US-009507513-2204USA005263:
Patient experienced redness and at the injection site; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included influenza vaccine for immunization. The patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)and flu vaccine concomitantly in separate arms. The patient experienced redness and at the injection site. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Had stiffness and pain radiating from site up to jaw and into wrist. Difficult to open mouth immediately after injection. They sent me to doc on site and applied ice. After 29 minutes symptoms started to subside. By the evening pain moved across back of shoulders blades. Increased headache with chills and alternating fever. Could not sleep due to pain. Next morning,today. Had abdominal pain cramping and diarrhea.  Unable to sit up or walk much due to weakness and feel will pass out.
Body aching, fever, extremely weak, vomiting, muscular twitching, did not seek revisit clinic due to ill state and fear of driving.  Called clinic and said they could not assist to either come in for a visit or call 911.
Patient began having spells lasting up to 2 minutes during which he would turn blue and have shallow and labored breathing. Spells have happenned in clusters of 2 or 3 and the clusters have been 5 to 7 days apart. Patient unresponsive to slightly responsive and usually falls into a deep sleep for an hour afterwards. He has been in the hospital 3 times for 12 full days. He was treated for reflux with Prevacid and Reglan on the last hospital visit. After that he did not have another episode for 16 days, and then had two. He will soon be admitted into another hospital for further observation. He is now 3 1/2 monthes old at the time of this report.  Nurse follow up on 06/18/04 states: "Delete: GI DIS NOS ADD: Reflux ADD: cough ADD:conjunctivitis ADD: mild URI "  Nurse follow up on 06/25/04 states: "ADD: presumptive GERD, laryngospasm, respiratory distress."  Nurse follow up on 06/16/04 states: "Apnea."
2/22 presented to ED with chest pain. Admitted to ICU. CT/ECHO  found pericardial effusion of right atrium. Patient stabilized and was discharged 2/25. hospitalizations are to be reported irrespective of attribution to the vaccine.
Information has been received from a RN concerning a 35 month old female child with no medical history who on 25Apr03 was vaccinated in the left arm with her first dose of varicella virus vaccine live (lot 641787/0758M). Concomitant vaccinations on that same day included her second dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 640790/1378L) which was given in her right arm. There was no illness at the time of vaccination. On 08Mar2005 (reported as 2004) the pt broke out in chickenpox. No lab or diagnostic studies were performed. It was reported that the pt still had the chickenpox. Additional information has been requested.
After about 6 hours of no symptoms, I began to feel very drowsy.  Then extreme nausea.  Shortly there after I began to shake very violently.  I wife had to lay on me to help get the shaking to stop.  I put myself to bed, and had a fever and sweats all night.  The next day I was very tired, and my muscles ached.   I went to bed very early that night, and seem to be fine now.  Blood type B+
he reported fever, vertigo, weakness, chills, lethargic, no appetite that started less than 24 hrs after shot and Lasted about a week.
My arm was immediately sore and was sore for a week.  Within a few hours from the vaccine being administered I was tired, hands and feet very cold, chills, headache and a fever.   This lasted for 3 days.  I was and am still fatigued and it has been 2 weeks since my vaccine.  On Friday, April 9, 2021  (8 days after vaccine) I woke up with a sore throat and a swollen gland in my neck on the right side (side of my injection).  The sore throat and my swollen gland is starting to subside on Day 14.  Throughout these whole 14 days I have had hot and cold "flashes" and while I already have anxiety my anxiety has been much worse (feeling of a pounding heart) since the vaccine.  It is not my normal anxiety.  On Day 11, Tuesday April 13, 2021 I woke up with a black spot on the right side of my chin closer to my bottom lip.  It does not hurt, not raised and it is just a black spot.  It is still there on Day 14 and slowly starting to fade but not by much.
