chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Light tingling in my head - super weird; Light tingling in my head - super weird; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration in left arm on 20May2021 at 07:00 PM (at the age of 36-years-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. No known allergies. the patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient received Bunch of vitamins within 2 weeks of vaccination. Nothing terrible, but within seconds to a few minutes after getting the first dose on 20May2021 at 07:00 PM, I noticed light tingling in my head - super weird. Not a big deal, but interesting and I thought this info may be valuable. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The report was non serious. Outcome of the events was unknown.  Information about lot/batch number has been requested.
This is a spontaneous report from a contactable nurse (medical assistant) on behalf of the physician. A 65-year-old male patient received PREVNAR 13 with NDC number: 0005-1971-02, lot number: X35262 and expiry date: Oct2020, intramuscularly at the right deltoid in the physician office on 11Mar2019 09:30 at 0.5 ml, single for immunization, and VITAMIN B12 (manufactured by American Regent) with lot number: 8131 and expiry date: Mar2020, intramuscularly at the left deltoid from 11Mar2019 to 11Mar2019 at 1 ml, at an unknown frequency for an unspecified indication. The patient's medical history included ongoing hypertension, ongoing hyperlipidemia, ongoing diabetes, and ongoing enlarged prostate; the patient takes medication for all of these. There were no concomitant medications. On 11Mar2019, the patient experienced itchy, swollen rash at injection site that moved down arm. It was reported that the doctor prescribed AUGMENTIN for treatment of the itchy swollen rash. The pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was administered on 11Mar2019 and the patient called today (18Mar2019). The patient thought the rash would go away but it did not so he ended up coming into the office today around noon to report the rash. He made an appointment for follow up on 15Apr2019 and she told the patient if his symptoms happen to get worse they will see him at the office sooner than 15Apr2019. This was the patient's first time receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The patient received vitamin B12 the same date (11Mar2019). The patient comes in every month for Vitamin B12 since Apr2015. The patient has been a patient of theirs since 2008. Therapeutic measures were taken as a result of itchy, swollen rash at injection site that moved down arm includes amoxicillin/clavulanate. The action taken in response to the events for cyanocobalamin, and outcome of the events were unknown.
Redness, swelling, warmth to injection site= 4CM, headache, body aches and localized injection site pain and itching.
Muscle Pain, muscle aches mostly in arms and legs. (The exact reaction I had to statin drugs)
Horrible fever, chills, and feeling of dread. Very weak muscles, sore muscles, and overall general weakness. Chest tightness and high heartbeat that felt like I was going to have a heart attack.
chills, t101, aching & rash on upper abdo, trunk & face 6-12 hrs p/inject; looked like a bad sunburn;
Vaccine was administered at 12:10pm The patient was observed for 15 minutes and sent over to her oncologist for an appointment. A CT scan was ordered- CT done (no contrast)  in the same building with daughter transporting. Daughter states mother became unresponsive after CT scan. She alerted the doctor and staff who responded. They moved her to an exam room. Noted agonal breaths on vital signs. CPR started. CPR stopped shortly after per the families request. Death pronounced at 2:34pm.
Unilateral Bell?s palsy. Onset was 9.12.21.  2nd dose of Pfizer vaccine was August 10th so she is about 4 weeks out CHIEF COMPLAINT:  NUMBNESS and FACIAL DROOP Assessment/Plan -  DIAGNOSIS at time of disposition:  1. Bell's palsy  MEDICAL DECISION MAKING Supervising Physician: Dr.  This is a 13-year-old previously healthy female presenting with 5 hours of complete left-sided facial droop without any other associated symptoms.  Patient is very well-appearing in no acute distress upon arrival with normal vital signs.  Patient has a GCS of 15, A&O x4.  Patient does have complete left-sided facial droop including the forehead making this most consistent with Bell's palsy and not a central neurologic process such as stroke.  Patient has no other neuro deficits on exam.  I did speak with Neurology who agreed with the diagnosis and advised on 1000 mg of Valtrex 3 times daily for a week and prednisone burst with taper over total of 10 days.  Patient was given 1st dose of both these medications here in the emergency department.  Patient will follow up with Neurology in 4-6 weeks.  Patient is also unable to fully close her left eye and therefore was given eye drops, eye gel for night and a eye patch which she was advised to wear while sleeping.  Dad was agreeable with this plan patient was discharged home in stable condition. Medications valACYclovir (VALTREX) tablet 1,000 mg (has no administration in time range) glycerin-hypromellose-PEG 400 (ARTIFICIAL TEARS) ophthalmic solution 1 drop (has no administration in time range) predniSONE (DELTASONE) tablet 50 mg (50 mg Oral Given 9/12/21 1536)
The next morning, I woke up with stiff and sore neck and that lasted for a couple of days. I took arthritis strength Tylenol every 8 hours for a day and a half and the pain went away. But then for the next two weeks I was having muscle aches in my legs. Like a general achiness in my lower legs. That persisted for another week and a half in different intensities. I also felt queasy off and on for two weeks, maybe every other day, and gradually diminished.  There were a couple of days immediately after the neck pain went away that I felt quite fatigued.
