chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had shingles shot, and got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles shot, and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine but experienced shingles from the latest dose of Covid vaccine. The patient stated that it was horrible, and shingles was not a joke. The reporter considered the adverse event to be related to Covid vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Circular, swollen, painful red rash around the injection site. About three inches in diameter.
No adverse event. Reporting per instructions by DOH. No errors, it looks like someone from immunization registry inputted the wrong information into the wrong profile and asked our store to report it. Patient information on our end, including DOB, was all correct. Names were very similar, but it looks like somehow the system added it to the wrong profile. There was no error made on our end. Removed the incorrect vaccines manually, and created a new profile manually and submitted a ticket to add vaccines to appropriate profile with immunization registry.
went to put needle on and it snapped at the neck; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5021, Expiration Date: Feb2025) for immunisation; for immunisation, Device Lot Number: HA3217, Device Expiration Date: Mar2025. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "went to put needle on and it snapped at the neck".  Additional information: Pharmacist calling about Abrysvo vaccine. Abrysvo Vial Adapter: packaging was discarded and does not see details on the adapter. Abrysvo Antigen Vial (Lot number: HF5021, Expiration Date: Feb2025, NDC: 00069020701). Abrysvo Diluent Syringe (Lot number: HA3217, Expiration Date: Mar2025, NDC: 00069025001). When she went to put needle on vaccine, it snapped right at the neck. States she had mixed it, drew it up, and then went to put the needle on and it snapped at the neck. Confirms no patient involvement. Abrysvo carton was discarded. The sample of the product is available to be returned. Informed of prepaid (courier site name) that may arrive to retrieve sample. The packaging was sealed and intact.   The reporter considered "went to put needle on and it snapped at the neck" not related to rsv vaccine prot.subunit pref 2v. Causality for "went to put needle on and it snapped at the neck" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Seven days after the vaccine was administered, I developed a rash over the injection site. It was a red rash. It expanded from 1.5 inches to 3.4 inches. PA said I had a COVID arm. She said it was mildly to moderately tender to touch. I remember putting Vani Cream on it. My blood pressure was elevated at the time. In about 5 days, the rash went away.
HEAVY MENSTRAL BLEEDING. REQUIRING 1 ER VISIT AND 2 DOCTORS VISITS.
Vaccine given in office 4/19 am. One day after his 4 year vaccines, his parents noted him on the floor and was throwing up and noted not being able to sit up. He was then taken to ER where he was admitted for acute cerebellar ataxia and had a normal CT and MRI showing only mild post inflammatory changes. The next day, he was fine and has continued to improve.
Every late afternoon & evening I have a terrible headache that doesn't resolve even with ibuprofen.  It doesn't affect me during the day.  This has happened six days in a row since the vaccine. If it continues I am going to try Tylenol instead.  Also, before my period starts, I usually lightly spot for two days.  After my injection, I started an extremely heavy period without any warning.  This is not typical for me.
This spontaneous report was received from a Medical Assistant regarding an unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was not provided. On unspecified dates since 03-OCT-2016, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M025867 with expiry date 24-MAY-2018, lot # L050956 with expiry date 17-DEC-2017 and lot# M024675 with expiry date 18-MAY-2016) (dosing details not known). The administered doses experienced a temperature excursion of 6.3 Fahrenheit(F) for 1 hour and 50 minutes, 6.6 Fahrenheit(F) for 1 hour and 40 minutes, 40.5 Fahrenheit(F) for 2 hours, 5.2 Fahrenheit(F) for 20 minutes and 6.3 Fahrenheit(F) for 1 hour and 50 minutes. Previous temperature excursions included 13.3 Fahrenheit(F) for 80 minutes, 9 Fahrenheit (F) for 420 minutes. The call was because of a data logger. No symptoms were reported. Additional information has been requested.
C/o chest pain, local reaction seen in office 2/25/09 T97.7 P75 R16 Erythema at injection site rest of exam normal, BP 124 / 76 Wt 215 lbs, 4/7/09 still having arm pain (per phone conversation).
