chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15 month-old girl received her ACTHIB vaccine, but it was later noted that the diluent of that box of ACTHIB vaccines was expired with no adverse event; Initial information received on 15-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient who received her ACTHIB vaccine, but it was later noted that the diluent of that box of ACTHIB vaccines was expired with no adverse event, while receiving HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site for prophylactic vaccination (strength, dose and expiry date: unknown).  On an unknown date, 15 month-old girl received her ACTHIB vaccine, but it was later noted that the diluent of that box of ACTHIB vaccines was expired with no adverse event with no adverse event (expired product administered) (unknown latency).  Child also received Prevnar and DTaP (manufacturer not provided) during that visit.   Action taken: not applicable  Outcome was Unknown for the event acthib vaccines was expired with 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 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.; Sender's Comments:  US-SA-2022SA511887:01408917
Inr decreased to normal despite being on chronic Coumadin for a fib. Started days after first injection still ongoing trying to adjust dosage.   Small sores all over his body being treated with betamethasone cream. Dermatologist refused to diagnose so unknown. GP says possibly  neurodermatitis. Started about a week after first  injection.
Information has been received from a 45 year old female nurse who on 16-APR-2009 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot number not available) to prevent herself from getting shingles since her husband had shingles recently and she had weak immune system. She had a breast cancer 3 years ago and had chemotherapy. Concomitant therapy included ARIMIDEX, simvastatin (MSD), vitamin D (unspecified), and calcium (unspecified). On 17-APR-2009 the patient experienced runny nose, headache, tiredness, chills and was vomiting after receiving ZOSTAVAX (Merck). The patient was recovering at time of reporting. The patient sought unspecified medical attention. The reporter considered her experiences runny nose, headache, tiredness, chills and vomiting to be other important medical events. Additional information has been requested.
This spontaneous report was received from a 65 year old female patient reporting on herself. The patient's concurrent conditions, medical history were not reported. On 15-JAN-2015, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date unknown). Concomitant therapies included PRED FORTE. On approximately 22-JAN-2015 ("a week later"), the patient had shingles on her eye. The patient received treatment for the event. No laboratory tests were performed. The outcome of ophthalmic herpes zoster was unknown. Causality was not provided by the reporter. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
Dull, aching pain in right chest.   Intermittent.  Occurs multiple times throughout the day and lasts from minutes to hours.  Was initially not concerned, as I had no shortness of breath or lightheadedness, and my radial pulse remained strong and regular.  Recently contacted my physician when I felt like it wasn't getting any better, and will get an EKG this afternoon.
The evening after receiving my vaccine my left arm was swollen and a red spot. The red spot was about 2.5-3 inches big . Over the next few days the red spot had grown larger. I did not have a fever or any aching in the arm. It was hot to the touch. By The 5th or 6th day, the redness and swelling had gone done completely. I did not receive medical care.
Fever, chills, body aches, injection site pain.  Recovered from COVID in 12/2020.
5/24 got second covid vaccine, symtpoms sated 30 hours after. he laid on the floor , couldn't talk, was having shaking. ER visit. nl labs   he felt a little better the next day  1 week later got up off of the couch, severe pain in achilles. given shots, pain med, x ray.   1 week after that, he had pain in the right (other ) achilles. given muscle relaxer, motrin. he got a splint.  last night started getting "electrical shocks" arms, legs. he started having confusion, couldn't talk. he was shaking.  h  got second covid vaccine he feels his symptoms have been exacerbated
CHEST PAIN; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: FW0161) dose was not reported, administered on 19-APR-2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient previously received non-company bnt 162 vaccine (dose number in series was 1) (form of admin, route of admin not reported, batch number: ER8736) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. On an unspecified date, the patient experienced chest pain following vaccination with non-company bnt 162 vaccine (dose number in series was 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: 11-APR-2022) dose was not reported, 1 total, administered on 24-DEC-2021 to Left Deltoid for prophylactic vaccination. Concomitant medications included naproxen. On 24-DEC-2021, within 6 hours from vaccination, the patient experienced fever, chest pain and chills following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series was 2). Laboratory data (dates unspecified) included: Body temperature (not provided) 100.5 (units unspecified), Oxygen supplementation (not provided) 98 %, and Pulse rate (not provided) 90's. The patient received treatment with Aleve. Patient's chest pain symptom was faded. Patient's health care professional (HCP) suspected that the vaccination causes chest pain. Patient did not go to emergency room (ER) and was discussed with an ER doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 25-DEC-2021, and fever, and was recovering from chest pain. This report was non-serious.
