chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Swollen arm. Patient instructed to go to Urgent Care. She expressed she was 'ok for now' and would let us know if it gets worse but swelling started to go down.
Received vaccine on Friday and woke up Monday morning @4am to use the restroom and when stood up R leg gave out and I fell to the floor. It took several minutes before I was able to have strength on R leg to stand. Following that I have had on and off pains in calf area of R leg with constant dull headache mainly on R side.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ 1 dose, orally, lot number N021308, expiration date 05-MAR-2019 (exact dose was not reported) for prophylaxis. The vaccine had been stored improperly in temperature of 10.58 degrees Celsius for 52 minutes. It was not reported if there were any previous temperature excursions. No adverse effects were reported.
Severe sore throat, dry cough, nasal congestion, chest congestion, headache, body aches....NO fever.  This episode was 5 months after first injection.  Ten days prior to onset of symptoms, I had been through 4 airports, on 2 airplanes, attended a funeral for my brother where there was multiple unvaccinated people.  I truly feel it was a URI related to fatigue and stress.  The URI symptoms lasted one week, with fatigue lasting 2 weeks.
Patient fainted after 12 s were given within 1-2 min. Slowly recouperated.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-SEP-2012, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Headache for 24 hours, fever of 102 degrees for 24 hours,  fatigue for 36 hours, flu like symptoms
no additional averse events; GARDASIL 9 was administered during a temperature excursion; This spontaneous report was received from a Certified Medical Assistant referring to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # S008153 expiring on 20-NOV-2021, for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of 48.4F and 32.7F for 15 minutes and 47 hours, respectively, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
10 mins following injection, breathing felt painful. Used albuterol inhalor 2 puffs per dr instructions.  Felt relief after 10 mins and left campus. Had painful breathing and utilized full course of medicine, increasing advair dose to 250/50 for 2 days. Unable to breath enough to complete yard work, called dr who said my lungs sound tight and wheezing. Started tapered dose of prednisone 40mg/4 days, 30mg/3 days, 20mg/1 day, 10mg/1 day. Am at day 4 today and feel relief?able to complete yard work.
Patient stated her left arm hurt after receiving pneumococcal and influenza vaccinations (30 Sep 10). The pain increased the next AM (1 Oct 10). She developed a fever later that night. Patient went in for emergency care on (1 Oct 10. Left arm began to swell and develop urticaria-like "welps" from her left shoulder down to her left elbow. She received diphendydramine, a steroid, Zyrtec, and another medication she was not able to rememeber. Patient states that after treatment she had a cough, sore throat and temperature > 100 degrees F for about a week. The symptoms have since resolved.
4/26; 6pm - 4/27; 12am: mild aches, fatigue, and mild chills 4/27; 12am - 6pm: extreme chills, extreme all-over body aches, nerve pain, myalgia, severe headache, weakness and fatigue, confusion and disorientation,  high fever 103 - 104 4/27; 6pm: fever got as high as 106.2 - Treated with ice packs and ice water and went to ER 4/27; 6pm - 9 pm: fever and other symptoms lessened, and continue to lessen now, 4/30
Pt was a non-responder to initial vax series about 2 yrs ago; Titers were recently checked due to a needlestick; Pt recvd 2 addtl doses of Hep B vax & still has not responded;
Moderate sore arm; Moderate headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 11:30(at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included intracranial hypertension and asthma. The patient had no known allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetazolamide (MANUFACTURER UNKNOWN) for an unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 15:00, the patient experienced moderate sore arm and moderate headache. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were 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 moderate sore arm and moderate headache was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recvd vax;mom states had high fever of 104;tx w/ apap & sponge baths;to MD;felt was rxn to MMR; fever lasted over 1 noc;
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The pharmacist was notified by another employee that the patient experienced arm pain after receiving the SHINGRIX vaccine. No additional details were available.
Moderna COVID-19 vaccine   Developed  a severe rash on left side of my stomach with two blisters 1/2? diameter in size.  I was sitting in the sun on my deck for about 2 hours and was wearing a shirt that covered my stomach.  Rash disappeared after 3 days.  Blisters are still present but look better.  No medical treatment required
headache; body ache; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of headache in an adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were unknown.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the shot a day before date of reporting.  The reporter asked was it OK to take aspirin or Tylenol for headache, body ache.