8/13 - Vaccine given at 11 am - 8/14 - Late afternoon felt "ill", headache, tired, no fever, noted redness and swelling at site - 8/15 - No energy, arm was sore - 8/18 - Called clinic, redness, swelling, warmth - started BACTRIM - then redness improving, swelling same - 8/21 - Woke up with numbness/weakness (R) arm.
Pt had GTC sz at 9:00 PM about 1 min and sz at 11:00 PM, went to ED. Pt was admitted for complex febrile sz follwing vaccines. Discussed the importance of preventing the fever from rising quickly, so when there is the first sign of a fever, mother should start measures to cool patient down.  This includes providing antipyretics. Acetaminophen and ibuprofen can be alternated up to every 3 hours if fever does not subside.
Expected arm soreness 24 hours after injection.  Following days without any adverse affects.  Day 7 (12/29/20) injection site was noticeably red with defined perimeter, sore, and slightly itchy.  A "knot" can be felt at injection site.  Symptoms persisted throughout the night and into day 8 (12/30/20, today).
I had chills and was exhausted the next day but I expected that.  I'm writing now because I have what i see is being called "Covid arm."  I have a mild red rash around the injectcion site that is a little itchy and is still sensitive when touched, 5 days later.
Per mom patient experienced change in attitude, behavior and personality lasting over the last 1 year+.  Woke up with night terrors and was aggressive in behavior, no longer happy.  Mom attempted to report this to her child's PCP and they refused to report.  I assured mom I would report this as requested.
Husband tested positive for Covid/ feeling awful, achy all over, nauseous, coughing; they both got really sick; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Medical Information Team.  An adult male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as DOSE 1, SINGLE (lot number: HG4680) for COVID-19 immunization; for COVID-19 immunization. The patient's relevant medical history included: "exposed to a friend with Covid", start date: 05Oct2023, stop date: 05Oct2023, notes: on Thurs (the day before Covid shot). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 07Oct2023, outcome "unknown" described as "they both got really sick"; COVID-19 (non-serious) with onset 09Oct2023, outcome "unknown" described as "Husband tested positive for Covid/ feeling awful, achy all over, nauseous, coughing." Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter (patient's wife) and her husband were exposed to a friend with Covid on Thursday (05Oct2023).  They got the Covid shot the next day on Friday (06Oct2023).  They usually get Moderna, but they were out of Moderna, so they got the Pfizer Covid vaccine.  Then they both got really sick, Saturday (07Oct2023).  Her husband tested positive for Covid this morning (09Oct2023).  She has taken two home Covid test and has been negative twice.  She was feeling as awful as he was, achy all over, nauseous, coughing. Reporter asked, "Is coughing a side effect of the Comirnaty 12+ 2023-2024 vaccine?"   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
death; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced death on an unspecified date. It was reported as what chemicals are in it that killed my mother. The patient died on an unspecified date.  It was not reported if an autopsy was performed. Case was reported as serious medically significant.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: death
Discharged. 79yo man with a history of parkinsons, CKDIII, HTN and anemia here with covid infection, weakness and intractable diarrhea. He was given fluids and admitted to observation. He did well with imodium and diarrhea stopped. PT/OT worked with the patient and stated home with assist. Hospital set him up with care for HHC. He was discharged to home in stable and improved condition.
