chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever and sever body aches and chills.  Generally manageable with Advil, but body aches never completely dissipated with NSAIDs.
pt recvd vax & develthrombotic thrombocytopenic purpura;
This RN was working with a student and the client was given a pediatric dose of 0.3ml COVID-19 instead of an adult dose of 0.3ml of COVID-19 by the student. Client left after being instructed to wait 15 minutes. She was notified of mistake and client returned to office later that day for correct dose of 0.3ml adult Pfizer COVID-19. She denies any side effects. She was contacted  again at 5 days after being given both doses and only reported some soreness at sight which she took Tylenol for and issue was resolved. No complications identified or reported.
sometimes get a little light headed; sometimes a little short of breath; feeling kind of weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (sometimes get a little light headed), DYSPNOEA (sometimes a little short of breath) and ASTHENIA (feeling kind of weak) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Irritable bowel syndrome. Concomitant products included VENLAFAXINE for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (sometimes get a little light headed), DYSPNOEA (sometimes a little short of breath) and ASTHENIA (feeling kind of weak). At the time of the report, DIZZINESS (sometimes get a little light headed), DYSPNOEA (sometimes a little short of breath) and ASTHENIA (feeling kind of weak) outcome was unknown.
This spontaneous report was received from a health care worker (medical assistant) regarding unspecified number of patients of unknown gender and age. The reporter states that on an unknown date the patients were vaccinated with VARIVAX (Merck) (dose, frequency, lot number, expiry date not reported). Also reported that on an unknown date, the patients were administered doses of VARIVAX (Merck) that were improperly stored and no adverse events were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
11/19/99, child fussy, not eating well. No fever or rash. Vaccination site-wnl. Suspect generalized adverse reaction to immunizations, lost 1/2 pound a objective evidence.
Pt received vaccine soon after began to c/o syncope episodes. Pt able to walk to cot and lay down. No sob noted.  Pt cold and clammy. 911 called paramedics out to assess pt refused to go to hospital. after 30 minutes pt began to feel better. 1st set V/S  530 pm  p-88, 02 sat 97, BP  104/80 waited 1.5 hrs for husband to pick pt up.  Pt stable no c/o no distress able to ambulate on own home with husband.
Large welt measuring 4x3 on back of right upper arm where VARIVAX shot administered.
p/vax pt exp chest/back pain; D; dizziness; h/a; muscle soreness; ear aches; sore throat; flu symptoms; tiredness; sleeplessness; joint pain;(feverish;myalgia;achy joints; earaches;stomatitis;dizziness continues to present)
Arm mildly sore evening after vax but no other symptoms. Following morning, started have mild muscle aches and fever. Tylenol kept fever down to around 100.5. By the evening, I had 103.2 temp even while taken tylenol and was advised by on-call RN to alternate tylenol and motrin for 3 hours until it decreased. Fever came down after 2-3 hours to 102.3. Fever down to 101.5 by next morning. Had mild headache, dizzyness and fever for next several days.
Pt. received 3 vaccines in the clinic. She received all three injections without issue. She walked to the front desk to check out with her mother and sibling and then lost consciousness for a few seconds and fell to the floor. She was standing at the check out counter in the clinic and hit the bridge of her nose as she fell. She awoke again within a few seconds but was disoriented and did not know what happened. She was able to recognize her mom and sister. RN and MA responded to the situation and had her lay still while the bleeding was stopped from her facial injury. RN had her sit up slowly and she still complained of dizziness. After 5 minutes, pt. said she felt better and was escorted to an exam room. VS HR124, BP102/66. She was complaining of chills and more dizziness. She was given a granola bar and bottled water. After 15 minutes, VS HR82 and BP 110/66 and improved color. RN advised that facial laceration should be checked by PCP or urgent care. Mother was comfortable taking her home and observing for any other signs of faintness over the course of the day.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 05-MAY-2016, the patient was vaccinated with PROQUAD lot # L050909 expiry date 14-JUN-2017, (dose, route and anatomical site of injections were not reported); that was inadvertently reconstituted with MENACTRA instead of the diluent. Concomitant therapies were not provided. No adverse effects were reported. NO product quality complaint (PQC) was involved. Additional information has been requested.
