chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 12 hours after receiving the shot (at about 2 am) began running a fever.  Fever ran anywhere from 99 to 102 degrees.  Associated muscle aches.  Not sure if it was related, but just as the fever began to spike, I experienced a sharp pain in my right knee which has faded away in the 24 hours since.  Fever lasted for approximately 10-12 hours, fading away by mid-afternoon leaving me with a headache.
typical soreness in left arm about 6 hrs later, then on Tuesday a couple days later my left ankle feels as if it broken. Extremely painful, hurts to walk on it. I went to accupuncture today and Dr. said there is so much inflamation she had a hard time inserting needles.
Today 10-6-10, patient came to the pharmacy with a bruise at the injection site and was still experiencing pain. He was instructed to see his doctor. Patient said he would schedule appointment.
16 DAYS POST VACCINATION OF H1N1 VACCINE. PT STILL HAS SIGNIFICANT POINT TENDERNESS AT INJECTION SITE, NO BRUISING OR OTHER ABNORMALITIES. ALSO C/O RAISED NONCOLORED RASHED ON STOMACH AND BACK SINCE VACCINATION.
2nd dose pfizer vaccine was given to patient on 07/09/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window.
product storage error; Dose administered more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (product storage error) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 7:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12 hours post puncture) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that patient had taken second booster dose. The number of doses per vial was 2 doses which was booster doses. On 01June 2022 the vial was initially stored in the refrigerator. On 06June2022 at 10:00AM the vial was first punctured. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions Total amount of time the vial was exposed to room temperature range was for more than 24 hours.
16:03: Vaccine Administered 16:13 Patient received there 2nd COVID vaccine and was monitored. After 10 minutes the patient demonstrated that she started the" I feel different, I am having tingling in my throat and it feels very different then it did before." She reported feeling dizzy and nauseous. She declined lying down. Pts vital signs were obtained HR 104, 99% O2, BP 138/88. Pt was given a sip of water and advised that she would remain in the clinic for additional monitoring. I advised the I could administer an Epi-pen and call the paramedics which she stated she didn't want at this time as she has never needed something like that before.   1633 - Patient was reassessed for vitals 132/88 BP, 99% O2 and 87 HR. Pt stated that she feels like her tongue is weird maybe swollen and it still feels weird to swallow, she isn't anxious but has a bit of a groggy mental haze. She stated that she feels weaker then usual and has a pressure in her head. I called Dr. and got permission to administer 25mg of Diphenhydramine orally. Pt stated that she has taken this medication before and that she will be safe to drive after taking this medication. Pt was advised that she would be monitored for another 20 minutes to ensure that the medication kicks in and symptoms start to resolve.   16:52pm 132/92 BP, 99% O2, 88HR. Hoarse voice, scratchy throat tongue is improving doesn't feel as swollen. Pt was evaluated by Dr.  17:26 Patient was discharged and advise to closely monitor her symptoms for the next 3 hours.   I received a call saying that patient was having some tingling in her lips and tongue and slight nausea. She was given 25 mg oral Benadryl by the RN. The patient was monitored for approximately an hour with serial vital signs. I briefly assessed this patient. She reports feeling some tingling in her lips with improvements in tingling in her tongue. She also reports feeling warm. Patient states that her throat feels scratchy and she feels like she has to clear her throat. Her heart sounds were normal and she has a normal respiratory effort and lungs clear to auscultation. No tongue swelling or posterior oropharynx swelling. Posterior oropharynx is pink and moist. Patient was advised that she is most likely having a reaction to the COVID vaccine. Patient should continue to monitor her symptoms at home. Patient states there will be someone at home with her. Patient was advised if she has any worsening symptoms such as tongue swelling, shortness of breath, chest pain, palpitations, body wide rash or throat swelling that she should report to the emergency department or call 911. Patient is advised that she can take another Benadryl. She was given 25 mg of Benadryl around 4:00 PM. Patient is advised that if her symptoms do worsen she can take another 25 mg of oral Benadryl in the next four hours. If she is on her way to the hospital or waiting for an ambulance she should take another Benadryl. Patient was also advised to take over-the-counter allergy medicine such as Claritin or Zyrtec for a couple of days. She is to call the clinic with any questions. Patient verbalizes understanding and has no further questions.
2.5 days later - after I ran/walked 5 miles on day 2.  I had chills, terrible headache, tremendous bodyaches.
