chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker regarding a approximately 11 year old patient of unknown sex. On 04-MAR-2015, the patient was vaccinated with expired dose of VARIVAX, lot number- J002318, expiration date- 22-FEB-2015, .5 ml, subcutaneous. No adverse event was reported. No concomitant medication was reported. No product quality complaint was involved. It was reported that potency was supported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I felt like a bolt shooting up, and I felt like my throat was closing and top of my mouth was painful and 3 days later I got a sore on my mouth. I started having fever and chills. I had a rash on my stomach my husband took pictures it would come and go. I was having hard time breathing, and strong palpitations, I couldn't take my heart medication because it would give me a strong headache and it would lower my BP. I went to clinic, they gave me antibiotic, they tested my sore in my mouth it was positive for herpes. I have had dizziness and vertigo. I still difficulty breathing and taking my heart medication. My concern still about my heart palpitations and vertigo.
This case meets criteria for vaccine breakthrough review.  Known exposures. SxS include 6 days of fevers, chills, SOB, cough, dizziness, headaches.
RIGHT ARM/SHOULDER PAIN; CHILLS; 101F FEVER; FATIGUE; HEADACHE; NAUSEA; ANXIOUS; VERY FEARFUL; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight was 127 pounds and height was 64 inches. The patient's past medical history included: percutaneous nephrostomy and concurrent conditions included: supraventricular tachycardia, fibromyalgia, thyroid disease, latex allergy, and sulfa allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 01-APR-2021 at 11:00 to left arm for prophylactic vaccination. The patient was previously treated with codeine phosphate for drug used for unknown indication. The patient experienced body aches, chills, drug allergy, fatigue, felt like hit by something/ in a fog, fever of 102F (Fahrenheit), frozen shoulder, headache, loss of appetite, poor injection technique, severe flu-like symptoms, slept a lot, sore arm and very sick following vaccination with first dose of covid-19 vaccine ad26. cov2. s  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 13-DEC-2021 at 16:45 to right arm for prophylactic vaccination. No concomitant medications were reported.  Following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), on 13-DEC-2021, the patient experienced right arm/shoulder pain, chills, 101 F (Fahrenheit) fever for 2 days, fatigue, headache and nausea. Laboratory data included: Body temperature (NR: not provided) 101 F. On an unspecified date in DEC-2021, the patient contacted her HCP (health care professional) regarding these side effects as she became very fearful and anxious since being made aware of updated CDC (Centers for Disease Control and Prevention) recommendations via the media. Patient reached out to her HCP/vaccination provider and was reportedly informed that they were changing their distribution plan for the Janssen vaccine which further upset her.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 101 F fever on 15-DEC-2021, was recovering from fatigue, headache, right arm/shoulder pain, nausea, and chills, and the outcome of very fearful and anxious was not reported. This report was non-serious. This case, involving the same patient is linked to 20211240244 (dose number in series 1).
Started at 1 AM with "chills, ? fever, headache, nausea, sore joints, achy, feels like the flu, jaw bone trying to lock up
Injection was painful. My arm hurt within 5 mins. A red area appeared within an hour, it was approx. 2 x 3 inches in size, hot, and hard, and painful, to touch stayed that way for about 11 days.
pt had a positive COVID test on 2/4/22 and was admitted to the hospital; dc'd 2/16/22 to Rehab; 2/26/22 transferred back to the hospital with labored breathing; CCU; BiPAP; pt is somnolent and not answering questions; CXR shows infiltrates and effusions; pt showed no improvement; too weak to ventilate; transitioned to DNR and pt expired in the hospital
A nurse reported that a 41 year old male tested positive for hep B core antigen being vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject had no relevant medical history, concurrent conditions, or concurrent medications. On 8/27/02, the subject received his first injection of Engerix B (5358A2). He received his second injection of Engerix B (5353B2) on 9/27/02. On 10/10/02, the subject attempted to donate blood. He was told that he could not donate blood because he was hep B core antigen positive; serology for hep B surface antigen was negative. The subject received his third injection of Engerix B (5355A2) on 2/27/03. Serology for hep B surface antibody was non-reactive on 4/7/03. Serologies for hep B surface antigen and hep B core antibody were non-reactive on 4/11/03.