Delayed reaction at injection site. Slightly sore, swollen, hot to touch,  red circle about 2inches in diameter at the injection site.  Faded over next 12 hours, no other symptoms just slightly red the next day, faded and now a slightly discolored no other symptoms.
Severe  total body muscle and joint pain.. Rigid/stiff neck with pain. Inability to pick simple objects up. Unable to get out of bed without assistance. Extreme difficulty to walk. Intermittent night sweats. Inability to concentrate.  Repeated visits to orthopedic doctor, and spine specialist.  No Diagnosis or advanced testing Orthopedic doc RX: cortisone injections to knees and hips. 10/6 / 2020 & 11/25/2020.   DX: Dec. 15, 2020, blood work included Sed rate  & non-cardio CRP.  DX  with Polymyalgia Rheumatica  .  RX : Oral corticosteroids. Patient remains on Predisone as of 08/3/2021
sore arm / arm pain; general blah feeling; fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of abdominal discomfort (first Covid vaccine bothered for 3 days and made stomach upset and vomiting but then went away).   On an unknown date, the patient received Shingles vaccine and PNEUMONIA VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm/arm pain), feeling abnormal (Verbatim: general blah feeling) and fatigue (Verbatim: fatigue).  The outcome of the pain in arm and feeling abnormal were recovered/resolved and the outcome of the fatigue was not reported.   It was unknown if the reporter considered the pain in arm, feeling abnormal and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, feeling abnormal and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 and 10-MAR-2023 This case was reported by the patient via interactive digital media. The patient did not had any worst reactions than any other vaccine, and got Shingles shot on the same day received Pneumonia vaccine. The patient had a couple days of just general blah and a sore arm, pretty much same as any other vaccine and expected mild fatigue, mild arm pain, general blah feeling. The patient recently also had a Tetanus booster and those could really make your arm sore. It was unknown if the reporter considered the pain in arm, feeling abnormal and fatigue to be related to Pneumonia vaccine. Follow-up would not possible as no contact details were available.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 29-APR-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ "2ml, 10 unit dose tube" and lot number K009752 with expiration date of 30-APR-2016, orally, which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 552 hours, at the lowest recorded temperature of 31 (-0.555555556) for 16 hours and at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 168 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Night sweats, achy x "couple days".  GI upset with frequent stools, denies diarrhea "7-10 days".
Tinnitus. I historically have had minor tinnitus, that happens infrequently and sporadically.  I had my first vaccination on Sunday and I really noticed this began yesterday on Tuesday, it has worsened and is more frequent than usual.  I decided to Google this symptom in regards to the covid vaccine and found this to be an adverse effect I should maybe report. I'm able to work and live normally, it's not that much of a bother at this time. I have not notified my pcp of this, and don't feel I need to be seen by them.
A non-serious spontaneous report of "administration H1N1 LAIV with expiry date of 01/15/10" was received from an office manager/healthcare professional concerning a seven-year-old male out of three patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 22-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
I was diagnosed and hospitalized with ITP - Idiopathic thrombocytopenic purpura or Immune thrombocytopenic purpura.  I have never had this before and have always been in good health.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 am at age of 48-year-old (Batch/Lot Number: EN6207) at single dose for COVID-19 immunisation.  Medical history included known allergies to sulfa drugs, diagnosed with COVID-19 prior vaccination. The patient is not pregnant. Concomitant medications within 2 weeks of vaccination included magnesium sulfate; montelukast sodium (SINGULAIR); fluticasone propionate (FLONASE); cetirizine hydrochloride (ZYRTEC); omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 on 25Feb2021 10:00 am at age of 48-year-old administered in arm left (Batch/lot number EN6202) at single dose for COVID-19 immunisation. The patient experienced ITP (idiopathic thrombocytopenic purpura or immune thrombocytopenic purpura) on 09May2021 22:00. The patient was diagnosed and hospitalized with ITP in 2021 for 7 days.  The patient had never had this before and have always been in good health. The event was serious for hospitalization, life threatening. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse event which included 5 bags of platelets, 5 IVIG (intravenous immunoglobulin) infusions, eltrombopag olamine (PROMACTA), P.  Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not resolved.