Arrhythmia; Heart rate 120 BPM; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jan2022 18:00 (Lot number: FJ5683) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. The patient had no other medical history, no known allergies. The patient took concomitant medications, she received Birth control, Hippo Vegan Complete within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 14Apr2021, when the patient was 22 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 14May2021, when the patient was 22 years old, for Covid-19 Immunization. The patient was not pregnant when vaccination. Prior to vaccination, the patient was not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: ARRHYTHMIA (medically significant) with onset 26Jan2022 20:00, outcome "not recovered", described as "Arrhythmia"; HEART RATE INCREASED (medically significant) with onset 26Jan2022 20:00, outcome "not recovered", described as "Heart rate 120 BPM". The events "arrhythmia" and "heart rate 120 bpm" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (26Jan2022) 120 BPM. Therapeutic measures were taken as a result of arrhythmia, heart rate increased, the treatment was given via IV. The case was reported as Non serious, No Results in death, No Life threatening, No Caused/prolonged hospitalization, No Disabling/Incapacitating, No Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning her 12 month old daughter who on 5/9/2005 was vaccianted once with a 0.5 ml subcutaneous dose of varicella virus vaccine live. Concomitant vaccine administered on the same day included measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that on 5/14/2005 the patient developed a runny nose and cold symptoms. On 5/15/2005 she developed a small vesicle on her arm and two on her face. She was not eating or sleeping well so her mother gave her chlorpheniramine maleate + Dextromethorphan hydrobromide + pseudoephedrine hydrochloride Pedicare and ibuprofen Mortin. On 5/16/2005 she developed lesions on her neck but was feeling better. It was noted that the doctor who administered the vaccines was never contacted. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Vaccine was administered at approx. 13:00. Within 5 minutes, patient developed tachycardia with HR between 140-160, flushing, tingling in the fingers, light headedness, tremors, and dilated pupils. She reported feeling "over stimulated". This resolved within 30-45 minutes, but within that time, the patient also developed erythematous modeling from the shoulder to the elbow of the arm that received the vaccine. Patient self-administered 10 mg of Claritin. That evening, patient developed body aches, nausea, and fatigue. The following day, the patient still had erythematous modeling from the shoulder to the elbow. All other symptoms have resolved.
This spontaneous report was received from a pharmacist concerning to a patient of an unknown age or gender. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medications. On 30-JUN-2016, the patient was vaccinated with the first dose of ZOSTAVAX (lot # L039126 and expiration date of 08-JAN-2017) 0.65 ml, subcutaneously for prophylaxis. On 07-MAR-2017, the patient received the 2nd dose of ZOSTAVAX (lot # M035147 and expiration date of 25-OCT-2017) with the same dose, route and indication as the first dose. No adverse effects were reported. Additional information has been requested.
Patient received Moderna COVID vaccine on 04/28/2021 at 1350 on left deltoid At 1355 patient started feeling lightheaded and passing out. Assisted patient to a room, he lay on exam table  and elevated his legs. At 1400 BP 115/56, HR 61, C/O feeling hot and lightheaded. Legs are elevated and patient closed his eyes At 1405 BP 114/60, HR 67, He reports feeling better but still weak At 1410 Patient sit up and drank some water At 1415 Patient reports feeling back to baseline Recommended patient to follow up with his PCP and Urgent if feel unstable
history is a bit complex. I had had occassional r shoulder pain in the past without a diagnosis or specific  Rx. 2 days before 2nd dose, i b raised upper L ulna. 2 days post 2nd dose, rather severe olecranon pain developed dwith expuisite tenderness and mild swelling, but no fever. Subsequently over a period of days and weeks, I developed worsening right and then left shoulder and some neck pain and some additional hip and other pain. Shoulder tyenderness was diffuse and mostly muscular, Siginficant limitations of ROM withinability to raise arms. Pain was worst at night and on awakening with some relief with acetaminophen (no NSAIDS as on Xarelto).
