chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient were vaccinated with improperly stored doses of ROTATEQ (dose and route not reported) which had lot # M007125 with expiry: 06-OCT-2017 and lot # M004542 with expiry: 07-OCT-2017. The vaccines were exposed to a temperature excursion of 9 degree Celsius for 1 hour 24 minutes, with an additional excursion of 10 degree Celsius for 2 hours for lot # M007125 with expiry: 06-OCT-2017. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Frequent diarrhea following vaccines lasting at least 48 hours. Fever up to 101.5 degrees.
Patient fainted after leaving vaccination administration room and passed out on the floor. Patient was conscious and 911 was called and arrived. Patient did not leave in ambulance and was doing fine.
This spontaneous report as received from a consumer refers to a male patient of unknown age with no reproted medical history. On an unspecified date late in August in an unspecified year the patient was vaccinated with ZOSTAVAX dose 1 (lot number, route, dose and frequency unknown). No other suspect therapy or concomitant medication was reported. On an unspecified date "about a week later" the patient experienced one itchy bump developed above and below his elbow, including under his arm. A total of six, itchy, hard bumps have emerged on the same arm in which ZOSTAVAX was administered. The callers has not sought medical attention for the event and reports no pain. The bumps have remained for over one week. The caller notes that he received the vaccine along with his wife, at the same date, time and location. His wife experienced no adverse symptoms. No treatment information was reported. The outcome of six, itchy, hard bump arm above and below his elbow, including under his arm was reported as not recovered not resolved. The reporters relatedness of six, itchy, hard bump arm above and below his elbow, including under his arm to ZOSTAVAX is unknown. Additional information has been requested.
developed warts on his hand on an unspecified date following administration of GARDASIL 9; Information has been received from a physician via a field representative through a message on the voicemail, referring to a male patient of unknown age. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  In 2018 (reported as "sometime last year"), the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date, strength, frequency and route were unknown) for prophylaxis.         On an unknown date, the patient developed warts on his hand on an unspecified date following administration of the suspect vaccine. The outcome of the event was unknown. The patient visited physician who did not think the warts were related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), so the patient was administered his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date, strength, frequency and route were unknown) for prophylaxis on a unknown date.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA001599:
first dose administered to a 17yr old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to a 17yr old) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to a 17yr old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose administered to a 17yr old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Upon presentation to Tent 4, participant identified himself as being, "a big baby when it comes to needles".  Received vaccine to LUE and was waiting in Obs area with son (who reported only being seated for approx 5 mins.).  A loud noise was heard and participant was observed laying out prone on the floor.    Clinicians assisted him to roll over where his eyes were red, wide-open gaze, and diaphoretic but was not responding to commands.  After turning him to his Rgt side he began to sit up and became slightly combative and was able to be calmed down.    Moved to Tent 6 to cot via wheelchair where is RUE BP was 180/100 at 11:09, and Lft radial pulse taken by MD was "60 and weak", Resp 16 and unlabored so no oxygen in use but nearby.  Upon further assessment, participant repeatedly stated that, "he just did not feel well" and when probed, c/o frontal headache, nauseated (but did not vomit), and weak.  Offered water to sip and by now lip no longer bleeding.  When asked, "what did you feel prior to falling out of your seat?", he stated, "I just remember that you all were around me asking me questions...hence could not recall moments leading up to being found on the floor and no type of aura was identified as well.  Reported a h/o HTN but did not take his medication today...other history is unremarkable.    Ambulance arrival approx 11:13, VS taken, assessed and transported to nearest facility.  Family returned and later reported that he sustained only a large "goose-egg" on the forehead and fat lip but otherwise was treated and released.
Round, erythematous, macular edema measuring approximately 5 inches diameter on left anterior upper thigh. Inguinal lymph node enlargement, tenderness left side. After 48 hours patient treated with ORAPRED PO BID. Symptoms resolved at follow-up after 24 hours ORAPRED.
Reactivation of HSV-2.   Reactivation of the Virus has not occured in approximately 3 years.
Received  5 TIMES THE NORMAL DOSAGE . NEVER DILUTED PFIZER COVID SHOT
Pt. states that after receiving the 2nd dose of Shingrix 01/07/2022, started experiencing symptoms that evening of chills and fatigue. 01/08/2022 Urgent Care visit with symptoms of tingling in the face, treated with Prednisone and Anti-Viral. Diagnosed with Bell's palsy, follow-up appt. with Dr. determined from previous Shingles infection (August/2021) too many "live-cell" interactions. Previous 1st dose of Shingrix 10/07/2021 experienced severe flu-like symptoms lasting 3 days.
This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 25-AUG-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L019835, the expiration date: 23-MAR-2017, 0.5 ml, intramuscularly. Temperature: 9.8 degrees C Time frame: 1 hour 22 minutes, Data logger: Yes. There was no prior excursions. No adverse effects were reported. There was no concomitant medication provided. Additional information has been requested.
