chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe reaction with severe headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid goiters/goiters on neck" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "severe reaction with severe headaches". The event "severe reaction with severe headaches" required physician office visit. Therapeutic measures were taken as a result of headache.  Additional Information: Reporter's sister had a severe reaction with severe headaches. She also mentioned she read some crazy stuff on the internet. The timeline of the headaches matched after she got the vaccine. Reporter confirmed severe reaction was in regard to severe headaches. It started after getting the vaccine. Patient got the vaccine either late 2021 or early 2022. She did not get the vaccine when it came out. The headaches lasted 2-3 weeks; later clarified it was 3 weeks. In the beginning she could not lift her head, she was just laying out. Prior to the vaccine she did not have headaches. she stated patient still gets occasional headaches. There was no prior Vaccinations (within 4 weeks). There was no family medical history relevant to adverse events. Called primary care doctor initially. She was told not to take anything because it would interfere with vaccine. When the patient was not able to go to work or do anything she was prescribed ibuprofen or Aleve.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immunized yesterday after pe, last night 20 minutes after going to bed breathing funny, in emesis, unresponsive. Called 911. 73% O2 100% . Transport uneventful. Unresponsive to painful stimuli.T 98.9 at ER. O2 83% on room air. Resp shallow.Eyes deviated & sluggish to react. Tachycardiac @180. CXR nl. UA glucose. BS 171. Intubated.Ativan & rocephin admin. Then grand mal seizure. Improved after 20 min. WBC 20.10.Extubated prior to transfer. Transfered to hospital. "fine" "stable"  Hx febrile seizure in past.   12/19/06 Received medical records from 2nd hospital which reveal patient admitted 12/1/06-12/2/06.  At initial hospital patient was found to be actively seizing & was treated and transferred to PICU.  Temp 102.5 on admit. Neuro exam at 2nd hospital found WNL & no further seizure activity noted.  To be followed by peds neuro outpatient & have repeat MRI.   Final DX: Febrile seizure.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Mild
Patient had a new onset of confusion with hallucinations and suicidal thoughts that haven't occurred in a long time. Started within 24 hours of 2nd moderna vaccine.
BIBA from home for "wet" cough, respiratory distress as per family. Pt with hx of stroke with R sided deficits.   HISTORY OF PRESENT ILLNESS:     66yo F PMhx of CVA with R sided deficits, GERD, DM, COPD, diabetic neuropathy, HLD, HTN, hypokalemia, leg edema, mood swings, RLS, slurred speech presents for cough. Per report pt having cough. Unknown duration, modifying factors, symptom severity. Pt is very poor historian and given prior stroke very slurred speech and communication difficulty.
Case numbers PHEH2011US05381 is an initial spontaneous report received from a pharmacist on 28 Sep 2011: This report refers to an 88-years-old female patient. Previously she was vaccinated with FLULAVAL (other manufacturer) in the left deltoid on 13 Sep 2011. She was vaccinated with FLUVIRIN (batch number: 1102201) in the left deltoid intramuscularly on 27 Sep 2011. She presented with dementia since a non-reported date. It was stated that the patient had not received any vaccines in the past four weeks. The physician instructed to monitor the patient for 24 hours. The causality and event outcome were not reported. No further information was available at the time of this report.
throat is swollen; Scratchy throat; Tonsils feel enlarged; have a dry cough; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included underactive thyroid and obesity. The concomitant medications included levothyroxine sodium (SYNTHROID) 75 mcg and phentermine (UNKNOWN MANUFACTURER). The patient had no known allergies to food, medications or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not tested for COVID-19. The patient has not tested for COVID-19 post vaccination. On 24Mar2021, at 10:30 , the patient experienced swollen and scratchy throat. She can't seem to clear her throat. Her tonsils felt enlarged and had a dry cough. The patient did not receive any treatment for reported events. The clinical outcome of swollen throat, itchy throat, enlarged tonsils and dry cough was not recovered. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts possible. No further information expected.
1004  RN responded to vehicle while pt in waiting lot after recipt of 1st dose Pfizer. C/O swelling to nose. Denies difficulty breathing, denies chest pain. Monitored 30 minutes. RN noted no swelling to nose. Pt  left lot approx 1035
No additional adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 31-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T024831 was confirmed to be valid, expiration date 18-NOV-2022, (dose, route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature from 47 degrees Fahrenheit (F) to 77 F (46.6 F) for 42 minutes. There was no previous temperature excursion. The call was because of a digital data logger. No additional adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001892: US-009507513-2104USA001896: US-009507513-2104USA001897:
Patient reported syncopal episode, but stated ? he was fine, and didn?t want any medical attention? Patient seen by medical team, refused medical transport and signed form Patient will be driven home by spouse
This initial spontaneous report was received from a Medical Assistant concerning a 2-month-old patient. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported. On 16-NOV-2021, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (oka-merck) virus vaccine live (PROQUAD) Lot # U009259 and expiration date: 19-SEP-2022, for prophylaxis (inappropriate age at vaccine administration). No adverse event reported.
