chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cough; barely keep anything down; chills; feels weak; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6207), via an unspecified route of administration on 16Mar2021 at 16:00(at the age of 61-years-old) administered in Arm Left as a single dose for COVID-19 immunisation.  Medical history included ongoing high blood pressure; ongoing blood cholesterol increased. Concomitant medication(s) included simvastatin taken for blood cholesterol increased from an unspecified start date and ongoing; hydrochlorothiazide, telmisartan taken for high blood pressure from an unspecified start date and ongoing. On 16Mar2021, the patient experienced chills, feels weak, barely keep anything down. On 18Mar2021, the patient experienced cough. It was reported that He had his first injection on 16Mar2021.He is still having chills, feels weak, and now he has a cough. He read on the information sheet that he should call his primary health care provider and he tried calling them but he isn't able to be seen until this Friday, 02Apr2021 and he is asking if there is anything else he can do or anything he can take. He reports before he had the Covid 19 vaccine, he was around someone who tested positive for the Covid 19 virus. He had to get 2 Covid 19 rapid tests and they had to be negative, then he was able to get the Covid 19 vaccine. After he had the Covid 19 vaccine he started having chills and he could barely keep anything down. He did what the information sheet said, he called his primary health care provider and he wasn't able to get in contact with her, so he went to an urgent care this past Saturday, 27Mar2021. The urgent care tested him again for the Covid 19 virus and that test was negative. Urgent care told him to reach out to his primary healthcare provider. He won't be able to get in with his primary healthcare provider until Friday, 02Apr2021.When probing for specific event details he reports he started having symptoms that night after he received the Covid 19 vaccine on 16Mar2021. He received the vaccine at about 4:00PM. When speaking of the caller not being able to barely keep anything down he says he's tried to eat small portions but that's all he can do. That started on the day of the Covid 19 vaccine. He's not sure if it was just because he got the vaccine or he had a nice sized lunch before the vaccine. The patient had no History of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date with the Pfizer vaccine considered as suspect. The adverse event did not result Emergency Room visit. The patient was visited to Urgent care on 27Mar2021 for the events. The patient did not experience any adverse event Prior Vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Mar2021.The outcome of the events was not recovered.    No follow up attempts are possible. No further information is expected.
Patient diagnosed with covid-19 on 9/30/2021 and sent by PCP's office with hypoxia.  Patient had cough and received monoclonal antibody infusion on 10/8/2021. Patient completed steroids on 10/9/2021 and had worsening SOB on exertion.
My menstrual cycle was delayed 7 days!  Not sexually active, with consistently 27 day cycles.  I have charted my cycles for 17 YEARS.
A non-serious spontaneous report of patient was given expired H1N1 yesterday was received from a health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 04-Feb-2010, the patient received expired H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Increased erythema, induration and tenderness (R) deltoid (site of injection).
brief, self limited sz assoc w/fever 40.8 approx 8hr p/vax;tetramune & MMR ? related;
approx 2yrs p/vax pt exp chickenpox rash w/8-10 lesions. no further info avail
BREAKTHROUGH INFECTIONS; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned multiple patients (exact number unknown) of unspecified age, sex, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient's(unknown number of individuals) received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose, start therapy date were not reported, frequency time 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, reporter was aware of a number of individuals that had breakthrough infections and suspected clinical vaccine failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the breakthrough infections and suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190135 This case, from the same reporter is linked to 20210837634.; Sender's Comments: V0 20210843298-COVID-19 VACCINE AD26.COV2.S-breakthrough infections. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0 20210843298-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Pregnancy- due July 5,  2021; rash on left arm around injection site. Has been itchy for a week but noticed rash in morning on 1/27/21. Redness in oval shape. About 4-5 inches across.
nauseous; tired and missed work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; FATIGUE (non-serious), outcome "unknown", described as "tired and missed work". Additional information: Caller States that he received 1st dose of Covid vacccine and that night he was nauseous and the next day he was tired and missed work. His 2nd dose is 16Mar and he is wondering if he can reschedule for a day earlier so that he does not miss work as he heard the 2nd dose will make him feel worse than the 1st dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs; expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported.  On 01-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, expiry date reported as 08-JAN-2023, once (dose, lot#, route of administration and anatomical location were not provided) as prophylaxis.   Therefore, expired dose was administered to a patient (Expired product administered). No additional adverse events (AEs) reported.
