chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician, concerning a 14 year old female patient, with anxiety and depression and no known drug allergies, who was vaccinated IM with the first, second and third doses of Gardasil, 0.5 ml, as follows: dose one on 29-MAR-2007, (lot #653736/0014U), dose 2 on 04-JUN-2007 (lot #656371/0181U), and dose 3 on 05-OCT-2007 (lot #659435/1265U). Concomitant therapy included sertraline HCl (ZOLOFT), mirtazapine (REMERON) and topiramate (TOPAMAX). In mid-April, following the first dose, the patient experienced a seizure. The seizures have occurred weekly. The patient was seen in the emergency room 4 or 5 times, and was examined by a neurologist (details not provided). A 24 hour electroencephalogram showed no epileptic activity, and imaging of the head showed no mass or tumors. The seizures were further described as tonic clonic, with aura. It was not known if the patient was actually hospitalized. At the present time, the patient was not being treated with anti-seizure medications, and the source of the seizures had not been identified. At the time of this report, the seizures were ongoing. The physician considered the events to be serious, as an other important medical event, and as disabling/incapacitating. Additional information has been requested.  3/23/09 Received hospital medical records of 3/29/07-12/11/2007. FINAL DX: no d/c summary dictated & neuro consult dx non-epileptic events, possible panic attacks. Records reveal patient experienced possible seizures since 4/2007.   Right anterior ilias spne tenderness & difficulty walking 8/3/07, hip x-rays neg.   Admitted on 11/14-15/07 for video EEG.  Symptoms included falls, shaking lasting 1-10 min, fatigue, dizziness, metal tast, unable to speak, heart fluttering, nausea/vomiting, anorexia.  Neuro examination WNL. Returned to hospital 12/11-12/12/2007 for continued possible partial seizure/syncope episodes.  Neuro examination WNL.  When 48hr video EEG neg, referred to psych.  4/29/08 Received Neuro consult of 11/8/2007. FINAL DX: Seizure, possible complex partial seizure.  Psychogenic nonepileptic events cannot be entirely ruled out.  Syncope. Records reveal patient experienced increasingly frequent episodes of fatigue, dizziness, metallic taste & disorientation.  Was currently on antiseizure meds & had normal EEGs & CT scan.  Antiseizure meds were d/c & pt scheduled for video EEG.
Pruritic macular rash on all extremities and torso. Started 8/12/2017.
Initial report was received from a consumer, who was also the patient's parent, on 02 November 2012, which also involved misuse (extra dose administered). A 14-year-old male patient had received an "inadvertent" dose two injection of "probably" a MENINGOCOCCAL VACCINE, Sanofi Pasteur (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced swollen lymph nodes, cellulitis at injection site, "stomach problems", and developed Crohn's disease. The patient received a meningococcal vaccine at age 12, which was believed to be MENACTRA. The patient had no illness at the time of vaccination and no known allergies. The patient's outcome was not recovered. Documents held by sender: None.
HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose); they had a leak out from the syring; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose)) and SYRINGE ISSUE (they had a leak out from the syring) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose)) and SYRINGE ISSUE (they had a leak out from the syring). At the time of the report, UNDERDOSE (HCP stated that she administered a vaccine to a patient, and then they had a leak out from the syringe (she applied less than the recommended dose)) and SYRINGE ISSUE (they had a leak out from the syring) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was an HCP stated that they administered a vaccine to a patient, and they had a leak out from the syringe, the reporter applied less than the recommended dose and stated that they don't have the information of the patient, but they think it was a booster dose.  Later, the reporter stated that they really didn't administered the vaccine, and they were probing the syringes and they had a leak.  No Concomitant product use was reported. No treatment information was provided.   Reporter did not allow further contact
Pt reported no adverse event at contact time of informing pt's family of administering increased concentration of vaccine
Dizziness immediately after injection.  Severe flu-like symptoms including extreme fatigue for 2 weeks following injection, missed 2 days of work.   Menstrual cycle started early the month after shot (I was ovulating at the time of second shot) then NO ovulation for 6 months following shot series.  I am now anemic to point of required prescription iron medication due to heavy periods after cycle resumed.
