chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 doses of Boostrix administered; Adult Engerix B instead of Pediatric dose; Adult Engerix B instead of Pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number yr7aa, expiry date 4th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 20th August 2022, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 20th July 2022, the patient received the 1st dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 20th July 2022, not applicable after receiving Boostrix and Boostrix Pre-Filled Syringe Device and unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On 20th August 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, 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-AUG-2022 Reporter's Comments: The pharmacist reported that the patient was administrated with 2 doses of Boostrix.  The pharmacist reported that the patient received a dose of Adult Engerix B instead of the appropriate Pediatric dose according to the age.  The Vaccine Administration Facility is the same as Primary Reporter. No adverse event was reported. The reporter did not consent to follow-up. Additional Supportive Information: The patient was administrated with 2 doses of Boostrix which led to Extra dose administered. The patient received a dose of Adult Engerix B instead of the appropriate Pediatric dose according to the age which led to overdose and adult product administered to child. This case was identified as duplicate of case US2022122103. The case US2022122103 was merged to this case as FU1, and deleted from system. This case was linked with case US2022122101 reported by same reporter.; Sender's Comments:  US-GSK-US2022122102:Same reporter US-GSK-US2022122101:Same reporter
Another customer in the store called over to the technician and pharmacist on duty stating the patient looked sick. He had dropped his timer that was counting down his 15 min post dose wait time. Pharmacist approached patient and asked him how he was doing. He was initially non-responsive, eyes were slightly glazed over. I repeatedly asked him his name and how he was doing. He began to respond after prompting, saying he felt very hot and sweaty. He stated he was thirsty and he hadn't eaten anything before his dose. Technician obtained a glass of water and a granola bar for the patient. Patient began to improve just minutes after food and water. He stated he thought he had stood for too long while waiting for his shot and hadn't eaten that morning so he began to feel sick. Patient recovered enough to call his daughter to pick him up from the store. His daughter arrived to pick him up and patient was able to walk out of the store without issue.
Patient received Covid Vaccine BUD. Vaccine expired on 10/13/22 and was given to patient on 11/10/2022
I woke up the next morning around 9 am feeling very dizzy. Upon trying to get out of bed I fell over because my vision was sideways. I layed back down for a few hours. Upon rising again, my vision was again sideways and the dizzying effects lasted intensely for the remainder of that day. The following day I was able to go to work but by mid-afternoon had to lay down again and was unable to do yoga for the following 5 days. For a total of 2 weeks, I felt nauseous and dizzy. Now, once a week I feel dizzy still but positional therapy has helped me get back to my work and exercise lifestyle.
First symptom noted is slowed thought processes.  Voiced feeling a tingling sensation throughout body, voiced dizziness.  Denies shortness of breath or difficulty breathing.  Had patient sit down.  Gave Eppy (1:1000) 50 mg./ml., 1ml. IM to left deltoid.  Gave Benadryl 50 mg./ml., 1 ml. IM to right deltoid.  Vital signs blood pressure 160/80, pulse 100, respirations 24.  R.N. stays with patient and husband while report of incident is called to patient's local physician.  Physician instructs to send patient to his office.  Husband takes patient to physician's office.  Physician calls Health Department and informs that patient is doing okay, will keep her at his office until closing and if continues to be okay will send her home.
Fever 100.1, severe muscle pain in back of legs, pain at vaccination site, 4 inch circular red mark around vaccination site, fatigue.
Lg swelling 20 cm (R) deltoid/arm, dizzy, fever, body aches, improving.
improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
High fever, chills, nausea, (R) arm (pneumococcal given) swollen, had a knot at injection site and under arm, lymph node at neck swollen, treated w/ ice pack and TYLENOL, and BENADRYL. MD prescribed antibiotic and steroid.
See History & Physical. This patient received a Pneumococcal vaccine probably on 3-25-09 and we do not know where. Patient came to agency on 3-28-09 with adverse reaction.  Malaise. 6/8/09 Received hospital medical records of 3/27-4/1/2009. FINAL DX: inflammatory or immune right arm cellulitis Records reveal patient experienced fever, SOB, tachycardia, altered mental status, intermittent low blood pressure, and right arm cellulitis w/swelling, induration & tenderness.  Tx w/IV antibiotics, resolved completely but developed diarrhea.  No antibiotics at d/c to home but on tapering steroids, nystatin powder for axillary rash & acidophilus.
temperature excursion for V ARlV AX/administered to patients; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 04-JAN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T010313, expiration date 24-MAR-2022, dose 1, 0.5 milliliter, administered subcutaneous for prophylaxis. Temperature was 32.4 Fahrenheit degrees (F) for 4 hours. There was no previous temperature excursion. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA010446: US-009507513-2101USA009977: US-009507513-2101USA010358: US-009507513-2101USA010348:
Reaction to ChickenPox vacc. Swelling to 1.5 inches by 3.5 inches at site.  Low fever.  Painful to touch, red, itching in surrounding area.  Was given Keflex and Claritin (to treat infection and allergy).  Reaction developed over 2 days - shot given Wed., reaction severe enough to return to Dr. on Friday.  At same time was given Hep. A in other arm - no reaction beyond slight bruise.  Previously had single vacc but no boosters of both with no reaction in 2001.
