chrisvoncsefalvay/vaers-outcomes huggingface dataset:
58 year patient was administered Fluzone High-Dose Quadrivalent; 58 year patient was administered Fluzone High-Dose Quadrivalent/ no AE; runny nose; chest congestion; severe sore throat; headache; body temperature 99.8 Farenheit; Initial information was received on 22-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via Global Media Information (under reference- 00824391) and transmitted to Sanofi on 22-Oct-2021.  This case involves a 58-year-female patient who experienced Overdose and Product administered to patient of inappropriate age, runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion), headache and body temperature of 99.8 Fahrenheit (Pyrexia) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 18-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number not reported and expiry date not provided] via intramuscular route in the left deltoid for prophylactic vaccination.  On an unknown date in Oct-2021 the patient developed non-serious runny nose (Rhinorrhoea), severe sore throat (Oropharyngeal pain), chest congestion (Respiratory tract congestion) and body temperature of 99.8 Fahrenheit (Pyrexia) (on 3rd day after shot) and headache (5th or 6th day after shot) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was a case of actual medication error due to Overdose and Inappropriate age at vaccine administration (latency was on the same day).  Relevant laboratory test results included: Body temperature - On an unknown date: 99.8 Fahrenheit  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test negative - On 20-Oct-2021: Negative  The patient was treated with paracetamol (tylenol) for Headache and performed steam inhalation and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  At the time of report, patient was recovering from Oropharyngeal pain and outcome of other events was unknown.  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.  There will be no information available on the batch number for this case.
Around noon I felt as though I should take my temperature.  At 12:16 it was 99.0.  At 1:14, it was 100.2.   At 4:15, it was 100.2 with chills.  I took 2 Tylenol.   At an early bedtime, 9:00, I took 1 Advil PM.  I slept well.  The next day I felt OK and did not have a fever.  My left arm had a bruise at the injection site and it was rosy color and itchy. with a red blotch.  It was the same the next day.  That eventually went away.
Patient received two doses of moderna prior to receiving a booster dose of pfizer. Moderna feb 26 2021 and jan 8 2021
The day after the vaccination, I was extremely tired and my whole body ached.  I also had a headache all day, even after taking Tylenol.
Arm was sore from 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore from 1st vaccine) 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 No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore from 1st vaccine). At the time of the report, PAIN IN EXTREMITY (Arm was sore from 1st vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was provided. Conmeds were not provided.    Reporter did not allow further contact
03/16 onset of fine macular rash on arms and back. Also c/o headache, nausea, vomiting, diarrhea, joint and muscle pain, satellite lesion. Lasted until 03/22. Pt took Excedrin, Tylenol, Motrin, and Benadryl for symptom relief.
Intense pain started 3 hours after vaccine, progressed to severe restricting ROM, lasting 48 hours, after which started to improve some but 3 weeks after vaccine still with moderate discomfort with motion.  Medical evaluation concern for bursitis 2/2 subacromial bursal injection due to improper administration of vaccine
Received Moderna COVID vaccine 12/31/20, 3 days later noticed generalized joint pain all over. Day 4 noticed both knees were red and tender and could palpate pockets of fluid. Had bilateral ankle and foot pain, right ankle swollen. Overnight 1/5-1/6/21 was in severe pain and unable to sleep, very difficult to walk on ankles and feet, stairs were very painful. Motrin relieved symptoms to where able to walk more comfortably but generalized achiness and tenderness to ankles and knees remain.
Initial and follow up information has been received from a physician via a wholesaler concerning a 73 yr old pt (previously reported as 4 pt's) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649111/0287P). Subsequently the pt developed the shakes and swelling around the injection site. The pt did not undergo a work up or hospitalization. No other information was available. In follow up information it was reported that 4 other pt's developed the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot649111/0287P) (WAES 0411USA02514, 0412USA01843, 0412USA01844, 0412USA01846). Additional information has been requested.
Fever 102 (normally 97.7), Elevated resting heart rate, 90 (normally 50) peaking at 120 BPM, Hypertension 181/97 (normally 130/73). Shaking and shivering.
Patient given DTPa on 04/29.  Right upper arm MMR given Right Arm Subcutaneously.  Upper right arm became very swollen, red and warm to touch on 04/30/2003.  States right upper arm also itchy.  No welts or open area noted.  No blisters.
positive Covid test (1/10/22); tiredness, cough, loss of taste & smell, muscle soreness
ACUTE STROKE OF BASAL GANGLIA, UNSPECIFIED TYPE AND ARTERY
Child developed symptoms of autism but we did not realize it was autism until speech teacher recommended he be tested. He was diagnosis at hospital. *F/UP report on 3/7/03: Autism*
Later that night patient vomited. Came into pharmacy three days later 5/17/2012 with localized rashy redness around the shot area including very slight itch and shot site felt callused.
