chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report (s) previously submitted on 12/12/2008. Information has been received from an office manager concerning a 24 year old female with no medical history who in April 2008, was vaccinated IM with a dose of GARDASIL and on 20-OCT-2008 was vaccinated IM with the third dose of GARDASIL (lot # 661530/0575X) in her left arm.  There was no concomitant medication.  On approximately 20-OCT-2008, the patient experienced myalgia and pain from the injection site all the way down to her arm.  The patient said the third dose was given a little bit "higher" in her arm compared to the first and second dose.  The patient had no symptoms with the first and second dose.  The patient was an athlete and could not raise her arm laterally and could not dress herself.  The physician prescribed an anti-inflammatory and an arm sling for one week but the patient had no improvement.  The patient said the first week after the third dose her pain was sharp but the second week the pain was a constant ache.  The patient saw a neurologist (unspecified name) on 11-NOV-2008 and she thought that the patient had an autoimmune reaction to GARDASIL.  The patient was prescribed a steroid (unspecified), LORTAB and physical therapy.  At the time of this report, the patient was not recovered.  Follow-up information received from the healthcare worker concerning the path forward included an ultrasound of the patient's shoulder.  If the patient's ultrasound was clear, the physician would recommend physical therapy.  As of the day of this report, the neurologist's report has not been received by the physician's office.  Additional information has been requested. Follow-up information was received on 28-JAN-2009 from the office manager indicating that she would not send the form back. No adverse experienced follow-up information was provided. Additional information is not expected.  1/23/09 Reviewed GYN & Neuro medical records. Neuro eval 11/11/2008: FINAL DX: left brachial plexopathy. Records reveal patient experienced LUE pain, tenderness & weakness, left hand weakness, inability to raise left arm since vaccination.  Had immediate intense pain which worsened & was from under left clavicle to left shoulder.  Tx w/steroids, pain med & PT.  Referred for EMG/NCS.  GYN records: Reveal patient in good health on day of vaccination.   RTC 10/28 with pain left arm & shoulder which affected ADLs.  Dx w/tendonitis & tx w/NSAIDS & sling.
Pt began feeling shaky + having racing heartbeat within 3 minutes after vaccine given. HR up to 160, pt visibly shaking. Maintained consciousness, no swelling of face/tongue, no decreased O2. BG sl elevated, 180. We monitored her vitals for ~ 45 min, and they eventually normalized + she felt back
Death  4/29/09 Autopsy Report states COD as sudden unexpected death in infancy (SIDS); & acute interstitial pneumonitis; & manner of death as natural.  Report also states recently diagnosed w/heart murmur & had been born a preemie twin.
HPI:  Shots (DTAP, IPV and Hepatitis A) were given in the am.  Fine whole day.  8 pm last pm fell asleep on the floor.  30 min later felt very hot.  Then he started shaking and twitching.  Mostly in joints wrists and fingers and ankles.  ?involuntary  But doing different things.  He was alert and conscious.  Really bad 2 minutes then slowed down.  Fever went down too.  Mom woke him up and had him watch a movie.  Fingers still twitching some. ?reaction to vaccine? Woke up seeming fine today.
Received First Dose on 02/06/2023 And a Second Dose on 02/07/2023; Initial Report Received on 10-Feb-2023.  A pharmacist reported that a 48-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received a second dose HEPLISAV-B one day later.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known allergies.  On 06-Feb-2023, the patient received the first dose of HEPLISAV-B vaccine (details not available) from another pharmacy location.   On 07-Feb-2023, one day after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 937234, expiration date 12-Sep-2023, NDC # 43528-003-05; route and injection site not reported) at this pharmacy. No adverse reactions were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Dizziness; head spinning; gait issues; unable to focus or see straight; sharp pains in the back of my head. I was unable to walk straight or drive my vehicle. Dehydration and unable to think clearly.
15-20 mins after receiving the vaccine she reported she had difficulty swallowing and difficulty breathing and was ?shaking."  a PA wrote in her note that when she ran in to help, she found the patient to be tachypneic, diaphoretic, warm with some red blotchy patches on face, chest & neck. Able to speak easily c/o trouble breathing & sensation of throat swelling & extremities feeling abnormal. No stridor. No facial edema noted by that clinician. Administered epi-pen 0.3mg   - IV  started , Benadryl 50mg IVP and solumedrol 125mg IVP. Patient reports she subsequently arched her back and had rigidity of her arms/legs and tremors.  Clinic PA reports that while she was there, pt was never hypotensive. Initially hypertensive after epi as expected with some favorable response after 10-15 min Staff there gave her IM epinephrine, IV Solu-Medrol and 50 mg IV Benadryl.  EMS was contacted and transported to the emergency room.  She arrived at the ER, was monitored for 2 hours, was started on pepcid and benadryl and discharged from the ER. She had a diffuse itchy rash. The following day she again developed recurrence of throat swelling. Went back to a different ER. Developed dyspnea immediately prior to arrival at ER. There was again given solumedrol and benadryl and pepcid and developed muscle rigidity and arched back for 10 minutes. Symptoms of SOB and dyspnea resolved with epinephrine. Was discharged from the ER with prednisone after being monitored for 5 hours.  Is continuing to take prednisone and benadryl. Rash is still present but improving with scheduled benadryl. Has new redness at injection site today. Continues to feel some throat swelling but no tightness today. This information was gathered from talking with pt today for a phone appt and also from her medical chart regarding her vaccination visit and two ER visits.