muscle weakness in her left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 2023, outcome "unknown", described as "muscle weakness in her left leg". Therapeutic measures were taken as a result of muscular weakness.  Additional Information: She had muscle weakness in her left leg and she was wondering if it's going to get any better. Patient added that it does not hurt but she had to use a walker. She's already seen 2 doctors and they don't have a clue.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient received the Moderna shot and fainted and loss of consciousness while sitting down waiting for the 15 minutes being observed.  He was unresponsive and slipped from the chair to the floor.  Wife alerted the Rph on duty and Rph went over and administer the epipen to him and called 911 for ambulance.  Patient became responsive before the ambulance arrived but was taken to the hospital to have everything checked out.  He then got discharged a few hours after on the same night.
After my J&J vaccine, about 2-3 days after I developed flu like symptoms, chills and headaches. On the 6th day after my vaccine, I developed a lump on the right side of my throat which progressively got worse. I also experienced diarrhea which lasted three days. I went to see my PCP, Dr. who ordered a CT scan of my neck. The CT scan demonstrated I had an ulcer in my throat located in my larynx box. MY PCP  doctor then referred me to  an ENT doctor, Dr. The ENT doctor gave me antibiotics and a shot in my arm. My throat kept getting worse and the ENT doctor have me reflux medicine and Prednisone and Bactrum medication. Today I woke up feeling much better although the pain and swelling to my left side of my throat and ear has gone down but I still have a sore throat and ulcer and is being treated with medicine.
felt a little achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt a little achy) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (felt a little achy) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, MYALGIA (felt a little achy) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Patient stated that after receiving the first 2 doses of the vaccine she felt a little achy and tired but that was about it.    This case was linked to MOD-2021-339316, MOD-2021-339317 (Patient Link).
This spontaneous report as received from a health professional refers to a female patient of unknown age. Informatino about the patient's medical history and concurrent conditions was not provided. On an unknown date, when the patient was a baby, she was vaccinated with a dose of RECOMBIVAX HB, (administration route and expiration date were not provided). No concomitant therapies were reported. The reporter stated that the patient's titers were negative (hepatitis B surface antibody negative) on an unknown date. On an unknown date in July 2015, the patient was inadvertently administered a pediatric dose (incorrect dose administered/underdose) of RECOMBIVAX HB lot # L001626, (administration route and expiration date were not provided). Following the vaccination the patients titers were still negative (hepatitis B surface antibody negative). According to the reporter the patient saw the physician for this events. The outcome of hepatitis B surface antibody negative and underdose was reported as recovered. The reporter did not provide a causality relationship assessment between the events and therapy with RECOMBIVAX HB. Additional information has been requested.
Patient states that the next day (11/12/19), typical local site reactions occurred (pain at injection site, tenderness, warmth in the upper arm, and redness). Starting two days after injection, the pain had subsided, but redness began to spread further down the arm. This continued until it reached the elbow. On today's date (10/20/19), the redness in the skin has begun to subside. Patient denies any pain or swelling with the redness, but mentioned a slight itchiness initially. When asked what measures she has taken, she stated she has taken ibuprofen, but no diphenhydramine because she was unsure that it was an allergic type reaction.
Arm soreness, chills, fatigue, mild swelling of fingers briefly for about 30 min 4 hours after shot
Minutes after flu shot given, caregiver started to complain of nausea with flushed face and neck. Stayed with clinic for 30 min following shot before leaving clinic.
got sick; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a patient (consumer or non-health care professional0 via Social media.  This case is linked to case 2020SA289370. (same reporter)  This case involves patient with unknown demographics who experienced got sick (illness), while patient received INFLUENZA VACCINE.  It was reported that, patient every year vaccinated with  INFLUENZA VACCINE (Flu shot) and every year got sick for 2-3 days.  Past medical treatment, family history and concomitant medication/therapy were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for illness.   There will be no information available on the batch number for this case.
6 hours post vaccine: fatigue, fullness of ears, soreness of arm, neck stiffness, and tingling of hands 12 hours post vaccine: fatigue, head feeling foggy/not able to think clearly, chills, low grade fever, sore arm  24 hours post vaccine: fatigue, full body aches, low grade fever, chills, sore arm
patient developed weakness in legs, arms and headaches with lethargy starting 8 days after shots, then sore throat and ascending paresis with difficulty walking but no fever.Strep and mono test were negative and patient was treated with frequent small eedings, bedrest and analgesics. he made 3 office visits over 6 days and showed signs of reduced weakness by early Feb.07. reflexes were 3+and symetric and he had mild foot parethesias. 02/02/07-Received records  GBS is mentioned in the notes but he is not 100% sure that he had GBS based on the fact that he did not have decreased reflexes. However, he also indicated that the lack of decreased reflexes could be related to the fact that he did not perform reflex testing until 9 days after initial symptoms. Reporter contacted a neurologist and discussed case, no referral to neurologist at this point. Will see patient again on Tuesday 2/6/07 . C/O tired, weakness in legs, tingling in feet.Headache, no stif neck. Possibly GBS.