First dose on 1/7/21, second dose 1/25/21. Covid positive on  2/21/21
HAD MEN B AND FLU VACCINES AT ABOUT 2:30 PM. WENT TO BASKETBALL PRACTICE. FELT ITCHY OF TORSO/ARMS/LEGS, SHORT OF BREATH, SHAKY, FATIGUE, SCRATCHY THROAT (RESOLVED AFTER TAKING BENADRYL), RASH AT SITE OF MEN B INJECTION, HEMATURIA. SEEN IN ER FOR SYMPTOMS. TREATED WITH CIPRO.
face was all swollen up; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and expiry date was not reported) via intramuscular, administered in Arm Right on 19Mar2021 11:45 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication was not reported. On 20Mar2021 10:00, patient experienced Face swelled up. Patient wanted to know if facial swelling be an allergic reaction to the vaccine or is it something else. Patient went back to work and worked that night and went to bed and woke up the next day with his face totally swollen. He read the literature and it said facial swelling could be an effect. He is not on any other medications. Vaccination facility type was Hospital. NO ER or physician's office required. Patient did not received any vaccine Prior Vaccinations.. Outcome of the event was recovering.  Information about batch/lot number has been requested.  Follow-up (22Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This male consumer (patient) reported that: Route of administration, Time of vaccination and time of AE was added. Case summary added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No information expected.
devel sx of flu w/aching in various parts of body;no temp;yellow thick drainage w/sl cough;tired stayed in bed x 1wk;clogged nose, sneezing, sore throat;
15FEB94 nausea, vomiting, fever, rash, h/a, photophobia over the next 2 wks; 4MAR94 adm w/viral sx & meningitis; now has pneumonia-ATB; 8MAR94 discharged-needs MRI as outpatient;
Inflammation of the stomach.  Had to be admitted to ER twice. My GI was bad and inflamed
Vaccine had a temperature excursion of 50F and was given to the patient, no adverse event; patient received the vaccine early in her pregnancy with no adverse event; Initial information was received on 22-Sep-2020 regarding an unsolicited non-serious valid case received from a nurse.  The case involved 34-year-old female patient who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] during pregnancy (Exposure during pregnancy) after the vaccine had a temperature excursion of 50F (Product storage error) .   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at 31 weeks of pregnancy. The date of last menstrual period was reported as 04-Jan-2020. The estimated due date is 10-Oct-2020.  Relevant medical history, medical treatment, vaccination details and family history were not provided.  Concomitant medication not reported.  On 12-Aug-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6621BA, expiry date 21-Mar-2022) via intramuscular route in the left deltoid for prophylactic vaccination. This was a case of actual medication error due to product storage error. This was a case of vaccine expoure during pregnancy.  Reporter stated that the patient had the vaccine that was part of an excursion and should not have been vaccinated. The reporter inquired time duration for the baby to be covered by the vaccine once administered and if the patients that received the vaccine during pregnancy and have delivered need to be re-vaccinated. The patient was revaccinated (repeat dose) on 21-Sep-2020 at 37 weeks of gestation. (dosing details not reported). At the time of report, no adverse event was 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 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.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was due for second before 1st April. Every pharmacy the patient had called listed on site as having the vaccine was out. The patient asked that what the company was doing to get the second dose to those who need it. The patient asked that the company should not be allowed to sell a first dose until those needing the second have received. Follow up received from consumer on 18th March 2019: The patient had the first Zoster vaccine and was persuaded by the advertising to switch to SHINGRIX. The patient had the 1st SHINGRIX shot in October 2018. The flu like side effects of the 1st shot were the worst the patient experienced. Six months was nearly up, the patient on several lists and have made numerous calls trying to get the 2nd shot. At the time of reporting, the patient said that the company oversold the SHINGRIX and promoted, but could not provide the supply come out for it and asked whether the 2nd shot would have some protection even if given late. The patient was actively looking for the 2nd shot. The patient was also looking to join any class action lawsuit against GlaxoSmithKline for taking his money, putting him through pain, and not delivering on product promised.
This spontaneous report was received from a pharmacist and refers to a 67 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (concentration, dose, route and anatomical place of vaccination were not provided). Subsequently, in November 2016, the patient inadvertently received a second dose of PNEUMOVAX 23 (concentration, dose, route and anatomical place of vaccination were not provided). Nevertheless, no  adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a nurse practitioner referring to a 9 year old male patient with type 1 diabetes mellitus. The patient's pertinent medical history was not provided and he had not any drug reaction/allergy before. His concomitant medications included insulin. On 31-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 subcutaneously, in the right deltoid, Lot # N005096 with an expiration date on 22-OCT-2018 (strength and dose were not reported) for prevention of pneumonia. On this same date, the patient had a fever of 102.5 (units not provided) (pyrexia) (also reported as "no laboratory studies were performed") and his right upper arm became swollen and painful from his right shoulder to his right elbow and his Mom had to cut off his shirt. The nurse practitioner reported that the patient went to an unspecified emergency room on this same date, where his injected arm circumference was 23 cm at the thickest part compared to 18 cm on the non-injected arm and the circumference of his elbow on the injected arm was 20 cm compared to 16 cm on the non-injected arm. Nurse reported that patient treatment received in the emergency room was ice packs and an unspecified dose of acetaminophen (TYLENOL). The patient was discharged from the emergency room to home and told to follow up with his primary care physician. At the reporting time, the patient was not recovered and was at home taking unspecified doses of acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The causality assessment between pyrexia, peripheral swelling and pain in extremity, and vaccination with PNEUMOVAX 23 was not provided. Additional information has been requested.
