chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Boostrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number CM7KN, expiry date 29th January 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 20-FEB-2023 Reporter's Comment: A healthcare professional called to inform that earlier that day a patient had received a dose of Boostrix that had expired on 29 January 2023. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Boostrix vaccine, which had led to expired vaccine used.
rash on her side, the size of a baseball; Body, back, and side itches; It was dark red and then went away/Stated it was kind of a bright red. It was really red. She has never seen a rash that red; she developed a little red spots a couple days after the first time. It also went away; she lost half an inch; This is a spontaneous report from a contactable consumer or other non-Hcp (patient herself). A 77-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 29Jan2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date the patient experienced rash on her side, the size of a baseball, body, back, and side itches, it was dark red and then went away/stated it was kind of a bright red. it was really red. she had never seen a rash that red; she developed a little red spots a couple days after the first time. it also went away; she lost half an inch (body height decreased). The patient underwent lab tests and procedures which included weight was between 102-103lbs. The outcome of the events was not recovered.  Information about Lot/Batch number is requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Vaccine administered 4/9/10 reported severe arm pain and immobility of arm. 4/10/10, 4/11/10 chills, aches. 4/11/10 erythema at injection site (2"). Sx resolved over course of 5 days.
Administration Error, Moderna vial punctured 1/3/22, refrigerated, and was used on 1/4/22 to administer 0.5ml to patient for Dose #2.  (Vial should have been discarded 12 hours after puncture)
patient came to pharmacy on 8/25/16 with swelling rash on her right arm; same arm that she got her PREVNAR 13. Patient said she used TYLENOL for pain and ice for swelling.
Bleeding from right kidney; Bleeding from right kidney; Left kidney is shrunken and function at about 10%; Left kidney is shrunken and function at about 10%; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982), via an unspecified route of administration on an unspecified date in Feb2021 (19:00) at single dose (at the age of 89-year-old on Left arm) for COVID-19 immunization. Medical history included arthritic knees and shoulder, prostate cancer, macro degeneration, hearing loss, congestive heart failure, Last right kidney bleed one a year ago (2020 to 2020). The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered:Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had no known allergies to medications, food, or other products. Patient had Bleeding from right kidney into nephoscimy bag. No noticeable bold from bladder. Left kidney is shrunken and function at about 10%. All events from 06Feb2021 04:00. No treatment was received in response to the events. The outcome of the events was recovering.
Information has been received from a physician via a published article title as stated above and from a website. It was reported that a previously healthy 17 year old female with myopia presented central with central and paracentral dark shimmering spots in the vision of her left eye for 3 days diagnosed as multiple evanescent [[name]] dot syndrome. The right eye was normal. She had received her first GARDASIL and meningococcal (unspecified) vaccination 1 month before the onset of visual loss. She had no history of fever or flu-like symptoms within the past year. She denied any health problems and no family history of vision problems. She had no history of neurologic problems and no pain on eye movement. The patient's maternal grandmother had psoriasis and severe rheumatoid arthritis. Best-corrected Snellen Visual acuity was 20/20 in the right eye and 20/200 in the left eye. There was no afferent pupullary defect. Amsler grid testing of the left eye showed central and paracentral scotoma. Findings on slit-lamp examination were normal except for 1+ anterior vitreous cells in the left eye. Fundus examination of left eye showed slight blurring of the optic disc margin, loss of the foveal reflex, 1+ posterior vitreous cells, and rare small [[name]] spots in the macula and nasal periphery. [[name]] 30-2 visual field testing showed enlargement of the blind spot in the left eye. Fluorescein angiography of the left eye showed subtle hyperfluorescent spots corresponding to the [[name]] spots seen on fundoscopy. Optical coherence tomography of the left eye showed loss of normal architecture of the deep retina. Findings on examination and testing of the right eye were normal. The patient was HLA-B27-positive, but was not HLA-B51-positive. On follow-up examination 2 months after the initial evaluation, visual acuity had improved to 20/20 in the left eye and the [[name]] 30-2 visual field was normal. It was reported that the association of the patient's multiple evanescent [[name]] dot syndrome with the GARDASIL and meningococcal vaccines could be coincidental. Both of these vaccines are administered to [[name]] women, and multiple evanescent [[name]] dot syndrome occurs predominantly in [[name]] women. Upon internal review, multiple evanescent [[name]] dot syndrome was considered to be an other important medical event since the patient lost vision in her left eye. Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Described as tired and achy for 2 days and then arm was still sore after that.
