chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00722319) and transmitted to Sanofi on 12-Aug-2021.  This case involves a two-month-old female patient who received an expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  On 11-Aug-2021, the patient received 0.5 mL dose of expired suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ359AAA and expiry date: 11-Jul-2021) via an intramuscular route in the left thigh for prophylactic vaccination (expired product administered).  On an unknown date, the patient received 0.5 mL dose of expired suspect HIB (PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  It was reported, "Caller states that 2 patients received expired doses of PENTACEL in the practice on 10AUG2021 and 11AUG2021 respectively. Caller asked about how to proceed after administering expired doses to these patients. Caller also revealed that the patient who was treated on 11AUG2021 received an expired ACTHIB vaccine as well."  It was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  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 by the regulatory authority. 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.
Patient began crying, non stop, less than an hour after vaccines were administered. 3 hours later, child was still crying hysterically. Child was re-examined by Dr. & sent to E.R. as a precaution. At 4:45pm we were notified crying ceased, hospital said all clear & no fever.
No adverse event -- 12 and up Pfizer Monovalent was given  instead of Bivalent COVID-19 Vaccine as booster
tinnitus; This spontaneous case was reported by a health care professional and describes the occurrence of TINNITUS (tinnitus) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient had not received any booster dose because of the event.  Treatment details were not reported by the reporter.   This case was linked to MOD-2021-009055 (Patient Link).
Muscle and joint pain, mild nausea, extreme fatigue, pain in arm where the injection was received, difficulty in moving the arm where the injection was received, redness and tenderness at injection site. The most severe symptom was the extreme fatigue, which lasted from late morning the date of the injection, through the Tuesday morning.
I started experiencing  sore throat, tiredness,  fever, and headache on 12/28/2022 in the morning. I took COVID-19 home test on 12/27/2022 which was negative. On 12/28/2022 I  took another COVID-19 test which was positive. I took COVID-19 12/31/2022, 01/01/2023- positive. On 01/05/2023 COVID-19 home test was faint. On 01/07/2023 and 01/08/2023 which was negative. I didn't call my doctor I just treated it as a cold. I took over the counter Vitamin C, Zinc and Tylenol as per needed.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 27-SEP-2012 the patient was vaccinated with dose 1, 0.5 milliliter (ml) VAQTA (lot#, expiration date and route not reported). On 26-MAR-2013 the patient was vaccinated with dose 2 (administered a day earlier than the 6 month mark), 0.5 VAQTA. No adverse effect reported. Nurse reported she would check with her manager on which information it was okay for her to provide and would call back with follow-up information. Additional information has been requested.
Patient received Gardasil vaccine IM in right arm and Tdap in left arm. She complained of burning and pain in that arm and then stated she felt achy. Patient was lowered into supine position where she started to seizure. Patient was given cold compress to injection site and Benadryl when she came to. Benadryl given at 2:20 pm. BP and Pulse taken and within normal limits. Lungs and heart assessed by nurse practitioner and reported normal.
pt recv vax 28JAN97 & mom noted AM 29JAN97 redden, now elevated rash to both arm wrist to shoulders & both legs ankles to hips;no fever or hive noted;
Information has been received from a registered nurse concerning a 25 year old female with a history of drug abuse who on 07-AUG-2006 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #653937/0637F). On 11-OCT-2006 the patient was vaccinated with a second dose of Gardasil. On 16-APR-2007 the patient was vaccinated with a third dose of Gardasil. Concomitant therapy included prenatal vitamins (unspecified). Subsequently the patient became pregnant. The patient's last menstrual period was on 11-JUN-2007 and the estimated date of delivery was 17-MAR-2008. On unspecified dates a urine drug screen, ultrasound, pap test, and a prenatal screen was performed. The patient contacted the physician by telephone. On 09-JUL-2007 the patient was hospitalized for substance abuse. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Extremely elevated heart rate (still elevated days after injection), vertigo, shortness of breath, headache, a sense of heaviness throughout the body, extreme fatigue (still days after injection), body aches and fever.
The patient developed a rash on both arms, both legs, and around his neck. He took a BENADRYL tablet and the rash disappeared within a few hours.