On the 4th day after the vaccine, I began to have my period, even though I am taking the pill and I skip the placebo pills so I do not  normally have a period. I have continued to menstruate every day since, sometimes very heavy and painfully, even as I continue to take my pills at the same time every day. I am not sure how long this will last. Today is the 6th day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "minor asthma" (unspecified if ongoing), notes: minor asthma. Concomitant medication(s) included: SERTRALINE, start date: 01May2010; MONTELUKAST, start date: 01Jan2010; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2000. Past drug history included: Quinolones, reaction(s): "known allergies: Quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fluzone QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Fluzone QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA318835(CLUSTER), 2023SA321113(CLUSTER), 2023SA319649(CLUSTER), 2023SA321127(CLUSTER) and 2023SA319055(CLUSTER).  This case involves a 11 months old female patient who was administered influenza quadrival A-B vaccine [Fluzone QIV] and was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.5 ml once of suspect influenza quadrival A-B vaccine (lot: U8192BA; expiry date: Jun-2024; strength: standard) via intramuscular route in the left thigh for Immunization.  On 16-Oct-2023 the influenza quadrival A-B vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
The patient's wife called during the evening on the day he had received the shot to report that he was complaining of a lot of arm pain. She had iced it and given him a dose of IBU. She also said he had some chills/had been shivering. I told her to monitor for fever, continue with the ice and IBU and to report back to me the next day. She called the following morning (6/21/2020) to report that he was still having a lot of muscular soreness/pain in the arm the shot was given but that there was not any redness or swelling at the injection site (she couldn't see where it had been given). She had taken his temperature and he did not have a fever. She was going to continue to monitor him for improvement over the next few days as I told her some patient's had reported similar findings that lasted 3-4 days after the injection.
Started with a terrible headache the morning after vaccine.  By the afternoon along with the headache, I had muscle aches.  By 1am, I was having a low grade fever, chills, and tachycardia (120-130bpm).
CA was float unfamiliar with office DTaP and IPV separate were ordered by physician in the EMR as pt was private and at the time private vaccine combined DTaP/IPV was out of stock, the combined DTaP/IPV was in stock in VFC inventory and administered by mistake instead of ordered individual IPV in addition to the appropriately ordered IPV individually. Family notified and had no ill effects will continue to be monitored.
Chest pain, Chest tightness, Shortness of breath, Pain worsens while lying down
Patient felt faint, stood up for assistance and lost consciousness and fell to the floor.  It was warm at the site and wait time approximately 1 hour.  Patient admitted that he was dehydrated.  Has a history of fainting.
SLE Lupus Acute Musculoskeletal Dysfunction  Myofascial Pain Syndrome  Sacroiliac Joint Dysfunction Food Allergies  Asthma  Poor appetite  IBS
Left deltoid pain 2 hours after injection, pain dulled by day 2 but never resolved. Difficulty raising arm and reaching to right side. Took TYLENOL 10/8. 10/10 saw nurse practitioner. Starting 10/11 took ALEVE BID for 7 days. 10/30/17 Saw Dr, eval and xray. MD prescribed prednisone for 7 days. To begin occupational therapy 11/2/17.
COVID vaccine breakthrough case. Pfizer 1/27/21 EL3247, 2/17/21 EM9810, and boosted 9/28/21 EW0169 and 6/10/22 FN2908
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 89 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Initial pain (Score 9/10) at the injection site.  Muscular pain prevented the use of the arm for up to 4 days. The pain was followed by a spreading loss of sensation on the skin at and around the injection site. Muscle feels as though it is perpetually contracted, even while it is clearly relaxed.  Loss of sensation in the skin and constant sensation of muscle contraction spread from the upper left arm (injection site) to the lower arm, palm, shoulder, and neck. The patient was prescribed naproxen which did not result in improvement of symptoms.  Since vaccination, the patient also has experienced heavier periods and much stronger menstrual cramps.
Patient received first dose of Moderna Covid 19 vaccine and neglected to inform staff that she had received first dose of Pfizer prior to this dose.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2009, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Patient received the bivalent COVID vaccine at local Pharmacy on 10/08/22. Mom called our office on 10/10 to report that the patient had tingling in her hands on 10/09 and tingling/numbness in her legs that felt like pins and needles. She was unable to walk and needed to be carried. Was sent to ED where labs were normal and she was sent home. Was evaluated in our office by PCP the next day where she also had swelling in left 4th and 5th fingers.  Close monitoring recommended for the next few days.
