chrisvoncsefalvay/vaers-outcomes huggingface dataset:
eventually required hospitalization for hemoglobin of 5.7; Flow following January dose lasted longer than 10 days; Menorrhagia following both doses; I am still having abnormal bleeding to this day; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient, non-pregnant received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration, administered in left arm on 11Jan2021 07:15 (at the age of 38-years-old) as single dose for COVID-19 immunization. The patient's medical history included migraines and known allergies to cephalosporins. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration, administered in left arm on 21Dec2020 07:15 as single dose for COVID-19 immunization and experienced menorrhagia following both doses and noticeably heavier flow after December dose that eventually stopped on its own. Facility type vaccine was hospital. The patient did not received other vaccine in four weeks and other medications in two weeks. On Feb2021, the patient experienced menorrhagia following both doses. Noticeably heavier flow after December dose that eventually stopped on its own. Flow following January dose lasted longer than 10 days and eventually required hospitalization for hemoglobin of 5.7. The patient received 2 blood transfusions, IV venofer infusions, oral TXA, and had to be started on birth control for the first time in her life in order to control the bleeding. She was still having abnormal bleeding to this day. The events resulted in emergency room/department or urgent care visit, and hospitalization for 3 days. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The patient underwent lab tests and procedures which included haemoglobin: 5.7 on Feb2021. Therapeutic measures were taken as a result of the events and included treatment with blood transfusion, IV venofer and lysteda. The outcome of the event vaginal haemorrhage was not recovered and the outcome of the events were recovered with sequelae.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101491088 same reporter/pt/drug, different dose/event
Felt normal until I was woken up with severe pain in my right wrist.  It hurt to touch and to move my fingers or hand at all.  I took ibuprofen and was able to fall asleep after an hour.  It felt sore the next day but I could use my fingers again.  By 4/12 it felt normal.  My upperarm also was sore but nothing out of the norm.
paralyzed; unstable, brain will never fully recover; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and unsteadiness. On an unknown date, the outcome of the paralysis was unknown and the outcome of the unsteadiness was not recovered/not resolved.   It was unknown if the reporter considered the paralysis and unsteadiness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the Shingles vaccine 3 years ago from reporting date and ended up in the hospital for two months paralyzed after months of rehab, the patient could walk again but she was unstable, her brain would never fully recover so now she was in an Alzheimer's research group.  The patient stated that she was alive but only because of her husband's non-stop care. The sad thing was the doctors and the hospitals did not turn the statistics into the CDC (Centers for disease control and prevention).  The follow up would not possible as no contact details were available.
Patient received first dose of COVID-19 vaccine Pfizer (LOT#: EW0150) on 4/2/21 and second dose COVID-19 Pfizer (LOT#: EW0161) on 4/23/21 Patient states 3 hours after the first dose he felt flushed, clammy and was pale. Patient took his own BP. Patient stated his BP was in the 200's. Patient recalls a reading of 210/190. Patient made a virtual visit. Doctor stated that he just needed to rest. A week later patient retook his BP and it was high. Patient stated he went into ED. Patient stated that he stayed in ED for observation and was not given any medications. Patient went to see PCP a week later. BP reading was still high. PCP told patient to just observe for any hypertensive symptoms. Patient was not given any medications for high BP. Patient did not experience any of these symptoms after his second dose. EMT took patients vital signs at 1615. BP: 131/91, HR: 104, O2: 97%. Patient states he "feels good." EMT retook patients BP at 1620. BP: 136/88. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID booster Pfizer dose. Per Dr., approval to proceed with COVID booster Pfizer vaccine was obtained from medical consult team via text message from RN, Vaccine Operations Lead. The patient did not report any symptoms during the 15 minute observation period. RN educated client on possible adverse reactions to COVID vaccine and when to seek medical care. RN educated patient on hypertensive crisis and when to go to ED. Patient verbalized understanding. Patient left vaccination site with his wife and son at 1715 unassisted and with a steady gait.
