chrisvoncsefalvay/vaers-outcomes huggingface dataset:
if they need to revaccinate a patient who was given YF-VAX vaccine with expired diluent with no reported adverse event; Initial information receivedon 25-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and  gender patient who was given yf-vax vaccine with expired diluent with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE  [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect YELLOW FEVER VACCINE (Lot: UJ386AA Expiration: 22Aug2022 Diluent: Lot: U6627AB Expiration: 20May2022)  once at an unknown dose via unknown route at an unknown administration site for immunization.   On an unknown date ,the patient was given yf-vax vaccine with expired diluent with no reported adverse event (expired product administered) (latency: same day) following the administration of YELLOW FEVER VACCINE.  Action taken : not applicable  It was not reported if the patient received a corrective treatment for the event.   Outcome:Unknown.  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 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.
developed a problem with my autoimmune system / Shingrex vac. could have contributed to this problem; ulcer on the inside of my lower lid; This case was reported by a consumer and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and skin ulcer. On an unknown date, the outcome of the autoimmune disorder and skin ulcer were unknown.   It was unknown if the reporter considered the autoimmune disorder and skin ulcer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The patient had the Shingrix vaccination and developed an ulcer on the inside of patients lower lid.  The opthomologist had done a biopsy but not yet received the results. The patient thinks that though developed a problem  with patients autoimmune system. The patient asked a question that it possible that the Shingrix vaccine could had contributed to this problem
11/2 developed redness and swelling at the site.  11/4 developed fever.  Fever faded and developed rash.  Likely Roseola.
TESTED POSITIVE FOR COVID ;      11-25-2021 AND 12-6-2021 BOTH TIMES, DECEASED 12-15-2021
Pt recv vax on 1/22/99; on same day pt exp swollen left leg (hematoma); vax given incorrectly
right arm redness, swelling, tenderness associated with enlarged lymph nodes right neck beginning the night of injection
No adverse event, but upon injection I notice fluid were coming out at injection site, after completion of injection and withdrawal of needle, vaccine was coming out of injection site.  Later in the day, I spoke to a Moderna representative, I was informed that dose cannot be repeated and it was determine that the needle was defective.  I was using retractable 3 ml 1 inch 25 gauge needle.
Phone call from client- Tdap immunization on 09/21/06 states felt "fine" yesterday woke today with mild fever, chills, emesis, headache, body aches, "can't keep my eyes open", redness and sore at site of Tdap injection states spoke with provider told her she had the flu and was unrelated to Tdap immunization.
Rapid heart rate triggered an A Fib needed to be hospitalized and put on medic to lower blood pressure and fix heart rythm . I currently still have elevated blood pressure.  Never had a fib before never was on meds  for heart.
SEVER ADVERSE EVENTS; SLEEPLESSNESS; SWEATING; MUSCLE CRAMP; CHILLS; MUSCLE PAIN; HEADACHE; NAUSEOUS; FEVER; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced sever adverse events. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced muscle cramp. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nauseous. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle cramp, chills, sweating, fever, headache, nauseous, sleeplessness, sever adverse events and muscle pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20210430851.
Within 2-3 minutes after injection, patient fainted and had what looked like a brief seizure.
27APR92 pt recvd Engerix-B & 1 wk later exp lightheadedness; 2nd wk exp dizziness & vertigo; 3rd wk exp speech impairment & slurred speech; tx Pred; 27MAY92 MRI showed white spot located on both hemispheres of white matter & demyelinization
patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; patients received a Flu shot from an extended shipment of Fluzone Quadrivalent/no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to cases 2019SA271944, 2019SA278136, 2019SA278137, 2019SA278138, 2019SA278139, 2019SA278140, 2019SA278141, 2019SA278135 and 2019SA271944 (same reporter).  This case involves a patient of unknown demographics who received Deteriorated dose of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED from an extended shipment.  Patients past history and concomitant therapy was not reported.  On Oct-2019, patient received a multi-dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot: UJ254AC) (no dosing details were reported.  It was of actual medication error case due to Deteriorated drug administered (Poor quality product administered) and Product shipment delay (Product distribution issue).  It was unknown whether adverse event was noticed or not.  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.
Administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 9:11 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other adverse reaction is reported. No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-390578 (Patient Link).
Nausea, headache, aching muscles and bones, sleepiness, slight fever.
3 hours after 2nd vaccine I felt Lower Urinary Tract Symptoms and Hematuria. The symptoms are frequency urinating, burning and pain peeing and blood in urine.