Pt received 2 mo. immunizations and check up at our office.  Then we learned that this pt had already received his 2 mo immunizations at the Health Dept.
some of the dose gushed down/ran down her arm and lost some of it; some of the dose gushed down/ran down her arm and lost some of it; Soreness in the right arm at injection site; A spontaneous report was received from a consumer, who was a 36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of the dose gushed down/ran down her arm and lost some of it and soreness in the right arm at injection site.  The patient's medical history was not provided. Concomitant product use was not reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 30 Dec 2020, during vaccine administration, some of the vaccine dose gushed down/ran down the patient's arm and some of the dose was lost. On the same day, the patient began experiencing soreness in her right arm, at the injection site.    Action taken with mRNA-1273 in response to the events was not provided.  The event, some of the dose gushed down/ran down her arm and lost some of it, was considered resolved on 30 Dec 2020. The outcome of the event, soreness in the right arm at injection site, was not reported.; Reporter's Comments: This case concerns a 36 year old, female,  patient. The patient's medical history is not provided. The patient experienced an unexpected event of inappropriate dose administration as some of the dose gushed down her arm and lost some of it. The patient also experienced an expected event of soreness at the injection site. The events occurred on 30 Dec 2020 during the administration of the first dose of mRNA-1273.  The sponsor considered the event, soreness at the injection site as related to mRNA-1273. Pain at the site of injection is listed on the company's fact sheet for the healthcare providers. The sponsor considered the event of inappropriate dose administration and exposure via skin (as some of the dose gushed down the arm) as not related to mRNA-1273.
1st day:  2hours after the shot, felt dizzy for rest of the day, low grade fever. 2nd day:  low grade fever, body aches, muscle weakness 3rd day : low grade fever, body aches, muscle weakness,  right fore arm and lower right  leg bottom half felt  little stiff, moved leg around to avoid getting stiff. 4thday : general weakness , Headache started in the night. 5th day: Nausea, dizziness , head ache 6th day, head ache, dizziness,  little stiff  right leg bottom half ( as if muscle is become stiff ) 7th day: dizziness , as if I move head one side whole body moves that side ( dizziness still there as of this reporting day)
Welts on back, buttocks, (L) neck pain radiated to Rt. side and swollen. (L) arm pain. Saw PCP for follow-up.
pt developed an injection site reaction around the site of injection. patient stated that it was severely red and it blistered. When patient presented at the pharmacy, a scab was noted on the affected site.
Started on 4th day, around 3 am,  woke up with severe muscle aches, extensive lower back pain(unable to walk properly), dizziness, severe nausea.  5th day- nausea,  headache, muscle aches.  No fever.  6th day(today) not getting better, still very nauseous, severe headache,  dizziness, stomach is upset.  Symptoms dont seem to be getting better.
Redness, swelling at injection site right deltoid - fever 100 degrees - 102 degrees - injection site pain, arm pain (arm injection was given) right arm pain.
Per CDPH, reporting to VAERS is required if a fully vaccinated person gets COVID-19. MD note: Comprehensive Assessment/Plan Assessment and plan  1. Covid - WBC on admission: 6.8 - Lymphocytes on admission 1.38 - CXR 7/31/21 IMPRESSION: Increased left infrahilar stranding. Enlarged 15 mm nodule, projected over the left lateral eighth rib. Enlarged Second, 8.1 mm nodule, projected over the lateral eighth rib; - LFTs 7/31/21 wnl - will order CRP D-dimer LDH ferritin CK procalcitonin - BUN/creatinine on admission 21/0.67 7/31/21 - will NOT start the patient on IV Remdesivir d/t her being on RA  - Precautions: airborne, droplet, contact. Negative pressure. Full PPE worn during encounters - will order Supplemental O2, tit Vaccinated on 03/05/2021 and 03/25/2021
Heart has been racing out of my chest; Feeling real bad; Getting real dizzy; Inappropriate schedule of vaccine administered (1 Dose- 31 August 2021 2 Dose-  09 December 2021); This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart has been racing out of my chest), FEELING ABNORMAL (Feeling real bad), DIZZINESS (Getting real dizzy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (1 Dose- 31 August 2021 2 Dose-  09 December 2021)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified (Already gotten two different heart diseases).   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced PALPITATIONS (Heart has been racing out of my chest), FEELING ABNORMAL (Feeling real bad), DIZZINESS (Getting real dizzy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (1 Dose- 31 August 2021 2 Dose-  09 December 2021)). On 09-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (1 Dose- 31 August 2021 2 Dose-  09 December 2021)) had resolved. At the time of the report, PALPITATIONS (Heart has been racing out of my chest), FEELING ABNORMAL (Feeling real bad) and DIZZINESS (Getting real dizzy) had not resolved.            No concomitant medications were mentioned. No treatment details were reported.