No adverse event; Medical assistant reports an expired dose of MMR II was administered to a patient on 02JUNE2022. Caller confirmed the dose was not involved in a temperature excursion.; This spontaneous report was received from a medical assistant referring to a 17-month-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 02-JUN-2022, the patient was vaccinated 3 days after expiring vaccine measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II) first dose, lot #T018635, expiration date: 29-MAY-2022, administered subcutaneously (SQ) at right lower forearm (RL) as prophylaxis (dose, strength was not provided) (expired product administered). It was spoke to manufacturer (conflicting information: also reported as no previously report this adverse event) and notified to the patient. The patient had no side effects. Per the patient, there should be no issue with the timing of vaccine. The dose was not involved in a temperature excursion. No additional adverse event was reported.
Pt recvd vax 16APR92 & pt devel pinkish-reddish small-bump nonpruritic rash distributed primarily on chest, stomach & shoulders; also exp a sore throat, aching & t100;
Patient ( 3/12/2009) received the 1st dose of COVID vaccine ( Pfizer Lot: FK9895) at 11:30am. At 1145am RN observed client?s nose bleeding and client holding a tissue against nose. RN responded. Client was sitting comfortably in chair holding tissue against nose. Mother of child denied significant medical history, medications, and allergies. Mother of child reported that the child has been seen my pediatrician for frequent nose bleeds. Per mother of child, the client is being evaluated for his condition.  Vital signs at 1145am were as follows: BP: 132/87, HR: 97, Spo2: 98. Client denied chest pain, difficulty breathing, nose pain and rash . Client was AOx4 ( person, place, situation, and time). Client was given water. Client was able to consume water with no difficulty. Symptoms resolved at 11:50am, client?s nose was no longer bleeding. Upon visual inspection the client?s nose was patent with no obstructions. At 1200pm vitals were taken and were as follows: BP: 118/67, HR: 96, Spo2: 98. Client was AOx4 ( person, place, situation, and time) Client denied chest pain, difficulty breathing, nose pain and rash .. Client left facility at 1205 with a steady gait,  unassisted, with mother and sister. Education was provided to client and mother on signs and symptoms of allergic reaction, and when to seek emergent care.
The patient was given the vaccine at approximately 11:30.  States he was told to wait but went to get ice cream.  When he began to drink about 15 minutes after the vaccine he felt a tingling in his throat.  He returned to the Health Department at 11:55.  No c/o difficulty breathing states that his throat  just feels "tingly and weird".  02 sat was 98%.  Given diphenhydramine 50mg IM in right deltoid.  Patient waited in clinic for 15 minutes and states the feeling began to subside.  Call to patient the next day and he stated that he felt "completely normal after 30 minutes."
Temperature 100 on the evening of 4/25/00. Woke up the next morning with red, approximately 1cm sized spots. On 4/25/00 to doctor and had full blown hives at 13:45.
I began to feel a slight pressure shift in my left ear, like one would feel in a pressurized cabin, and began to hear a loud ringing in my left ear. The Tinnitus has persisted without stopping since 5/31/21. It has significantly affected my hearing  to that side and is uncomfortable.
first dose of Twinrix in Oct 2021, and received Engerix-B and Hep A (Merck) for the 2nd dose a month later; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in Oct 2021), Engerix B (2nd dose received on unknown date in November 2021) and Hepatitis A (2nd dose received on unknown date in November 2021).   On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-Oct-2022 Reporter's comment: The registered pharmacist stated that a patient received their first dose of Twinrix in Oct 2021, and received Engerix B and Hepatitis A (Merck) for the 2nd dose a month later.  The reporter asked whether the patient should still get the Twinrix, how could we proceed. Health-care professional did not had patient demographics and did not had any vaccine information to provide (Lot, expiry date). The consent to follow-up was requested to follow up via mail.  Additional Supportive Information: Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination.
Day 6 post shot: low grade fever,  Body Aches, Chills, Tiredness, Headache and nausea
none at time of injection, developed allergy rashes and blisters 5-6 weeks later
10-15 min after FLUZONE IM bilat periorbital erythema with eyelid swelling, severe cough/wheeze, treated with epinephrine 0.15, ZYRTEC, Albuterol nebulizer, ORAPRED 15 mg in office and continued x 2 days, PATADAY eye drops and continued ZYRTEC x 2 days.