Information has been received from a physician concerning a 65 year old female patient with high blood pressure, with allergic reaction to erythromycin and a history of cerebrovascular accident who on 30-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665532/0711Z) (Expiration date: 29-APR-2011). Concomitant therapy included MICARDIS, WELCHOL and AGGRENOX. The physician reported that a patient called the office on 02-AUG-2010 to report after receiving ZOSTAVAX (Merck), she experienced flu like symptoms, fever, chills and vomiting that started on approximately 30-JUL-2010 (over the weekend). On 02-AUG-2010 the patient recovered from flu like symptoms, fever, chills and vomiting. Additional information has been requested.
suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tiredness she could hardly walk; muscle aching; Joint pain; felt very sick and couldn't really function; could hardly walk; stayed in bed all day; This is a spontaneous report from a contactable (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:00 (Batch/Lot Number: GL9269) as single dose, dose 1st via an unspecified route of administration, administered in Arm Right on 21Jan2021 (Batch/Lot Number: el8982) as single dose for covid-19 immunization. Medical history included apnoea from 2019 to (Verbatim: Apnoea, Diagnosed 2 years ago) , hypertension ( Verbatim: Blood pressure high, diagnosed 15-20 years ago). The patient's concomitant medications were not reported. Family Medical History Relevant to adverse event was none. On 10Mar2021 the patient woke up to a big reaction. The patient had exploding diarrhea, extreme tiredness she could hardly walk, muscle aching, joint pain, felt very sick and couldn't really function, she stayed in bed all day, got better in the late afternoon. It was as if the patient had covid, then it disappeared. The outcome of the events was recovered.
Administered to a 6 year old child; Administered to a 6 year old child; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33AT7, expiry date 7th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th May 2022, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 9th May 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and adult product administered to child. On an unknown date, the outcome of the wrong vaccine administered and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 9-May-2022 Additional Supportive Information: The 6 year old patient was administered with Boostrix, which led to wrong vaccine administered and adult product administered to child.
22SEP93 pt recvd vax around noon; had brief uncomplicated febrile sz that evening; t102;
Information has been received from a registered nurse concerning a 5 year old patient with no know allergies who on 08/14/2001 was vaccinated with a first dose of varicella virus vaccine live. Concomitant therapy included levothyroxine NA (LEVOTHROID). On 08/27/2001, the pt developed a large localized welt at the injection site and a mild fever which was treated with acetaminophen (TYLENOL). On 09/01/2001, the pt developed a generalized diffuse rash with itching began on the trunk and spread to other parts of the patient's body. No vesicles were noted. On 09/04/2001, the pt was seen in a physician's office and treated with diphenhydramine hydrochloride (BENADRYL), as needed. As of 09/06/2001, the pt has not recovered from the papular rash and itching. Additional information has been requested.
Received MMR, DTAP, IPV~10 min later started to sneeze, itchy scalp. ~ 30 minutes later was covered with hives. Never developed wheezing, vomit, etc. Resolved after Benadryl. No known food or medicine allergies. Eats eggs alot.
Two weeks after the vaccine I had a rash on my arm. It was at the site of the injection site and radiated out to my whole upper forearm. It was a little painful. It was one large area of redness. It lasted two or three days.
Right arm sore after first shot on 3/30/21, but better after a few days.  Received second shot on 4/20/21, also in right arm.  Soreness was worse after 2nd Covid shot but diminished within a week.  Problem is that anytime since, when patient has been actively using his arms more than briefly, they have gone weak and he has had to stop and rest them in a lowered position.  This occurs during such things as painting, picking fruit; even fishing.  (Both shots were in the right arm but both arms/shoulders experience the weakness the same.)  Patient has been a carpenter/handyman all his life and has never experienced this before.
This is a spontaneous report from Pfizer sponsored program. A contactable female consumer reported for herself. This female patient of an unspecified age and ethnicity receive PREVNAR 13, via an unspecified route of administration on an unspecified date '5 years before reporting' at single dose for pneumonia immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated that had asthma and it turned into bronchitis and got deathly ill after the shot, on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
pt recv vax 7SEP96 & 2 days later pt exp a neuritis around the scalp area;
The most pronounced symptom is fatigue, I'm feeling quite fatigue and headache. No fever on Sunday, fever on Monday and Tuesday. I do also have a runny nose. I am not taking any antivirals due to kidney toxicity with the Paxlovid.
There were two adverse events.   #1 The next morning when I woke up (3/9/2021), I had two large blisters just below the nape of my neck.  When I touched them, they burst.  They were extremely painful and took several weeks to heal.  The area was painful or sensitive for several months.  #2 I don't know if this event was related or not, but VSafe called me and told me to file a VAERS report...  On March 20th, I experienced an incident where I had crackling in my throat (I could hear a sound like crumpling cellophane), I had trouble breathing.  I just couldn't catch my breath and couldn't take a deep breath.  My heart was racing.  I used an inhaler, but I didn't think it did anything at the time.  Just when things started going black, I told my husband to call an ambulance.  I sat down on the bed and the darkness receded.  I don't know if the inhaler worked or if my adrenaline kicked in...  but I felt a little better, but still had trouble breathing, so we went to the Emergency Room.