Patient is a 53 year old man who presented for evaluation of shortness of breath and fevers. His wife had recently tested positive for COVID-19 and he subsequently tested positive at well. Noted some hypoxia while monitoring pulse ox at home. In the ER, he was hypoxic on RA and initially required 2 L o2 to maintain saturations. His chest xray showed evidence of pneumonia, started on Decadron for treatment. He improved and is now saturating well on RA. Elected to monitor off steroids at discharge; pcp may resume if he has rebound in symptoms.  Tolerated activity today without any significant desaturation. Discharge instructions were printed and explained. All questions were answered.    Other medical problems addressed:   -Hyperglycemia: a1c 5.9; lifestyle modification and monitoring for now.  -Hyperphosphatemia: resolved
A 71-year-old female received a tetanus and diphtheria toxoid adsorbed vaccine 8 years prior during an emergency room visit. The patient experienced a red and swollen arm after receiving the vaccine and at the time of the event the patient was advised to treat using massage. Patient had recovered. This event was reported to MBL's distributor, Merck, by a pharmacist. The pharmacist had obtained the information as part of the patient's health history. Patient's primary doctor was contacted; he had no further information regarding the event. MBL is not able to obtain any further follow-up information.
Elevated fever following first DTaP 101-102 started 24 hours later lasted approx 24 hours treated with Tylenol.
Client was vaccinated at her place of employment.  When I called them, said representative from a pharmacy came over and gave the vaccines.  States she did not have access to lot numbers or dose number in series.   Having body aches, pain in left arm, redness and swelling, pain has moved from her arm to her neck, shoulder, axilla, and left breast.  Cant touch her left breast of move her arm w/o pain.
Pt recvd Engerix-B & 30JUN92 exp rash on arms/thighs/knees & generalized urticaria; hospitalized 6JUL92;
pt vaxed 19FEB90; had pain in lt shoulder then radiates down to the elbow & into the wrists for 2 months; MRI scan showed subacromial bursitis w/mild to moderate rotator cuff tendonitis; tx w/clinoril, Aristocort inject;
Gas; Heart burn; Abdominal discomfort; Frequent bowel movements; Sick; Nauseous; General feeling of being tired; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN5318) via an unspecified route of administration in the left arm on 22Feb2021 at 11:45 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, high blood pressure, IBS (irritable bowel syndrome) and known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included indapamide (MANUFACTURER UNKNOWN), celecoxib (MANUFACTURER UNKNOWN), anastrozole (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN); all for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN5318) via an unspecified route of administration in the left arm on 01Feb2021 at 11:45 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. On 23Feb2021, the patient experienced nauseous, gas, heart burn, abdominal discomfort, frequent and urgent bowl movements, general feeling of being tired and sick. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events which included bland diet and pepcid started from an unknown date. The clinical outcome of the events nauseous, gas, heart burn, abdominal discomfort, frequent and urgent bowl movements, general feeling of being tired and sick were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Started off with hives about 9-10 days after receiving Moderna booster shot. Took allergy medicine everyday to reduce itchiness. Eventually noticed that little scratches to the body created raised red lines. Thinking it could be dermatographia.
no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from Other Health Professional and refers to a 1-year-old male patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W011624, expiration date: reported as 24-FEB-2022 but upon internal validation was set as 06-APR-2024, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008835:
Positive for COVID-19 after fully vaccinated, leading to severe disease and admission to ICU
This medically confirmed report (initial receipt 19-Sep-2014) concerns a 63-year-old male patient. The patient recently underwent a surgery for aortic aneurysm excision (exact date unknown). It was unknown whether the patient received any other medications or immunizations. If the patient received anything else, it would have been outside the facility. On 17-Sep-2014, the patient received intramuscular AFLURIA injection (batch number T56805) at 0.5 ml annually. On 18-Sep-2014, approximately 12 hours after vaccination, the patient passed away. The cause of death was unknown. It was believed that no autopsy would be performed. The outcome was reported as 'death'. Reporter's comments: The reporter assessed the causality as serious and unlikely due to AFLURIA.