I had an anaphylactic reaction.  Couldn't breath, pharmacist placed cold water bottle on my neck.  They called 911, but it subsided after about 5 min.  EMT's checked me out and I went home.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EH9199) via an unspecified route of administration in left arm on 26Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown.
needs to take pain medication after the covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "needs to take pain medication after the covid-19 vaccine".  Additional Information: Patient had a familiar who need to take pain medication, she stated this was not related to a side-effect of the vaccine. They would like to know why immunity last longer in people who had Covid-19 than in people who only received the Pfizer-BioNTech Covid-19 vaccine. They stated that anything documents if they were going to have a booster (a third dose). She hadn't had the vaccine yet because there are many rumors. They stated that people who had covid-19 prior to the vaccine were protected up to 9 months or a year and people who received the vaccine but didn't have covid-19 prior to vaccination have a shorter protection time against Covid-19 (3 months), she also said that people who had Covid-19 and then the vaccine were getting very sick sand this were not happening with people who did not have covid-19 and received the vaccine. They said a familiar needs to take pain medication after the covid-19 vaccine however this were not related to a side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
parent reports complaints of headache and muscle aches, and fatigue by child since immunization.  Exam unremarkable, treatment recommended - observation. vaccine not admistered at this office.
11:00AM constant sneezing 4-5 hours, then  chills  and headache, loss of appetite; at night fever, intense night sweating, body aches, nausea, shoulder pain. Weakness next day in AM.   All symptoms have  resolved today, injection site redness only.
headache; muscle and joint ache; nausea; chills; fever; fatigue; A spontaneous report was received from a consumer concerning a unknown patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who experienced effects and till today fever, fatigue, headache, muscle and joint ache, nausea, chills.   The patient's medical history,is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 24/Jan/2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) for prophylaxis of COVID-19 infection.    Experienced fever, fatigue, headache, muscle and joint ache, nausea, chills.   No lab data I reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, fever, fatigue, headache, muscle and joint ache, nausea, chills, were unknown.   The reporter did not provide an assessment for the events, fever, fatigue, headache, muscle and joint ache, nausea, chills.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
This patient advised she received annual influenza vaccine on 10/27/2016 to left deltoid. She reported while walking out of clinic her arm was itching and site burned where Band-Aid was applied so she immediately removed thinking it was the Band-Aid (has allergy to latex, but clinic advised using latex free Band-Aids). Over the next hour the tingling burning sensation continued down her arm to fingertips. 2 hours later the vaccine site was swelling and was extremely painful to touch 10/10. She said her index and pointing finger went numb first then progressed to all fingers/thumbs and her fingers looked swollen to her. She had a friend drive her ER but stopped at urgent care as pain was progressing up the left side of her neck and down into her chest and her lips/tongue were tingling. She said she could talk and had no issues breathing at this time. On arrival to urgent care she had to contact insurance for medical clearance (insurance requirement) advising her tongue was now swollen and she was having difficulty swallowing, she could not speak clearly. Once cleared, she was taken immediately to back where providers treated her with epi, IV steroids and discharged 4 hours later with 4 days of oral steroids. This is day 1 post vaccine and her arm still burns with tingling in arm/not fingers, is slightly swollen at vac site but there is no site redness.
From faxed correspondence received at manufacturer on 9/13/02, it was reported that a 15 year old male was vaccinated with first dose of Td in the right deltoid on 8/8/02. Lot number is V0530AA. Within 24 hours after vaccination, patient developed tenderness and swelling inferior right arm extending from axillary region distally towards elbow, no redness noted. Swelling extended down lateral right chest wall just beneath the posterior axillary fold. Patient complained of decrease strength in lifting right arm. No numbness of extremity or digit. Reactions lasted for 2 weeks then relapsed with same symptoms 14 days later. Positive axillary adenopathy. From faxed correspondence a clarification on lot # was received. Lot # is U0530AA.
this is to report of COVID vaccination errors. Patient received  his 1st dose of Moderma COVID vaccine on 8/20/2021, On 9/17/2021, when nurse was administering the 2nd dose to him, failed to ask him what type of COVID vaccine he received for as first dose, therefore, he received his 2nd dose of COVID vaccine as the Pfizer one.  no an advise reaction occurred to him so far as I am submit this report
When I woke up on 12/18/2021 (the day after my booster), I felt very fatigued. As the day went on I developed a very low-grade fever that lasted about 12-14 hours. I had developed a very large, red, swollen lump at the injection site (maybe 3" in diameter) that was very sore to the touch. As the day went on the discomfort at my injection site migrated into my arm and underarm area. The lymph node in my under arm area on my left side also felt swollen. I noticed that I lost some strength in my left arm due to the pain/swelling. Approximately 24 hours after my booster I did experience some body aches (mostly in my left arm and left side of my body). By 12/19/2021 most of the symptoms had subsided and the only remaining side effect was (and continues to be at the time of this submission) discomfort/pain at the injection site and my underarm area. It has decreased in intensity, but it still there.