has been having ear problems "1 ear feels like it is half deaf"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 17Sep2021, for Covid-19 Immunization. The following information was reported: HYPOACUSIS (non-serious) with onset 2021, outcome "unknown", described as "has been having ear problems "1 ear feels like it is half deaf"".  Additional information- The patient had ear problems. The patient 2nd vaccine was administered beyond the 21 day advisable limit. The patient also wanted to know where his specific vaccine was produced and was looking for the lot number.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash at the injection site with a slight raised area at the center; Rash is red and slightly itchy; Soreness at injection site; This is a spontaneous report from a contactable consumer, the parent. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 01Apr2021 at 13:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal hay fever, eczema and allergy to metals such as nickel. Concomitant medications included norethisterone acetate, ethinylestradiol (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) from an unknown date as birth control. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 01Apr2021, the patient experienced soreness at injection site the day of injection and the day after. The patient had no other side effects. On 09Apr2021 at 09:00, the patient experienced a rash at the injection site with a slight raised area at the center. The rash was red and slightly itchy. The rash was approximately 1.5 by 1.5 inches. The patient did not experience any other side effects (as reported). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event soreness at injection site, rash at the injection site with a slight raised area at the center which was red and slightly itchy were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Extra dose of Hep A vaccine was given. Advised Dr no further action require. Spoke with mom and was advise, as per mom patient is doing okay and has no symtoms.
Flu shot given 29Oct02 in right arm, was hurting for a couple of days and then wasn't noticed for a couple more days and then the pain returned. The pain has lasted until this date. Also as of last night a bruise on the forearm about 8inches long and 3inches in width appeared.
Admitted for strengthening after hospital stay for RVR but had worsening dyspnea on 7/22/22 and tested positive that day. Treatment includes medication, CXR, and labs.
5/13/2023 - 5/19/2023 (6 days)  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness  Fall, initial encounter  COVID-19 virus infection COVID-19    HOSPITAL COURSE: Patient is a 70 y.o. male with a PMHx of DM type II, Depression, GERD and hx of gastric ulcers who presented to the ED due to weakness. In the ED, vitals signs and labs were stable. CXR without acute process. Resp film array resulted positive for COVID-19. He was unable to ambulate in ED therefore requested admission for placement.    On admission he remained stable from a respiratory standpoint. During admission he was noted to have SVT. This was not corrected with vagal maneuvers or adenosine. Cardiology was consulted and patient underwent TEE with cardioversion. Suspected underlying rhythm was aflutter with RVR. Eliquis was started. He was also noted to have reduced ejection fraction during procedure so limited echo was repeated before discharge. Limited echo showing EF 40% with akinesis. Cardiology recommended a repeat limited echo in 1 month, 2 week Ziopatch and he was continued on Eliquis. He was seen by PT/OT who recommended home with home health and therapies. He was discharged in medically stable condition.
Affected deltoid ached from right away after getting injection. Pain continued to increase for several hours until the next morning. Pain still present but mild 1 month later. Patient complaining of difficulty at times moving arm from flexed position to extended position.
No adverse event by patient. Reporting that Zoster was inadvertently given instead of Varicella. Patient had not had any Varicella before.
Information has been received from a physician's assistant concerning a 15 year old female patient with no medical history and no drug allergies who in approximately August 2009, "about a month ago" was vaccinated with the first 0.5mL dose of GARDASIL intramuscularly. Concomitant vaccine administered on the same day included hepatitis virus vaccine (unspecified). The patient experienced syncope immediately after vaccination. There were no lab diagnostic studies performed. The patient recovered within 15 minutes with no additional problem and was able to leave the office. Follow-up information received from a registered nurse indicated a 15 year old student with no illness at time of vaccination but had reported that the patient had stayed up all night and no pre-existing allergies, birth defects, medical conditions who was vaccinated IM with the first dose of GARDASIL (Lot # 662300/0100Y) at left deltoid on 20-AUG-2009. On 20-AUG-2009 the patient had syncope for 3-5 seconds. She was placed in Trendelenburg position on 20-AUG-2009. This is one of several reports from the same source. Additional information is not expected.
After the 4th dose I started getting severe night sweats and sweating profusely all day ling for no reason. I went to the Dr. and he thought it was menopause. It came out nowhere. A few weeks later I started having tingling in my hands and feet and my right eye started twitching constantly.
This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Non-painful Rash x 3 days since date of occurrence on 1/21/17.
Information has been received from a nurse practitioner concerning a female patient with migraine headaches and mild Tourette's disease who was vaccinated with the first dose of GARDASIL at her unspecified gynecologist's office. Concomitant therapy included HALDOL and AVIANE. Subsequently the patient developed intermittent palpitations, fatigue and lightheadedness after the first dose of vaccine. The symptoms worsened and became more persistent after the patient received her second dose of GARDASIL. The dates of administration of the doses, as well as the date of onset of the symptoms, was unknown. The patient was examined in the office on 28-SEP-2009. An EKG and thyroid function tests were normal. A Holter monitor has been scheduled. At the time of reporting, the patient had not recovered. Additional information has been requested.
Chills, Nausea, Vomiting, Feeling unwell, overall Body Aches
Woke up at 3am with a with blood curtailing screaming. From that point on had high blood pressure, refused to lay down, when he finally could not stay awake he would stop crying and "rest" standing up in his crib. Just fyi this is a baby that has slept through the night since 3 months and napped like clock work! This was definitely from these shots. The worst part is u make kids get so many at once, which one did this???