Patient received Janssen COVID vaccination on April 6, 2021. Pt had no symptoms initially after vaccination. Pt started coughing up blood and having episodes of dyspnea on April 25, 2021. Pt went to Urgent Care earlier in the day on May 11, 2021 - no medications were given, told he was fine. Pt then went to Medical Center and was found to be pale, diaphoretic, and tachycardic in triage.  Pt vitals were temp: 36.6; pulse: 128; respirations: 22; BP: 161/129; SpO2: 97.     Hospital medications: carvedilol 6.25mg PO BID, enoxaparin sodium 40mg SQ Q24h, azithromycin 500mg/sodium chloride 250mLs @ 250 mLs/hr IV Q24h, ceftriaxone sodium 2gm/sodium chloride 50mLs @ 100mLs/hr IV Q24h, lisinopril 2.5mg tablet PO QD, metoprolol tartrate 5mg IV Q5MP prn tachycardia.   ER disposition: consult for admission Dx: hypertensive urgency, tachycardia, suspected COVID virus infection, bilateral pneumonia
Measles-like rash, starting on head / face, moving caudally. Began on day 10 after vaccines. Worsened overnight from day 10 to 11. Supportive care.
Information has been received from a registered pharmacist concerning a patient who, "recently" (on an unspecified date), was vaccinated with a dose of ZOSTAVAX (Merck) (lot # and expire date not reported), intramuscularly instead of subcutaneously (also reported as sucutaneously). The registered pharmacist stated physician told him, "recently" (on unspecified date), the patient had some local bruising at the injection site. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Dizziness 2 days, headaches 3 days, itiching 3 days, weakness 4 days; took TYLENOL.
muscle ache, mild fever, joint soreness 9/30 at 9am hand blisters  10/2 at 8am
The 1st 2 shot and booster she had a slight headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (The 1st 2 shot and booster she had a slight headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 016B21A and 012A21A) for COVID-19 vaccination.     Patient never had COVID+ test or diagnosis. Patient did not have a history of Pericarditis or myocarditis.  Concurrent medical conditions included Penicillin allergy and Sarcoidosis. Concomitant products included ROSUVASTATIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (The 1st 2 shot and booster she had a slight headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (The 1st 2 shot and booster she had a slight headache) outcome was unknown.            Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient was taking other medication.   This case was linked to MOD-2022-647505, MOD-2022-647512 (Patient Link).
0918 C/O dizziness and blurred vision. Reports Hx of labile BP 177/96 , HR 75, 97% says No BP meds. 0925 expressed Dizziness improved. 0930 Dizziness resolved BP 160/88, HR 77. 0937 left ambulating with her husband for home.
Headache, Myalgia, Fever, chest pain, chills Narrative: Per employee report: Had 2nd dose Mon. [2/22] around 3 pm. The next two days [2/23, 2/24] had fever chills, muscle aching, chest pain, headache. Off work for those two days. Now recovered and back to work.
pt recvd vax @ approx 10AM & by the evening pt lt leg was swollen & red (softball size by the next morning); mom took pt to ER & MD felt was allergic react to the DTP & placed pt on ATB;
Received 2nd Novavax vaccine 8/22/22 at 1100am. at 11:00pm on 8/22 started with joint pain, progress to fever 103, severe rigors,  chest pain, severe  bilateral hip pain, headache, nausea, tachycardia-HR of 140 bpms, dizziness, lightheadedness, diaphoresis. Went to ED approx 0300 am on 8/23/22
This spontaneous report as received from a physician reported an unspecified number of patients received improperly stored VARIVAX on unspecified dates. The physician was also unable to provide the lot#/exp for the VARIVAX in question. The physician mentioned the VARIRAX was exposed to minus 4.3C "since January 2013". No adverse symptoms reported. Physician inquired about the stability of VARIVAX exposed to minus 4.3C. Physician inquired if these patients need to be revaccinated or not. Additional information has been requested.
Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid-19) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Birth Control . Treatment details were not provided.; Reporter's Comments: Based on reporter's causality the event is assessed as unlikely related to mRNA-1273. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Pt recvd 3 doses of Engerix-B exp no adverse exp, however did not convert; plan to revax;
Belle's Palsy, Left side of face.  Treatment Anti-Viral and Prednisone.   Has not normalized to date.
7AUG91 vax given, APAP given 5PM; c/o not feeling well t101, APAP given & inc fluids; Later t103 APAP given-10PM t105 & taken to ER; poss rxn to DTP;
17 year old  patient received Moderna vaccine.  Parent decline any adverse and or allergic reaction.
Within 4 hours patient started with a headache and then overnight had terrible headache, nightmares, fever and chills. She did not sleep due to these symptoms. She feels better the next day.
Felt really badly days 3,4,5, post vaccination with extreme fatigue, headache and wild swings of BP uncontrolled, muscle pains in neck and shoulders.  Followed by 2-3 days of extreme fatigue and feely badly every week for 3-5 weeks.  Continue to have uncontrolled BP and fatigue.
Left thigh was bright red. Left leg was swollen. Fever, lethargic from Thursday night 11/30/17 to Saturday 12/2/17.
4 pts were given a series of 3 doses of Engerix-B & it was determined that all pt now have no antibody; series completed in 1989;
Fever, Naseau, pass out, no appetite, beyond body aches, no taste, fatigue. arm soreness.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received SHRINGIX for prophylaxis. On 24th January 2019, the patient received the 2nd dose of SHINGRIX. On 24th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site erythema and injection site itching. On 7th February 2019, the patient experienced rash. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was the wife of the patient. The patient experienced injection site reaction consisting of itching and redness which began immediately after the injection. Two weeks later, the patient reported rash which began on the trunk of the body, and spread to arms and head. The rash was becoming worse and spreading. The reporter gave consent to follow up.
Severe numbness and tingling in both arms, both legs, hands and feet. It was very creepy. Shortness of breath intense for about an hour. Armpit very sore on left side where I got the dose.
Heart rate 155 while resting and irregular. I have no other medical problems. Heart beat also felt irregular.
Received vaccine around 3 pm. She left pharmacy and then called back around 7 pm complaining of an intense pain running from the arm receiving the injection up to her neck. She says it began minutes after injection. Advised patient to seek medical help.
Refrigerator containing Fluzone went down to 29.1F. After that excursion, vaccine administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2020SA038346, 2020SA032577, 2020SA038343, 2020SA038467, 2020SA038474, 2020SA038473, 2020SA038466, 2020SA038472, 2020SA038471, 2020SA038470, 2020SA038469, 2020SA038468, 2020SA038351, 2020SA038348, 2020SA038344, 2020SA038302, 2020SA038347, 2020SA038349, 2020SA038350, 2020SA038352 and 2020SA038343.  This case involves a 15 months old male patient who 0.5 ml dose of IPV (VERO) [IPOL] (lot number PIF541M expiry date 07-Dec-2020) via unknown route in the right thigh for Prophylactic vaccination on 15-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. It was an actual medication error case due to Product storage error temperature too low.  It was reported that refrigerator containing Fluzone went down to 29.1F and the vaccine was given to the patient in spite of being compromised.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in 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.
Very bad headache and aching for 24 hours after shot. Intermittent headaches for 10 days following shot. Doctor visit on 6-7. Treatment includes taking regular doses of Tylenol to control headache and use Flonase and Allegra.
Chills, Headache, Tiredness, pain at injection site, lump and soreness at injection site.