Suspected vaccination failure; mild case of shingles; This case was reported by a consumer described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 9th March 2021, 771 days after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follow: The case was reported by the patient herself. The age at vaccination was not reported. The reporter stated that she took the Shingrix vaccine about 2 years prior to the report and was now experiencing mild case of shingles at the time of reporting. The reporter would like to know if she could or need to get the vaccine again. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming herpes zoster were unknown. The reporter did not consented to follow up.
The pt experienced a rash on the abdomen, spots on left and right thigh above the knee, numbness. Treated with over the counter Benadryl.
a patient received Fluzone High Dose at the age of 57, no AE; a patient received Fluzone High Dose at the age of 57, no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 years old patient (gender not reported) who received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ242AA, expiry date: 04-May-2020, via intramuscular route in left arm on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant treatment was received.  It was of actual medication error due to overdose and inappropriate age at vaccine administration.  It was reported that, no adverse event was observed.  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 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.  List of documents held by sender: none.
Wrong Dose Administered.  Pfizer multi-vial dose was not diluted with saline prior to administration.  Patient received the 0.3 mL IM in L thigh, tolerated well at time of administration. No noted adverse event at time of admin.
Pt recvd 2nd DTP/HIB/OPV w/in 30 min devel inconsolable crying which persisted x 3 1/2 hrs; Mom gave APAP; Pt observed x 1 hr then became alert, playful, smiling & took formula;
Information has been received from a 25 year old female with a history of allergy to medications in the "Neomycin family" who at the age of "4" was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Marketed in the US in 17-MAR-1995). In approximately July 2006, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 17-JUL-2006, the patient developed injection site swelling and redness. The patient reported she was unsure how the vaccine was administered. The patient also developed fever, diarrhea, pneumonia and enlarged spleen in the next few days. The patient visited the emergency room and various tests were performed including blood tests, x-rays and a CT Scan (results not provided). The patient was not admitted as an inpatient. The patient reported therapy however, the patient reported she currently had pain in her side. The patient hadn't visited a physician recently due to lack of insurance. The patient reported that she lost her job during the period of all of the events she experienced in 2006. No further information is available.
Starting with a large swollen red area around shot place, then I had what was either a rash or hives on face, neck, arms.
allergy symptoms due to first dose; throat irritation; like allergic reaction to pollen; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on 22Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced allergy symptoms due to first dose, throat irritation and like allergic reaction to pollen on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021544988 same reporter/vaccine different patient/AE
w/in 15min of vax pt had reddened blotched areas on face, trunk & perineal region;no tx required;mom cont to give pt APAP;both inj sites were extremely red p/30min;
Inadvertently gave 0.5 ml influenza vaccine to a 2 yr old. Dosage should have been 0.25 ml.
This is a spontaneous report from a contactable nurse. A 18-year-old male patient received TRUMENBA (lot M68769) on 28Jul2016 at single dose. The patient medical history was not reported. Ongoing concomitant medication included PAXIL at 50 mg daily. The patient experienced headache on 29Jul2016 with outcome of not recovered, chills on 29Jul2016 with outcome of not recovered, fever on 29Jul2016 with outcome of not recovered, cough on 29Jul2016 with outcome of not recovered, nausea on 29Jul2016 with outcome of not recovered, weight loss due to decreased appetite (current weight: 144 lbs) on an unspecified date in 2016 with outcome of unknown, decreased appetite on 29Jul2016 with outcome of not recovered, pain on 29Jul2016 with outcome of not recovered. No treatment was received in response to the events. The reporting nurse mentioned it was a suspected adverse reaction with the administered vaccine. Follow-up (07OCT2016): Follow-up attempts are completed. No further information is expected.
Arm where she got the shot is on and off numb; This is a spontaneous report from a contactable consumer (patient's spouse). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA , Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as 1st dose for covid-19 immunisation. On 05May2021, the patient experienced arm where she got the shot is on and off numb. Patient got her second shot from Pfizer, the first one was no side effect. Now it was10Jun2021 or 11Jun2021, patient was that normal because she called the doctor and do not have appointment right away as we have to stand in line. So as said it was better to ask Pfizer, it could tell if this was normal or not normal. The clinical outcome of event was not recovered.  Information on lot/batch has been requested.