(This Report is the case oif Reference duplication of this case is U1998-00913). It was reported that a 40 year female received fluzone SV"98-99 USP on October 3,1998. Reportedly approximately oneand a half weeks later the patients "complained of tingling down arm, impairs grip, intermittent". From additional information received on 11/23/98 it was reported, "Reviewed, no additional information at this time. Follow up #1 (06/07/02): During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added Impaired  grip, Intermittent coded to neuropathy). During the second internal review of this file on 08/28/02, it was  deemed necessary to amend the report by changing the latest received date from 06/07/02 to the correct date of 06/06/02. The narritive was also updated to state that this is the report of references and U1998-00913 is the duplicate.
I have never had an allergic reaction to Tylenol, acetiminfen or Prednisone before taking the vaccines or booster.  However, on August 10th, 2022, I took Tylenol at 9:15pm for my symptoms of COVID-19.  At 11:00, approximately,  I began to feel itchy on my arms.  Then I started feeling itchy on my neck and my neck felt lumpy.  I felt large bumps on my arm.  I took photos for my doctor.  I woke up and saw that my arms, legs, upper back, upper chest and neck are all blotchy.  It looked like hamburger meat.  I took one Benadryl.  The next morning nothing had changed.  The Benadryl had not helped.  I was unable to get help from my doctor that day.  I contacted a virtual healthcare provide.  I was prescribed Prednisone.  I had serious side effects from Prednisone, sweating, my right eye was watering and insomnia.  My doctor contacted today, Monday August 15, 2022.  He had seen the pictures and told me I had hives.  He suggested to cut the pills in half and I am tolerate this so far.  My hives seem to be a bit better as of now, but late in the evening it gets worse.  It is not as lumpy but pink like a sunburn.
About 8pm on the 27th of sept,,  as I was about to get up from a sitting position , I encountered such severe vertigo that I could not stand up. I waited a bout 15 minutes to see if it would subside but it only got worse and was accompanied by severe nausea. My husband then checked the paperwork I received after my flu shot at 12:pm that day and per instructions carries me to our auto and drove me to the ER. The instruction sheet stated this was a serious side affect.                                               I encountered such severe
I?ve had three periods since receiving the vaccine. All were mostly on time. The adverse effect I am experiencing is increased menstrual cramping. Normally my period cramps are bad on the first few hours of the first day of my period. Since the vaccine my period cramps have been painful for two to three days of each cycle.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 09-FEB-2016 the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route not reported, lot # L034372, expired date: 08-SEP-2016). The vaccine exposed to 6.9F for 34 minutes. No previous excursions. Concomitant therapy was not reported. No adverse effects. This is one of the two reports from the same reporter. Additional information has been requested.
Chills; Headache; Body aches; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 11:15 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and supraventricular tachycardia (SVT). The patient had no allergies to food, medications or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN) both taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 11:15 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 14:00 the patient experienced chills, headache, body aches and exhaustion. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, headache, body aches and exhaustion were recovered on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Day after vaccination mom noticed injection site was red and swollen, child reported pain. 2 days after vaccination injection site is more swollen and red (nickel sized) with underlying papular nodule palpable.
7  days post shot extreme facial swelling between eyes, forehead, nose, lips.  Red postulates. Heat. Inflammation.  itching. Most of this occurred on vascular malformation (port wine birth mark).  Symptoms continued to escalate until treated with prednisone.  Problems continue to persist. Continuing prednisone (60 mgs).
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Many people my age had the shingles shot now we are all getting shingles. This needs investigated as too many people are still getting shingles. We got our shingles shot at store five years ago. My husband and I both have shingles now. We paid a fortune for that shot as our insurance would not pay. I say fraud.
Per verbal report over phone from patient: Patient's lips got "tight" approximately five minutes after administration. A rash formed around the patient's neck that lasted around 30 minutes. Local reaction - swelling around injection site, warm to touch. Local reaction took approximately 1 day to go away. No difficulty breathing. Pharmacist who administered vaccination advised pt to take a benedryl, but pt did not take against medical advice. Pt made full recovery with no lasting adverse effects.
Shivers, fever (close to 100F), pounding headache, nausea/loss of appetite, fatigue  All still present 31 hours after the injection.
Pericarditis - hospitalized for 5 days. Discharged with the following medicines: Colchicine and Ibuprofen.
Pt  had swelling and pain from injection site to her elbow. Pt reports the pain was there for the next 5 days.