HISTORY AND COURSE IN THE HOSPITAL:   1. Acute on chronic hypoxic respiratory failure. The patient is a 71-year-old female with past medical history of chronic respiratory failure, on home O2, comes in with history of increasing shortness of breath. She was found to be COVID positive, ID and Pulmonary was consulted. She was started on Decadron 6 mg daily, IV remdesivir, breathing treatments. She was also found to be fluid overloaded.  She was started on IV Lasix 40 mg b.i.d. with treatment, she noted marked improvement.  Shortness of breath improved.  She completed 5 days of remdesivir and also 6 days of Decadron and 4 days of Prednisone, and oxygen saturation was back to baseline. She has been advised to be compliant with Bumex at home, and to weigh herself every day and if she gains 3 pounds to take extra dose of Bumex.  Once she was symptomatically better, she has been sent home with home care and home O2.  2. Iron deficiency anemia and stool occult blood positive .Hematology and GI was consulted. She was given IV iron and because of her multiple comorbidities and COVID, she has been advised to follow up with GI as an outpatient for EGD and colonoscopy when she is out of isolation for  COVID.  3. Diabetes mellitus with uncontrolled blood sugar. She was on Lantus insulin, Lispro with meals and SSI .improved once the steroids were tapered.  4. Critical illness myopathy.  PT/OT was consulted. They felt she can go home with home care. I recommended her going to subacute rehab, but the patient refused and prefers to go home. I have also advised her that if she finds it difficult to go to the primary care physician. I have given her a name of a primary care physician who can come to her house. She has been advised to follow up with the primary care physician in one week and Pulmonologist as needed and GI in 2 to 3 weeks.
Fast heart beats in 2nd and 3 rd day afternoon around 2:00 PM and lasted 1-2 hours each afternoon.  In 2nd afternoon, it was severe enough that I had to rest in bed due to precautionary measures.
62-year-old female with past medical history of COPD, chronic pain syndrome, arthritis presented to the emergency department complaining of productive cough, shortness of breath, abdominal pain with nausea and poor appetite for the past few days.  Pt + for COVID on 10/16/2021.  Treatment: oxygen, albuterol, breo, DX also with colitis with acute abdominal pain, treatment: antibiotics. Discharged to home.
Severe headache 7/10 pain scale (24 hrs after shot for 6 hrs) Muscle soreness consistent with flu symptoms (began at 12 hrs lasted until 36 hrs) Crankiness/irritability (within 30 mins) Mental fogginess (within 30 mins) Cold chills (began with headache at 24 hours after shot - lasted 6 hours, no fever) Fatigue (began 6 hrs after shot, ongoing)
Intermittent weal at injection site since the 8/16 vaccine was given, it is describes as a large red welt that would appear approx. every other day since injection, this reduce to every other week since 4/16, reports itching but no pain, no open areas.
Less than 24 hours after the shot, I have severe body aches to the point I'm stiff.  My entire left side is in a tremendous amount of pain.  I have a severe headache and my eyes are hurting.  The body chills are almost unbearable.
Overdose; Adult product administered to child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-year-old patient who received HAV (Havrix 1440) for prophylaxis.   On 19-MAY-2023, the patient received Havrix 1440. On 19-MAY-2023, an unknown time after receiving Havrix 1440, the patient experienced overdose (Verbatim: Overdose) and adult product administered to child (Verbatim: Adult product administered to child). The outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-May-2023  Vaccine coordinator stated that an adult dose of Havrix was administered to a 2 year old patient last Friday, which led to overdose and adult product administered to child. The reporter consented to follow up via email. The reporter did not verify the date of admin.  HCP did not have any additional patient identifiers, nor did she have details surrounding the event.
muscle weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced MUSCULAR WEAKNESS (muscle weakness). At the time of the report, MUSCULAR WEAKNESS (muscle weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment products were not provided.   Reporter did not allow further contact
After receiving the vaccination, and the nurse being aware of his previous adverse reaction, he sat for approximately 5 minutes before being released.  I drove him home, approximately 1 mile away, and he fainted twice in the car.  I took him to a neighbor, and he fainted once on the sidewalk and again as we got him to the couch.  He slept for about an hour at the neighbor's house and asked to go home.  He called me from home but didn't remember how he got home or that he was home.  He sounded very confused on the phone.  I came home about 30 minutes later, and he had been sleeping again.  When I woke him, he was oriented to time and place, but he continued to be lethargic.  His energy level increased, we pushed fluids to increase blood volume, and he had a headache for the remainder of the evening.
2 days p/vax pt exp h/a, agitation, weakness & fatigue;sx resolved in 1wk;