No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 5-months-old male patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength not reported) lot # R031056 with expiration date of 04-JUN-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.
patient was given ActHIB with two diluents instead of vaccine/no AE; Initial information received on 06-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 month old female patient who was vaccinated with two diluents of HIB (PRP/T) VACCINE [ACT-HIB] instead of vaccine (lot number: UJ135AB, expiry date: 26-Nov-2020) via an unknown route in the left vastus lateralis for prophylactic vaccination on 03-Jan-2020.  Medical history, medical treatment, vaccination, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It is an actual medication error case due to Active ingredient not added to diluent. It was reported that patient was given Act-HIB with two diluents instead of vaccine.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna, Vaccine administration date=25Feb2021 / Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jan2021 as dose 1, single (Lot number: 037K20A), in left arm, on 25Feb2021 as dose 2, single (Lot number: 002A21A), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Nov2021, outcome "unknown", described as "Vaccine brand other=Moderna, Vaccine administration date=25Feb2021 / Vaccine brand=Pfizer / BioNTech, Vaccine administration date=05Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Patient bled rather severely at administration due to likely hitting a blood vessel during administration. Patient reports one day after vaccination: fatigue, profuse sweating, very low-grade fever, cold sweats, low temperature. This progressed several days to day 4 (Sunday evening) fire department responded to patient reported unable to recognize surroundings and severe fatigue. They surveyed house for CO2 poisoning and did not find evidence of that. Patient declined hospitalization. Symptom improvement by 10/12/21 (got flu shot on 10/13/21 so must have felt much better).
administration of Quadracel vaccine to 22-month-old child with no reported adverse event; Initial information received on 18-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 22 months old female patient  to whom diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] administered with no reported adverse event.  The patient's past vaccination(s) included DTaP/IPV on 03-DEC-2021. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 13-Jul-2022, the patient received 0.5 ml  dose of suspect  diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection, (strength; unknown)  (lot C5862BA: expiry date; 01-APR-2023)  via intramuscular route in unknown side of leg for (Immunization)Prophylactic vaccination.  On 13-Jul-2022 it was reported administration of quadracel vaccine to 22-month-old child with no reported adverse event (product administered to patient of inappropriate age) (latency; same day)  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event administration of quadracel vaccine to 22-month-old child with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Congestion; fatigue; sinus issues; scratchy throat. I thought I had a cold, then after a few days the cough and the 101 fever came in. The fever only lasted one day on 101 and it went down to 99 for the next 2 days. I called the doctor and was prescribed PAXLOVID. The temperature went away after 24 hours. The cough also became sporadic. I still have this taste in the back of my mouth that tastes like reflux with acid, however I have not lost any taste at all. The biggest symptom I had was the exhaustion. It is better now but it is still lingering after weeks.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mLper Vials instead of 0.25 mL/ vial.
I received my second dose of moderna vaccine on 1/23/2021. I had done well with the first one other than sore arm and fatigue. I felt ok day one, but day 2 arm injection site was painful. I took ibuprofen and went to bed. Woke up in the middle of the night with severe left shoulder pain that seemed to radiate to the clavicle and neck. Fever, chills also. I called off from work and slept until noon the next day, a full 48 hours post injection and felt much better with exception to the left shoulder. I have continued to have intermittent pain in the arm, that also now results in numbness and tingling of my fingers and left hand. I can hardly sleep at night due to the pain. there is not much that will relieve it, other than finding maybe a pillow for support, but that only lasts a short time and then I am awakened with pain again. It seems to be the joint itself that is affected. And instead of getting better it seems to be getting worse.
On Sunday, June 27, 2021 I woke up with a migraine/headache and nausea. The other symptoms included fatigue, muscle pain and dizziness.  These symptoms lasted until the next day. The following two days my symptoms were not severe but I still wasn't feeling well.
Patient states experienced soreness on arms where shingrix shot was administered on the day she received vaccination. Two days later, she developed swelling, blistering, itchiness, redness on arms, & redness spread to almost the armpit. Soreness and red rash on left breast seen. Patient experienced headache but no fever. Right eyelid & tongue are swollen. Pharmacist advised patient to promptly seek medical attention with physician when she called pharmacy to report symptoms. Patient went to see her primary physician the same day. Pharmacist followed up with patient and patient says her physician advised her to take benadryl & ice pack, as it appears to be a reaction from vaccine & follow up in a week
Dad reports that patient woke up during the night (due to bad weather - was scared) but found him to be warm.  No fever at school when checked at lunchtime, but 100.7 at 3 p.m.  Dad reports child was 100.1 upon arrival home.  He has also complained of a headache and sore throat. Mom called school this am to report that Pt would be out of school again today due to a fever and stuffy nose. Brought to MD today whom felt it was related to FluMist administration on 10/7/09 per Mom.
