chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain and weakness beginning 2/28/2021, hospitalized 3/2/2021-3/8/2021 for rhabdomyolysis (peak CK = 112,000) and severe transaminitis (ALT and AST in the 2000's).  No preceding injury or trauma, no drug or excessive alcohol use.  By 3/19/2021 patient still unable to  get out of chair without using arms, significant proximal mm weakness.  Inflammatory markers elevated and CK and liver enzymes still surprisingly high.  Re-hospitalized  3/22/2021.  Still in hospital, improving, on date of report (3/23/2021).
COVID-19 VACCINE WITH THE EXTENDED EXOIRATION DATE OF 07/31/2022 WAS GIVEN ON 08/02/2022
Lt arm became numb in evening of 4/30/03 and stayed numb until present. On 5/4/03 on awakening noted entire Lt side of body was numb and vision was blurred. Was seen in ER on 5/5/03 and began prednisone-if s/s don't improve to return to Dr. for MRI etc.
nausea, dizziness, fever, chills,shaking,  severe fatigue, headache, body aches
Excruciating pain in left arm starting at shoulder - no movement or feeling - weakness - numbness - tingling
Patient became lightheaded, she vomited, had trembling and twitching of the right side of her face. Began 30 minutes after injection was given.
pt recvd vax 18FEB94 & 22FEB94 exp h/a, neck pain, abdo pain, SOB x 3 days; 25FEB94 exp neck & chest pain, back pain, lethargy;poss also syncopal or presyncopal episode; to ER & hospitalized; sinusitis, myalgia, cephalgia, bradycardia;
No adverse effects were reported; The patient was administered the first dose of the GARDASIL quadrivalent in April of 2013. The second dose of the GARDASIL quadrivalent on an unknown date in June of 2013. The aptient was then administered a dose of GARDASIL 9 on 05/14/2019; This spontaneous report was received from a nurse, referring to a 33 year old patient. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided.  In April 2013, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot number 1495AA with expiration date 22-AUG-2014. The second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was administered in June 2013, lot number 1495AA, expiration date 22-AUG-2014, both by intramuscular route, for prophylaxis (strengths were not reported) .   On 14-MAY-2019, the patient was administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and administration route were not reported) lot number N023828 and expiration date on 25-JUN-2020.  No adverse effects were reported.
Pt stated on 8SEP91 AM, rt upper arm was slightly swollen & red @ inject site; rt upper arm started swelling & became red w/hard area @ inject site; Nurse observed erythema on rt upper arm, warm to touch;
got sick; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient via interactive digital media.  This case involves an unknown age and unknown gender patient who got sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. There will be no information available on the batch number for this case  On an unknown date the patient developed a non-serious "got sick (illness)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Author/Reporter Comment: No thank you! Last time I got one I got sick for 2 weeks."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick).  At time of reporting, the outcome was Unknown for the event got sick.
screamed inconsolable for 5 1/2 hrs; during evening of immun date; fever 103 lasting 12 hrs; cranky for next 2 days; mom discussed w/pvt MD & adivsed APAP; pvt MD gave DT but recommends DTaP for booster;
Uaricella - Information has been received from a physician concerning a 41 month old Caucasian male patient who on 17 Sep 1007 was vaccinated IM in the left arm with a first dose of varicelle virus vaccine live lot 623125/0546E.  There were no concurrent conditions or known drug allergies.  On 12 Mar 2000 the patient broke out with chickenpox.  On 13 Mar 2000 the patient's mother reported that the patient had less than 50 pox.  It was noted that 7-10 days later, the patient recovered.  No further information is expected.
Given in left arm red, swelling, rash with bumps all over. Lasted 1 week.
hives/rash, itching, closing of the throat, pins/needles up and down the arm
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 49 year old female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, 1 total administered on left arm on 09-MAR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient went through an antibody test and result was negative (confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211052305-covid-19 vaccine ad26.cov2.s- Confirmed immunological Vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
I experienced hives within a half hour on my chest and neck. After 9 days the hives returned on my legs and arms with a itchy, burning sensation.; I experienced hives within a half hour on my chest and neck. After 9 days the hives returned on my legs and arms with a itchy, burning sensation.; I experienced hives within a half hour on my chest and neck. After 9 days the hives returned on my legs and arms with a itchy, burning sensation.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN#6203) via an unspecified route of administration in the left arm on 21Mar2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 50 mcg from an unknown date for unspecified indication. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in the right arm on 28Feb2021 at 14:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 00:00 the patient experienced hives within a half hour on chest and neck. After 9 days on 04Apr2021, the hives returned on legs, arms with itchy and burning sensation. The patient did not receive any treatment for the adverse events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events hives, itchy and burning sensation was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vaccine was administered in POD setting. After receiving vaccine, patient wandered away from vaccination table where other family members were receiving their vaccines. She became suddenly dizzy and fainted, falling backwards and hitting her head on the floor. Nurse reached her within 3 seconds of event and patient was returning to consciousness. EMT were present and assessed alertness, orientation and vital signs which were stable. Patient was given po fluids and glucose and an ice pack was offered. Patient left clinic setting with parents in no distress 15 minutes later. Parents were instructed to call private physician with questions/concerns and to proceed to the nearest ED if patient complained of head ache, dizziness, nausea/vomiting or altered mental status. Follow up phone call the following morning confirmed that patient had no adverse outcome related to syncope and subsequent trauma to head.
