chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered the Adacel to a patient on Saturday, but after they left, noticed that the vaccine was expired with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age /gender patient who was administered the Diphtheria-2/tetanus/5 ac pertussis vaccine [ADACEL] on saturday, but after they left, noticed that the vaccine was expired with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 04-Mar-2023, the patient received suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 milligram (mg) total (lot U6968AA and expiry date-07-Feb-2023) via intramuscular route in the left deltoid for immunisation but after they left, noticed that the vaccine was expired with no reported adverse event (expired product administered) (latency-same day).  Action taken was not applicable.  it was reported that Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age.  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 guidelines. 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 case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns an 83-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular, Batch number: 13049221A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
Administration of expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received HBV (Engerix B) (batch number d423n, expiry date 1st June 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 15th June 2022, unknown after receiving Engerix B and Engerix B 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: 16-JUN-2022 Reporter's Comments: The office manager reported that male patient received a dose of Engerix B on 15th June 2022 and the dose had expired on 1st June 2022.  The reporter was consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Around 11 hours after injection - muscle aches/pain that lasted for multiple days with chills/cold sweats.
Lost voice; Lose of appetite; Feet and legs very swollen; Muscle aches; Headache behind right eye; Fever for one day(temp unknown); Not sleeping at night; Tight vocal cords; Feel lousy; This is a spontaneous report received from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6199 Dose number: unknown) as a single dose via unspecified route of administration in the left arm on 05Mar2021 at 16:30 PM for COVID-19 immunisation. The patient's medical history included high blood pressure and high cholesterol. Concomitant medications included venlafaxine, lisinopril and atorvastatin all for unknown indications from unknown dates. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient had no symptoms associated with COVID-19 and not had a COVID-19 test. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Mar2021, the patient had headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night. Therapeutic treatments included ProAir Inhaler and advised to drink lots of fluids. Events lead to doctor or other healthcare professional office/clinic visit. Clinical outcome of  the events headache behind right eye, lost voice, tight vocal cords, feet and legs very swollen, felt lousy, fever for one day (temp unknown), lost appetite, muscle aches, could not sleep at night were reported as recovering/resolving. No follow-up attempts are possible. No further information is expected.
Pt is post lung transplant in 2003. She had 2 episodes of syncope and therefore came to the ED. She was found to be in A. fib with RVR. She was also found to be COVID positive.
I exp headache, fever, body aches, chills, sweating and racing heart rate(tachycardia). I went to ER for heart rate shot up to 155 beats per min while sitting in a chair was prescribed Migraine and Benadryl. I do exp heart rate regulation which is usually under control unless I'm hot.
pt recv vax in SEP94 & exp burning on inj; 27SEP94 pt devel swelling in rt deltoid; presented to MD was treated w/warm compression & APAP as needed;
didn't receive the entire dose; felt the medication on her skin/medication leaked out around the needle during injection; felt the medication on her skin/medication leaked out around the needle during injection; A spontaneous report was received from a healthcare facility staff member concerning a 39 years old, female patient who didn't receive the entire dose of vaccine, felt the medication on patient's skin and medication leaked out around the needle during injection while administration of Moderna's COVID-19 vaccine. The patient's medical history included Augmentin as a child. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: not provided) on an unknown date. On 17-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Batch number004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The reporter reported that, patient didn't receive the entire dose, felt the medication on her skin and medication leaked out around the needle during injection while administration of vaccine. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events: therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: This report refers to a case of accidental underdose and syringe connection issue for mRNA-1273 (Batch number004M20A) associated with the event of exposure via skin.
Fever getting worse; Headache still worse; Feels pressure in neck, head and eyes; Feels pressure in neck, head and eyes; Feels pressure in neck, head and eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 09Aug2021 (Lot number: FA7484) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Aug2021, outcome "not recovered", described as "Fever getting worse"; HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "Headache still worse"; MUSCULOSKELETAL DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious), OCULAR DISCOMFORT (non-serious) all with onset Aug2021, outcome "unknown" and all described as "Feels pressure in neck, head and eyes". No follow-up attempts are possible. No further information is expected.
Patient developed urinary retention and weakness and numbness in lower extremities  25 April 2021  (12 days after vaccine)
I noticed a small red circle on my arm on the 22nd. It continued to get bigger each day until it was about the size of a softball on the 24th. It was warm to the touch and slightly itchy. Over the next few days the size didn?t change but it started to get less red until it finally went away on the 26th.
Oxygen dropped into the mid to upper 80's, fever, rash and hives at injection site, extremely heavy menstrual cycles beginning a little over a month after the first dose of the vaccine. Menstrual cycles are the worst they have ever been since getting the vaccine and the extreme bleeding has not resolved over a year later.
