chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; temperature excursion for PROQUAD that reports doses were administered following the excursion; This spontaneous report was received from a physician and refers to a 12-month-old patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 22-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose 0.5 ml, lot # T021642, expiration date 21-DEC-2021(route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the maximum temperature excursion of 16.2 degrees Fahrenheit (F) for 2 hours and 28 minutes. The event was reported due to digital data logger. There were no previous temperature excursions. There were no additional adverse events (AE) reported.
numbness in the arm/patient could not feel touch, as with a pinch, but could feel a pin prick; Information has been received from a physician via a field employee referring to a 12 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not reported.   On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, lot# and expiration date unknown) for prophylaxis.   On the same date, following the injection, the patient experienced numbness in the arm, while still in the physician's office. The physician informed the field employee that patient could not feel touch, as with a pinch, but could feel a pin prick, performed by the physician. No treatment was given to the patient. The outcome of the event was unknown.   The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Patient arrived with the mother, information verified and explained to mother by vaccinating nurse that booster not yet eligible but insisted and said i  don't have to worry about it and insisted. I Informed the Manager after the dose given and she spoke with the mother. Pt given 1/2 dose Moderna as booster dose.
Significant swelling of the shoulder area. Currently still swollen on 8/6/2019, five days post injection.
This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 63-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included tingling sensation (got prior to appearance of the fever blisters). Concurrent medical conditions included fever blister (breaking out on face, in mouth, on eyebrows almost weekly). Concomitant products included SHINGRIX. In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional information received as follows: After receiving SHINGRIX, the fever blisters on the patient's face, inside her mouth, and on the eyebrows went away almost immediately. The patient reported that the tingle she used to got prior to the appearance of the fever blisters went away. The current physician was unknown. Lot numbers of SHINGRIX were unknown. The patient did not give consent to follow-up.
Fever (101.8 at highest), chills, arm pain, vertigo, body aches 24 hours after injection. Symptoms abated after 36 hours.
Information has been received from a consumer concerning her 19 year old daughter with penicillin and amoxicillin allergy and no previous medical history reported, who on 25-FEB-2008, was vaccinated with the first dose of GARDASIL, 0.5 mL, injection. On 28-APR-2008 was vaccinated with the second dose, and on 03-SEP-2008 was vaccinated with the third dose. There was no concomitant medication. " One month ago" on approximately 28-SEP-2008, the patient experienced that falling after the third dose of GARDASIL, the patient was not recovered from hair falling. On an unspecified date a blood test was performed (result not provided). The patient sought unspecified medical attention. Additional information has been requested.
My COVID-19 infections symptoms started on 12/03/2022. I had a severe headaches, vomiting, diarrhea, cough, and  difficulty breathing. It turned to shingles and then to respiratory issue. On 12/06/2022 I tested positive for COVID-19 infection. I tested negative for COVID-19 infection on 12/11/2022. On 12/12/2022 I developed rashes on left side of my upper body. On 12/15/2022 I went to a walk-in clinic since I had shingles and breathing issue they prescribed me with amoxicillin and steroids. On 01/04/2023 I did a telehealth with my doctor who prescribed me with tramadol for pain. I went to my doctor yesterday 01/12/2023 he did a full blood work I haven't received my results yet. As of today 01/13/2023 breathing issue has got better but not fully recovered yet.
I have been experiencing memory slippage like forgetting names and making foolish choices.  I am suffering cognitive loss.  My neck stiffness has become severe pain starting from my neck and shooting up into my skull, behind my eyes.
Information has been received from a registered nurse referring to a 76 year old male patient with allergy to mercury. The patient was a nursing home patient. The patient was administered one dose of PREVNAR 13 and unspecified flu shot on an unspecified date (reported as a few months ago). The patient was administered a dose of PNEUMOVAX 23 (dose, route and lot# not reported) in 2013. On 17-FEB--2016 the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route and lot# not reported) for vaccination. Concomitant therapy was not reported. It was reported that as of early 19-FEB-2016, the night nursing staff noticed this patient's face and lip to be swollen, the patient was treated with BENADRYL and prednisone. The reporter noted that when she assessed the patient the morning of 19-FEB-2016, the patient clearly had a different facial expression. At the time of reporting, the outcome of the patient was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
pt ex fever 102-103, chills, h/a, dizziness, decreased activity and decreased appetite
Approximately  20 hours later I developed fever that climbed to 101.6. Took 500mg Tylenol. Fever abated.  24-36 hours after vaccine, I  developed heart palpitations, high heart rate, increased blood pressure Visited primary care doctor and had EKG. Confirmed abnormal EKG, referred to cardiologist. Appointment on 3/4/21. Heart symptoms consistent until two weeks post vaccination, 3/2/21. Heart symptoms seem to be easing.  No previously known heart problem or high blood pressure.
While giving vaccines to patient, I accidentally gave him the influenza vaccine that was meant for his sister. I informed mother of patient and went to inform provider. Provider went to room to speak with patients mother.
