chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not reported, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 03-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
mom states about 7min p/vax pt arms became straight & had some mild shaking, fixed stare, then became limp;pt stated felt tired & c/o nausea;was in the car @ this time & took to ER-collapsed in ER & was given 02 & adrenalin;d/c from ER;
Vaccine received about 5 PM. Felt lightheaded that evening. Had fever 103 degrees in morning and flu-like sympt.
Due to the recent update per the CDC and FDA regarding immediate stop to the Janssen Vaccine. Staff  is following up with patients whom have received the vaccine within the last 3 weeks to verify if patient has developed a severe headache, abdominal pain, leg pain, or shortness of breath. Patient answered YES to Leg pain (RL) and Shortness of breath; Pt states she is currently using her inhaler to help w/ sx's. Pt was scheduled w/ nurse x triage.
Patient experience sharp pain and swelling on (L) hand wrist in the evening after getting the vaccine in the afternoon. He could move his left wrist due to swelling last night. But he can move it this am.
approx 6-10 hrs p/vax devel swelling & pain @ inject site, progressed to local overlying papulo vesicular rash, resolved over next 3 days; had similar reaction to 1st dose;
Heavy legs, restless legs, hypersensitivity which moved into her upper body days later (shoulders). No tx for this by her MD. Seen on 12/26/07. Dr. told pt it could have been a virus that got to her.
Woke up 6/10/04 complained of left arm pain, swelling and numbness, numbness radiated into left side of chest. Arm felt like pins and needles.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of GARDASI (lot number, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: very dry mouth
Redness, itchiness, hives, hardness , and heat at area of injection cropped up 1 week and 1 day after injection.  Participated in daily email V-safe checking but they stopped texting the day before  new symptoms started
Arm soreness and nausea  began at 4:00pm on 04/07/2021 and are continuing.   Back pain/cramps/spasms; headache; tightness in chest; chills began at 5:00am on 04/08/2021 and are continuing.
Security notified us that a person had crashed their car into a building as she was leaving the campus.  It was discovered she was a person who had received a vaccine here at the clinic.  Emergency number was called by someone and paramedics showed up to the scene and patient was taken to the hospital.
1hr p/vax round red raised lesions appeared on face & back of neck, spread to shoulders was referred to Hosp ER given APAP told was allergy; Next day rash spread to face, trunk, extremities- (hives)
L thigh vastus lateralis area red-almost purple-10-12 cm diameter, swollen.  Persisted for >5 days.
Breakthrough case COVID-19 after fully vaccinated (1doseJanssen vaccine   )
Patient has contracted shingles after receiving Zostavax Vaccine. He has rash and pain. Patient was prescribed Valacyclovir to treat the shingles out break.
I received the second dose of the Pfizer vaccine on Friday, March 5th at around 10:00AM. On Saturday March 6th around 9:00PM, I started experiencing a tingling sensation in my eyelid that spread to the left side of my head, arm, fingers, and toes.  The tingling sensation spread to the right side of my body by the following Friday, one week after the shot.  I had high blood pressure, rapid heart rate, head and ear pressure. It is now April 2nd, four week after the second Pfizer dose, and the tingling sensation continues to come and go. I have had a left side headache off and on most days since the second dose.
huge red spot with a knot in it and it's hard; huge red spot with a knot in it and it's hard; huge red spot with a knot in it and it's hard; chills; horrible headache; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (huge red spot with a knot in it and it's hard), INDURATION (huge red spot with a knot in it and it's hard), SWELLING (huge red spot with a knot in it and it's hard), CHILLS (chills) and HEADACHE (horrible headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced RASH MACULAR (huge red spot with a knot in it and it's hard), INDURATION (huge red spot with a knot in it and it's hard), SWELLING (huge red spot with a knot in it and it's hard), CHILLS (chills), HEADACHE (horrible headache) and PYREXIA (fever). At the time of the report, RASH MACULAR (huge red spot with a knot in it and it's hard), INDURATION (huge red spot with a knot in it and it's hard), SWELLING (huge red spot with a knot in it and it's hard), CHILLS (chills), HEADACHE (horrible headache) and PYREXIA (fever) outcome was unknown.            Treatment information was not provided.  No concomitant medications were reported.  On 11 Jun 2021, The patient reported after they got their  second vaccine yesterday that they have a huge red spot with a knot in it and it's hard. The patient is also  experiencing chills, possibly a fever and a horrible headache.
Initial report received from a healthcare professional on 03 January 2014. A male patient, whose age, medical history and concomitant medications were not reported, had received FLUZONE QUADRIVALENT batch number; dose, route and anatomical site of administration were not reported on unspecified date. On unspecified date, in evening after vaccination the patient experienced neurological event and was hospitalized. Corrective treatments and laboratory investigations were not reported. The outcome of event was not reported. Documents held by sender: none.