A report has been received from a Pharmacist concerning a 38 year old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The reporter stated that the patient had administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Generalized macular, erythematous rash.  More prominent on lower extremities.  Began one day after vaccine administration.  Mother first noticed single lesions at injection site.  Given Benadryl liquid 12.5 1/4 teaspoon every 4-6 hours.
This spontaneous report was received from a registered nurse refers to a 2 month old male patient. On 20-AUG-2012, the patient was vaccinated with first dose of ROTATEQ, (lot number, expiration date not provided, route oral) and he spit up the dose. No concomitant medications were reported. On 19-OCT-2012, the patient received his second dose of ROTATEQ, (lot number, expiration date not provided and route oral) and spit it up. The third dose of ROTATEQ, (lot number, expiration date not provided and route oral) was given normally on 20-DEC-2012. The patient sought medical attention (office). additional information has been requested.
Patient called us 2/16/17, and issues started 12/20/16. Bled more than normal immediately after receiving per patient. Patient did ice on and off after as told to do so by RPH. Had a bruise there for about 2 weeks or more. Still had bruising and swelling when went to urgent care on 1/10/17. As of 2/16/17 no bruising but still some swelling per patient. Constant, dull, throbbing pain radiating from shot site to elbow. Every now and then will have sharp pains. Dr refuses to treat her because he did not administer the vaccine but she plans to go back to the urgent care for additional treatment, she states she just wants pain relief. Advised patient that all we can recommend is to ice on and off for 20 minutes. But advised her to go back to her doctor for treatment.
This is a spontaneous report from a contactable consumer via a Company sales representative. A 17 years old male student received TRUMENBA on 30Aug2015 between 14:00 and 16:00, intramuscular in deltoid, at 0.5 ml single. No other vaccines were given. Medical history and concomitant medications were not provided. Adverse event following prior vaccination: none. Within 30 minutes of vaccine administration, the patient experienced bradycardia and low blood pressure. The patient was looked over by a physician there and was later taken to the emergency room (but it was unknown if he was admitted to the hospital). Events outcome was unknown.
Initial unsolicited report was received from a consumer, who is also the patient. This case is related to case ID 2014SA099610 (same patient). A 62 year-old female patient with a history of MS, hair loss and tired had received on an unspecified date an Influenza vaccine (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later, developed "the flu twice this season with chapped lips". The patient also experienced 2 episodes of nails shredding down to the quick, dry mouth, plugged nose and tearful. Concomitant medication included AUBAGIO. The patient has arm surgery scheduled for March 2015. No further information was received at the time of the report. Outcome was unknown. Documents held by sender: none.
Dose Number: 1/Date of start of drug: 03Jul2021/Dose Number: 2/Date of start of drug: 24Apr2021; Increase in the heart rate; The first symptoms were a rash on the torso, which formed into blisters; The first symptoms were a rash on the torso, which formed into blisters; Felt the same pain in the lymph nodes in the right arm as I did when receiving the vaccine; Tingling pain in arm; Tingling pain; Swollen lymph nodes; First traces of shingles became evident; This is a spontaneous report from a contactable consumer. A 21-years-old male patient received second dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 03Jul2021 08:00 (Batch/Lot Number: EW0150) (at the age of 21-years-old) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications was reported as none. If covid prior vaccination and covid tested post vaccination was reported as no. Known allergies as N/A. If other vaccine in four weeks as No. The patient historical vaccine included received first dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on 24Apr2021 10:00 (Batch/Lot Number: EW0175) as SINGLE for covid-19 immunization. He never had chickenpox, and he vaccinated against the varicella virus. On 08Jul2021 at 08:30, the first event recorded was an increase in the heart rate, which led to me visiting local urgent care for treatment. The first symptoms were a rash on the torso, which formed into blisters. Felt the same pain in the lymph nodes in the right arm as he did when receiving the vaccine. Currently experiencing sharp tingling pain and swollen lymph nodes. Upon that a week later in Jul2021, the first traces of shingles became evident. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was treated with Valtrex for all events. The outcome of all events was recovering.  Follow-up attempts have been completed and no further information is expected.
6hr p/vax pt c/o nausea, vomiting, weakness, myalgia, T100-101;sx lasted approx 40hr;used APAP alternating w/Ibuprofen or naproxen;
This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to an unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On 30-DEC-2016, the patients were vaccinated with an improperly stored VAQTA, with lot # M033611, expiration date 02-MAR-2018 (route of administration, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine  was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007903: US-009507513-1701USA007904: US-009507513-1701USA000848.