I was a vaccinator at clinic.  I requested Hep A, MCV4, and Monkeypox for an adult patient.  I was given a prefilled syringe of Hep A, a vial of MCV4, and MPX by the vaccine manager.  I was unaware I was given state vaccines and administered vaccine to patient.  It was later discovered the vaccine were state and the patient was under vaccinated.  Corrective Actions is being taken.
He became delirious/unresponsive to name for about 15 seconds. He came back to and started sweating profusely and became pale.  After about 5 minutes, he wanted to lie down and then passed out. He came back to about 30 seconds later and felt better after drinking some water. He vomited at 2:02 p.m. At about 2:20, he felt well enough to go home.
Information has been received from a 21 year old female pt, with unknown allergies, who "as a child" was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). In 1987, at the age of 21, the pt developed rubella. Unspecified medical attention was sought. Additional info has been requested.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen (J&J) Vaccine on 3/6/2021. Presented to ED on 10/21/2021 with complaints of chest pain and shortness of breath for approximately 1 week. Per patient she tested positive with a COVID home test on the prior Thursday. Hospitalized for COVID pneumonia and acute respiratory failure.  Developed ARDS and required mechanical ventilation. Unable to wean off vent and received trach and PEG. Throughout hospitalization patient received: dexamethasone, baricitinib, broad spectrum antibiotics, paralytics, remdesivir, and pressors. Suffered cardiac arrest on 11/10/2021 with ROSC. Expired on 11/11/2021.
PNEUMOVAX injection 3/4/2011 - local reaction within 24 hours - Ret office 3/8/2011 - area very warm erythematous - center mild necrosis - Cephalexin 500mg Bid x 10 day - suggest cool pack 3/11/2011 - decreased fluctuance around injection site still very tender 3/14/2011 fluid noted behind center of injection site - C/S-negative - ultrasound no abscess. Saw surgeon for debridement of wound area.
severe tinnitus; severe tinnitus/history of tinnitus; Dizzy; Vertigo; Malaise; This is a spontaneous report from a contactable pharmacist. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in left deltoid on 05Apr2021 AM (Batch/Lot Number: ep7533) as DOSE 2, SINGLE for covid-19 immunisation at Pharmacy or drug store. Family medical history relevant to events included tinnitus-No issues prior to vaccine, not had problems with it for a couple of years prior. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Mar2021 (Batch/Lot number: eL9629) administered in left deltoid via intramuscular for covid-19 immunisation and experienced tinnitus, vertigo and dizziness. No prior Vaccinations (within 4 weeks). Patient complained of severe tinnitus, dizzy, vertigo and malaise on 19Apr2021. The events required visit to Emergency Room and Physician office. Treatment included meclizine. Symptoms started in two weeks after the second vaccine PCP suggested meclizine 75 mg-QID. Patient still has serious symptoms, 2-3 times/monthly. Seriousness Criteria: Important medical event. No relevant tests. The outcome of events was not recovered. The reporter consider Pfizer product had a casual effect to the adverse events.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events severe tinnitus, disease recurrence, dizziness, vertigo, malaise and suspect drug BNT162B2 cannot be excluded.  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.
Body ache; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 29Jun2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 26May2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. On 30Jun2021, the patient experienced body ache, fatigue and headache. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ache, fatigue and headache were recovering at the time of this report.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Pfizer-BioNTech COVID-19 Vaccine EUA -increasingly sore arm starting about three hours after injection -fatigue, body aches, headaches starting around 10pm the night of the injection
Twelve hours after the vaccine I got a fever, chills and body aches which lasted 12 hours. I discovered I was pregnant three weeks after the second dose of the vaccine on Feb 9th and Miscarried on Mar 14th. I was nine weeks pregnant. I had an eight week ultrasound and the baby was small.  Due Date 10/16/2021 Pregnancy Second
1020 injections given, 10 seconds later pt became pale and lightheaded. pt was helped to lying position with feet elevated. Pt reported headache. Pt observed in clinic for 90 min before she left clinic with mom.
swelling, redness, itching, warmth & soreness @ site of inj;pt returned to office on 25OCT96 sterile abscess;
pt seen in office on 5-23-19 states - rash started on Rt deltoid 2 days after getting shots - rash lesions spread to back & groin during the following week.   pt was given Hydrocortisone 2.5% ointment & Zyrtec Allergy childrens 10mg oral tablet.
"The office had a power outage that required us to move the vaccines to another location. Unfortunately it was determined by the partmentDe of Health and the vaccine manufacturer that the vaccine was believed to be non-viable after this move. No adverse event has been reported."