4/28/2022-Sent by ortho  was going to have surgical treatment of chin on chest deformity referabl to subluxation spondylolisthesis at C7-T1 with cord compression.  Temp-101, HR 128 and RR-28 spo2 around 88 on 3L NC. Baseline oxygen use HS. Covid + test. CRP-15.6 and WBC-13.7 CTA no PE but b/l infiltrate concerning for pneumonia. New onset paroxysmal a fib with chronic St-T wave changes, rate is controlled, continue home dose of COreg. Admit sepsis and acute hypoxic resp failure d/t b/l pneumonia. Administered  decadron, remdesivir, Lovenox, ceftriaxone and doxy. 5/2/2022- Cont. IP stay, remains on 3L nc spo2 above 90%. 5/3/2022-Vitals WNL. CRP-1.7 and WBC-12.4    maintaining spo2 on 3L . D/C to home, will follow up with ortho to have surgery
Adverse effect of other vaccines and biological substances, initial encounter on 2022-11-01.
About 2 weeks after the second injection, I developed chest tightness and easy shortness of breath (1 flight of stairs). I swim over a mile, three times a week and have not experience those symptoms. The symptoms lasted about 3 months and then went away.
5:45 pm complaint feeling dizzy. Patient became pale skin dry and warm. Patient remains alert and responsive. Vital signs pulse 66, B/P 116/70; 98 F Resp. 16. Patient head placed down between legs for 30 mins.
I had my vaccination on 02/20/2021. On 02/21/2021 I started to have a very high fever of 103+. I felt like I had the flu with muscle and joint pain. This lasted for 4 to 7 days. On 02/22/2021 I did take Advil to help with the fever.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 16-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Had HBV vax on 12/30/19 about 3 pm. Says that night, throat and tongue swelled up. +SOB at first, now able to breathe. Now afebrile.  Hasn't taken any meds. Denies any new foods, changes in environment, or encounters with new animals/plants.   Assessment and Plan T78.3XXA Angioedema, initial encounter  (primary encounter diagnosis) Plan : ? PREDNISONE 20 MG TABLET - Take 2 Tabs by            mouth once daily for 5 days           ? DIPHENHYDRAMINE 25 MG TABLET - Take 1 Tab by            mouth every 6 (six) hours as needed for            allergies Likely etiology of throat/tongue/uvula/tonsillar swelling. Medication administration and possible side effects reviewed ED/return cautions reviewed.  Patient expressed understanding.
6 cm x 2.5 cm bump. erythema, elevated, pain, swelling, ecchymosis. later 4.5 cm x 3.5 cm distally less pain. Narrative:  Patient seen in person by occupational health NP. Initial myalgia, sore L arm at injection site. Later developed 6 cm x 2.5 cm bump redness, elevated, pain, swelling, ecchymosis, then later 4.5 cm x 3.5 cm distally less pain. Instructed to take ibuprofen and zyrtec. Will continue to monitor.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Patient tested positive for COVID at nursing facility and was brought to the ED with shortness of breath for the past week. Patient diagnosed with COVID19 pneumonia and currently undergoing inpatient hospital treatment.
Swollen eyes and lips. Welts all over torso, arms, and legs. ER visit was required.
A physician reported via a company representative that a 6 month old female, with a history of a mild protein allergy, received her third dose of Prevnar on 01/02/2002. That same day, the infant developed a fever, constipation, and vomiting. A blood culture collected that day was positive for Streptococcus pneumoniae. On 01/05/2002, a urinalysisi and urine culture were negative. The infant was treated with Rocephin and Ceftin. A repeat blood culture on 01/07/2002 showed no growth. Streptococcal septicemia is considered medically important. FOLLOW-UP information received from the physician on 03/26/02 identified the serotype as group 9. The physician also reported that the infant was seen by a physician and has recovered. Additional follow-up information was received on 04/02/02 via telephone call. The physician on 01/02/02 visit,a blood culture was collected and the preliminary results showed no growth in 12-24 hours. Final results were positive for Streptococcus pneumoniae. Thus, the child was a 4 month old when she received her second dose of Prevnar on 11/05/01. On 01/02/02, at 6 month of age, she was diagnosed with streptococcal bactermia.
Two hours after vaccine, temp increased 106 deg. 10/14-10/17/08 vomiting, rash 10/16/08 developed ataxia -> admitted to hosp. CSF within normal limits.  12/18/08-records received for DOS 10/17/08-C/O fever since vaccinations. Tonsillar exudates noted. Assessment:tonsillopharyngitis.  Tonsillar exudates noted. Assessment:tonsillopharyngitis. krk 2/17/09-records received for DOS 10/21-10/23/08-DC DX Acute gastroenteritis. Presented with ataxia, fever over last few days and vomiting. Developed fever day of immunization at which time pharyngitis was diagnosed. Developed rash while on antibiotic azthromycin. Ataxia began on 10/21/08-in ED left acute otits media. poor oral intake. Diarrhea began on 10/22/08. No ataxia or fever while hospitalized.
Information has been received from a pharmacist referring to a child of unknown age and gender. No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with an unspecified dose of (Oka/Merck) VARIVAX (lot #, expiry date, dose and route unknown). There was no concomitant medication reported. On an unknown date, after receiving the dose of (Oka/Merck) VARIVAX, the patient developed a "rash" on an unspecified location. The outcome of rash was unknown. It was also reported the patient's mother (currently pregnant with gestation unspecified) then contracted the rash. Additional information has been requested.