Feeling of something caught in throat but nothing is there; Feeling tired; Nausea; Diarrhea; Fever, feverish; Headache; Swollen top lip (worsened); Bruising at injection site; Swelling at injection site; Rash at injection site; Redness at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular). On 04-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site bruising (Verbatim: Bruising at injection site), injection site swelling (Verbatim: Swelling at injection site), injection site rash (Verbatim: Rash at injection site) and injection site erythema (Verbatim: Redness at injection site). On 05-MAR-2023, the patient experienced tiredness (Verbatim: Feeling tired), nausea (Verbatim: Nausea), diarrhea (Verbatim: Diarrhea), fever (Verbatim: Fever, feverish), headache (Verbatim: Headache) and lip swelling (Verbatim: Swollen top lip (worsened)). On 06-MAR-2023, the patient experienced lump feeling in throat (Verbatim: Feeling of something caught in throat but nothing is there). . Thethe outcome of the lip swelling and lump feeling in throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.     It was unknown if the company considered the injection site bruising, injection site swelling, injection site rash, injection site erythema, tiredness, nausea, diarrhea, fever, headache, lip swelling and lump feeling in throat to be related to Shingrix.   Additional Information: GSK Receipt date: 09-Mar-2023 Patient was calling to report side effects from his Shingrix vaccine.  On March 4, 2023 he began noticing the bruising, swelling and rash at the injection site.  These symptoms ended a day or two ago, meaning approximately 7th March 2023.  On 5th March 2023 he began feeling tired, with nausea, diarrhea, fever and headache.  He also started noticing that his top lip was swollen on the right side. The nausea, tiredness, diarrhea, fever and headache are almost gone as of date of reporting, 9th March 2023, but the lip was more swollen than before. The reporter offered medical disclaimer, referred to HCP, offered after-call survey.   The reporter also offered MI number to pass along to his HCP, but he declined. The reporter consented to follow up.
pt brought to Ed for worsening confusion, hypoxia, increased weakness, and decrease in oral intake; diagnosed positive for COVID 9 days before this hospital admission; DNR; treated with Redesivir, antibiotics, convalescent plasma, Decadron, Baricitinib; pt's condition during hospitalization continued to decline; pt passed away in the hospital
PERCEIVED HUMIRA FAILED THERAPY; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (PERCEIVED HUMIRA FAILED THERAPY) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous). On an unknown date, the patient experienced DRUG INTERACTION (PERCEIVED HUMIRA FAILED THERAPY). At the time of the report, DRUG INTERACTION (PERCEIVED HUMIRA FAILED THERAPY) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Formulation of Humira was reported as Solution for injection in pre-filled pen.   No concomitant medication was reported.   On an unknown date, the patient experienced PERCEIVED HUMIRA FAILED THERAPY.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the mailbox were missed to be booked-in.
Extremely itchy all over. Redness on neck, chest, arms and trunk. Raised red areas over same
my right hand begin to swell out and itch/hand swelling/it is in the arm pit; my right hand begin to swell out and itch; my right hand begin to swell out and itch/hand swelling/it is in the arm pit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown), via an unspecified route of administration, administered in Arm Right on 14Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Jul2021, patient experienced my right hand begin to swell out and itch/hand swelling/ and it is in the arm pit on an unspecified date in Jul2021. Patient reported that I had the vaccine on my right arm and just this afternoon vaccination, my right hand begin to swell out and itch and wanted to know it was possible side effect of could come that late. It just started this afternoon and begin to swell you know my hand swelling. Patient stated, I was sorry can you speak slow for me please. No, it was not the written on its says, it was said something right possible to had swelling and joint pains and a muscle pains and itching but it was in the arm pit but I was just trying to know if this could be possible that it could be bad and it said to side effect to get something know only about can had rash, itches, hives so was it possible it could be this late from start, of course because I had you know few days ago possibly this could be late before I had my concern side effect. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.
about 7mins p/vax pt started feeling numb in arms & legs w/nausea & sl chest tightness;also c/o some lightheadedness;denies any itching;pt had eaten breakfast;pt was not nervous about receiving vax;
This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. No current condition was reported. The patient's medical history included cancer survival. On 16-AUG-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported). No concomitant medication was reported. On 19-AUG-2014, patient reported to pharmacist that on an unspecified date in August 2014, she experienced that an area at the site of ZOSTAVAX administration was red and warm. The outcome of an area at the site of ZOSTAVAX administration was red and warm was reported as not resolved. No PQC was involved. The causality between event an area at the site of ZOSTAVAX administration was red and warm and ZOSTAVAX was unknown. This is one of the several reports. Additional information has been requested.
This spontaneous report was received from a nurse concerning to a 4 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine #1 5/27/21.  Vaccine #2 6/17/21.  On 6/19/21, he was working at a climbing wall and his shoulders were sore.  He rubbed them and noticed 2 small lumps in the supraclavicular area.  He presented today for evaluation.    A quick pubmed search revealed case reports of same (but not many) .  I wanted to report this.   https://pubmed.ncbi.nlm.nih.gov/33685772/  Supraclavicular lymphadenopathy is rare in children and young adults.
