chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX. Concomitant products included WELLBUTRIN and Atorvastatin. On 26th April 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced muscle soreness. On 26th April 2018, the patient experienced injection site erythema, injection site discomfort, injection site itching and pain in arm. On 27th April 2018, the patient experienced fever, chills, fatigue and injection site burning. In April 2018, the outcome of the fever, chills and fatigue were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site discomfort, injection site itching, pain in arm and muscle soreness were recovering/resolving and the outcome of the injection site burning was unknown. The reporter considered the injection site erythema, injection site discomfort, injection site itching, fever, chills, fatigue, injection site burning, pain in arm and muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The nurse reported that she received SHINGRIX and she started getting redness, discomfort and itching at the injection site that day. The next day the patient had a low grade fever, shivering, chills and fatigue and the injection site had a big red reaction, about 4 inches by 2 inches, that was very tender to the touch. Her arm was also sore, but she could do what she needed to do. The fever and fatigue would have kept her from work on Friday (27th April 2018), if she was working. At the time of reporting, she had burning, itching and redness at the injection site and her muscles were sore. The patient stated she was only 98 pounds.
Pain and slight swelling in left arm at injection site with pain upon movement and touching site, muscle aches all over body, severe pounding headache/migraine, fever up to 101° 12/24/2020 at 11:00 am, first fever at 100.3° at 3:14 am 12/24/2020, tachycardia at 164 bpm at 3:30 am 12/24/2020, tachycardia into high 120s with walking 12/24/2020 around 10 am 12/24/2020, chills, light sensitivity, weakness when fever spikes, and overall malaise.
Pt was seen on 11/8/23 by clinic and was administered hepatitis B vaccine- HEPLISAV. She was over 37 weeks pregnant at time of vaccination. She does not report any adverse reactions.
left arm injection site  with erythema, swollen and warm to the touch Patient reports taking benadrl on morning of  4/22/2021 after noticing the reaction,  "No improvement yet"
Patient given VARIVAX & MMR 2-11-11 at well child check up. Developed parotitis on 2-12-11 & adm. to hospital on 2-13-11 for IV antibiotics & ID & ENT consult. ID did not suspect parotitis was caused by MMR based on time course of events. Patient fully recovered by 2-18-11.
Pt has 1" spot on right cheek- took to MD had Temp of 103 rectal. MD states had bad viral infection possibly related to immunizations.  Nurse follow up on 07/07/04 states: "Per review of hospital discharge summary, discharge diagnoses were acute febrile illness and mild facial cellulitis (CELLULITIS). "
BREAKTHROUGH COVID 19 INFECTION.  MILD SX OF URI CONTINUE.  RECEIVED REGEN-COV TODAY 11/30/21
MOTHER REPORTED HE HAD ADDITIONAL SEIZURES, VOMITING, EXTREME FATIGUE,STIFF ARM, SLURRED SPEECH, COULDN'T WALK WELL.  MOSTLY AFFECTED RIGHT SIDE.
kind of like flu; minor unwell feeling; The initial case was missing the following minimum criteria: No Adverse Effect. Upon receipt of follow-up information on (01Mar2021), this case now contains all required information to be considered valid.  A 71-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: EM9810), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing vertigo, dizziness, balance problems, visual problems, abdominal problems, weight fluctuation from an unknown date and unknown if ongoing caller mentions his weight changes every time he goes to the doctor. He lost 80lbs in a year, but his weight was starting to go back up. There were no concomitant medications. The patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot Number: EL3246), via an unspecified route of administration in left arm on 21Jan2021 at 13:10 (Age at vaccination 71-years-old), as DOSE 1, SINGLE for covid-19 immunization and experienced nausea, feeling unwell, chills, he supposed that he was dehydrated. The patient experienced minor unwell feeling and kind of like flu on an unspecified date. The patient underwent lab tests and procedures which included weight was lost 80lbs in a year on an unspecified date. The clinical outcome of the events was recovered on unspecified date.   Follow-up attempts completed. No further information expected.
This spontaneous report as received from a healthcare assistant (HCA) (also reported as administrator) concerning unspecified number of patients of unknown age and gender. Between 09-MAY-2017 to 13-JUL-2017, unspecified number of patients were vaccinated with improperly stored doses of VARIVAX lot # M047661 with expiry date: 02-DEC-2018 (dosing details, route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 6 F to 14 F for a duration of 9 hours. Data Logger was involved. No adverse effects were reported. There were no previous temperature excursions. Additional information has been requested.
1500 reports pt for facial swelling 0.3mg epi-pen IV started, 25mg benadryl IV slow push, 8mg dexamethasone, 500mg NS. Swelling resolved.
Headache, fever, soreness in arm, extreme fatigue, foggy brain, forgetfulness, pain in right calf,
High temperature 105+, soreness, Fatigue, Diariah, chills.
Over a week later, my arm is itchy, the area of the shit is warmer than the rest of my arm, and if I press it, it?s mildly painful (uncomfortable). It?s not red or discolored at all.
