chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingrix unapproved diluent administered; Shingrix unapproved diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   On 17-JUL-2023, the patient received Shingrix. On 17-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix unapproved diluent administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix unapproved diluent administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter consented to follow up via email.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter reported that an unapproved diluent was used to reconstitute Shingrix and it was administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient's mother, falsified form noting daughter's date of birth as 1/15/2009 and age as 12. Her correct date of birth is 11/15/2009 and her correct age is 11. We did not discover this until billing the vaccination, at which time the vaccination had already been administered. No adverse reaction has been reported at this time.
This spontaneous report as received from a licensed practical nurse refers to an adult patient of unknown age and gender. On 31-DEC-2014 the patient was vaccinated with two pediatric doses of RECOMBIVAX HB (each dose 0.5 ml, total dose: 1 ml, route: intramuscular) (lot# unknown) which was improperly stored (exposed to centigrade degree for 24 hours). No adverse effect was reported. Additional information has been requested.
rash over chest/rash from the neck down to above bra line/'very angry red'; 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 PF-06928316 (ABRYSVO), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 02Sep2023, outcome "recovering", described as "rash over chest/rash from the neck down to above bra line/'very angry red'".  Additional information: Patient is reporting adverse event from Abryovo; reports rash over chest. Asking for treatment recommendations. Patient confirms she had the vaccine on Friday 01Sep2023 given by a pharmacist and the next day (either in the morning when she woke up or during the day) she developed a rash from the neck down to above bra line. She didn't pay attention to it at first 'but it grew' and became 'very angry red' yesterday and today. It seems to have stopped today but it is not responding (unclear of how it is not responding). Concerned the vaccine gave her RSV if it is a live vaccine. States she doesn't get rashes. Confirmed she is over 60 years of age. Patient is asking if it is a live vaccine.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
BODY HURT; FEELING COLD; SHAKING/CHILLS; JOINT SORE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced body hurt. On 12-MAR-2021, the subject experienced feeling cold. On 12-MAR-2021, the subject experienced shaking/chills. On 12-MAR-2021, the subject experienced joint sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking/chills, and the outcome of body hurt, joint sore and feeling cold was not reported. This report was non-serious.
Patient received Moderna COVID vaccine on 1/16/21 (lot # 042L20A), 2/11/21 (lot # 024M20A), and Pfizer COVID vaccine on 9/3/21 (lot # FD8448). On 1/3/22 and 2/1/22, patient tested positive for COVID. On 2/1/22, patient admitted to our CCU intubated with acute respiratory failure with hypoxia, hemoptysis, and recently diagnosed  NSCLC of right lung with metastasis to bone, liver, and likely brain. As of today (2/4/22), patient is still intubated in CCU.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe
Inadvertently received 2nd dose too early - Day #20 rather than Day #28. No adverse effects reported.
got covid a week after her first dose of the vaccine; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318), intramuscular, administered in the left upper arm, near shoulder on 29Jan2021 at a single dose for COVID-19 immunization.  Medical history included ongoing anxiety. Concomitant medications included bupropion hydrochloride (BUPROPION HCL XL) taken for depression related to vicarious trauma; lorazepam (manufacturer unknown) taken for anxiety and insomnia related to secondary trauma and zolpidem (manufacturer unknown) taken for insomnia related to secondary trauma all from an unspecified start date and ongoing. On 02Feb2021 the patient's fiance tested positive for covid19. On 03Feb2021 she was tested and she just got the results back as negative. The patient stated that she might still have COVID so she did get retested on 08Feb2021 and is waiting for results. She is scheduled to get her second dose on 21Feb2021. The patient then reported that she got COVID a week after her first dose of the vaccine (as reported) on an unspecified date in 2021, and wanted to know what to do if she had to reschedule her second shot. She had called Pfizer because it was the only phone number on her paperwork, and learned that I needed to call the convention center where I got the shot with her question. Ultimately, she didn't have to reschedule and received her second dose of the vaccine as scheduled.  No follow-up attempts possible. No further information expected.
Sore arm, entire back pain and stiffness, Neck muscles sore and stiff, Fever, Chills, pain in shoulder joint, eyes pounding and extreme light sensitivity,  Most of the adverse reactions gone, except sore shoulder joints and stiff neck muscles
Patient needed proof of Varicella to go to LPN school. She thought she had Varicella disease as child but has no record so she needed to get vaccinated instead of titers as it was cheaper. She came in today with large red bullseye measuring 11 CM. Middle red with lighter red extending from middle red. Very swollen and hot but no fever. She tried Ibuprofen, BENADRYL (said made worse) and cold compresses.
pt recvd vax about 1PM mom says seemed to turn white immed p/shots; woke about 630PM screaming & mom picked up & seemed to grasping for air & then became limp & pale for a few seconds; seemed sleepy p/this but no fever or no other problems;
Pt vax 3rd dose; found to be non responder.  Outcome reported as unprotected.