The day after (4/21/21) pt reported symptoms of hives on chest, breathlessness and swollen eyes. pt was hospitalized and treated. Pt was asked not to take 2nd dose by hospital staff
Sore arm 5 days, headache, chills, dizzy about 2 days
Woke up with nausea, chills, sweats. Went to the bathroom, then fainted on the way back to bed. Sore arm, shoulder and armpit for two days following vaccine.
Moderna COVID-19 Vaccine EUA 3-March to 7-March: sore left arm, then later sore neck, chills, aches all over body and general blahs. Took Tylenol Extra Strength 500  MG as needed 8-March to 15 March : forehead and left side of upper face  swollen, red and slightly itch . I Put some Polysporin ointment on and it seemed to help a little. Called my doctors office on 12-March, they these symptoms were due to the Moderna shot and that I should ride it out until they went away.
Information has been received from a registered nurse (RN) concerning a female who in May 1986, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The RN reported that in May 1986, the patient experienced knee arthralgia. Subsequently, the patient's knee arthralgia resolved. Follow-up information was received from the RN who indicated that she did not have access to the patient's records as the event happened many years prior. Additional information is not expected.
No additional AE reported; The nurse was documenting the information before administration and noticed the vial was expired; This spontaneous report was received from a physician referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   The physician reported a near miss for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On an unknown date in October 2021, the product was drawn into the syringe but not administered. The nurse was documenting the information before administration and noticed the vial was expired (expiration date was 07-OCT-2021) (intercepted product administration error).  No additional adverse event reported.
Sudden onset left sided chest pain and pleurisy like symptoms approximately 4 hrs after vaccine.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of GARDASIL 9, (lot# M023169 and expiry date 13-JUN-2018) (strength, dosing details, route and anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. This is one of 3 reports received from reporter source. Additional information has been requested.
This spontaneous report as received from a physician refers to a unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of (Oka/Merck) VARIVAX (dose and route were not reported) lot # K010441 expiration date 22-JUL-2016 that were improperly stored. The temperature excursion for the (Oka/Merck) VARIVAX was found to be supported with in-house stability data. Secondary suspects and concomitant therapies were not reported. No adverse symptoms reported. Additional information has been requested. This is one of several reports received from the same reporter.
Had chicken pox vaccine on 9/22/03. On 9/30/03 developed fever of 100.4 with no other symptoms. Was seen by MD, who wrote a note saying she did not have a communicable disease. On 10/13/03 had mild temp (100.2) and rash under one arm. She was seen by MD who said the rash was not chicken pox.
Redness, swelling, pain at injection site. Patient advised to take ALEVE and use cold compresses for comfort, right arm.
From initial information received on 17Jan05 from a health care professional regarding an adverse event occurring, it was reported that a four month old male pt received his second dose of Acthib, lot UE234AC, administered IM in the left upper thigh, his second dose of Daptacel, lot number C1679AA, administered IM in the right upper thigh; a second dose of Ipol, lot number X1040, administered IM in the left upper thigh and a second dose Prevnar, lot number 495170, administered IM in the right upper thigh on 12Jan2005. Five days later, on 17Jan05, the pt developed torticollis. At the time of this report, it was unk whether the pt had recovered from these events. As per the pt's mother, the infant had previously experienced an episode of torticollis following his two month vaccinations, however, no specific details were provided regarding the previous event. Follow-up received on 10/08/2005. Additional information, the patient was examined by immunilogist at an unspecified time and it was determined that the patient is allergic to pertussis.
PT WALKED UP OBS NURSE TO REPORT FEELING DIZZY  AND LIGHT HEADED. PT LOOKED PALE.  LOWER PT TO THE FLOOR  KEPT PT IN OBSERVATION FOR EXTRA TIME/ UNTIL PT VOICE AND DISPLAY THAT SYMPTOMS RESIDES.
Swelling of left lymph node in armpit, dull pain radiating from upper left ribs to back.   Redness/warmth/ occasional itching near injection site. Redness and warmth swelling 11x3inches around arm.   Took Ibuprofen 800mg 3x daily. No relief.  Prescribed Keflex 500 MG 3x daily with improvement.
p/vax awoke w/h/a;vomited x 2 gastric fluid;kept water &some food in stomach, worked 8hr shift;devel head congestion w/productive cough 5/15/99;5/16/99 noted soreness @ inj site as well as redness & warmth, itchy, fatigue;devel 2 lesions;
Donor felt tingling bilateral arms and legs approximately 15 minutes after injection.  Lasted 5-10 minutes.  Donor appeared pale.