Patient had a positive COVID test on 2/07/2022 and expired on 2/19/2022.
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. All patient experienced flu like symptoms who received Shingrix. This case is linked with US2020022431, reported by same reporter.
Swelling; redness; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 24th June 2022, the patient received the 2nd dose of Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced swelling and redness. On an unknown date, the outcome of the swelling and redness were not recovered/not resolved.   It was unknown if the reporter considered the swelling and redness to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comments: This case was received from patient's cousin via interactive digital media. The patient had Shingrix shot on Friday and the swelling and redness seem worse on the date of reporting than before. The patient asked if it was normal. The follow-up would not possible as no contact details were available.
Swelling, redness, hot to touch. Dx: Cellulitis. Rx: KEFLEX 500mg TID x1 wk.
Initial and follow-up information has been received from a physician concerning a patient who was inadvertently vaccinated with a dose of Pneumovax 23 instead of a fourth dose Prevnar. The physician stated that there was an error on the part of the office. Specifically, 70 doses of Pneumovax 23 were ordered instead of Prevnar because both products were next to each other on the order form. It was reported that 40 doses were administered with the belief that they were Prevnar. It was reported that there was no confusion in regards to product packaging. The physician stated that the problem had been corrected at the office and did not foresee any future problems. On an unspecified date, the patient returned to the physician's office and was vaccinated with a fourth dose of Prevnar. There were no adverse experiences reported. Follow-up reported that the patient had "done well" and no pneumococcal infection had been noted.erse experiences reported. Additional information is not expected.
Administered on Friday March 5th, Saturday 6th site became very sore, Sunday 7th developed red raised rash, sore, burning and itched at site and down to and across bicep. Continued to worsen Sunday evening down and all across left bicep muscle. Bicep muscle also became very sore to touch. Ached, burned, itched. Measured 4 by 6 inches across. Continued same on Monday and Tuesday of following week. Used ice packs, cortisone cream and ibuprofen. Today, March 10th, it has gotten a little less red, less painful, sore and itchy.
Acute and immediate onset of difficulty breathing, full body pain, unsteadiness, and death at 112 days post injection. Blood glucose of 610 at time of death, organ failure and "swollen heart" per attending ER physician.  Patient has no history of diabetes or other long standing health conditions or illnesses and was in good health.
Pt reports "prickling" sensation to bilateral face, BUE, and BLE. . Reports sensation as persistent and states she took allegra PTA d/t her having the same s/s after first dose administration. Shortly after arrival to med obs #1, pt states she thinks her face feels tender and "slightly more warm than usual." Pt offered water and permitted to pull mask down while she is observed for comfort and per her request. VS at 1117: BP 132/81, HR 72, RR 18, O2 sat 97% on RA. VS at 1144: BP 129/83, HR 64, RR 17, O2 sat 100% on RA. VS at 1200: BP 128/66, HR 65, RR 18, O2 sat 99% on RA. VSS at time of d/c to home. No s/s of distress noted at time of discharge. Pt escorted to exit.
feels like I was hit with somethinng; chest pain in the middle of her chest; A spontaneous report was received from a consumer concerning a 56 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt like hit with something/ feeling abnormal and chest pain in the middle of her chest.  The patient's medical history was not included. Concomitant products were not included.  On 02 Feb 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0:007M20A) for prophylaxis of covid 19 infection.  On 02 Feb 2021, the patient experienced chest pain in the middle of her chest felt like she got hit in the chest with something.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, felt like hit with something/ feeling abnormal and chest pain in the middle of her chest were unknown.
Post vaccination mother stated that patient developed redness about 3 inches in diameter to left thigh Hep AM IM site and tenderness.  Mother stated feels a ball.  Pt guarding site.  Pt was prescribed Cephalexin Monohydrate 125mg/5ml, Reconstituted suspension, Oral GIVE 5 ML BY MOUTH EVERY TWELVE HOURS FX 7 DAYS TILL ALL TAKEN
This spontaneous report was received from a registered nurse and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 03-AUG-2017, the patient was vaccinated with a dose of improperly stored VAQTA injection (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained. Sender's Comments: US-009507513-1708USA010049: US-009507513-1708USA010050: US-009507513-1708USA010051: US-009507513-1706USA002146: US-009507513-1708USA010048.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (Patient takes Micardis 80/20 but has not taken it for almost 2 months.). Concomitant products included TELMISARTAN (MICARDIS) for Blood pressure abnormal.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication information provided.  Patient reported no allergies to medications, food and other products. Patient has never tested positive for COVID-19.   This case was linked to MOD-2022-493510, MOD-2022-493749 (Patient Link).
after 1st and 2nd doses of shot - my L armpit lymph nodes swelled and became tender and painful.  After 1st dose the pain subsided after 3 or so days; wasn't too bad just uncomfortable.  After the 2nd dose the lymph nodes swelled even more than the first time and there was a constant pain/discomfort that lasted for several days with no relief from tylenol and mild temp relief from hot compresses.