The female patient was feeling uneasy , after 5 minutes of second dose of Pfizer vaccine ,was conscious and talking to her mother ,she was complaining about being cold,when paramedics arrived ,paramedics took her vitals and saturation all looks good,but she was complaining about being cold
pt recv vax; unconsolably crying for 6 hr; mom was told to give apap & dph & to give pt a tub bath;
Patient said itching to arms started within 5-10 minutes.  Reported to me at 1:05. Benadryl 50mg IM given at 1:10. Parent came to take child to Doctor at 1:45PM.
This spontaneous report as received from a pharmacist refers to a 62 years old female patient. The patient was vaccinated with a 0.65ml dose of ZOSTAVAX (lot # was reported as H013018, expiration date was on 09-OCT-2013) subcutaneously in her ponosterior right deltoid on 29-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The following day, on 30-OCT-2012 the patient noticed a hardened area in the injection site location. Today, on 31-OCT-2012, the patient had a rash developing at the injection site. The pharmacist did not know if the patient had been treated for the adverse event, nor did he know if the patient had reported this adverse event to her physician. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention via consulting pharmacist. Additional information is not expected.
Initial report received on 02 July 2009 from a nurse. A 63-year-old female patient, who has a current medical history of lupus, had received an intramuscular right deltoid injection of MENOMUNE A/C/Y/W-135 (lot number UF501AA) ON 18 June 2009. Prior to vaccination, the patient had laboratory data that revealed a positive ANA test (date not reported). The patient had not received any other vaccinations within four weeks of 18 June 2009. Six days post-vaccination on 24 June 2009, the patient reported she required medical evaluation for symptoms of profound fatigue which caused symptoms of nausea, memory loss, mild headache and shortness of breath. As a result, the patient has experienced "loss of work." Treatments received were not reported. Subsequently, a chest X-ray was completed that was negative. A CBC (complete blood count) and chemistry panel were completed; however the results of these tests were not reported. At the time of this report, the patient had not recovered. Documents held by sender: None.
Site: Pain at Injection Site-Medium, Systemic: numbness and tingling of arm-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium
Rather severe, persistent joint pain in fingers of both hands starting evening of injection, lasting through most of second day.  Pain subsided, but joint stiffness two days after injection.   Difficulty sleeping first night after injection.
warm touch; Sore knot; Red knot; Fatigue; Tender; A spontaneous report  was received from a consumer, concerning a female patient born on 1 Jun 1960 (60years) who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced sore knot, red knot, fatigue, warm touch and tender  The patient's medical history was not provided. Concomitant was not provided. On 15 Jan 2021, prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number 012L20A) intramuscularly on left arm for prophylaxis of COVID-19 infection and later at bed around 23:00 experienced more sore Red, tender and warm touch knot above the arm pit.  Treatment reported was Tylenol and symptoms are ongoing.  Consent for follow-up given.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events  sore knot, red knot, fatigue, warm touch and tender is not resolved.
Patient said a week after the shot (flu), he felt throbbing pain when lifting arm up to today.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No information about patients' medical history, concomitant medication and concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, from lot # M041184 with expiry: 31-MAY-2018, prophylaxis. The vaccine lot was exposed to temperature of 0° C to 1° C for 30 hours and  -1° C or colder (-2°C) for 225 minutes (15 Cycles). The temperature excursion was detected by digital data logger. It had no previous temperature excursion. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1707USA007928:
Approximately 5 minutes after receiving the vaccine, the client called out for help. He reported feeling like he was going to faint. He then did lose consciousness while seated in the chair. He remained upright with minimal assistance and regained consciousness after approximately 30 seconds. No injury to the client. He remained in clinic for another 10 minutes, drank juice and water, and left clinic independently.
After Janssen booster was given patient stated he felt dizzy, on his own patient laid himself on the floor. Pt stated this happens to him after getting vaccines. Vitals at 12:23 were heart rate of 77, 96% on room air, 100/70 blood pressure. Pt given ice pack and bottle of water. Pt remained on floor for approximately five minutes at which time he moved into a chair with arm rest. Vitals at 12:48 were heart rate 84, 99% on room air, 100/72. Vitals at 13:10 were heart rate 80, 95%, 112/76.
LIGHT BUT DISTINCT, METALLIC-LIKE TASTE IN MY MOUTH, PERSISTENT AND LARGELY UNVARYING FOR WEEKS.; This spontaneous report received from a patient concerned a 72 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included mild glaucoma. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included vitamins nos.  On APR-2021, the subject experienced light but distinct, metallic-like taste in my mouth, persistent and largely unvarying for weeks. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 120/60 mmHg, Oxygen saturation (NR: not provided) 99 %, and Pulse rate (NR: not provided) Under 60. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from light but distinct, metallic-like taste in my mouth, persistent and largely unvarying for weeks. This report was non-serious.
Left upper arm swollen 4 inches around at injection site, then progressed with swelling from left elbow up to left shoulder. Injection site was hard ant. hot to the touch no fever