Coughing, chest tightness, decreased saturation, itching forehead and back, rash on upper back
24 hours after shot, the site was red and warm to touch with a big knot in the center.  By Thursday 8-5-21,  the knot and reddened area were the size of a golf ball and the left armpit area was tender, and a palpable lump was felt in the armpit,  but moved a round,  so hard to find.  By Friday 8-6-21, the reddened area is still warm and the same size, but the knot and tender rea are about the size of a tennis ball and the armpit is still tender, pain with movement.  Also 30 hours after the vaccine, I had a fever of 102.2, ear ache, slight sore throat, severe body aches, chills, fatigue,  headache, nasal congestion.  It lasted about 12-14 hours.
Subsequent to receiving vaccination the pt developed 4-5 chickenpox lesions on the face and approximately 20 on her trunk. the pt was also running a low grade fever. The pt was treated with aspirin and Aveeno  bath and lotion.
Case number PHEH2013US023931 is an initial spontaneous report received from a health care professional on 13 NOV 2013. This case refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11076 and expiry date: APR 2014) at a dose of 0.5 ml intramuscular on 07 NOV 2013, which was reached 0 C for about 1.5 hours on 06 NOV 2013. No adverse event was reported following this administration error.
Noticed rash on thigh (L) around 7:0 pm, No c/o discomfort to area (7/15/2010).
Tues, 12/28 -7 hours after booster - chills, fever, and body aches started Wednesday 12/29 -The next day - fever continued 101.2, chills, body aches, weakness, heart rate 11, vomiting, fatigue, cold sweats, awful headache Thursday 12/30 - could control fever and body aches with naproxen; however-OTC pain meds did not touch the headache, noticed injection site is red, swollen, warm, and itching Friday - arm still red and itching, tired
Injection site pain, Tiredness, Headache, Muscle cramps & pain, Chills, Joint pain (extreme), Fever, Feeling Unwell.
5-10 minutes after receiving vaccine developed fullness and feeling of swelling in lower lip and throat.  Persisted and given benadryl 25mg po and symptoms resolved within about 10 minutes.  HR, BP, oxygen saturation, and lung exam all normal throughout the 90 minute monitoring period.
Tingling in lips and throat, sensation of swelling in lips, not visible, that started 25 min. after the vaccination and lasted about 2 min.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Mar2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: 4th day after last dose of Paxlovid and a negative Covid home test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: 4th day after last dose of Paxlovid and a negative Covid home test, the patient started experiencing symptoms again. First day of symptoms included congestion, second day included congestion, chills, body aches, and fatigue. There were no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke with a mild fever (temp. not taken) and moderate body aches at 5 AM (~15 hours post vaccination).  Turned into slightly more severe of both these symptoms by 8:30 AM.  Not very functional.  Went to bed with sweats.  Fever broke around 1 PM.  Still felt achy the rest of that  day.  Mild aches the next 2 days but functional.  Day 4 was achy and very emotional but functional.  Day 5 was near normal.  OK after that.
Pt called 5/22/06 @ 09:54 AM. Received 2nd injection on 5/9/06 of Twinrix. 1 week later, experienced soreness in joints of L hand then R hand. C/o difficulty forming a fist. L hand soreness has resolved. R hand still sore. Instructed to call PCP. Pt states used Advil to help relieve soreness.
11/3/21 pt presents to hosp with c/o LLQ and RLQ abdominal pain, worsening with some nausea, also saw dentist today for an abscessed molar; 11/4/21 pt had an appendectomy; later had a cough with increasing SOB; initial COVID test was negative; was given dexamethasone; repeat COVID test on 11/11/21 was positive; treated with remdesivir; respiratory problems worsened; DNR/DNI; pt was using CPAP; pt's condition worsened and she passed away in the hosp; death certificate and med records sent to info@vaers.org per VAERS request
We administered the second dose of the Moderna COVID-19 vaccine on Friday, April 16th. We were contacted by the patients family to report that the patient began a fever and chills the night of 4/16, she subsequently began having  nausea, vomitting, and sweating followed by a seizure, and was taken to the emergency department where she died the following day.  She was encouraged to receive the vaccine at the encouragement of her oncologist.
tested positive for COVID 19 today; tested positive for COVID 19 today; This is a spontaneous report from a contactable consumer (patient's son). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunisation. Patient previously took BNT162B2 in Jan2021 for COVID-19 immunization. There was no additional vaccines administered on same date of the suspect. There was no prior vaccinations (within 4 weeks). The patient medical history and concomitant medications were not reported. On 16Feb2021, the patient experienced tested positive for covid 19 today.The reporter father tested positive for COVID 19 today. The doctor recommended a Bamlanivimab infusion which is a new agency authorized drug. The caller thought that  it was recommended to wait 2 weeks before an infusion treatment. Is that true? He just wanted more information on how to proceed. There are no studies on the drug because it is something very new. The doctor probably wants his dad to start the infusion because of age and comorbidities, but if it was recommended to wait two weeks the caller would like to know. The reporter doesn't know the lot numbers or anything for his father vaccines. There was no visit of emergency room and physician office. The patient underwent lab tests and procedures which included COVID 19 test positive on 16Feb2021. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Two days after receiving the shot, I started to have tinnitus in my left ear. I just now realized that it possibly could be a side effect of getting the vaccine
Left arm redness and swelling. Tender at injection site. Warm to touch. Seen by MD on 7/22/10.
