chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 month old patientan expired dose of Acthib with no ae; Initial information regarding an unsolicited valid non-serious was received from a Physician (Reference number- 00533747) and transmitted to Sanofi on 23-Mar-2021s.  This case involves a 15 months old male patient who received 0.5 mL expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ143AA and expiration date: 22-Mar-2021) via intramuscular route in the right deltoid (expired product administered) on 23-Mar-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was actual medication error due to expired vaccine used (on same day).  It was reported that after administration they noticed that it expired yesterday.  At the time of report, the patients experienced no adverse 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 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.
Pain arm and muscles; Pain arm and muscles; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 13Apr2021 at 13:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On an unknown date in Apr2021, the patient experienced pain in arm and muscles. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain arm and muscles were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist, referring to her son, a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history. On an unknown date, the patient was vaccinated with a dose of PROQUAD that had been stored in the refrigerator for an unspecified amount of time (reported as "at least a week"), for prophylaxis via intramuscular route (dosage, lot number and expiration date were not reported). There was no adverse effect reported.
Patient developed neck and chest discomfort, low grade fever 48 hours after second dose of vaccine, came to the Emergency Department 2 days after symptom onset, admitted with low grade fever and very mild troponin elevation and elevated acute phase reactants
After about 1 1/2 hrs. he started having blurred vision, felt dizzy, unbalanced and felt like he was drugged up and blood pressure became elevated. Couldn't sleep that night and started having chills, pain in the arm that went up to his head along with a horrible headache affecting his eyes. Last night he couldn't sleep with the same symptoms. Having chills, pain in the arm that goes to his head along with a headache. Was given meds for blood pressure that was elevated.
Infant had fever to 103.9, rhythmic movements, period of apnea < 1 minute, required 4 breaths of CPR, 20 compressions. Pt brought to ED. 12/8/06 Received medical records from hospital which reveal patient had experienced bronchitis s/s of fever, cough & congestion for approx 4 days prior to admit on 11/14/06.  Was on antibiotics for same.  Temp in ER was 103.4.  Parents reported seizure like activity for approx 5 min with apnea & cyanosis.  During hospitalization, continued to improve on antibiotics & was d/c to home on 11/16/06 to continue oral antibiotics. Final DX: LLL Pneumonia; febrile seizure; & bronchitis, resolved.
Developed shingles at age 4 following administration of Varivax at age 12-18 months as recommended.
Vaccines received by child 5/8/07. Onset swelling right upper arm yesterday, no fever and 5/13/07 arm also itches and "feels hard". 6/1/07 seen in clinic by MD with findings as large, warm, red, indurated and clearly demarcated area of swelling approximately 6" x 3" over lateral upper arm. MD instruction to parents: Ice pack to the area at 10 min. at a time 3-4 x/day Ibuprofen 200 mg=2 tsp every 6-8 hrs for pain. Benadryl 2 tsp. every 6 hrs. as needed for the itching.
It was a 5.6 inch red ring around my injection site. I exp itching went to doctor prescribed Prednisone.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning 10 to 15 patients of an unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included properly store sterile diluent (manufacturer unknown). On an unspecified day in August 2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot numbers N013695 and N000326; with expiration dates on 21-MAR-2019 and 14-OCT-2019, respectively. The storage temperature was 47 to 77 degrees Fahrenheit (°F) for a time frame of 30 minutes. There was also a previous temperature excursion of 47 to 77 degrees Fahrenheit (°F) for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1708USA012976: US-009507513-1708USA012974: US-009507513-1708USA012975: US-009507513-1708USA012972: US-009507513-1708USA011949:
9/4/2021-Symptoms include fatigue, post nasal drip, non-productive cough and sore throat. Denies fever, chills, anosmia, dysgeusia and headache.    Sick contacts: works in school system, frequent sick contacts    SARS-CoV-2 immunity status: fully vaccinated    Patient reports history of: seasonal or environmental allergies    Patient has taken cough suppressants and antihistamines with partial effect   Sig: Take 400 mg by mouth every 6 (six) hours as needed for Pain
A non-serious spontaneous report of tachycardic, diaphoretic, dizziness, fever, body aches, malaise, headache, vomiting, cough, and sore throat has been received from a physician concerning a 47-year-old male patient, subsequent to receiving FLUMIST. The patient's medical history and concomitant medications were not reported. On 18-OCT-2009, the patient received FLUMIST. On18-OCT-2009, the patient experienced dizziness, fever, body ache, malaise, headache, vomiting, cough, and sore throat. He went to the emergency room and was also found to be tachycardic with a heart rate of 120 beats per minute, diaphoretic, and intermittently febrile with a temperature of 100.9 F. The outcomes for the reported adverse events were not reported.