Pt had immunizations in office 11/10/2005 am, mom called our office after hrs and spoke with DR. Mom stated she is in car with child and his legs have blue splotches and legs and feet swollen and he started fussing. Mom took pt to ER for eval per DR orders per mom PT DX possible vaccine reaction. Tylenol given ant legs massaged after 40 minutes pt did better.
Patient received1st dose of Pfizer Pediatric dose on 10/01/2022 Lot FL2757. Product removal update on 10/25/2022 for Lot FL2757
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 04-JAN-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R005865 with expiration date in 22-OCT-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001831: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
got the first Pfizer vaccine dose, then got Covid and became severely sick, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late; got the first Pfizer vaccine dose, then got Covid and became severely sick, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late; got the first Pfizer vaccine dose, then got Covid and became severely sick, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late; This is a spontaneous report from a contactable consumer or other non hcp (patients cousin). A 6-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that she received her first vaccine dose on 25Jun2021 but is not able to get the second dose until the end of Aug or early Sep. Caller was asking if that is ok reporting that she has spoken to her HCP for advice as well and she was told to wait a little bit. During this call the caller also reported that her cousin, who also lives in (name withheld), who is in her 50's, got the first Pfizer vaccine dose, then got Covid and became severely sick on an unspecified date in 2021, missed her second dose and when she tried to get her second dose 8 months later was told that it was too late and she would have to repeat the series so instead she switched over to (name). Offered to transfer the caller to safety to report this occurrence, caller declined. The patient underwent lab tests and procedures which included covid test: got covid on an unspecified date in 2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
expired dose of Menactra was inadvertently administered to a patient; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 18 years old female patient who received expired 0.5 ml booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U5839AA and Exp. Date 05-Mar-2019) via intramuscular route in the left deltoid, on 03-May-2019.  The patient's past vaccination(s) included Menactra in Jun-2011.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  It was unknown whether the patient had any adverse reactions.  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 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.  Documents held by sender: none.
HOSPITALIZED BREAKTHROUGH CASE WENT TO ER ON 10/18/21 WITH SOB THAT STARTED ON 10/17/21.  DIAGNOSED WITH PNUEMONIA AND ACUTE RESPIRATORY DISTRESS SYNDROME.  PRESENTLY NOT ON VENT, ECMO OR IN THE ICU. SMOKES 2 PACKS PER DAY.
Patient became suddenly short of breath, unresponsive, attempted CPR unsuccessfully and patient expired.
administrating only the diluent portion / administration of the diluent alone; administrating only the diluent portion / administration of the diluent alone; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received Shingrix. In July 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The account manager from Glaxosmithkline called to report that he was informed by a third person, that an health care professional was administrating only the diluent portion of the Shingrix vaccine to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, the patient received Shingrix vaccine through 26th July 2021 to 29th July 2021. The reporter gave the health care professional contact information but did not specify if the health care professional agreed to be contacted for follow up or not. There was no further information regarding the date of the administration, nor lot number or expiration date of the vaccine. No further information was given to the account manager or to the agent. This case was 7 of 9 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165607:Same reporter US-GLAXOSMITHKLINE-US2021AMR167670:Same reporter US-GLAXOSMITHKLINE-US2021AMR167671:Same reporter US-GLAXOSMITHKLINE-US2021AMR167672:Same reporter US-GLAXOSMITHKLINE-US2021AMR167673:Same reporter US-GLAXOSMITHKLINE-US2021AMR167674:Same reporter US-GLAXOSMITHKLINE-US2021AMR167677:Same reporter US-GLAXOSMITHKLINE-US2021AMR167676:Same reporter
pt exp swelling in all joints, diffuse rash, maculopapular;spoke to child's pediatrician re: rxn;vax given @ hosp (pvt);
My lips broke out and blisters and turned red and dry; My lips broke out and blisters and turned red and dry; My lips broke out and blisters and turned red and dry; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for COVID-19 immunization. The following information was reported: LIP BLISTER (non-serious), LIP ERYTHEMA (non-serious), LIP DRY (non-serious) all with onset 03Mar2021, outcome "recovered" (2021) and all described as "My lips broke out and blisters and turned red and dry".  Additional information :after the second Pfizer shot my lips broke out and blisters and turned red and dry and they have lasted for about a month and a half and then it cleared up and then after my booster shot on 07Oct2021 that night my lips turned red and blisters broke out a the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.