Pt broke out in hives and has had a steroid shot with no relief. she is also taking hydroxyzine 25mg at bedtime.
dizziness; vertigo; This is a spontaneous report from a sponsored program. A contactable consumer (patient's grandchild) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 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's medical history and concomitant medications were not reported. Calling on behalf of her grandmother who experienced dizziness and vertigo after the 1st dose of the vaccine. The outcome of the events was unknown.   Information about the Lot/batch number has been requested.
I got the first dose of the Pfizer vaccine on 04/12/2021 and started getting severe migraine headaches on the left side of my head. The headaches are throbbing and continuous. On a pain scale of 10/10. I used Tylenol 1000 mg alternated with Ibuprofen 400 mg every 6 hours with very minor relief. I started using over the counter migraine medication (combo acetaminophen 250 mg, Aspirin 250 mg and Caffeine 65 mg per tab) I have been taking 2 tablets a day starting 4/20/21 with some relief, pain scale is still 5-6/10.
red swollen arm rt upper red area is 5x6cm & edema is 15x16cm;
This spontaneous report was received from a physician via a company representative regarding a 54 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated a dose of ZOSTAVAX (dose and lot # were not reported) intradermally instead of the recommended subcutaneous route. On an unknown date (reported as a while ago), the patient had an unspecified rash from an unspecified cause. The patient's outcome was unknown. The relatedness between the event and therapy with to ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Shingrix around 5 months ago and for 24 hours was dry heaving; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry heaves in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dry heaves (Verbatim: Shingrix around 5 months ago and for 24 hours was dry heaving). The outcome of the dry heaves was resolved (duration 24 hrs).   It was unknown if the reporter considered the dry heaves to be related to Shingrix.     It was unknown if the company considered the dry heaves to be related to Shingrix.   Additional Information: GSK receipt date: 30-OCT-2023 The patient self-reported this case. The reporter stated he had his first dose of Shingrix around 5 months ago (from the date of reporting) in 2023 and for 24 hours was dry heaving. The event only lasted 24 hours and was resolved. The consent to follow up requested.
Generalized severe pain and stiffness  in muscles and joints, making it difficult to walk. Dr prescribed Felxeril 5 mg 3 x day, Naproxen 500 mg every 12 hrs.
Patient called on 3/2/22 to report symptoms of left-sided chest pain and generalized tissue pain on the left side of her chest and armpit area. She also noted lymph node swelling in her left armpit area. She stated the pain was coming and going and would be sharp/stabbing at times.
Information has been received from a physician concerning a 17 year old female patient who on 30-MAY-2012 was vaccinated with the first 0.5mL dose of GARDASIL (lot# 672834/0131AE). It was reported that on 30-MAY-2012 the patient fainted. She came back to and passed out again and she stopped breathing for a few seconds until she came back again. The physician reported that the patient felt woozy after 30 seconds of GARDASIL being given. The patient also stopped breathing but recovered within 10 minutes. The physician specified that the patient not only had a syncopal episode but stated there was tonic clonic movement involved. It was also reported that less than one minute after the vaccination, the patient experienced a syncopal episode and a tonic clonic seizure. The physician stated that on 30-MAY-2012 the syncopal episode and seizure lasted less than two minutes. No treatment was administered. After stopping the therapy, the adverse events improved. The physician stated that the patient was fully recovered before she left the office on 30-MAY-2012 (also reported the patient was called at home and said she was fine). Upon internal review, the stopped breathing and the tonic clonic seizure were determined to be other important medical events. Additional information has been requested.
Slight Injection site pain; Brain fog; Immediate HA; Feeling cold; Dry/cold mouth; Fatigue; This is a spontaneous report from a contactable Nurse. A 64-year-old (non pregnant) female patient received bnt162b2 (Pfizer-BioNTech covid-19 vaccine, Solution for injection Batch/Lot Number: EN5318) dose 1 via an unspecified route of administration in arm right on 26Jan2021 15:45 PM (at the age of 64-year-old) as single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included high blood pressure, meniere's disease, infrequent cluster migraines, arthritis, tendonitis from an unknown date and unknown if ongoing. The patient previously took emetrex and experienced drug hypersensitivity. Concomitant medications (other medications in two weeks) included armour thyroid, pantoprazole, biotin, B160/40/Pro/E taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccine in four weeks. The patient did not receive any treatment for adverse events. The patient did not have COVID prior vaccination. And post vaccination patient had not tested for COVID. On 26Jan2021 at 04:00 PM, she had slight injection site pain, brain fog, immediate HA, feeling cold, dry/cold mouth and fatigue. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Stated that less that one hour after injection at approximately 4:15pm, employee experienced diarrhea, confusion, and a headache. Donor states that she no longer feels confused.