no adverse effecct; 18 year old was inadvertently administered a dose of Proquad; This spontaneous report as received from a health professional via employee referring to a 18-year-old patient.    The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 11-NOV-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# and expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (product administered to patient of inappropriate age). On the same day, other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (lot# and expiry date, strength, dosage information, route of administration, anatomical locations and indication were unknown). No adverse effects were reported. No additional information was provided. No product quality compliant (PQC) was reported. The outcome of product administered to patient of inappropriate age and no adverse event was unknown.
Pt felt dizzy and then passed out for approx. 45 seconds then came too and complained of being very hot. EMS was called and she was checked out but refused to go to hospital. She left with her brother.
Moderna COVID-19 Vaccine EUA Swollen Lymph Nodes under armpit (axillary lymphadenopathy) Large swollen, red and itchy lesion ay injection site
NO KNOWN ADVERSE REACTIONS, PATIENT WAS GIVEN 3RD BOOSTER SHOT AFTER PATIENT GUARDIAN SIGNED UP FOR A 3RD DOSE.  AS OF RIGHT NOW 3RD DOSE IS NOT APPROVED
Throat itching  Wheezing Shortness of breath All together and 10 minutes after vaccination
vaccinated 10/17, 10/19 red rash at injection site with severe itching-Recommended hydrocortisone topically and Benadryl. 7 pm called again. Rash worse. Patient feels it looks like the shingles. Recommended contact her physician tonight for further treatment
PFIZER MONOVALENT WAS GIVEN STEAD OF PFIZER BIVALENT COVID 19 VACCINE
Went to pain management to spine due to pinched nerves; Went to pain management to spine due to pinched nerves; Had fever for first COVID 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (Went to pain management to spine due to pinched nerves), SPINAL PAIN (Went to pain management to spine due to pinched nerves) and PYREXIA (Had fever for first COVID 19 vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 04-Mar-2021, the patient experienced PYREXIA (Had fever for first COVID 19 vaccine). On an unknown date, the patient experienced NERVE COMPRESSION (Went to pain management to spine due to pinched nerves) and SPINAL PAIN (Went to pain management to spine due to pinched nerves). In March 2021, PYREXIA (Had fever for first COVID 19 vaccine) had resolved. At the time of the report, NERVE COMPRESSION (Went to pain management to spine due to pinched nerves) and SPINAL PAIN (Went to pain management to spine due to pinched nerves) had resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
feeling more fatigued than normal after receiving the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 85-Year-old male patient received the second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot number and Expiration date not reported) via an unspecified route of administration on 15Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient is usually fatigued however is feeling more fatigued than normal after receiving the vaccine. The outcome of the event was not reported.  Follow-up attempts are completed. No further information is expected.
Patient a 17 year old female developed supraventricular tachycardia post-immunization reaction.
Raised, hard, red, warm and itchy  area at injection site. Started size of quarter and has increased to twice that size.   No change since Thursday morning. Fatigue and sleepy all day Thursday. Overnight had feverish chills and headache. Tylenol helped relieve those symptoms.
I was feeling tired for a while and I also had a cough that would not go away. I went to take a COVID-19 test on 03/06/2023, which came back positive. They gave me PAXLOVID and another medication for the cough.