Menveo - Administration of the liquid portion; Menveo - Administration of the liquid portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA756A, expiry date 31-OCT-2023) for prophylaxis.   On 26-JUN-2023, the patient received Menveo. On 26-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo - Administration of the liquid portion) and inappropriate dose of vaccine administered (Verbatim: Menveo - Administration of the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-JUN-2023 The nurse reported the administration of the MenCYW liquid conjugate vaccine component without the menA lyophilized conjugate component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter asked when they could administer a valid dose of Menveo to this patient. The reporter consented to follow up.
No further adverse events reported; Gardasil 9 was administered to a 5 month old patient; This spontaneous report was received from a certified medical assistant and refers to a 5-month-old male patient. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On 12-FEB-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # T026168, expiration date 04-DEC-2022, 0.5 milliliter (route not reported) for prophylaxis (product administered to patient of inappropriate age). No further adverse events were reported. There was no product quality complain.
Headache and fatigue that lasted 9 days. Elevated temperature and some muscle aches on day 4. Used Excedrin for the headache.
Few hours after having 1st dose I started having Severe burning pain in my upper right side of my back 3 days later I went to urgent care and qas told that I have shingles was prescribed valacyclovir a few days later pain was pretty much gone. About a week later I then started having the pain again in my back and had a small rash on my left side of my back. Extremely itchy, tingling, burning sensation and painful went to urgent care and was.told the rash is fading and the pain should subside
Mom states pt started screaming about 130PM called clinic p/ 11/2 hrs ; mom brought pt to clinic & pt seen by MD; pt irritable-cries & screams esp when moved; pt cries if touched anterior fontonells full-LTM inject-meningeal irrtation;
Unknown booster for covid. Residing at facility where vaccine was administered. Developed swelling in arm the following day. Patient reports ongoing swelling. Admitted to hospital 1 week later. Ultrasound of left upper extremity showed extensive DVT of axillary, subclavian, brachial.
p/vax reports child lt arm inc redness on 8/12/99 & worse  8/13/99; lateral arm red, hot & rash-whelp looking from shoulder to elbow region & very hot to touch;? temp, no temp taken;pt to MD 8/13/99 tx for cellulitis & allerg react to vax;
One day after vaccine I missed worked, was in bed all day with fever of 101.8, headache, body aches, abdominal pain etc.  On 4.2, I couldn?t breathe after attempting a lower-than-normal intensity elliptical workout (I do 60+ min elliptical workouts 5x/week and 6+ mile walks the other 2 days/week). Following that event I had significant trouble getting a full breath and had dull upper left back pain and very localized pain in upper left abdominal area/lower left rib area that got worse at night. I had a telemedicine appointment with my pcp on 4.14, was Rx?d advair and albuterol. Had another telemedicine with my pcp on 4.16 because breathing and localized pain were more concerning. PCP sent me to the ER. At the hospital ER they found elevated troponin-I and an abnormal ekg (normal chest X-ray and cat scan) and diagnosed me with an NSTEMI heart attack. They transferred me the other hospital where they did more testing.  Troponin-t was normal, ekg was determined to be a normal atypical variant. I completed an exercise stress test and the cardiologist determined that I would not have been able to complete the full 15 min with no abnormalities if I?d just had an NSTEMI so they changed the diagnosis to Acute Myocardial Injury.  On 4.23 lab results showed troponin-I is still elevated.  I still cannot Get a full breath and still have some left back and lower rib pain
numbness and tingling starting in left arm and traveling to other libs and face; numbness and tingling starting in left arm and traveling to other libs and face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 (Lot number: FA7485) at the age of 24 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hemiplegic migraines" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; AIMOVIG; AMITRIPTYLINE; SPRINTEC. The following information was reported: HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 27Jul2021, outcome "not recovered" and all described as "numbness and tingling starting in left arm and traveling to other libs and face". It was unknown if therapeutic measures were taken as a result of hypoaesthesia, paraesthesia. Additional information: The patient took dose 2 on 17Aug2021 administered on left arm and lot number FC3181. The patient did not receive any other vaccine within four weeks. The patient was covid prior to vaccination. The patient has not been tested for covid post vaccination. No follow-up attempts are possible. No further information is expected.