COVID-19; coldness; sleep disorder; injection site pain; Myalgia; joint ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), FEELING COLD (coldness), SLEEP DISORDER (sleep disorder), VACCINATION SITE PAIN (injection site pain) and MYALGIA (Myalgia) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy NOS.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (COVID-19), FEELING COLD (coldness), SLEEP DISORDER (sleep disorder), VACCINATION SITE PAIN (injection site pain), MYALGIA (Myalgia) and ARTHRALGIA (joint ache). At the time of the report, COVID-19 (COVID-19), FEELING COLD (coldness), SLEEP DISORDER (sleep disorder), VACCINATION SITE PAIN (injection site pain), MYALGIA (Myalgia) and ARTHRALGIA (joint ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
pt recvd vax & 3-5 mins later exp anaphylaxis (chest & throat tightness, flushed, numbness arms bilateral); treated w/EPi & DPH;
Had fever of 106 the evening of the day shots were given 4/7/04. Afebrile on 4/8/04.
pt reported that within several hours after the vaccination was administered, she was rushed to the local hospital and diagnosed with vaccine-induced sepsis.
currently in hospital (ICU). Fainting, lightheadedness, extreme fatigue, petechiae, extremely low platelet count, possibly kidney damage, nose bleed, weakness,
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 21-JUL-2014 the patient was vaccinated with a dose of PNEUMPVAX23 (dose, route, lot number and expiration date were unknown). On 11-JUL-2014, the patient was vaccinated with a dose of PENUMOVAX23 (dose, route, lot number and expiration date were unknown). No adverse event was reported. Additional information has been requested.
rash to neck & shoulders, seen about 15mins p/vax; was referred to MD immed;
Injection site red; Injection site swollen/ injection side be huge; Injection site painful; Injection site hot/warm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site warmth to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient inquired, how long should the injection side be huge, red, swollen, painful and hot or warm. The patient asked how long the side effects remains. The patient stated that will contact the physician.
Swelling ~ 5x7cm at insertion site R deltoid) and extending to R elbow with bruising.  Tenderness extending from elbow through axillary area and down to R chest wall.  Headache, nausea, Chest Pain and heaviness started that night and resolved with valsalva maneuver, but returned 2 more times over the course of the next 2 days.  Now still feels heavy.  Am going to the doctor.
administered an ACTHIB last week and the diluent expired 30mar2023 with no reported adverse event; Initial information received on 12-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 months old male patient to whom an HIB (PRP/T) vaccine [ACT-HIB] was administered last week with expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) concomitant(s) and family history were not provided.   On 06-Apr-2023, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine with expired diluent, powder and solvent for solution for injection (Lot number Diluent: U7260AA; expiry date: 30-Mar-2023 and  lot number Powder: UJ652AA; expiry date- 04-Apr-2023) (strength: standard) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  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.
Pain under arm . Started as soreness per usual . Now  I have a lump in my arm pit . Very sore . Painful when I try to massage it . I had not heard of this effect so thought I would report it . I will contact my Doctor if it hasn?t subsided in 7 days .
Severely Swollen gland left side of face.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Er2613/eie2613) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included COPD (Chronic obstructive pulmonary disease). Concomitant medication were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. 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 vaccination. On 03Apr2021, the patient experienced severely swollen gland on the left side of the face. The adverse event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient received Cephalexin 500mg, thrice daily for 7 days as the treatment for the reported event. The clinical outcome of the event severely swollen gland on left side of the face was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I had chest pains. My platelets cell was 543 and white blood cells count was 26000. I went in to the ER after 4 days and was diagnosis as having a heart attack. Cholesterol 203 results. triglycerides was 85.
Johnson and Johnson COVID Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Patient admitted to hospital for myocardial infarction one week following the J & J COVID-19 Vaccination. required emergent PCI with drug-eluting stent for occluded left anterior descending coronary artery. Patient subsequently developed congestive heart failure and a left ventricular thrombus requiring long term anticoagulation therapy.
Bladder infection; This is a spontaneous report from a contactable consumer (patient).  This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ET6955 with Expiration Date Jul2021), via an unknown route, on 19Mar2021 (at the age of 59-year-old) as single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After vaccine, in Mar2021, the patient had bladder infection. The event was reported as non-serious. She was consuming water and Cranberry juice for bladder infection. She was also prescribed nitrofurantoin 100 mg. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
I have had the symptoms of nausea, chills, and headache. It seems to be getting worse each day, I feel weaker physically fatigued.; I have had the symptoms of nausea, chills, and headache. It seems to be getting worse each day, I feel weaker physically fatigued.; I have had the symptoms of nausea, chills, and headache. It seems to be getting worse each day, I feel weaker physically fatigued.; I have had the symptoms of nausea, chills, and headache. It seems to be getting worse each day, I feel weaker physically fatigued.; I have had the symptoms of nausea, chills, and headache. It seems to be getting worse each day, I feel weaker physically fatigued.; I have had the symptoms of nausea, chills, and headache. It seems to be getting worse each day, I feel weaker physically fatigued.; This is a spontaneous report from a contactable other healthcare professional. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1686), intramuscular on 06Jan2021 13:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (BUPROPION [BUPROPION HYDROCHLORIDE]). On 07Jan2021, the patient stated, "I have had the symptoms of nausea, chills, and headache. It seems to be getting worse each day, I feel weaker physically fatigued." The outcome of the events was not recovered.