T102, shaky & sweating 3-4hr p/vax;T101.2 p/APAP;no red, no swelling inj site;26MAR98 345Pm no temp activity fine now per mom;
Hives; occurred 2-6 hours after event; resolved with oral Benadryl, topical treatment
32 year old patient got IPOL (with no reported adverse event); supposed to get the TUBERSOL test but instead got IPOL (with no reported adverse event); Initial information received on 28-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2021SA149533 and 2021SA148624 (same reporter).  This case involves a 32-year-old female patient who received intradermal 0.1 ml dose of IPV (VERO) [IPOL] (lot R1F801M, expiry date-28-Sep-2021) by mistake instead of TUBERCULIN TEST [TUBERSOL] for tuberculin test on 09-Apr-2021 (product administered to patient of inappropriate age) and (wrong product administered).  Medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  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 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.
Numbing in right side of face, numb and tingly scalp, numbing shoulders with pain, tingly hands and forearm, tingly and numb lower legs and feet, extreme fatigue, and anxiety.
Head ache and fever started the evening of March. Severe vertigo and nausea began sometime overnight or early the next morning. I was bed-ridden most of the day. I took zofran and ibuprofen. From then on the severe vertigo happened only while changing positions such as laying down and getting up. I saw a nurse practitioner on March 16th who told me it was due to ear wax. I received a prescription (meclizine) for the nausea and dizziness and bought an ear wax kit. The next a friend said her husband had the exact same symptoms as I was experiencing and that it was called facility. My husband assisted me with the epley maneuver twice on March 17th. By March 18th the vertigo was gone, with just slight dizziness during the day.
Headache; Arm hurt; This is a spontaneous report received from a non-contactable consumer. A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jan2021 as unknown, single dose for COVID-19 immunisation (Age at the time of vaccination 13-year-old). The patient medical history and concomitant medications were not reported. It was reported that, the patient had COVID shot on 03Jan2021, on the next day (04Jan2021) patient arm hurt with headache. Cleared by next day. The outcome of events was recovered on 05Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
approx 15 minutes after receiving the vaccine, client started c/o tingling in hands and arms bilaterally, as well as clammy hands and light headedness. She also said her eyes were foggy.  Vital signs monitored and o2 given per mask. She c/o frontal area head pain, resolved after being on O2 for 5 minutes. 4:05pm says clamminess in hands and light headedness improved. She was release to drive home and told to report to ER if she has any more problems.  client does report today of having daily headaches since she received her shot.
pt recvd vax 26OCT95 & 2NOV95 pt exp raised bright red rash that start on trunk & face but now covers whole body;5NOV95 fever 104+; 6NOV95 fever down & rash faded some;7NOV95 fever back up to 103.0 & rash bright red;8NOV95 ear infect
Cold sweating, lethargy, nausea and vomiting , swollen lymph nodes under left arm.  Lasting a little over 48 hours.  Lymph nodes under left arm are still slightly swollen.
Headache, Myalgia, chills, fatigue, sweats Narrative: Stayed home from work due to symptoms
Pt states he started experienceing problems with 3rd Anthrax shot and some sx's were - anxiety, panic attacks, short term memory loss, nausea, inability to concentrate, jittery, sore arm.
Confusion; Taking in a lower voice than normal; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and DYSPHONIA (Taking in a lower voice than normal) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-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 02-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion) and DYSPHONIA (Taking in a lower voice than normal). On 03-Mar-2021, CONFUSIONAL STATE (Confusion) and DYSPHONIA (Taking in a lower voice than normal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: No specific follow-up information recorded.
Pt received HPV #2 and Flu vaccine in office. Pt was waiting 15 min after HPV vaccine. Mom reported Pt broke out in rash. Gave 20mL of BENADRYL in office. Before administering BENADRYL Pt complained of itching and headache.
On 10/25/2021, at about 1:20pm, about 24 hours after the shot, spiked a fever of 101 degrees, and suddenly could not walk, no strength in leg bilaterally. Put her to bed, and by the next day she was fine.
There was no adverse event. The patient is currently fine with no symptoms. The patient received a Pfizer dose which I thought was the patient's first dose. The caregiver of the patient was also unaware the patient previously received 2 doses of Moderna, 1st dose on 1/30/2021 and 2nd on 2/27/2021. He is a new patient of that caregiver and the caregiver was given instruction by case management to get his covid vaccinations started. This vaccination error was only identified when I was logging the vaccination on a database.
Headache, Myalgia, Fever,  Fatigue, chills, Temp 100.6, Narrative:
In  early June 2021, a nodule became palpable just distal to the MCP joint of the long finger of my right hand. It was tender to touch but not painful otherwise. There was no redness. It continued to enlarge until about August 1st, when it spontaneously decreased in size.  A hand surgeon saw me on 6/15/21 and said it was probably a retinacular cyst on the tendon.  By the way, the second dose of the vaccine was given on 1/25/21, Lot 030L2A.