Arm red swollen hot, chills, congestion, sinus, body aches, cough, no energy
This spontaneous report was received from a medical assistant and refers to a 8 week old patient of unknown gender. On 30-AUG-2014, the patient was vaccinated, at another facility, with what may have been either PREVNAR or PNEUMOVAX 23 (route of administration and dose were not reported, lot reported as: H45594, expiry date not reported). No adverse effect was reported. Additional information is not expected, because there is not consent to contact the reporter.
About 9 hours after getting the vaccine, my wrist started hurting like I had sprained it. I couldn't twist my wrist.
Narrative:  Patient received the 1st dose of the Moderna COVID-19 vaccine on 2/25/21. On 3/5/21 he advised his primary care provider of onset of a 2 inch in diameter rash at the injection site. Resolved without issue. He received the 2nd dose on 3/26/21 with no problems reported.
pt exp fever, pain, swelling, inc warmth, induration or lump w/o abscess, abscess formation-required drainage, hives-poison ivy; surgery on rt arm 24OCT91;
Expired Harix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-year-old male patient who received HAV (Havrix 720) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 22nd February 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 22-FEB-2023 Reporter's comment: The reporter reported that the patient received an expired dose of Havrix pediatric dose on the day of reporting. Havrix presentation (pfs- Pre-Filled Syringe) confirmed by batch number look up. The reporter was consented to follow up. Additional supportive information: The patient received expired dose of Havrix pediatric, which led to expired vaccine used.
Pt developed rash on chest and legs 9 hours after receiving vaccine. Mother also noted fever tmax 99.8 today. Diagnosed with allergic urticaria today 10/3/18. Prescribed Benadryl and instructed to follow up with primary care doctor in 2 days. Appt scheduled in clinic for 10/5/18.
Staff reports that around 6PM the child experienced weakness in the legs, dizziness, nausea and headache.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 11-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 30-APR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Headache, Myalgia, NauseaVomiting, 1st Dose: Pain at injection site x 6 days, chills, HA,nausea,fatgue,bodyaches, tiredness x 24hr. Narrative: 1st Dose: Pain at injection site x 6 days, chills, HA,nausea,fatigue,bodyaches,tiredness x 24hr.
Chills, fever of 103.4, tingling/ numbness in the opposite arm of the injection. This lasted for 36 hours. However, obvious left arm muscle weakness and mild cramping in same arm is still present. Maybe a coincidence? Getting an EMG test today to evaluate the extent of nerve involvement and check for signs of muscle atrophy.
Hard to read the Lot number on my card. The night of the injection, I started to feel a flare of pain in my left arm at the injection site. by the next day, it was bigger and kept getting bigger. It was a circle of three inches of diameter and it was under the injection site - red, hot, inflamed and painful and hard as a rock. On February 3rd, I went in to the doctor and she looked at it and said it was infection and prescribed a 5 day course of antibiotics. It resolved it. By the end of those five days, symptoms were gone. Every single night when I position my arm into a sleeping side position - I feel a sensitivity in that area deep into the tissue - it feels like a deep soreness.
This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (one glass a month), and non smoker, and other pre-existing medical conditions included: no relevant medical history and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096 expiry: UNKNOWN) dose was not reported, 1 total, administered on 27-MAY-2021 for prophylactic vaccination (dose number in series is 1). No concomitant medications were reported.  On 26-DEC-2021, at evening, the patient experienced symptoms of dry cough, dry throat and headache. On 27-DEC-2021, on the day of reporting, the patient tested positive with rapid home test (suspected clinical vaccination failure and suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209034.; Sender's Comments: V0-20211258550-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Booster vaccine was given 3 months after the second dose. Patient did not present any symptoms.
Fever approx 102-103, achey, dizzy, weak, fatigue.  Large, red and VERY tender area around injection site.
I tested positive for COVID-19 on 11/11/2022. I had a scratchy throat, cough, congestion, and a fever of 100. I was prescribed azithromycin and a cough syrup. I still have congestion and cough at this time, but no fever.