Joint/muscle aches; Joint/muscle aches; Mild headache; Sneezing; Sniffling; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3248, expiration date was unknown), via an unspecified route of administration in the left arm on 27Jan2021 at 11:45 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the hospital. The patient had no medical history; she had no known allergies. Concomitant medication included escitalopram. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She was not tested for COVID post vaccination. On 28Jan2021 at 15:00, or around 30 hours post-vaccination, the patient experienced joint/muscle aches, mild headache, sneezing, and sniffling. The patient did not receive any treatment for the adverse events (AEs). The patient was not recovered from all the events.
bleeding coming from the injection site after the needle was removed his arm; This is a spontaneous report from a contactable other HCP (anesthesiologist) reported for himself. This male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose on the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated after receiving COVID vaccine on an unspecified date (reported as "today") he noticed bleeding coming from the injection site after the needle was removed his arm. Patient said he had the vaccine he took the needle out he bleed a little bit he said he was afraid he was injected wrong possible into a vein nothing was swollen nothing was bruised red. Patient stated he was unsure if the vaccine was administered intravenously or intramuscularly. Outcome of the event was unknown. The report was assessed as non-serious.  Information on the Lot/Batch number has been requested.
I had my vaccination on 01/03/2023. On 02/24/2023 I started to have congestion and cough. I tested COVID-19 Positive on 02/25/2023. I contacted my physician on 02/26/2023 and I was prescribed something for the nose congestion and cough.
This spontaneous report as received from a nurse via a field employee refers to a 17 year old patient. On 16-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose and route unspecified). The patient also received a dose of (Oka/Merck) VARIVAX on an unspecified date before the ZOSTAVAX was administered, and also on an unspecified date after the ZOSTAVAX was administered. No known adverse effects. Additional information has been requested.
allergic reaction to vaccination; flu like symptoms; swelling face; throat closing; miserable; elevated temperature; crying; feeling unwell; cold symptons; congested; couldn't breathe; couldn't swallow; refused food and water/really needy; refused food and water/really needy; Inappropriate age at vaccine administration; accidental underdose; This case was reported by a consumer via call center representative and described the occurrence of allergy to vaccine in a 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In May 2019, the patient received the 3rd dose of Boostrix. In May 2019, several hours after receiving Boostrix, the patient experienced allergy to vaccine, influenza-like symptoms, facial swelling, throat constriction, feeling miserable, body temperature increased, crying, feeling unwell, cold symptoms, nasal congestion, difficulty breathing, unable to swallow, fluid intake reduced, appetite absent, inappropriate age at vaccine administration and accidental underdose. The patient was treated with antihistamine. On an unknown date, the outcome of the allergy to vaccine, influenza-like symptoms, facial swelling, throat constriction, feeling miserable, body temperature increased, crying, feeling unwell, cold symptoms, nasal congestion, difficulty breathing and unable to swallow were recovered/resolved and the outcome of the fluid intake reduced, appetite absent, inappropriate age at vaccine administration and accidental underdose were unknown.   It was unknown if the reporter considered the allergy to vaccine, influenza-like symptoms, facial swelling, throat constriction, feeling miserable, body temperature increased, crying, feeling unwell, cold symptoms, nasal congestion, difficulty breathing, unable to swallow, fluid intake reduced and appetite absent to be related to Boostrix.  Additional details were provided as follows:  In May 2019, the patient had the Boostrix vaccine and reported that the patient experienced an allergic reaction to the vaccination. Within a couple of hours, after receiving the vaccine, the patient experienced flu like symptoms. And felt miserable and had an elevated temperature and wasn't feeling well and refusing food and water and was really needy.   Five hours later, her whole face started to swell and her throat started closing up. The patient was crying that the patient couldn't swallow.  The patient was describing her symptoms as cold symptoms with a temperature and the patient was congested which got worse with face swelling and the patient couldn't breathe. The patient was taken to the emergency room and stayed for a few hours until the reaction resolved. They gave her an antihistamine and monitored her condition for a few hours before released.  The mother of the patient claims that her daughter's pediatrician already reported the information. The Mother believed that the Boostrix vaccine was her 3rd DTap dose but she couldn't be certain, which led to inappropriate age at vaccine administration and underdose were unknown. The reporter consented to follow up.