Received vaccination on 12/30/2020, had positive Covid test result on 1/6/2021, was hospitalized with respiratory issues on 1/11/2021, and discharged home from the hospital on 1/18/2021
This spontaneous case was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concurrent, historical conditions and concomitant medications were not provided. On 29-AUG-2018, the patient was vaccinated with properly stored but expired M-M-R II (lot number: M029918 with an expiration date 13-JUN-2018) for prophylaxis. No adverse effects were reported.
pt was given monovalent vaccine rather than bivalent; pt returned later that day to get bivalent
Tendonitis- pt recieved physical therapy. md suggested mri but patient declined due to cost.
3/12/21 had few minutes of speaking incorrect words which led to eval for TIA 3/17/21 had dopplers of carotid with unequal blood velocities 3/24/21 covid vaccine #1 4/15/21 covid vaccine #2 4/21/21 CTA chest to look for cause of carotid velocities being different and pulmonary emboli were found
Information received by wife. Patient was fatigued 4/10/21 after vaccination. His wife stated that she talked with him and he seemed fine. When his wife went to bed early that evening, the patient was sitting in the recliner in the living room. On the morning of 4/11/21, patient's wife found him unresponsive in the recliner. She called an ambulance but patient was deceased. Patient's wife stated that she noted a trashcan next to the chair the patient was sitting in. The trashcan did not have emesis in it but patient's wife assumes he had been nauseated that evening before he passed away.
A mother reported that her 33 month old son received his 2nd dose of DT and IPV on 08/28/00. Later that evening, he developed redness, swelling and "hardness" that was "the size of a quarter" at an injection site on the right leg. Both vaccines were injected into the right leg. On 8/29/00, he was limping due to pain at the injection site. He developed a red, raised, "blotchy" rash at the injection site. On 8/30/00, the rash increased in size to an area 6.5cm by 5cm and he continued to limp. The red area in the center of the rash remained hard. On 8/31/00, the rash increased in size to an area 8.5cm by 7.5cm; the child refused to wear clothing that would rub against the injection site. The mother contacted the physician, who recommended Advil and applications of ice. As of 9/1/00, the induration was beginning to resolve.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/03/2021 and 01/31/2021. They were vaccinated in the thigh, which is not a preferred site for an adult. I do not have any further information about why the thigh was used instead of the deltoid. They became symptomatic for COVID-19 on 10/14/2021 and tested positive for COVID-19 same day, at the nursing home at which they were a resident. I see no indication this person was hospitalized related to this illness. They died on 10/24/2021. COVID-19 is in part one of the death certificate.
No adverse event; Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent).    Concomitant product use was not provided by the reporter.  It was unknown if patient reported any adverse events.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-663507, US-MODERNATX, INC.-MOD-2022-663578, US-MODERNATX, INC.-MOD-2022-663502, US-MODERNATX, INC.-MOD-2022-663552, US-MODERNATX, INC.-MOD-2022-663563, US-MODERNATX, INC.-MOD-2022-663577 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663578:Same reporter US-MODERNATX, INC.-MOD-2022-663507:Same reporter US-MODERNATX, INC.-MOD-2022-663502:Same reporter US-MODERNATX, INC.-MOD-2022-663552:Same reporter US-MODERNATX, INC.-MOD-2022-663563:Same reporter US-MODERNATX, INC.-MOD-2022-663577:Same reporter
got the flu and nearly died; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).   This case involves an adult patient who got the flu and nearly died (Influenza), while patient received vaccine INFLUENZA VACCINE.  Patient had received INFLUENZA VACCINE in past and got flu (Influenza).  The patient's medical history, past medical treatment(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu and nearly died (Influenza) (non-serious), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown the event Influenza at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report as received from a physician via company representative, refers to a female patient of unknown age. The patient's medical history and concomitant therapies were not reported. The Field Representative read an article from an unknown author, that in 2015 the patient was vaccinated with GARDASIL (dosage, and anatomical location were unknown) for HPV prophylaxis. On an unknown date after receiving the vaccine the patient experienced bouts of acute pancreatitis and was diagnosed with chronic pancreatitis. The patient was seen by multiple unknown physicians and was hospitalized for an unknown period of time. The outcome of pancreatitis chronic was unknown. Upon internal review pancreatitis chronic was considered to be a medically significant event.
No additional AEs or PQC reported.; Caller reported expired dose of MMR II administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 01-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin, rHA) (M-M-R II), dose of 0.5 mL administered subcutaneously, lot number: T022310, expiration date: 30-JUN-2022 (dose number and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event).