Product beyond use date was 11/9/2022 and this product was used on 11/16/2022.  Writer called Pfizer and CDC for guidance and was informed that product was still stable for 7 days after beyond use date, therefore no further interventions needed.
I woke up and the room was spinning. I had help getting out of bed. I started vomiting severely. This lasted for about 3 days. I went to the doctor and was prescribed an anti-dizzy and anti-nausea medicine called meclizine. It took about 3 days for the symptoms to subside. I was good until I woke up with it again on November 18, 2022. This happened after I had dose 4 on 10/13/2022 Moderna Bivalent left arm GH9702). This time it lasted much longer. I was not able to go into the doctor, so we did over the phone consult. She prescribed the medication again. I'm on day 7 and I am still having to take them. It has improved but there is still some dizziness when I wake up in the morning.
Bad so called rash, nurse took pictures of it, still have it, not going away.  Pain when it was coming to the ttop on my skin, still feel some pain, it is still here.
Member reported to clinic on 17 December 2020 to report taunt, warm skin around injection site. Patient stated he noticed redness and swelling on 16 December but thought it would subside. He reported to the clinic on 17 December when he realized that the swelling and symptoms were not subsiding. Myself and Doctor asked had he taken any medication to help with the pain or discomfort. Member stated he hadn't taken anything and wasn't planning on going to the doctor unless he was directed too. Doctor instructed the member to be mindful of the changes in symptoms to include streaking in the skin and progressively worsening symptoms. Member was advised to notify us in the event he decided to go to a hospital and stated he would go if he needed too.
Shivering when I went to bed at midnight for about 5 minutes.  Woke up a few times during the night, not quite shivering, but not well either.  at 7:00 am I was fine.
30 minutes after injection, patient developed a headache. 8 hours after injection, she started to experience chills, muscle aches, nausea, and shooting pains. Patient was treated with 400 mg Ibuprofen and one 750 mg Tums. 16 hours after injection, patient could hardly move. She was treated with 1000 mg of Tylenol, 50 mg of Benadryl, and 1000 mg of Tums. 18 hours after injection, patient had profuse sweating, but was feeling better. 24 hours after injection, patient was too lightheaded to be able to stand up for any length of time. 28 hours after injection, patient finally was able to eat, but chills and shooting pains 4 hours later.  She was treated with 400 mg Ibuprofen and within an hour started feeling better.  When I checked on her this morning 42 hours after injection, she stated she was feeling 'okay.'
Red itchy patchy rash under both arms from elbow to axilla as well as between legs and near groin.  started after 2nd dose and has not gone away. worsens with warm weather and sweating
Started with headaches 9 days after Cervarix vaccine. Began to run fever in the evening on 8/3/2011 for 3 days. Doctor did a full blood work and everything came back negative.
Arm and hand with feeling of numbness and heaviness; Arm and hand with feeling of numbness and heaviness; site where the vaccine was applicated became red and swollen, with pain; site where the vaccine was applicated became red and swollen, with pain; site where the vaccine was applicated became red and swollen, with pain; This is a spontaneous report from a non-contactable consumer (patient herself) received from the COVAES portal.  A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: Ep7533; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 05Apr2021 15:00 (at the age of 35-year-old), as single dose for covid-19 immunization. Medical history included allergic rhinitis from an unknown date and unknown if ongoing, and known allergies to cats, dogs and mites from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 11Apr2021, the patient experienced arm and hand with feeling of numbness and heaviness, and after a week the site where the vaccine was applicated became red and swollen, with pain. The patient did not receive treatment for the resulted events. The outcome of events was reported as not recovered.  No follow-up attempts were needed. No further information was expected.
Blood in stool, dark red, almost black for 4 days, 5th day stool is white and thick, 7th day and 8th day increased fussiness, screaming for long periods of time (10-15 min) not able to console, wake up screaming, choke and forcefully spit up a lot all at once. Occurs 3-4 times a day, uncomfortable when laying on his back and difficulty falling asleep, squirmy and whiny even when falling asleep in mom's arms.