Light red rash on back and right leg. Redness and edema and fever at site. Follow up 05/07/2003: "04/11/2003: Spoke with mom regarding report of rash and fever noted after receiving immunizations.  Mom stated that on day that patient received the shots, he was fine.  Later on that evening, however, he developed a rash with red splotchin on his back and legs.  Mom stated that the rash and splotching subsided after a day or so.  Mom stated that she did not take patient to see an MD, and now he is better with out rash or fever."
Patient received the flu shot in the past, with no issue. In doctor's office a few months ago, experienced light dizziness/nausea when receiving PPD shot, patient alerted doctor to reaction. When patient received flu shot on 10/01/2018 at approximately 7:00pm, he was fine. After 5 minutes, the patient experienced syncope and lost consciousness for a few minutes while seated with girlfriend. He did not fall or experience any trauma; slumped in seat, but awoke after a few minutes. Patient then felt very lethargic after waking, but remained seated for approximately 15 minutes (alert). Patient then felt better and left the pharmacy. Did not have to perform CPR or give Epi-pen to patient. Counseled patient to receive future vaccines in doctor's office and to follow-up with PCP.
Initial report received on 20 December 2006, from the patient. A 34 year old female patient with no known allergies, no concurrent illnesses, no pre existing medical history, and who was not taking any medications, had received a right deltoid (route of administration not reported) dose of Fluzone SV 2006-2007 USP, lot number U2199AA on 14 December 2006, around 4:00 to 5:00 pm. Approximately two to three hours post immunization, the patient developed a fever, burning eyes, cough, difficulty breathing, and swelling of her eyes and lips. She was treated in the emergency room with Epinephrine, steroids, and Benadryl. The patient denied having any other vaccinations within four weeks of the vaccination on 14 December 2006. The reporter was unsure of the number of past flu vaccinations the patient had received, but did report there were no adverse events with any past vaccinations. At the time of this report, the patient had recovered.
normal local site reactions at first- redness and bruising not of concern; two days after vaccine administration severe pain along spinal cord and tingling/burning feeling in the extremities and feeling hot (no fever); this has been intermittent ; it comes and goes, not always present each day but can interrupt sleep
pt recv vax & w/in min pt exp sz;pt was hosp;dx w/neuritis;some months later dx as having a brain tumor in the lt cerebral hemisphere;MD opinion that this event was compatible w/tumor that was found some months later;
This spontaneous report as received from a desk assistant via company representative, refers to a female patient of unknown age. The patient's concurrent conditions, drug reactions/allergies and medical history were not reported. On an unknown date, the patient was mistakenly vaccinated with a fourth dose of GARDASIL (strength, dose, route of administration, lot number and expiration date were unknown). The reporter specified there was an overdose. There were no concomitant therapies reported. No product quality complaint was involved. Additional information has been requested.
Patient had high fever to 104 with lethargy on day of vaccinations, after they were given. 2 days later she developed hives that lasted for 2-3 days. Patient had full recovery.
one dose of V ARlV AX was administered to a patient while it was undergoing a temperature excursion.; no adverse event; This spontaneous report as received from a medical assistant and refers to a male patient of unknown age.     The patient's concurrent conditions, medical history, and concomitant medications were not reported.    On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter (route of administration and anatomical localtion were not reported) (lot # U012222 has been verified to be a valid lot number, expiration date reported as 16-APR-2023) for prophylaxis.         The vaccine was administered while undergoing a temperature excursion (product storage error). The patient did not report any adverse events from receiving the varicella virus vaccine live (oka/merck) (VARIVAX) dose.
Patient reports when she stands, her knees and ankles give out. She is also reporting sleeping more than usual. Lastly, she reports developing a fever of 101F.
slight tightness of throat; felt hot on left side of the body; knocking on left side of the head; started wheezing; itchy on my stomach; involuntary spasms; jaw went to one side and back again; toes were twitching; entire body had spasms; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), SALBUTAMOL (ALBUTEROL HFA) and IBUPROFEN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing), PRURITUS (itchy on my stomach), MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 15-Jan-2021 for Adverse reaction, at an unspecified dose and frequency. On 16-Jan-2021, MUSCLE SPASMS (involuntary spasms), TRISMUS (jaw went to one side and back again), MUSCLE TWITCHING (toes were twitching) and MUSCLE SPASMS (entire body had spasms) had resolved. At the time of the report, THROAT TIGHTNESS (slight tightness of throat), FEELING HOT (felt hot on left side of the body), HEAD DISCOMFORT (knocking on left side of the head), WHEEZING (started wheezing) and PRURITUS (itchy on my stomach) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
0930 Injection area turned red and patient complained of it being itchy. No c/o SOB or s/s of distress noted. Dr. with patient. 1015 rechecked injection site. Returned back to normal. At discharge.
Rash: x 2 days, arms, head and neck. Rash is itchy. He had low grade fever and has been fussy for about 3-4 days.
Bad gout flare-up, worst symptoms and longest lasting flare-up to date.  Three days of intense pain in left knee, ankle, and foot 4/1-3.  Whole leg was swollen and currently (4/8) ankle and foot are still swollen and achy.  Low-mid grade fever from 4/1 to 4/6. Still experiencing fatigue.  Consulted primary care physician, 4/8, and may do a video visit next week if symptoms persist.
