chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chronic debilitating headaches, chronic diahrrea, severe back & abdominal pain, tingling in hands and feet,numbness in hands & feet, stabbing pain in lower legs and feet, inability to stand, inability to walk, difficulty breathing, swollen lips, chest pain in conjunction with neck pain, loss of hair, chronic debilitating fatigue, nausea, vomiting, short term memory loss, inability to concentrate, stares off in the distance for long periods of time.  These started right after the vaccination and continue to this day & have made her life as she knew it unmanageable.  She can no longer attend school.  Numerous trips to her pediatrician, blood tests, urine test, stool tests, emergency room visits, referred to neurologists, nutritionist.  No one knows how to treat her.  There is no treatment apparently.  3/16/09 Received consult records of 2/24/2009. FINAL DX: probable chronic fatigue syndrome, possibly exacerbated by recent EBV infection; reactive depression; likely vasovagal episodes; possible anxiety disorder. Records reveal patient experienced fatigue, nausea, numbness/tingling of hands/feet, HA, neck pain, intermittent diarrhea, chest pain w/SOB & heart pounding, intermittent difficulty walking, difficulty concentrating, decreased appetite, insomnia, apathy, moody, irritable.   Approx 1 wk after initial HPV & Depoprovera injections, 11/12/08, developed waxing/waning fatigue which escalated to missing school in Dec & Jan.  Suggested antidepressant & counseling.  3/9/09 Received PCP medical records of 2/2007-3/2/2009 included ER records of 2/9/2009. FINAL DX:none provided Records reveal patient experienced good health on 11/12, received depo-provera 1st dose along w/HPV #1.  RTC 2/11 s/p ER visit 2/9 for chest pain, cough, runny nose, phlegm congestion.  Parent reported back pain, hand tremors, leg pain, leg swelling, back pain, dizziness, joint stiffness, decreased concentration, fatigue, intermittent diarrhea, nausea since 11/08.  Missed several days of school.   Developed leg heaviness, gait disturbance, & LE weakness & increased fatigue. Referred to ID & Neuro but no records available.      ER records 2/9/09 FINAL DX: atypical chest pain Records reveal patient experienced sharp nonradiating chest pain, rapid breathing & tingling of hands/feet all of which had resolved by the time she was seen in ER.
This spontaneous report as received from nurse practitioner refers to a patient of unknown age who is one of her daughter's friends. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency and route unknown). On an unknown date, the patient had stroke (medically significant) after vaccination with GARDASIL. The outcome of stroke was unknown. Upon internal review stroke was considered as medically significant event. Additional information has been requested.
Information has been received from a registered nurse concerning a 27 year old female who on 19-MAR-2007 was vaccinated IM 0.5mL with her first dose of Gardasil vaccine (yeast) (lot# 656049/0187U). There was no concomitant medication. On 19-MAR-2007 the patient experienced a rash on her wrist (wrist not specified) about 4 hours after receiving the vaccination. The rash was described as itchy, bright red bumps and slightly raised. On 21-MAR-2007 the patient reported a similar rash on one leg (leg not specified) from knee to thigh. Subsequently, the patient recovered from itchy, bright red bumps and, slightly raised wrist rash. At the time of the report, the patient's rash on one leg from knee to thigh persisted. The patient sought unspecified medical attention. No further information is available. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. The patient also reported a bright red raised rash on her thigh in the evening after vaccination. Subsequently, the patient recovered from itchy, bright red bumps and slightly raised wrist rash and the bright red raised rash on her thigh. The patient reported no rash or itching at the injection site. The nurse reported that it could have been a possible allergic reaction. No further information is available.
Sore arm; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199, Expiration date: an unknown date in Jun2021) via an unspecified route of administration in the left arm on 05Mar2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 05Mar2021, the patient experienced sore arm, chills and fatigue. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, chills and fatigue were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hives beginning 2-3 days after 2nd vaccine dose. Has been taking benadryl nightly since. Seen at our office on 7/12/21 and treated w/ prednisone.
Developed diffuse urticarial eruption about 3 - 4 days after 2nd dose of Pfizer vaccine
I have extreme join and muscle pain, (shoulders, arms, hands, back, hips, knees, legs) so bad that I cannot sit or walk.  I have a slight fever and headache.
Information has been received from a physician's assistant concerning a 1 year old male who on 08/28/01 was vaccinated with varicella virus vaccine live. Concomitant vaccination 08/28/01 included streptococcus pneumoniae vaccine (Prevnar). The physician's assistant reported that both vaccinations were received in one leg. Subsequently, the pt developed an injection site reaction; itching, scratched lesions and scabbing. The pt was seen on 09/07/2001. In FOLLOW UP, the physician reported that the 'local vesicular reaction " were 'not atypical or adverse" and that "this was not a reportable event", therefore the physician indicated "we didn't pursue it"
It was reported that a male pt received flu vax on 10/21/98. Subsequently he complained of malaise, then Transient Global Amnesia, confusion (i.e., put on tie and forgot shirt, unaware of date and time, unable to read clock). From additional information received on 02/01/99, additional pt, responsible information and laboratory data were given.
Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine; Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot). At the time of the report, COVID-19 (Patient tested positive for COVID-19 after 1st dose of the Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient delayed getting her 2nd dose because she had COVID/It's been over 42 days since she received her 1st shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Non-significant follow-up: Reporters email address updated; Sender's Comments: This case concerns a female patient, age unknown with no relevant medical history, who experienced the unexpected event of COVID-19. The event occurred after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (event onset date unknown). The rechallenge was not applicable since only information about first dose was disclosed. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
Day 10 after receiving booster shot I developed HIVES all over my body. I went to Urgent Care and received a steroid shot and Rx antihistamine. A few days later, hives were still there so went to my regular Dermatologist where we are still waiting for it to resolve on its own with antihistamines and prescription steroid cream. I am currently on Day 6 of the Hives.
Cough and high fever, well appearing on exam started 5 days after vac adminstration.
10 hrs afterwards body aches gradually worsening, 12 hrs after fever, aches, chills lasting for 36 hrs.
Pain in (R) foot about 3:20 pm, received shot about 10:30 am.
Patient received Zostavax on left arm and has a rash close to where Zostavax was administered and is complaining of itching and slight pain. Directed to see MD or urgent care/ER.
Ring worm type sores 3-four days after injection. Itching and continues breakouts for two weeks.
Dizziness, Tachypnea, NauseaVomiting, HYPERtension, no other events occured Narrative:  Employee c/o dizziness and nausea after 15 minutes of sitting, and then using the restroom. Sits back down and vs obtained. b/p 212/128 manual and machine. pulse and o2 normal. Patient continues to feel poorly, wants to lie down. Patient tachypneic, with some SOB. Has high b/p baseline, but says he took his b/p meds this AM. Hasn't had reaction to vaccines previously. Epi administered and 911 called, as patient agrees to this. A&O,pleasant and anxious. Transport to hospital for eval with paramedics.
Left arm became swollen under (towards hand) the injection site in an oblong shape, about size of golf ball. Two areas below swollen area were noted to be hard to palpation. Treatment included warm compresses, TYLENOL by mouth, and elevation of limb while lying down. Swelling has since subsided.
Lump and red rash at site of injection. Pain radiating down to wrist. Fever starting 12 hours after injection - treating with ADVIL and ice pack.
Fever; Diarrhoea; Pain in my arm; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 42-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 14Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (She was COVID positive before the vaccine). The patient concomitant medications were not reported. On the 14Apr2021 patient got the vaccine and patient had fever and diarrhea and pain in her arm on 15Apr2021. Patient have already filed a report. Since patient got this reaction with the first dose is it recommended to get the second dose on May 5th? All her symptoms are gone except for the pain in her arm. The outcome of the events fever and diarrhoea was recovered on 15Apr2021 and pain in arm was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Localized redness, swelling and warmth around area where vaccine administered. One day after vaccine given.
severe swelling redness, tenderness of left upper arm with rash - 3 discrete patches
09/04/21  he patient presents with 96 year old female with a medical Hx of Dementia, COPD, hypertension, congestive heart failure, paced rhythm, peripheral vascular disease. Presents to the ED Altered mental status per EMS. EMS reports of met sepsis criteria, patient being tachycardic and febrile, they report that over the last couple of days patient has become more confused at her nursing facility. History is limited at this time.l.  The onset was 3  days ago.
Redness, erythema, swelling of site of Varivax injection - about 3-4" diameter, warm to touch and itchy. Reaction gone within next 24 hours.
same afternoon would awaken from sleep & cry high pitched cry intermittently;mom reported next day shot site of DTP was red around site & mom reported red areas (splotchy-like areas/down from the site in a line);t99.4;
Localized adverse reactoin at vaccination site including redness, swelling, itching and pain. Several inches in diameter.
At 9:30 PM (4 hrs after injections/ pt went to ER with SOB, pain and inflammation (RT) arm. F/u with primary on Friday 9/14/09. Pt forgot he had pneumonia shot last May!
flublok being administered to pediatric patients with no adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER), 2022SA402443(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505(CLUSTER) and 2022SA402619(CLUSTER).  This case involves a 10 years old male patient to whom INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].being administered to pediatric patients with no adverse event.   The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (strength, formulation was unknown, lot UJ887AA and expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for immunization.  On 13-Sep-2022 the patient developed a non-serious event of  flublok being administered to pediatric patients with no adverse event (product use issue) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: dry mouth-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient states she has intermittent tingling in her extremeties, no definitive diagnosis by her providers.