Shaky, confused, SOB, fall, BP elevated, O2 sats decreased, weakness, nausea, elevated pulse
-rash over entire body, mostly on trunk and inner thighs (solid), less on extremities -light itching -lasted for 4 days
Patient's wife called store where injection given on morning of 10/26 -> said patient had short term memory loss (confusion) that seemed to be slowly improving.
patient tested COVID-19 PCR positive on 3/23/21 after high risk exposure  at work
Initial misuse report received from a healthcare professional on 04 April 2013. A child was administered an expired dose of ADACEL. No more information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Patient up to date on COVID vaccinations who had incidental positive COVID test during routine facility placement testing.  Asymptomatic throughout stay. Provider d/c note from hospital below:  "70 yo F, Hx of L femoral fracture with ORIF on 5/2/2022 (10 screws placed) who was just discharged day before admission who arrived with signs of erythema and green discharge from her wound noted by wound care at home. She was sent to the Hospital for further evaluation. In the ED, she was tachycardic, BP was stable, Imaging showed medially displaced distal femoral fracture with loss of fixation and signs of tissue swelling. Physical exam demonstrated erythema of the skin around the knee. She was started on Vancomycin, Rocephin, and IV fluids. Orthopedic surgery was consulted and evaluated her, and determined need for an attempt for a repeat ORIF with potential for leg amputation of ORIF unable to be performed. She was covered with Zosyn instead of Rocephin for concern for deeper structure infection. The doctor performed ORIF successfully with minimal complications. Surgical and blood cultures were obtained and showed no growth for at least 2 days. Her cellulitis improved with antibiotics, and she was determined to not need Zosyn. She exhibited minimal pain post-surgical. PT/OT recommended rehabilitation and PM&R was consulted who deemed her appropriate for in-patient rehab. On day of discharge, she had one bowel movement without need for lactulose, a COVID test was performed and came back positive. She is fully vaccinated with 2 booster doses obtained before admission. She is asymptomatic. She will need severe respiratory isolation for 10 days. Per Doctor, she will need BID aspirin for 30 days for DVT prophylaxis. She is toe-touch weight bearing on the LLE with dressing changes when the dressing is saturated. She will be discharged to Rehabilitation in stable medical condition. CBC in 2 days to make sure her Hgb remains stable". D/C note from rehab facility below: "70 yo F PMH HTN, obesity, HLD, who presented to the Medical Center 5/2/22 for a periprosthetic supracondylar L femur fracture. She is s/p ORIF and rehabilitation. She was instructed to be NWB on the LLE but states she did intermittently bear weight. She had a loss of balance at home that resulted in her shifting a significant amount of weight to the LLE. Orthopedics was consulted and noted a complete loss of distal fixation on her imaging. She was found to have a medially displaced distal femoral fracture extending to the femoral component of the TKR, S/P repair with plates and screws with the doctor 5/23. Her course was complicated by post operative cellulitis. She was started on Vancomycin and Zosyn.   She has a history of SVT and PVCs and is continued on metoprolol.    Course at rehab was complicated by asymptomatic course of COVID 19. "
muscle is still a little tender in that spot; It is black and blue; developed a large bruise on left arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number :EN6200 and Expiration date:30Jun2021), via an unspecified route of administration, administered in left arm on 24Feb2021 13:30 (at the age of  vaccination 76-year-old) as dose 1, single for covid-19 immunization. The second dose was scheduled for 24Mar2021. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol, aspirin , rosuvastatin taken for anticoagulant therapy , famotidine taken for gastrooesophageal reflux disease Aug2020 to an unspecified stop date, ticagrelor taken for anticoagulant therapy, start and stop date were not reported. The patient did not take additional vaccine on same date or within 4 weeks. On 26Feb2021, the patient reported that within 2 days of first dose she developed a large bruise on left arm and tenderness, was concerned about it because it was still there. It is two inches down from where the injection went in and also looks like somebody punched her in the arm. The patient does not know if bruise is because of the Brilinta. She knows she did not bruise herself by bumping her arm. On an unspecified date, the  patient had the muscle was still a little tender in that spot. It was black and blue. The mark was still there when she rubs her arm. Bruise was still visually there. Bruise had improved. It was fading, but still there and visible. The outcome of event Bruise and Skin discolouration were recovering, while the outcome of the event Muscle pain was unknown.  No follow-up attempts are possible. No further information is expected.