Pt had vaso vagal reaction when "coming to " pt had dystonic reaction. Vitals stable, Follow up  at Urgent Care.
Fever, chills like I?ve never get before. I was trembling. My fever was 103, I took an ice cold shower to combat it. My headache was horrible and I think i was very dehydrated. I drank water but I kept urinating as if I couldn?t hold any water in. My  watch warned be for an hour long period that my heart rate was 120+ when i was laying down with the chills.
Pt reports fever the day following the injection and sought care at urgent care for further evaluation with father. Denies any other symptoms or complaints.
localized reaction redness baseball sized On 1/16/2021 she noticed small red area. By 1/17/2021 redness spread and it was warmer and raised. Reaction lasted approx 24 hours. No shortness of breath and not itchy. Patient took benadryl at night and used cool compress and anti itch cream otc. She was seen on 1/18/2021 at office and advised she may have had localized reaction but received no perscription. Was told she may have had antibodies to the virus.
Headache, Myalgia, Arthralgia, Flu-like symptoms, woke up slightly restless on eve of 23rd, increased nasal congestion, profound fatigue following 48hrs difficult moving/getting out of bed, severe low back pain, left deltoid sore x 3 days, chills no documented fever, alternating Acetam Narrative:
After 10 minutes of the patient vaccine administration, he referred feeling very dizzy with difficulty to breath  . He was pale,  sweaty, trembling . He referred loss of vision.  The patient was seated and his blood pressure was measured with results:   (1) 83/45mmHg (2) 102/67mmHg (3) 115/70mmHg  911 was called since the patient was debilitated. He left with the ambulance.
herpes zoster, postherpetic neuralgia and hearing problems; herpes zoster, postherpetic neuralgia and hearing problems; herpes zoster, postherpetic neuralgia and hearing problems; Information has been received regarding a case in litigation regarding a patient (pt) of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On or about 30-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia and hearing problems. As a result of these symptoms, the pt was seen and treated by medical providers in was still under their care. The pt symptoms resulted in physical limitations not presented prior to using zoster vaccine live (ZOSTAVAX) product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. The pt suffered serious, progressive, permanent (disability), and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The events were related to zoster vaccine live (ZOSTAVAX).
Lethargic, crying, fever, wake up screaming lasted about 24 hour. ER gave IBU and sent us home.
Heart rate was fast and that it was 68; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rate was fast and that it was 68) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (Heart rate was fast and that it was 68). At the time of the report, TACHYCARDIA (Heart rate was fast and that it was 68) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
9/29 immun. (DTaP and MMR) given R thigh because of diffuse bruising and hard tissue both arms. Mother states his leg got red and swollen and became so hard and large he couldn't walk. Taken and admitted and given antibiotics/steroids for possible cellulitis, possible "allergic reaction." Mother states blood work drawn also. The discharge summary received on 1/20/04 states immune rreaction.
Swelling and pain left third MP joint, followed over next 10 days by left wrist pain and swelling, bilateral knee arthralgia without swelling, swelling and pain left fourth MP joint, bilateral elbow pain and swelling. Summary diagnosis: Migratory arthritis. New diagnosis:  Migatory synoyitis.  Symptoms and signs of which lasted until April 2010.  In May 2010 developed dialated cardiomyopathy with left ventriclar ejection fraction of 30%.  Much cardiac medication with uncertain prognosis.  Not yet causing disability.
long COVID; long COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Feb2021, outcome "not recovered" and all described as "long COVID".  Additional information: The patient had long COVID and hadn't had taste or smell since Feb2021.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had covid in march, Nausea, headache, chills, could not move my left, loss of appetite, shaking. no energy and weak.  Took 1 Aleve. Doing fine now.
Received Tdap vaccine 9/30/12 - ED visit 10/03/12 for dizziness (systemic reaction). (R) arm swollen, red, tender at site of injection. Antibiotics at ED.
This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a 48 year old female patient who had no relevant medical history. On the 13-Oct-2014, the patient received AFLURIA (batch number T51108) 0.5 mL once via the intramuscular route for protection against seasonal influenza virus. The vaccine that was administered was stored at about 70F for 72 hours, which was a medication error. No adverse reaction had been reported since administration. Outcome was reported as recovered.
DIED; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) one total, dose not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced died. On an unspecified date, the patient was died from unknown cause of death. It was unknown whether the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20210703030-JANSSEN COVID-19 VACCINE-died. This event is considered unassessable. The event 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; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Shortly after vaccination, patient developed dizziness and tingling sensation along jawline.  Patient mildly hypertensive.  Approximately 15 minutes later, dizziness developed but tingling sensation also experienced in bilateral feet.  Evaluated in ER and ultimately sent home without further complication.