Information has been received from a consumer concerning her daughter, a 20 year old female with a history of severe reaction to wasp stings who on 05-SEP-2007 was vaccinated with her first dose of Gardasil.  There was not concomitant medication.  The patient woke up the next morning on 06-SEP-2007 with hives on her torso and knees.  She was treated with an intramuscular shot of an unspecified antihistamine and a prescription for oral steroids.  Additional information has been requested.
Started Wednesday 12/1 with thigh rash that spread upward to face; then chills started the next day 12/2; and on third night 12/3 severe both-hand swelling/pain/numbness/tingling, the swelling/pain was so bad could not sleep for more than an hour, fingers looked like sausages and I was afraid my skin would burst. It was nearly impossible to do daily activities.  Monday 12/6 started over-the-counter meds (Aleve, Claritin, and Pepcid) that did not help much so Friday 12/10/2021 started steroids (methylprednisolone) and the steroids have significantly reduced the pain and swelling but the numbness and tingling in both hands persists and there is new swelling and small rash on left wrist. Outcome still to be determined as the steroids are a 6-day course and I am only on day 2.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, unspecified patients were vaccinated with improperly stored of PROQUAD (1 dose of lot #L030587 with expiration date 10-FEB-2017, 3 doses of lot #L040412 with expiration date 13-APR-2017; route unknown). No adverse effects were reported. On 02-AUG-2016, multiple patients were administered improperly stored doses of PROQUAD (lot #L030587 with expiration date 10-FEB-2017, lot #L046506 with expiration date 17-MAY-2017, lot#M006101 with expiration date 01-AUG-2017, lot #L040412 with expiration date 13-APR-2017, lot #L050908 with expiration date 14-JUN-2017; dose and route were not reported). The lot numbers listed were improperly stored at 16.3 degree Fahrenheit (F) for 4.5 hours and then back in range. There was no previous excursion and data logger was not involved. No adverse effects were reported. At the time of the report, the nurse could not confirm which lot numbers were administered. This is one of several reports received from the same reporter. Additional information has been requested.
Within 6 hours of receiving vaccine, local erythema and swelling commenced with distal spread of erythema and swelling from Left deltoid to left wrist. 12 hour after vaccination, pt presented to local ER with c/o robust local rxn. F/C, HA. Pt treated with abx (IM, PO) Benadryl, and IV fluids. Pt now with residual pain in left shoulder.
Increased warmth, dizzy (lightheadedness), itchy, nausea immediately following first varicella immunization. No SOB nor chest pain, but felt tired and weak. This resulted in prolonged clinic visit for observation. Reaction resolved without any additional intervention.
1st noted on waking, 1/22 am, 6x6cm area of erythema & irregular induration surrounding injection site. Edema of > 2/3 of interior thigh, no erythema. Resolved by am of 1/24/00.
No other information available.; Caller reports administration of ROTATEQ after temperature excursion; This spontaneous report was received from a health professional, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 18-JAN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 2 milliliters (ml), administered orally (po) (dose and vaccination scheme frequency were not reported; lot number 1691141, which have been verified to be a valid lot number, expiration date reported and validated as 01-NOV-2021) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 1.3 degrees Celsius (C) for 19 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.
This case was reported by a physician via call center representative and described the occurrence of fever in a 16-year-old female patient who received BEXSERO (batch number 166901A, expiry date 30th November 2018) for prophylaxis. Co-suspect products included MENVEO (batch number M17038, expiry date 31st March 2019) for prophylaxis. On 13th June 2018, the patient received BEXSERO (intramuscular) .5 ml and MENVEO (intramuscular) .5 ml. On 13th June 2018, less than a day after receiving BEXSERO and MENVEO, the patient experienced fever, headache, nausea and pain. On an unknown date, the outcome of the fever, headache, nausea and pain were not recovered/not resolved.  The reporter considered the fever, headache, nausea and pain to be related to BEXSERO and MENVEO. Additional details were provided as follows: The patient received MENVEO and BEXSERO in the reporting physician's office, a day before the reporting date. The patient complained about achiness, mild fever, headache and nausea. This case has been linked to case US2018107283, reported by the same reporter.