This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 010A21A and 07F21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) and HYPERSENSITIVITY (she just had some allergies growing up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Expressed thanks to Moderna that her breathing has been easier) had resolved and HYPERSENSITIVITY (she just had some allergies growing up) had not resolved. Concomitant medications were not reported. Treatment medications were not reported.
27OCT97 pt recv vax & several hr later-local soreness in rt arm & shoulder;5NOV97 neck shoulder, back pain;17NOV97 pain in rt shoulder & neck, T100, nausea, diarrhea;dx serum sickness rxn;
Child developed fever, vomiting and weakness the evening of the vaccination on 11/12/19.  Vomiting persisted for 5 days. Fever persisted for 1 day. Weakness for 3 days. Poor appetite for 7 days.  Supportive therapy with hydration recommended. Improving clinically by day 10.
in mid-June 2021 I started experiencing pain in my feet.  They started swelling and feeling tingly... almost like they had fallen asleep.  Minor tingling also started occurring in my hands.  On certain days the discomfort in my feet was enough to limit my walking.  I noticed on certain days my shoes fit tightly and my calfs were very tight with the ankles showing signs of swelling.  The symptoms continue through the date of this filing...sometimes better/sometimes worse.
Eight days after I received my vaccination (2/9/21)  I developed an itchy raised red rash at the injection site. It was hot to the touch and was itchy and measured about 3.5 inches across by 5 inches down. The rash diminished after 2 days and was completely gone in 4 days. I also experienced fatigue and muscle aches in my back, shoulders and neck for two days beginning on (2/9/21).
Department was notified patient passed away on call back to confirm 2 dose appointment scheduled on February 27, 2021 to receive the COVID-19 vaccine. Department unaware of patients cause of death.
This literature-non-study case was reported in a literature article and describes the occurrence of DEMYELINATION (Fulminant onset of inflammatory demyelinating disease) in a 49-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. LITERATURE REFERENCE: A single-health system case series of new-onset CNS Inflammatory disorders temporally associated with mRNA-based SARS-CoV-2 vaccines. Front Neurol;13:796882. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, after starting mRNA-1273 (Spikevax), the patient experienced DEMYELINATION (Fulminant onset of inflammatory demyelinating disease)  (seriousness criterion medically significant). At the time of the report, DEMYELINATION (Fulminant onset of inflammatory demyelinating disease) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter considered DEMYELINATION (Fulminant onset of inflammatory demyelinating disease) to be related. Concomitant and treatment medications were not reported. Company comment: This literature non-study case concerns a 49  year  old, male patient with no medical history reported, who experienced the unexpected, serious medically significant event of demyelination. The event occurred within two weeks after the administration of an unspecified dose number of mRNA-1273 vaccine. The report stated that the patient experienced a fulminant onset of inflammatory demyelinating disease. No further details such as blood tests, lumbar puncture tests, nerve conduction studies, electromyography, imaging study diagnosis tests or hospitalization dates were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2022-537972, MOD-2022-537932 (Patient Link). Sender's Comments: This literature non-study case concerns a 49  year  old, male patient with no medical history reported, who experienced the unexpected, serious medically significant event of demyelination. The event occurred within two weeks after the administration of an unspecified dose number of mRNA-1273 vaccine. The report stated that the patient experienced a fulminant onset of inflammatory demyelinating disease. No further details such as blood tests, lumbar puncture tests, nerve conduction studies, electromyography, imaging study diagnosis tests or hospitalization dates were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A non-serious spontaneous report of 9 month old daughter received H1N1 LAIV  and cold which was manifested by wheezing and runny nose was received from a parent concerning her nine-month-old daughter, subsequent to H1N1, Intranasal. The relevant medical history included diagnosis of vesicoureteral reflux at three months of age, otherwise healthy. The patient's concomitant medication included trimethoprim and sulfamethoxazole liquid 1.5 ml once daily orally for treatment of vesicoureteral reflux since past six months and will continue for another three months until she is one year of age. She will be assessed for possible surgery for the repair of the defective valve. On 30-Nov-2009, the patient received H1N1, Intranasal for an unspecified indication. Eight days after the vaccination, the patient developed wheezing and a runny nose and was seen by the pediatrician who found by auscultation that child's lungs were clear and the patient was afebrile. The patient was diagnosed with a cold that both the physician and the parents felt was due to the interactions of the child in the day-care center. The cold lasted only a day or two for which no treatment received. The patient was fine ever since. She was playing, eating, drinking, and sleeping well. The outcome of vaccination error and cold was resolved.
BLOOD IN URINE WITH CLOTS; BODY ACHES/WHOLE BODY HURT; MUSCLE ACHES; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, frequency 1 total,  administered on 07-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included medication for high blood pressure. On 08-APR-2021, the patient's "whole body hurt" with muscle aches and body aches. On 16-APR-2021, the patient experienced "blood in urine with clots", sometimes the clots were dry and other times they were wet. Patient experienced blood in urine each time he urinated having started on 16-APR-2021 and he had never experienced this prior to receiving the vaccine. Patient stated that he did not experience any other side effects such as fever, abdominal pain or leg pain. Patient had not yet sought medical attention and had not taken any  medications to treat his adverse effects. Patient stated that he had planned to reach out to a healthcare professional on 19-APR-2021 (tomorrow). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, body aches/whole body hurt and blood in urine with clots was not reported. This report was serious (other medically important condition).; Sender's Comments: V0:20210436909-Covid-19 vaccine .Ad26.Cov2.S-Blood in urine with clots. This event(s) is considered unassessable. The event(s) 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(s).