-LIMPING FOR 4 DAYS. -NOT ABLE TO SUPPORT BODY WEIGHT DAYS 2-4 -Limping not evident on day of consult - Dr.
2 cm hives on torso, front of chest and back. Father is a physician-described hives as macular papular. Father gave BENADRYL 25 mg. Capsule at 4 pm, at 10 pm 12 1/2 mg chewable and RANITIDINE to cover antihistamine receptors. Today hives gone-fever, 100
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 17-SEP-2015 a 13 year old patient was vaccinated with (Merck) PROQUAD (strength, dose, frequency were not reported) (inappropriate schedule of drug administration). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Headache, CHILLS, BILATERAL NECKS GLAND SWELLING, LETHARGY Narrative:
This spontaneous report was received from a doctor of pharmacy concerning unknown number of patients (age and gender unspecified). On an unknown date in 2012 (reported as from August of 2012 through September of 2012) (exact dates unspecified), the patients were vaccinated with a dose of an improperly stored PNEUMOVAX 23 (lot number, expiry date, dose and route unspecified) at a clinic associated with a hospital. No adverse event was reported. This is one of the three reports from the same source. Additional information has been requested.
Malaise/not feeling great; Shivers; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th September 2019, less than a day after receiving Shingrix, the patient experienced shivers. On 25th September 2019, the patient experienced malaise. On an unknown date, the outcome of the shivers was recovered/resolved and the outcome of the malaise was not recovered/not resolved.   It was unknown if the reporter considered the shivers and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after receiving 1st Shingrix dose in his left arm at his physician's office and experienced shivers that lasted all night long. The following day the patient was not feeling great (malaise). The patient reported that he was starting to come out of it, however it was still slightly lingering around. The reporter consented to follow up.
Running, Burning Nose, Sneezing and a tight chest. (Like a mild asthma) Took an Antihistamine.
deep, aching pain in muscle of inj p/inj & slowly & steadily resolving; currently no tenderness, muscle wasting or loss of strength
Migraine, sensitivity to light, fever, chills, body aches a lot of pain at shoulder . Brutal experience , felt so bad considered hospital
Case number PHEH2012US011964 is an initial spontaneous report received from a health care professional on 11 Jun 2012 and a follow up received from the healthcare professional on 06 Aug 2012. This report refers to a 12-year-old female patient. Her medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that on 06 Jun 2012 she was vaccinated only with 0.5 mL intramuscular dose of MenCWY liquid conjugate component of MENVEO (batch number: X10123) without being reconstituted with Men A lyophilized conjugate into her left deltoid. No adverse event was reported following the maladministration. On 12 Jul 2012, she was vaccinated with full dose of MENVEO (batch number: A10123) which was MenA lyophilized component mixed with MenCYW-135 liquid conjugate component of MENVEO into her right deltoid muscle. She was doing great; no adverse event was reported after vaccination. Follow up information received from the healthcare professional on 06 Aug 2012: Updated patient demographics and the patient was vaccinated with full dose of MENVEO on 12 Jul 2012.
the syringe broke and cut her; the syringe broke and cut her; This spontaneous report was received from a patient (nurse) via human resource registered nurse (Rn) regarding a 44-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reactions were not provided. On 05-SEP-2019, while the patient was receiving vaccination of pneumococcal vaccine, polyvalent (23 valent) (PNEUMOVAX23) a dose (1 dosage form) (lot# R033080, expiry date: 06-JUN-2020) (strength, dose number anatomical location and route of administration were not provided) for prophylaxis, "the syringe broke and cut her (injury, syringe issue)". The syringe broken into two pieces and the location was on finger flange of the syringe. The patient sought medical attention and washed her hand and placed a band-aid. The syringe tip cap was attached properly prior to use and the syringe tray was intact and undamaged on receipt. The cellophane cover of the syringe tray was intact and completely sealed. The syringe carton was not damaged prior to use. The outcome of the events was unknown. The reporter's causality assessment was not reported.