Immediately after Flucelvax administration, Patient, fainted in her chair. The mom instantly grabbed the patient, administering technician opened the vaccination room door and called for someone to call 911. Patient lost conciousness for no more than 10 seconds. Technician immediately called 911 at 3:53pm and explained the situation. While Employee was on the phone with 911, Technician got some water for Patient, and once EMS was on their way, got an ice pack for her arm. Employee suggested moving her to the floor, and her mom declined. Employee asked if this has happened before and mom said no. Employee asked if Patient had eaten anything today, to which her mom replied that she had had some brown sugar oatmeal with lunch. Employee asked if she wanted a something with a little sugar, and her mom asked for apple juice. Patient took a sip, but then became nauseous. She did not fall down out of her chair. EMS arrived by 4pm. Pt's mom told EMS that Patient had been at a party last night, and was laying on the couch all day today prior to coming her for her vaccination. Tech stated that Patient was nervous prior to vaccine administration. EMS wheeled Patient out to the ambulance at 4:06pm. On 11/7/22, Employee called the patient's mom to follow up with her to see how Pt is doing. She said that she was taken in to the ER where they performed an EKG, which was normal. It was determined that she was really dehydrated, so she was given 2 bags of IV fluids. Today She is feeling better, but is tired and has a headache.
administered post excursion with no reported adverse event; Initial information received on 24-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 years old female patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) post excursion with no reported adverse event (poor quality product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
This spontaneous report as received from a pharmacist on 11-NOV-2014 refers to a 64 year old female patient with allergy sulfa and allergy latex. There was no pertinent medical history. On 04-NOV-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (strength, dose and lot# were unknown), intramuscular for vaccination. Concomitant therapies included FLUZONE (also reported as none). On 04-NOV-2014, the patient had bruising at the injection site of ZOSTAVAX. Pharmacist also noted that the patient received FLUZONE at the same visit-although it was unknown if it was administered in the same arm as the ZOSTAVAX. There was no treatment was given for adverse event. There was no lab diagnostics studies performed. The patient visited pharmacy for seeking medical attention. The outcome of event was reported as not recovered/not resolved. Additional information has been requested.
Walking out of pharmacy patient couldn't move her left arm, was very painful. Pain was felt traveling down her arm and into her fingertips. Within 10 minutes her entire arm couldn't he lifted and was purple and ice cold. Fingers swollen a bit and skin on top of hand had dark purple rings around it, lasted about 30 minutes. After almost an hour of pain and tingling her feelng started to come back slowly and she could move her left arm. Cold and then purple color went away. Now 3 hours later, just left with a very swollen injection site, half a tennis ball size.
I had no symptoms after my first Pfizer dose.   Approximately 2 days after receiving my second Pfizer dose (5/7/21), I began to experience adverse symptoms. I had not changed my diet, soap, detergent, medications, etc. Therefore, the only logical explanation was that I was having an adverse reaction to the vaccine.   On Sunday night (5/9/21), I began to develop red, itchy, and streak-like rashes down both of my arms and across my chest. My underarms became very itchy and swollen. Since then, I have randomly been experiencing repeat flare-ups of these same symptoms.   I was dorming at college at the time of my first flare-up, and immediately scheduled a Telehealth session with a school physician, who recommended that I come in the following day to see the dermatologist. I saw the dermatologist, who had no explanation for my reaction. I was given Benadryl.  Recently, I saw my ENT for an unrelated reason, but mentioned my vaccine reaction to him. He agreed with me that it sounded like a reaction involving my lymph nodes under my arms, and recommended that I see an immunologist. I will likely be doing that.  I have many pictures of my rashes and swollen underarms from different points in time starting 5/9/21, and up until a few weeks ago. I will gladly send these pictures if requested.  Today, I still get occasional flare-ups, but they are less severe. I also believe that I am experiencing enlarged lymph nodes in my right breast.