One day after vaccine administered child had 4 inch red raised wheal at injection site. Two days after vaccine child's leg was swollen from groin to below knee and extending all the way around the leg. Leg was purple in color. Went to ER. Was admitted overnight for IV antibiotics. d/ced on antihistamine. 06/12/2006-3 page short stay record received from Biloxi Regional Medical Center-at time of admit c/o swollen red tender Left thigh. 5/18/06 site red and 5/20/06 site very red swollen hard and tender with c/o pain. Temps 100.2-100.3. Walks with difficulty. At time of admission afebrile. Left thigh edema and erythema and warmth documented . WBC 11.3. ER admitted concerned regarding cellulitis. Non toxic as CBC normal and afebrile. Rapid improvement. DC to home with RX Hydroxyzine every 6 hours
I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; I am 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headach; Throughout the day I experienced severe chest pain; At first I thought it may have been heartburn; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 15-years-old male patient received second dose of bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 13Jun2021 at 15:00 (at the age of 15-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Facility type of vaccine was pharmacy or Drug Store. No, other vaccine in four weeks. None of other medications in two weeks. No, covid prior vaccination, no, covid tested post vaccination. No, known allergies. No, other medical history. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 23May2021 for COVID-19 immunisation. It was reported that on 14Jun2021 at 04:00, the patient experienced i am 15 years old, no side effects on the day of vaccination. woke up in the middle of the night with fever and chills. typical side effects occurred the following day (fever, fatigue, chills, headache, throughout the day patient experienced severe chest pain, at first patient thought it may have been heartburn. Therapeutic measures were taken as a result of, at first patient thought it may have been heartburn. Patient was 15 years old, no side effects on the day of vaccination. Woke up in the middle of the night with fever and chills. Typical side effects occurred the following day (fever, fatigue, chills, headache, etc) however throughout the day patient experienced severe chest pain. At first patient thought it may have been heartburn but after taking tums (antacid) the chest pain was not reduced in the slightest leading me to believe it could not have been heartburn. The pain was severe and could be described as the sensation of swallowing something too large however with a more painful and long lasting feeling. No, treatment for AE. The outcome of event was recovered.  Information on the Lot/batch number has been requested.
Hives, tongue swelling lip swelling. Lasted approximately 12 hrs- Improved with BENADRYL.
LEFT DELTOID SWOLLEN, RED, HOT TO THE TOUCH, GENERALIZED FEVER AND BODY ACHES
Case number PHEH2016US027024, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 42 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error.
Pain and stiffness in my left arm i kept my arm moving but it was really sore i was really hot. I had fatigue and a couple of days i had spots on my ankle and spread on my leg back and then my arm. I did a lot of research and then went to the dermatologist and different doctors. Doctor found that my valves were not working properly.
Problem # 1: EDEMA (ICD-782.3) (ICD10-R60.9) New onset right scrotal swelling after recent second COVID-19 vaccine. Edema on exam, without tenderness or evidence of torsion. Urinalysis today is negative. Concern for infection is low. We did discuss possibility this could be an immune response to his vaccination. He has no known previous history of epididymitis or orchitis. Our office has recently been made aware there have been documented cases of orchitis or epididymitis in active COVID-19 cases. The data/research in regards to similar symptoms from solely a vaccine is limited/nonexistent as far as we know. Recommended conservative measures including: Allowing time for swelling to go down, regular use of NSAID (ibuprofen or Aleve 23 times daily x2 weeks), ice alternating with heat, and scrotal elevation. Will schedule him for a follow-up visit in 2 weeks to reassess swelling. He will let us know of any new concerning changes in the interim.
A non-serious event of flu symptoms has been received from Hoffman-La Roche Inc. (ref #07 US10920 Team B) from a physician in the USA concerning a child.  No medical or drug history was provided for this patient.  On an unspecified date, the child received FluMist.  "A physician reported FluMist was given to a child.  The child's father then got the flu and the caller felt the child developed symptoms."  Outcome for the reported adverse event was not reported.  Additional FluMist dosing was not reported.  The reporting physician did not provide a causality assessment for the adverse event reported.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  MEDI0006234 is a linked case involving the child's father.
upper arm developed a hard, red & very itchy whelp which has worsened after 9 days from receiving vaccine.
felt chest pain after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt chest pain after the vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 0441321A or 0441B21A) for COVID-19 vaccination.     The patient's past medical history included Sickness (patient may had COVID-19, was very sick at that time. Not confirmed as COVID-19.) in February 2020.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (felt chest pain after the vaccine). At the time of the report, CHEST PAIN (felt chest pain after the vaccine) had resolved.            No concomitant medication reported. No treatment information provided.  Patient may had Covid-19 in February 2020 and was very sick at that time. Patient was not diagnosed as Covid-19   This case was linked to MOD-2021-406236 (Patient Link).