Patient received her booster vaccine on 10/27/2021. Was found on the floor on 10/28/2021 at the facility at that moment her heart rate was 142. Patient was transferred to the hospital and from there to Larger hospital and went into cardiac arrest and could not get her back. Patient passed away on 10/29/2021 at 11:44am. We discussed with the facility medical director and was advised to let Pharmacy know. As per medical director he doesn't know if the cause of death was due to booster vaccine or patient medical history since cardiac arrest has been reported previously with covid vaccine. Patient had history of some cardiac disease hypertension disease, heart failure acute on combined systolic and diastolic heart failure, and history of MI.
Initial onset of rashes and itching first couple months after vaccine.  I assumed this is a side effect of the vaccine.  I do not generally take vaccines every year (I do not get the flu vaccine). The last five weeks experiencing severe tinnitus and diagnosed/treated labrynthitits in left ear  (treated with Prednisone).  Initially thought it was an ear infection. Note:  Prior to the last give weeks, my mind was very quiet, and I only sensed this feeling of sounds during waking up from a deep sleep.     5-6 weeks ago started feeling slightly "off balance" or "not right- not grounded".  That slowly escalated into the tinnitus and labrythitis mentioned above.  Severe dizziness, throbbing and heartbeat in ear... Feeling of blood pressure in the ear.  As I am writing, I can hear the consistent hissing, or like a signal sound which is coordinated with my heartbeat (like a pulsating rhythm).  I thought at one point it was similar to cell phone signal sounds that can be heard as feedback in speakers when a message arrives.  At times during the day it becomes louder, and at night it can sometimes become loud like a static sound, making it harder to sleep/stay sleeping. I am generally health conscious, work-out 7 times a week, watch my diet (vegetables, limit meal sizes, watch carbs and sugar intake) - very routine week over week. Am working remotely for almost all of the last 1.5 year.  I did have slight high blood pressure (not diagnosed nor any meds) prior to taking vaccine.
very bad reaction for about four days after the pneumonia vaccine. Severe swelling and redness with a fever and chills. The night that I received the vaccine the arm swelled up and they were swelling all in my armpit and several of my lymph nodes were swollen and pain was so bad I could barely move my arm and that's when I had a fever and chills. The next day, Saturday I was very swollen and red and it hot to the touch with red streaks going from the injection site up underneath my armpit to where the lymph nodes were swollen and painful. I used ice and ibuprofen and cortisone cream to ease the symptoms. Today is day six it is 1 AM and it is painful and itchy and still slightly swollen however the heat is gone. I have never had any type of injection react this way.
Diarrhea; Headache; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Congestive heart failure. Concurrent medical conditions included Rheumatoid arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09-Jul-2021 contains significant information event outcome updated(From unknown to recovered)
Chills, Fever, Body aches  Shingles vaccine.....not on the list
Herpes zoster, secondary transmission - Information has been received from a female nurse who developed shingles following exposure to a child who was vaccinated with varicella virus vaccine live.  Unspecified medical attention was sought.  Follow up information from the nurse report that upon further investigation, she concluded that the child probable did not receive varicella virus vaccine live because the child was not old enough according to current dosing schedule.  she noted that the outbreak of herpes zoster was probably not due to exposure.
The patient has had no side effects at this time.; PEDVAX HIB was accidently used as the diluent for MMR-II and VARIVAX instead of the Merck sterile diluent; Because of the PEDVAX HIB being used as the diluent for both MMR-II and VARIVAX, the patient received 1mL of PEDVAX HIB instead of the recommended dose of 0.5mL therefore receiving double the recommended dose of PEDVAX HIB.; Also, the PEDVAX HIB was given subcutaneously instead of intramuscularly since it was mixed as diluent with MMR-II and VARIVAX.; This spontaneous report was received from physician and refers to a 12-month-old female patient. The patient's concomitant therapy included pneumococcal vaccine conj 13v (crm197) (PREVENAR 13). The patient's concurrent conditions, medical history, allergies and drug reactions were not provided.  On 30-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) , 0.5 ml, administered subcutaneously, lot #U011995, expiration date: 15-APR-2023 (strength and dose number was not provided), and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, administered subcutaneously, lot #U039726, expiration date: 15-DEC-2023 (strength and dose number were not provided) for prophylaxis. Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #U039951, expiration date: 22-JUN-2024 was accidentally used as the diluent for both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) instead of Merck sterile diluen (product preparation error). Because haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) being used as the diluent for both measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX), the patient received 1 ml of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) instead of recommended dose of 0.5 ml, therefore receiving double the recommended dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (accidental overdose). Also, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was given subcutaneously instead of intramuscularly since it was mixed as diluent with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) (incorrect route of product administration). The patient has had no side effects at this time (no adverse event).
This spontaneous report as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.