chest pains/discomfort, shortness of breath / diagnosed with cardiomyopathy and acute cerebrovascular disease; chest pains/discomfort, shortness of breath / diagnosed with cardiomyopathy and acute cerebrovascular disease; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for and for its intended purpose: the prevention of shingles (dose, route of administration, and lot # not provided). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered chest pains/discomfort, shortness of breath, and was diagnosed with cardiomyopathy and acute cerebrovascular disease. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient's symptoms resulted in physical limitations not present prior to use of the suspect vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. As a further tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive permanent, 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, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The events were considered to be related to the suspect vaccine.   Cardiomyopathy and acute cerebrovascular disease were considered to be disabling events. Upon internal review cardiomyopathy was considered to be medically significant.
24-28 hours after vaccination I had body aches, chills, headache, cough, leg cramps and temperature of 100.8 (I usually run about 95). I slept 14, 12 and 18 hours per day the first 3 days after vaccination. I have been improving each day but still tire easily and still have a cough when taking deep inhalations (as of Feb. 10).
17-year old patient was administered the pentacel vaccine with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 17-year-old patient was administered the Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Jul-2023, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength (lot: UJ841AA, Expiry date: 19-Feb-2024) via intramuscular route in the right arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was 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.
presents with progressively worsening shortness of breath, very aggressive cough, subjective fevers on the background of her COVID-19  Treated w/ Roceph, Zith, Vit E 1200 iu daily, vit D weekly, po thiamine
Patients husband reported abnormal movements, speach, weakness and disorientation, hyperactivity.
HEPATITIS A dose #1 given 3/12/07.  Dose #2 was due in 6-18 months- which would be the earliest 9-12-07-it was given 7 1/2 weeks early.  Mother stated patient had a "slight" fever 2 hours after that resolved with Tylenol.  She did not check it with a thermometer.
Incredible headache; Congested; Fever; Nausea; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congested), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Incredible headache) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache. Previously administered products included for Product used for unknown indication: Janssen in May 2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 16-Dec-2021, the patient experienced NASAL CONGESTION (Congested), PYREXIA (Fever), NAUSEA (Nausea) and MYALGIA (Body aches). On 20-Dec-2021, the patient experienced HEADACHE (Incredible headache). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Congested), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Incredible headache) outcome was unknown.            No concomitant medication provided.
Dr. called about a pt of his who has suffered from a facial rash since he received AVA during the war. (1991) He continues to suffer from a slight rash (red discoloration) on his face.
The patient had tightness in the throat. Then her lips started to tingle and her face looked red and swollen.
Menstrual irregularities, including frequent, excessive, and missed menses x4 months and continuing
Patient received routine 4 month DTaP during check-up on 1/02/06 around 2 PM.  Pt awoke at 0535 this morning with fever to 101.8.  Parents sponged pt and gave 60 mg. acetominophen.  About 0720 pt suddenly screamed violently and arched his back for 4-5 seconds.  He was then limp and lethargic for another 2 minutes.  No tonic-clonic movements or eye-rolling.  Exam at 0900 shows alert, playful, afebrile child with normal neurologic exam. Follow-up Information 26-APR-2006: Febrile seizure approximately 40hrs after 2nd DTP, IPV, Comvax, PCV, continued fever and irritability at 96 hrs post vaccines - diagnosed with acute otitis media. Dx by primary physician on 1-4-06.
About 2 hours after the 2nd dose vaccine, I began to have upper leg aches.  By 4 hours I was hurting very badly in both legs and had a very stiff neck and a headache.  I have arthritis all over my body.  I am not sure if the vaccine brought on the pain or if my arthritis caused the pain.  But, I have not had that much pain with my arthritis before the 2nd dose vaccine.  I was in so much pain I could not find a comfortable position in my bed to be able to go to sleep.  I was awake until dawn.  Finally,  the pain became less and I was able to fall asleep and sleep about three hours.  Today, 3-8-21, I feel fatigued and still have minor pain in my ankles.  Like I said I have never been in so much pain before.  The 1st dose vaccine only gave me a very sore arm.
10 x 12cm erythema/heat. C/O headache, fever, nausea. Promethazine 6.75mg/15cc 2 tsp q6 prn nausea/vomiting. Alternate cold/heat to arm. Acetaminophen 325mg x 2 q6 prn.