During the first 5 days after injection, had tiredness, headache, muscle pain, back ache, headache, joint pain, fever, nausea, felt unwell, swollen lymph nodes, diarrhea, arm pain. At 2pm on the 2nd day after the injection, had upper lip twitches, and right side of the face had 50% feeling. Had facial tingling, itching. This lasted 2 days, thought occasion lip twitches lasted several more days. Day 5 developed small blisters on right hand and left side of face, near the ear. This spread into more bumps, and swollen face, neck, ear (and eye lids one evening) with hives.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided.  On or about 19-MAR-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-FEB-2016 the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was subsequently treated by a physician for ongoing and worsening symptoms of herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
One week after my shot, the area around where I received the shot started severely itching..In 24 areas a huge red raised area had appeared and continued to be hot and itchy. 3 days later, it is still the same size, hot and itchy.  I went to see my primary doc and she prescribed an antihistamine which I have only taken at night because I have to be alert during the day;.
Mild fever, headache, and tiredness in the morning  Took Advil  Improved within 24 hours
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Pt says she believes the vaccine was administered too low on her arm and it was not administered to the muscle. She also questioned whether the vaccine dose will be viable because of administration technique.
On 12/25/00, reported 1st symptoms of sinus congestion and uncontrollable coughing. On 1/3/01, seen in ER with numbness and paralysis. Transferred to another hospital where she was told the dx was Guillain-Barre Syndrome. Is recovering. 60 day follow up states patient is experiencing blurred vision in the right eye. Sinus infection starting 12/21/2000
About a week later of having my vaccine I had a rash, very inflamed and very red, from my shoulder to my elbow. I did not do anything I believe. I put Hydrocortisone cream on it. By the time I went to the doctor it was already subsiding.  The doctor said it was a delayed allergic reaction that he has only seen in healthcare professionals. He did not prescribed me anything.
anxiety was kicking in really bad/anxiety episode/triggered her anxiety; metallic taste; arm pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer product, lot EK5730, expiry date Mar2021) via an unspecified route of administration on 18Dec2020 (reported as today at 11:45, unknown if AM or PM) at a single dose on the arm as Covid 19 Vaccine. Medical history included cervical cancer since 2010, both mother and father have had cancer; post-traumatic stress disorder (PTSD); anxiety; had been on therapy counselling. Concomitant medications included hydroxyzine, sometimes uses medical marijuana, sometimes taking prenatal vitamins just because of the whole virus and stuff thing going around; the patient might not be pregnant but become pregnant (consumer was unsure- PENDING CLARIFICATION). She's in the middle of a divorce but she just takes the prenatal vitamins because of the higher doses to help run her immune system because of the virus. The patient received the vaccine today (18Dec2020) and she was not sure what these ingredients were. She's a single mother and an EKG and EEG tech working around Covid positive patients. She inquired if any of the ingredients or the vaccine itself do cause cancer. She really had a bad anxiety and PTSD and she didn't know but her anxiety was kicking in really bad right now. She's currently having anxiety episode now. The more she got home, the more she's thinking and that's kind of triggered her anxiety. She already has anxiety taking the vaccine/have anxiety about this Covid19 vaccine. She inquired if the lady knew like what triggered the anxiety if there's like any ingredient that could potentially cause cancer, do they spike protein, do those cause cells to mutate which causes cancer, so many answers and questions the patient had and there were no answers to her questions, nobody knew because it's still being studied and that's also where her anxiety was getting triggered and all about this was just unknown. She was just trying to figure out if there's a chemical ingredient made to be administered in the vaccine because being a mother she was trying to find answers and nobody seemed to have any answers and all she heard was she did not have. It was also stated that after she got the vaccine, she had really metallic taste for about an hour and a half and it finally went away. She also had a regular arm pain at the injection site, it's normal like how one get flu shot and stuff. The patient had no investigation assessment. Treatment for the events was reported as no. The outcome of the event metallic taste was recovered on 18Dec2020 while the rest of the event was unknown.
Patient was scheduled to receive Pfizer pediatric dose (0.2ml/10meq. He received Pfizer's adult dose (0.3ml/30meq). During the time of observation, the child did not exhibit any signs/symptoms of any distress or adverse reaction
Pt experienced red, raised welt, warm to touch, slight red rash, no pain reported, some itching.
pt was given HD flu shot instead of regular while in line with residents at flu clinic done by store given at facility. facility told about the error to let patients who received the HD flu shot who were under 65 years old; no reported adverse events from facility to us
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperature and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDASIL on 30-APR-2013 (lot number: 672232/1495AA; exp date: 22-AUG-2014) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Pain and bruising at the injection site lasting several weeks; Aching type pain in other limbs, accentuating any other muscle soreness; General fatigue and malaise (similar to flu, but without gastrointestinal) for 2-3 days; after a week or so, experienced very first ever eruption of a HV2 lesion (despite exposure over 14 years with no eruptions!).