Information has been received from a physician concerning an approximately 17 year old female with plantar warts since August 2005 who in August 2006, was vaccinated with fist dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medication.  In September 2006, the patient received second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) 1 month after the first dose.  The patient sought medical attention. The physician noted as of 16-NOV-2006, the patient's plantar warts resolved.  The patient noticed that the plantar warts resolved (on an unspecified date in 2006) after the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) was received.  A different physician administered the HPV rL1 6 11 16 18 VLP vaccine (yeast).  No other information was available at the time of reporting.  Additional information was received from the physician who reported that is not an adverse event.  The warts had been present for 2 years and were refractory to liquid nitrogen, imiquimod (ALDARA CREAM), and laser treatment.  Additional information is not expected.
patient received both Pentacel and Ipol in error with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00752128) and transmitted to Sanofi on 02-Sep-2021.  This case involves a nine-month-old male patient who received third 0.5 mL (total, once) dose of IPV (VERO) [IPOL] (suspension for injection) [lot RIS97, expiry date 03-Oct-2021] at right thigh and third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (suspension for injection) [lot UJ543AA, expiry date not reported] at right thigh (route not reported for both suspects) on 02-Sep-2021 for prophylactic vaccination (extra dose administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE RHBSAG (YEAST) (RECOMBIVAX) for and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of actual medication error due to extra dose (polio vaccine) administered (latency was on same day).  At the time of report, no adverse event reported.  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.
Feeling numb and tingle sensation down my arms , both legs and the left side of my face
His arm was very sore and he was very tired. He went to his PCP and was told these are normal SE's.  He was not prescribed any medicine.
Rashes occurred after the 1st dose and continued after 6 months after the second shot. Rash stomach on back. It would rotate from different spots of my back and stomach. Rashes stopped in September.
My left eye was swollen shut the morning after the vaccine.    The swelling has gone down to droopy eyelid as of now, 3 days after the vaccine.  But is still not back to  normal.
Within 6 hours of the injection, this patient's left TMJ became stiff, and extremely painful. The pain lasted 48 hours then resolved.
she took it upon herself to hold doses x 2 days; occasional headache; This is a spontaneous report from a contactable other healthcare professional and contactable consumer via Pfizer. A 45-year-old female patient received tofacitinib citrate (XELJANZ XR 11mg), via an unspecified route of administration from 01Apr2021 (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication; and bnt162b2 (BNT162B2), via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she took it upon herself to hold doses x 2 days after first covid vaccine dose on 17Mar2021. Patient was advised to contact MD when inquired about whether to hold doses again when she received her 2nd covid vaccine dose on 14Apr2021. The patient also did report occasional headache but could not "associate " headache with Xeljanz. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, the safety profile of the drug and in agreement with the reporter, there is not a reasonable possibility that tofacitinib citrate contributed to the occurrence of the event. of Headache.
Patient was given Moderna vaccine more than 6 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given Moderna vaccine more than 6 hours after first vial puncture) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given Moderna vaccine more than 6 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given Moderna vaccine more than 6 hours after first vial puncture) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's concomitant medication was not reported. No treatment information was provided.
patient developed red raised warm area at varicella injection site, symptom started 17 hours after injection, site increasing in size, patient recommended to take Benadryl by mouth every six hours and Ibuprofen every 6 hours and report to ER if systemic symptoms develop or symptoms currently, worsen.
rash began the morning after vaccination and covered trunk and inner arms.  rash is still ongoing as of 01/03/22
Patient presented to emergency department on 3/27/21 with weakness, lightheadedness, decreased appetite and vomiting.  Patient tested positive for COVID-19.  Chest xray was negative for acute process.  Patient was saturating 92% on room air.  Patient received remdesivir and steroids.  Oxygen was weaned off prior to discharge.  Patient was discharged to a rehab facility.
My daughter states that she has lower spine pain that is constant.; She says the pain feels like a bruise, "like ouch, I don't want to move; 101 fever; Loss of appetite; Headache; Nausea; Weakness; Shaking; Slight and stuffy nose; She says the pain feels like a bruise, "like ouch, I don't want to move; This is a spontaneous report from a contactable consumer (patient's parent). A 13-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Jun2021 15:15 (at the age of 13 years) (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. Medical history included none. Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient historical vaccine included, patient received BNT162B2 via an unspecified route of administration, administered in Arm Left on 13May2021 03:15PM (at the age of 13 years) (Lot Number: ER8729) as dose 1, single for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug Store. Reported Event: My daughter states that, on 04Jun2021 at 10:00 she has lower spine pain that was constant. She says the pain feels like a bruise, "like ouch, I don't want to move" Withheld also has to lay in a semi fetal position to feel most comfortable. This symptom is the most concerning of the other symptoms, 101 fever, loss of appetite, headache, nausea, weakness, shaking, slight and stuffy nose. Since the vaccination, patient had not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 on 04Jun2021. Treatment received for the events was unknown. The outcome of the events was not recovered.   Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.