HTN exacerbation, discomforts within 2-3 days that lasted over a month and required multiple office visits and medication increases to control HTN.
No issue right after the shot, Just sore at the injection site. About 8 days after, it started itching and formed a rash. It then became very hot and swollen. The swelling spread out from the injection site in a circle that increased to about 4 inches in diameter around the injection site. It lasted approx. 4 days and then started dissipating. Took about a 10 to disappear completely
Information has been received from a 66 year old female with high cholesterol and hypertension and a history of knee replacement who on 30-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included diclofenac sodium (+) misoprostol (Arthrotec), ezetimibe (MSD), "Demfri Brazil" and hydrochlorothiazide (+) valsartan (Diovan HCT).  On 30-JUL-2007 the patient developed a lump at the injection site that was very sore.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  On 4-AUG-2007 that patient had recovered.  A product quality complaint had not been involved.  No further information is expected.
administration of diluent portion only of Rotarix to a patient.; administration of diluent portion only of Rotarix to a patient.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 952C7, expiry date 9th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 24th May 2021, the patient received Rotarix lyophilized formulation (oral) and Rotarix Oral Applicator Device. On 24th May 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered 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 details were provided as follows:  The patient was administered only diluent portion only of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine. The reported batch number 95F2C7 was not found in sales data sheet, hence was updated to 952C7. The reporter consent to follow up.
Extreme lethargy, frequently impossible to wake, sudden drop in weight, more difficulty breastfeeding than in the hospital.
Three weeks after I got the shot I began to get the following symptoms: Headache (2/4- present) Achyness  (2/4-present) Fever (to 101.2) 2/5 Chills 2/5
arm swelling down to elbow, soreness for multiple days; arm  swelling down to elbow; arm  swelling down to elbow/It was unspecified as to which arm was swollen.; a fever; Information has been received from a 52 years old female patient via a field representative referring to herself. The patient's concomitant medication included methotrexate. The patient's pertinent medical history included autoimmune disorder. The patient's drug reactions or allergies were unknown.    On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis.      On an unknown date, the patient developed arm swelling down to elbow, soreness for multiple days and a fever after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It was unspecified as to which arm was swollen. The outcome of the events were recovered. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Rash developed over the next 3 days and continued to spread.  It was also itchy. Pt. dx with varicella disease.  Treated with steroids.
The second dose was given on March 28 2021..  Two weeks later a rash developed on the torso, this would not go away even with prescription steroids. Patient's health declined through april and May.  In June he went to his doctor but since he had taken steroids he was told to come back in two weeks and have labs done. He was so sick and ended up in the ER on July 5 2021. He was in kidney failure. A bone marrow biopsy resulted in a diagnosis of Waldenstrom macrglobulinemia which caused kidney failure. He was put on emergency dialysis and transferred from hospital to Cancer Center.
Significant swelling at injection site starting immediately after injection and lasting 3 weeks before clearing up.  Patient reported it was "baseball size" swelling with corresponding discomfort.  She also reported having a severe headache that began the day of vaccine and lasted approximately 24 hours and which kept her in bed.  She also reported feeling ill which did not resolve for approximately 1 week after vaccination.
Information has been received from a emergency medical technician concerning a 17 year old patient who was vaccinated with MMR II and had negative titers to measles.  This is one of several reports from the same source.  Additional information has been requested.
Left arm injection site area red, swollen, painful, chills; S - myalgias, dizziness, nausea; O - Site warm erythematous and indurated 3x4 cm similar appearing 1 cm area proximally; P - Keflex, Motrin - Follow up on 8/17 OD to Bactrim
Itchy fluid filled blisters all over my feet and some on hands. Going on 3 weeks now.
Rash, throat swelling, dizzy, itching, pressure in chest, slight difficulty breathing. Took 50 mg. Benadryl (Diphenhydramine HCl).
Approximately one hour after receiving vaccine, complained of heart beating fast and left chest pain.  Seen at Hospital Emergency Department.  HR 101; Bp 102/61; RR 16; Temp 98.3; O2 sat:  98%.  complained of headache in ED;  MD dx - palpitations.  HR 96 at discharge from ED.  No complaints at 2 pm.