This spontaneous report as received from a physician refers to a 65 year old male patient, who was also a dentist, with hyperlipidemia. On an unknown date ("many years ago") the patient was vaccinated with a dose of RECOMBIVAX HB (dose, lot # not reported). The patient was probably vaccinated when the vaccine was first released. However, physician states he was not sure if the vaccine administered was RECOMBIVAX HB. Physician states an antibody titer was drawn for the patient on 17-NOV-2014. The result was patient failed to seroconvert; the test was non reactive and was less than 3.1. The causality was not reported. Physician stated he would probably revaccinate this patient. Additional information is not expected because the physician gave no consent to be contacted.
Ileocolic intussusception with perforation after attempted reduction via air enema. Intussusception occurred 18.5 days after vaccination.
Suspected Vaccination Failure/Received both Shingrix, then started to break out; Broke out, near/above eyes, face. Spots like pimple; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 2nd dose of Shingrix. In November 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 8-Nov-2022 Reporter's comment: The patient received both of his/her shingrix vaccination and noticed after his/her 2nd vaccination he/she started to break out.  The patient developed a spot above his/her left eye, a spot on his/her nose and cheek. The 1 on his/her cheek went away. But the other spots did not.  The patient recently developed another spot now close to his/her right eye.  The patient did not fully understand what was going on. The spots almost looks like a pimple or a boil. The patient was told it only meant it was working. But he/she had heard other medical professions that he/she need to had it checked out by a dermatologist. The patient was wondering was this normal after the shingrix vaccination. If you could let him/her know that he/she would appreciate it so much. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L0085744, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
By the date of 7/23/2011 on my sons left thumb was a very large pus filled area around the knuckle also very red and visibly painful. We went to the urgent care since it was a Saturday and had only gotten bigger. She thought it was from an infection but there was no puncture area, it looked as if it's coming from the inside out. She popped it and gave an antibiotic and bandaged it. This was the first of 4 events I believe. Each time in the exact same area. The last time, at our physicians office, she said it looked herpetic and gave him acyclovir which withered it almost instantly.
The patient was not feeling herself, but could not specify what was wrong; A 62-year-old female was vaccinated with Fluad Quadrivalent; This spontaneous case was received on 02-Nov-2020 from a pharmacist via Health Authority (reference number: SEQW20-04648) and concerned a 62-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 31-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention (explicitly coded as 'Inappropriate age at vaccine administration'). The batch number was not reported.  On the same day, after receiving Fluad Quadrivalent, the patient was not feeling herself, but could not specify what was wrong. No corrective treatment was applied.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 62-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient was not feeling herself, but could not specify what was wrong. For feeling abnormal, causality is unassesable. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.; Sender's Comments: A 62-year-old, female patient was vaccinated with Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient was not feeling herself, but could not specify what was wrong. For feeling abnormal, causality is unassesable. Product administered to patient of inappropriate age is assessed as not related, per company's conventions.
day of injection w/in 2 hours arm sore, burning and hot to the touch. woke up the following day with headache, tired and dizzy. day 2 armpits itching, tired dizzy and joint aches, sweating, feeling hot; no fevers from 9/22: headache, sweating, now getting really cold too, itchy arm pits and very sore and hurting knees and legs.  Headaches have not stopped.  When I over heat I want to throw up.  I still feel terrible.  I keep taking my temperature, especially during hot and cold episodes and no fever.  I still struggle to get up in the morning and I am an early riser.  I do not feel like myself. dizzy for 4 days, blacked out twice on 9/17, shooting bolt lightning pain through elbow and down legs and into knees started 2nd week after inj and not stopped. aching still there. about 1 week, after vaccine left hand paralyzed during night HA, joint pain, (left worse than right) persisted until currently. arm pit itching stopped on 10/11
She has been experiencing fatigue since then; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue since then on an unspecified date in 2021 with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was given his second dose of HPV vaccine. Pt. reported to provider that during administration he felt a sharp pain that radiated up to his neck. He reports that he has had ongoing left arm and shoulder pain that keeps him awake at night. The patient followed up with his PCP on 05/26 due to this continual pain. His PCP reports that his neurovascular exam was intact, mild pain at the injection site without skin changes.  PCP opted to increase his NSAID and trial Robaxin for his muscle spasms.
Patient started going in and out of consciousness about 2 minutes after administration and was unresponsive. Pharmacy staff immediately called 911 and EMTs arrived about 5 minutes after. EMTs assessed the patient. Patient was given water and juice but declined food. After 35-40 minutes, the patient felt well enough to walk out of the store with her mother.