have had the Shingrix shot and have shingles/ Suspected vaccination failure; currently have shingles; The pain is not for the faint of heart; The itching is not for the faint of heart; This case was reported by a consumer via interactive digital media 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 and ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGLES VACCINE (RECOMBINANT NON-LIVE)) for prophylaxis.   On an unknown date, the patient received Shingrix, Shingrix and SHINGLES VACCINE (RECOMBINANT NON-LIVE). In July 2022, unknown after receiving Shingrix, Shingrix and SHINGLES VACCINE (RECOMBINANT NON-LIVE), the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 12-Aug-2022 Reporter's Comments: The patient self reported the case via via interactive digital media. The patient currently had shingles. The patient had the Shingrix shot and the booster and the shingles vaccine prior to Shingrix. The pain and itching was not for the faint of heart. It had been 2 weeks then. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Information has been received from a licensed practical nurse concerning a 7 year old male with allergies and a history of occasional otitis media who on 07/27/1995 was vaccinated with varicella virus vaccine live without reaction. Concomitant therapy included Claritin. On 02/13/2002, the pt developed chicken pox and presented with 75 lesions. The pt was treated with Benadryl as needed. The nurse also reported that the pt's sister developed varicella post vaccination with varicella virus vaccine live (see WAES0203USA01152). Unspecified medical attention was sought. Additional info has been requested.
Conjunctivitis (Pink eye) - eye pain, blurriness, swelling, pus and tearing   This began the day after I received the first shot (within 15 hrs) and worsened over the next few days.   I have used home care: cold compresses and tried to keep eye clean.   In addition I had the other reactions: headache, chills, soreness of left arm and muscle soreness in entire body, fatigue, loss of appetite and diarrhea.
The patient crying during the administration; Patient started to gag and almost vomited/gaging; half of the dose was administered/unsure how much was swallowed/mom requested stopping/half of the container was gone; This spontaneous report has been received from a medical assistant concerning to a 6-month female patient.   The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On unspecified dates, the patient received 2 doses of each of the following vaccines: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dosage, vaccination scheme frequency, lot number and expirations date were not reported) as prophylaxis; and also diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 7v (crm197) (PREVENAR) (dosages, vaccination scheme frequencies, routes of administration, anatomical sites of application, indications, lot numbers and expirations dates were not reported).  On 28-JUL-2022, the patient received the third doses of otavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dosage and vaccination scheme frequency were not reported; lot number 1742417 with an expiration date reported and established as 14-OCT-2022) as prophylaxis; and also also diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) administered intramuscularly (IM) on the right thigh (RT) (dosage, vaccination scheme frequency, route of administration, anatomical site of application and indication were not reported; lot number UJ659AA with an expiration date reported as 31-JAN-2023) and  pneumococcal vaccine conj 7v (crm197) (PREVENAR) administered intramuscularly oon the left thigh (LT) (dosage, vaccination scheme frequency, route of administration, anatomical site of application and indication were not reported; lot number FG5300 with an expiration date reported as 31-JAN-2023). On the same date, it was reported that only part of the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient, because shortly after started the administration, the patient started crying, gagged and almost vomited (retching). Therefore, and the parent (also reported as "mom") stopped the remaining administration, about half of the dose was administered (also reported as "half the container was gone") but it was unsure how much was swallowed (incorrect dose administered).   There were no reactions after stopped the rotavirus vaccine, live, oral, pentavalent (ROTATEQ). It was recommended to repeater.  It was added that a call was placed to manufacturer and the medical assistance (MA) was told that since half of the container was administered, it was no recommended to repeater added a dose and the patient's mother was aware and agreed.   The outcome of the event crying, and retching was not provided. The causal relationship between the events and the suspect therapies was unknown.
All over body rash the afternoon after getting the vaccine.  Extremely itchy legs.  Symptoms dissipated by mid-morning the next day.  Went to urgent care.   Only had a little bit of rash at that time.  Doctor suggested Benadryl and Zyrtec.  Had a bad flare-up of redness on the back and under the arms on the way home from the appointment.  Took Benadryl when I got home.  That helped a lot.   Took Zyrtec in the morning and Benadryl in the PM for the next 2 days.  No more rash,  just a little bit of itchiness.