Apparent dermatographia urticharia. Any skin contact makes skin become bright red and itchy hives soon pop up.
"Unknown" was influenza. -- Severe fatigue, weakness, loss of balance, aches and pains, chills, eyes needing to be shut, "fuzzy" brain. Basic flu-like symptoms. -- Advil and Super Tylenol, fluids, bedrest.  1 month and still not back to normal.
Information has been received from a physician concerning a male pt who eight years ago, in approx 1997, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Suspect vaccination at the same time included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). Eight years ago, in approx 1997, the pt experienced severe arthralgia.   Unspecified medical attention was sought.  Subsequently, the pt recovered.  A product quality complaint was not involved. Additional information has been requested.
shingrix is a 2 dose series and this was a 3rd dose.  noted 4/22/20 when pt came in for next injection.
Mild redness swelling at the injection site/(L) deltoid muscle, no systemic signs. Improved with icing, pain medication. 03/13/2019 patient got 1 shot yesterday on left delta for TDaP, redness and swelling and sore noted after shot given. Here for F.U. Localized reaction to TDaP; ok to use ibuprofen to decreased inflammation.
Patient received vaccine approx  5-10 minutes patient fainted in his chair. A cardiac nurse was waiting to receive their vaccine and rushed over to help too. Patient began to convulse. We tried to get patient to respond approx 2 min later patient woke up and complained about being thirsty. We gave him Apple juice and placed a cold pack on his neck. Called 911, We took BP it was 77/49 pulse 45, we laid patient down and retook BP 123/73 Pulse 68. After 5 more min BP 135/85 pulse 72. EMS arrived and took patient away
Onset of symptoms: 01/04/2021@12:00PM Temperature: 102F Fatigue, muscle ache, diarrhea, nausea, "heaviness in the chest" Individual was tested yesterday to rule out COIVD19 with PCR (molecular test) and the antigen test.  Both test came back today: negative.
This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a 50-year-old female patient who received SHINGRIX. Concomitant products included doxycycline, gabapentin, vitamin D, diclofenac sodium, estradiol and CLARITIN D. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, 1 days after receiving SHINGRIX, the patient experienced hives. On 17th April 2018, the patient experienced Bell's palsy (serious criteria GSK medically significant), headache and numbness. The patient was treated with prednisone and Valacyclovir. In April 2018, the outcome of the hives was recovered/resolved. On an unknown date, the outcome of the Bell's palsy, headache and numbness were recovering/resolving. The reporter considered the Bell's palsy, hives, headache and numbness to be related to SHINGRIX. Additional details were reported as follows: This case was received via email. This case was already reported to a doctor. The age at vaccination was not reported. The patient's concomitant medication included multivitamins. The parent medical history included, breast cancer (diagnosed in July 2017) for which double mastectomy surgery was performed in September 2017. The patient received SHINGRIX on left arm. Three days after receiving SHINGRIX, the patient experienced terrible pain on left side of head, numbness, droopy mouth and possible Bell's palsy. The patient stated that, she went to the emergency room and the doctor prescribed her with prednisone and valacyclovir for possible Bell's palsy. The reporter did not provide any additional information. The patient denied permission to contact their physician.
Onset of tinnitus in right ear.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 (Lot number: FF2589) at the age of 81 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE BESILATE; LEVOTHYROXINE; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 17Feb2021, when the patient was 80 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Left), administration date: 27Jan2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Sep2021, outcome "not recovered", described as "Onset of tinnitus in right ear. "Therapeutic measures were not taken as a result of tinnitus. Additional Information:The patient did not receive any other vaccine in four-week prior vaccination. The patient did not tested positive prior vaccination. The patient did not tested positive post vaccination. The patient did not have known allergies.  No follow-up attempts are possible. No further information is expected.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 12:58 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 04-Mar-2022 at 12:58 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided. Vaccine administration time was reported as 12:58:15
Fever. Chills. Nauseous, joint pain, headache Until approx  10 pm sunday night Ok on 3/22/21
Diagnosed with stroke-like syndrome. Received COVID Bivalent booster and PCV15 vaccines on 11/30/22 with no observed adverse events immediately following the vaccines. Called PCP on 12/1/22 reporting headache with 6/10 pain with nausea and dizziness for the last 1.5 days with suicidal ideation. Was told to go to the ED immediately. When to ED on 12/1/22 presenting with mild headache, blurred vision, and slurred speech. Tests were negative for stroke but was found to be in Afib with RVR and was given digoxin, metoprolol PO and IV for rate control, and IV fluids then admitted and consulted by cardiology. Was then placed on amiodarone and converted back to sinus rhythm then transitioned to PO propafenone and metoprolol. Ramipril was stopped due to low BP and trazodone and tizanidine were stopped due to drug interactions. Was seen by cardiologist and PCP post discharge and her condition has resolved.
This spontaneous report as received from a nurse refers to a 5 months 26 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.