pt recvd vax; began 30mins p/ vax w/ high pitched cry & lasted x 12 hrs, inconsolable crying; to MD 48 hrs p/ vax;
20 minutes after injection, I began feeling progressively warmer as if I had beads of sweat on my forehead.  I began to feel light as if my body was light. The Lead Monitor came over and had my blood pressure and oxygen levels checked over the next 40 minutes before I felt actually fine and able to walk out.  At no point did I have trouble breathing although that question was repeatedly put to me.  Then at home I took it easy but noted anything out of the ordinary. 1.5 hrs after the injection and lasting only 2 minutes, I felt like a band was being tightened around my head to the point of discomfort but not pain. 24 hrs after the injection, for less than one minute, my left temple felt pressure as if I had a head cold. I haven't had a headache in a decade so this was unusual for me. 10 hrs after the injection, I was awakened to by cramping from lower Achilles to foot in my right leg only. This lasted painfully for 12 minutes.  My right foot  itself felt numb. I would stand to stretch the muscle/ tendon but then immediately felt nauseous. I hate feeling nauseous so I would lay back down only to have to stand again due to the pain of the persistent  cramping. This was 12 minutes of excruciating leg cramps. When usually I might have only one or two very brief leg cramps per year. 14.5 hours after injection, I awoke very thirsty adn my skin felt very dry. I drank water and applied hand lotion. Thereafter the vaccine site felt sore but the injection site would have been invisible but for the bandaid outline that narrowed down where the injection had to have been located. The vaccine site was never red or pink or raised at all. Just a pin prick if you really looked for it.  As a follow-up, the second Pfizer dose was Lot  EM9809 on Feb. 26, 2021, and I had no reaction at all. No visible injection site in right arm, no warmness, no light-headedness, no cramps, nothing at all happened.
A hlth care professional reported that a pt rec'd an injection of Prevnar and developed fussiness. No further information was available at the date of this report. Manufacturer's Comment: The reporter was unable to specify the number of pt's who experienced this event. Additional reports will be generated when identifying information is provided.
This spontaneous report was received from a medical assistant and refers to a currently 13 years old patient of unknown gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # L024993 with expiration date 17-SEP-2017, (route of administration and dose number were not provided). No adverse effects were reported. It was reported that the vaccine experienced a temperature excursion of 29F for 16 days. This is one of several reports received from the same reporter. Additional information is not expected since no consent was given to reach follow up.
Rash/hives on neck, trunk, axilla, face, no open lesions x 2 weeks. Low-grade fever (<100*) x2 days. Took PO diphenhydramine 25mg & PO acetaminophen x 3 days.
Information has been received from a certified medical assistant referring to an unspecified patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M004116 with expiration date 12-OCT-2017, 0.5 ml, route unknown). The GARDASIL was improperly stored at 29.8 degree Fahrenheit for 256 hours. There was no previous temperature excursion and it was unknown whether data logger was involved or not. No adverse effects were reported. Additional information has been requested.
Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; Started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus; This is a spontaneous report from a non-contactable consumer. A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 16Jul2021 10:45 (at the age of 42 years old) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID-19 prior vaccination. On 17Jul2021 17:00, the patient started with intense sinus headache in the first 2 days, slight chills, no fever, tiredness. Then felt the chest and congestion come on in day 3-4, now coughing, stuffy nose, mucus. No treatment was received for the events. The patient was covid tested post vaccination via nasal swab on 21Jul2021 with negative results. The outcome of the events was recovering.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.