Extreme fatigue persisting over several days, leg and arm weakness, slight cough, headache, rash
Pain  in and red, swollen splotch on arm at injection site upon awakening 7 days after shot. Hurt to move arm, extremely sensitive and painful to touch, warm, spreading. By evening went to Urgent Care and they diagnosed as cellulitis. Prescribed an antibiotic and a topical steroid; both for a week. At start was about 2 inches, but has expanded to about 4 inches in diameter on arm at shot site. After 2 full days of medication, it is starting to itch, but is still large and warm. After 3 full dates of medication, it is starting to go down, pain is minimal unless touched, but it itches at times, and has some blood-vessel like lines around injection site. Still warm, but not as much as it was.
C/O dizziness, HA, weakness, hot - 30 min after immz.  Trtmt. BENADRYL 50 mg po. 6/6/08-records received for ER visit DOS 5/19/08-Assessment:allergic reaction. C/O feeling weak all over, dizzy, chills and sweats. One of several children seen in ED from same school.
Patient was given the Pneumonia vaccine Friday 8/2/10 afternoon around 12:45. At the time of injection she had no reaction. Patient came into the office Monday with complaints of redness,swelling and heat at the injection site that traveled around the bottom of her arm that was present over the weekend. By the time she came in Monday the reaction was almost resolved. It was documented in the chart and physician has been informed.
Information has been received from a medical assistant (MA) concerning a 76 year old male patient with no known drug allergies, hypertension and a history of prostate cancer who on 29-JUL-2008 was vaccinated IM into the arm with a dose of PNEUMOVAX lot # 659149/1383U. Concomitant therapy included atenolol and CASODEX. The medical assistant reported that on 30-JUL-2008, the patient developed cellulitis of the arm after receiving the PNEUMOVAX. On 30-JUL-2008 the patient was evaluated by a physician (oncologist) and was admitted to the hospital for approximately 1 1/2 weeks. He was treated with unspecified antibiotics and the symptoms resolved on an unspecified day. No other symptoms or treatment reported. No other information was available. This is one of two reports from the same source. Additional information has been requested.
Patient's parent reports that patient had headache and stated he was itching following the vaccinations at 6 pm that evening. Also, that evening the mother reports that the patient's injection site on the left arm became red and arms bilaterally were swollen. Patient's mother also reports that patient's left arm had a 3" x3" area on left arm that was hot to the touch and firm. Mother states that patient then developed a rash and neck pain on Saturday Sept. 12th, 2015 as well as still having the headache. Monday September 14th, 2015 the mother presented the patient to the emergency room. At the emergency room the mother reported the patient was hypertensive with blood pressure of 148/70. Mother reports ER prescribed a steroid to be given for five days. Patient's mother stated that the school nurse from the patient's school called mother on Tuesday Sept 15 and informed mother that her son was still complaining of headache, neck pain, his blood pressure was elevated and he was flushed. Mother reported adverse event to Health Department on Thursday September 17th, 2015.
Patient had swelling, reddness, and hard where the vaccines were administered.  Patient also got a rash spots on her back all over.
Mild sore throat, headache, and cough consistent with viral upper respiratory symptoms ~3 days after receiving vaccine. Duration 5 days.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Mar2021, outcome "recovered" (Mar2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: It was unknown if other vaccine in four weeks or other medications in two weeks. It was unknown if Covid prior to vaccination and if Covid was tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt lives at nursing home; positive COVID test on 1/13/22; given IVFs; over several days pt became more lethargic, non-responsive, with tachypnea, fever; given Vitamin C, Pepcid; was seen by NP; supplemental O2, Depomedrol, Dexamethasone, Azithromax; DNR, comfort measures only; pt found not breathing and no pulse; expired in the nursing home
I had swollen in my arm that was from my shoulder to the end of my arm.  Then I had flu like symptoms that last for 24 hours.  Then in Jan, I had severe sore throat, congestive, and fatigue that lasted for 14th hours.  I think I had COVID-19 but I did not get tested for it.