WAS GIVEN EXPIRED VACCINE/PRODUCTS HAD REACHED THEIR LISTED EXPIRATION DATES; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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 not reported, batch number: 1808986 expiry: 01-MAR-2022) dose was not reported, administered on 08-APR-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 08-APR-2022, the patient experienced was given expired vaccine/products had reached their listed expiration dates. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of was given expired vaccine/products had reached their listed expiration dates was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150157, 20230150255, 20230150340 and 20230150423.
The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023; No adverse event; 68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (68-year-old patient received expired Bivalent first booster dose of Moderna COVID-19 vaccine on 01MAY2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 28-MAR-2023, Dose administered on 01-MAY-2023).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 28-MAR-2023. The vial did not undergo any temperature excursions. Expiration date was reported as 15-JUN-2023 No treatment information was reported.
Report # 20000281531 describes arthritic symptoms in a pt who rec'd Engerix-B. The pt is allergic to sulfa and adhesive tape. Concomitant medications were not specified. The pt had no illness at the time of vaccination. On 11/10/99, the pt rec'd a booster 1ml IM-R deltoid dose of Engerix-B. One hour following vaccination, on 11/10/99, the pt experienced severe pain radiating from the injection site and decreased strength. She also experienced back arthritic symptoms. The pain persisted on 5/17/00  and was not relieved by ibuprofen (Motrin) or acetaminophen (Tylenol). The pt also continued with decreased strength in the injection arm. As of 10/16/00, the pain in her R arm continued. It throbbed at times and hurt up into her shoulder if she lifted something heavy.
Patient was given vaccine #2 and approximately 15 minutes post vaccination she developed a cough. She used two puffs on her inhaler and then she started to feel tightness in her throat. She was then given 25 mg of liquid Benadryl. She then developed trouble swallowing and was given 0.3 mg of sub-q epinephrine. Patient did not develop any respiratory distress and vital signs remained stable. She was transferred to the Emergency Department.
No adverse event; First dose on 02-Feb-2021 and second dose on  20-Mar-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02-Feb-2021 and second dose on  20-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included ADALIMUMAB (HUMIRA) for Ulcerative colitis.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02-Feb-2021 and second dose on  20-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02-Feb-2021 and second dose on  20-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment details were reported.   This case was linked to MOD-2022-679858.
Patient reports that he developed redness and swelling in this right upper arm at the site of his PPV23 vaccine that he received in the AM.  Patient reports his arm redness and swelling worsened and his "whole arm and hand swelled up."  He reports he saw a doctor that prescribed an Rx of Augmentin and his symptoms have continued to improve.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Itching at injection site (back of upper arm).  Welt formed about 2" x 1".  Increased to 3"x 1" within 2 hours.  By 10 PM entire upper arm red, swollen, hot, itching.
The patient received the shingrix vaccine too high in the shoulder and has experienced limited range of motion and pain. She tried aspirin and heat patches but still is experiencing pain. I had her follow up with her doctor and they are referring her to physical therapy. Her pain started immediately with the vaccination but it has not been painful to touch.
145HR for approximately 5 minutes.; This was a spontaneous report from a contactable nurse herself (non pregnant). An 38-year-old female nurse (patient) reported received of first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscularly left arm on 05 Feb2021 09:30 am at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced 145 beats per minute Heart Rate for approximately 5 minutes on 05Feb2021 13:30. Facility type vaccine in hospital. The outcome in response to the event recovered in 2021.  Information about Lot/Batch number is requested.
urinating constantly; up all night, back and forth; This is a spontaneous report received from a contactable female consumer (Wife) reported for her husband (Patient). This consumer reported similar events for two patients. This is the second of 2 reports.  A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose bnt162b2 on 05Mar21. On 28Mar2021 patient got his last shot with wife. The wife and patient have been urinating constantly, up all night, back and forth. The event outcome was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374640 Same reporter/ product, similar event, different patient
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with the first, second and third dose of GARDASIL (lot # unspecified) respectively in July 2009, October 2009 and August 2010 for prophylaxis. No adverse effect reported. Physician reported GARDASIL was not administered in his office. Additional information is not expected.
Fever and shaking chills, stomach cramps, brain fog, cloudy vision, joint stiffness, headache.
MMR, Hib vaccines administered October 6. Febrile seizure requi9ring intubation and stabilization-10/13.