This case was reported by a healthcare professional and described the occurrence of dry cough in a female subject of unspecified age who was vaccinated with FluLaval vaccine for prophylaxis. On 7 November 2006 the subject received an unspecified dose of FluLaval (unknown). On 7 November 2006, at an unspecified time after vaccination with FluLaval, the subject experienced dry cough and red, "pastey" eyes. At the time of follow-up reporting, 04 December 2006, the outcome of the events was unspecified. Follow-up was received from the reporting healthcare professional on 04 December 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.
18yo here for follow up on SOB and chest pain on 2/16.  Got Pfizer COVID booster shot on 2/15 at 10:30am and felt ok afterwards except for a sore L arm.  On 2/16 in the early morning developed body aches and chills. Then around 11am on 2/16 developed SOB with walking and talking (felt like he had to take "extra" breathes to "get enough air"). That sensation lasted all day, didn't get worse. Yesterday, had one 10 second episode of chest pain that went away and didn't return. Ambulance was called to dorm room around 6pm for evaluation. By the time the ambulance arrived, sx had resolved with exception of L arm soreness, mild headache and mild body aches. He was told that "everything looked good" and declined transport to the ED.  Since this AM, pt has felt well with exception of a sore arm. Not currently having any issues with breathing or walking. Feels back to baseline.  Denies fever. Has not taken any medication today.  Has never anything like this in the past, has remote history of asthma.
sciatica pain; sciatica pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single and administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "sciatica pain" (unspecified if ongoing); "bulging disk" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SCIATICA (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "sciatica pain". Additional information: The patient says she is in pain but was told by the pharmacist that she cannot take ibuprofen (ADVIL) for 2 weeks after the vaccine or it would decreased the efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, dizziness, nausea, tired, fatigue, loopy feeling & mild fever At injection sight: muscle ache & tenderness in upper arm
pt recv vax 24OCT95 & 25OCT95 pt injected arm became swollen, inflamed & pink;f/u info recv from MD office indicated the inj site was red, warm & tender;also pt had a fever of 100.0;pt seen by MD & tx w/ATB;
Was given flu shot.  She went home and spot became itchy.  Her wrist swelled up and started feeling sharp and shooting pains down to her wrist.
After the first dose, I experienced tinnitus about every day for a week or two afterwards. The tinnitus would be present in one or both ears and last about 5-10 minutes. Illness set in roughly 30 min after the second dose. Illness has lasted throughout the last 4 days, and even through today. This would indicate the vaccine has made me ill for about 5 days now. Caused me to go to the doctor as I assumed the reaction couldn't be from the vaccine so long after the dose.
Experiencing body soreness / soreness experiencing is all over body; Congestion; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 15:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome, hypothyroidism and obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methylphenidate hydrochloride (CONCERTA), levothyroxine (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 22:00, after receiving the first dose of vaccine, the patient experienced body soreness and congestion. Patient felt it was worth mentioning that her period started two days ago and was usually accompanied with body soreness in the lower abdominal area that can be quite severe, however the body soreness that she experienced then was all over her body which was not common for that monthly event. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body soreness and congestion was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Around 24 hours after vaccine, pt went limp, eyes rolled back. Positive breathing. Event lasted a few seconds. Afterwards , patient was clingy and "out of it" for a few hours.
Inconsolable high-pitched screaming, rising body temperature lasting up to 7 hours after the vaccines were administered. Treated with Tylenol, but it didn't help.
Asymptomatic patient who had an immediate temperature of 100.8 degrees F, which they felt was too fast; This is a spontaneous report from a   contactable physician.   A male patient of an unspecified age started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration on 17Dec2020 at single dose for immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced  had an immediate temperature of 100.8 °F, which they felt was too fast . The patient resulted positive to Covid 19 virus immediately after receiving the vaccine when the temperatura was 100.8°F. Five minutes later the body temperature was 99.8 °F, the patient returned negative the Covid 19.   Information about lot/batch number has been requested.