Later that day following the patient's Pneumococcal vax the patient went to the ER with high fever, redness, and swelling on his right arm in which is the injec. site. The ER has not prescribed the patient with any meds to treat reaction.
pt given immun 230PM; by 5PM had temp to 100.5 & large swelling of leg w/crying for 30 minutes 4cm x 6cm;
Hives all over entire body that started 3 days post vaccine.  Telehealth appointment prescribed 10mg prednisone, 10gm montelukast, 25 mg hydroxyzine
covid Pfizer was draw up using only 0.8ml of diluent not the full 1.8 ml
patient received IPOL instead of the intended TUBERSOL with no reported adverse event; patient received IPOL intradermally with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient who received ipol instead of the intended tubersol with no reported adverse event and received IPOL intradermally with no reported adverse event, after receiving vaccine IPV (VERO) [IPOL].  The patient's past vaccination(s) included IPV. The patient's past medical history, medical treatment(s) and family history were not provided.   On 12-Sep-2022, the patient received a dose of suspect IPV (VERO)( lot V1A121M and expiration date: 30-Jun-2023) at a dose of 0.1ml once via intradermal route in the left arm  for prophylactic vaccination.  On 12-Sep-2022 (latency: same day),the patient developed a non-serious events "patient received ipol instead of the intended tubersol with no reported adverse event "(wrong product administered) and "patient received IPOL intradermally with no reported adverse event "following the administration .The patient has not reported any adverse reaction  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event  Outcome: unknown for both events   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.
pt c/o reddened area over lt forearm & swelling of fingers;pt came to clinic;noted to have 1 large grapefruit size reddened raised area over lt forearm;no other reddened areas noted;c/o tingling & swelling in hands;urticaria @ that one site
Non-Responders to Heplisav-B Vaccination; Initial Report Received on 02-Nov-2021. In a retrospective chart review that was conducted in 2 HIV primary care clinics, Patient is an HIV positive patient, at least 18 years of age, with documented history of HBV vaccination administration prior to November 2017, and negative for both HBsAg and anti-HBs after previous HBV-vaccination.    Baseline laboratories included HIV RNA 55,492, CD 4 count 97 cells/uL, CD 4 17%, negative for anti-HBc and negative HCV co-infection.    On an unspecified date, the patient received and completed both doses of HEPLISAV-B vaccine.    On an unspecified date, the patient was noted as not having achieved seroprotection.  Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Redness below injection site appeared next day, but disappeared within 3 days.   I thought it might be adhesive reaction.  This evening itchy spot appeared at that same location (size  9 X 3 cm) - small red raised dots within.
w/in 12hr of vax pt became irritable & inconsolable w/t100.3R & was adm to hosp next day;
swelling tongue & lips; swelling tongue & lips; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (swelling tongue & lips) and LIP SWELLING (swelling tongue & lips) 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 medical history reported).    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (swelling tongue & lips) and LIP SWELLING (swelling tongue & lips). At the time of the report, SWOLLEN TONGUE (swelling tongue & lips) and LIP SWELLING (swelling tongue & lips) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
This spontaneous report was received from The director of nursing regarding 2 unspecified patients of unknown demographics. There was no information about concurrent condition. Sometime between 18-APR-2015 and 23-OCT-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L012042, expired date as 18-NOV-2016, route, dose, dose number and strength were unspecified). On 18-NOV-2015 and 19-NOV-2015, unspecified patients were revaccinated with PNEUMOVAX 23 lot # L017406, expiration date 20-FEB-2017, 0.5ml intramuscularly. On an unknown date in November 2015, the patient developed cellulitis at the injection site. Patient received unspecified antibiotics for treatment. The outcome of cellulitis at the injection site was unknown. Causality between cellulitis at the injection site and PNEUMOVAX 23 was unknown. This is one of the two reports that received from the same source. Additional information has been requested.
red rash w/edema, pain w/inj site 7mm + 6mm in area;
headache, body ache, chills, fatigue, nausea. Felt much like the beginning of COVID19 symptoms but no fever or cough.  All started at 5 AM and intensified throughout the day of 3/30/2021.  Took Tylenol PM to go to bed at 8 PM. Woke feeling much better the following day and continued feeling better and back to normal by 12 noon 3/31/2021.
Fever, headache, vomiting, violent shaking from chills, soreness, neck pain, no sense of taste
Patient started experiencing moderate-severe abdominal pain one week after the first vaccine dose. Abdominal pain subsided over 2 days.  Patient has never had any issues with constipation or gas, cramping, menstrual pains. This was the first time she experienced so much abdominal pain.
Information has been received from a health professional concerning an 18 month old white female who on 27-FEB-2006, at 3:15 pm, was vaccinated with a first subcutaneous dose in the upper thigh of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot# 647648/0318P). There was no illness at the time of vaccination. A rash and fever, of 102-103, started on 08-MAR-2006 that was evaluated at three different emergency rooms, one which diagnosed viral exanthema, another that diagnosed scarletina, and the third which diagnosed a reaction to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Additional information has been requested.
Tiredness; Full body ache; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 10:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and allergy to surgical glue. 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. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MANUFACTURER UNKNOWN), loratadine (CLARITIN), vitamin D nos (MANUFACTURER UNKNOWN) and probiotics all from unknown dates, for unknown indications and unknown if ongoing. The patient previously received amoxicillin/ clavulanic acid (AUGMENTIN) on an unknown date for an unknown indication and experienced allergy to antibiotic. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 09:45 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 15:00, the patient experienced tiredness and full-body ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 tiredness and full-body ache were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Syncope twice with possible seizure activity; Syncope twice with possible seizure activity; This spontaneous report was received from a healthcare professional via FDA referring to an 18 years old male patient. The patient's concurrent condition and medical history were not provided. Information of the patient's adverse event following previously vaccination was unknown. Concomitant medication included diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL).  On 05-AUG-2019 at 11:55, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025730, expiration date not reported, but upon internal validation established as 18-JUN-2021; dose detail and strength were not provided) intramuscularly in the left arm for prophylaxis. On 05-AUG-2019 at 11:55, the patient experienced syncope twice with possible seizure activity. Emergency room/department or urgent care was visited. The outcome of syncope and seizure was unknown.     The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Follow-up information was received from the healthcare professional on 05-OCT-2020. Since the reporter did not have the patient's details, was unable to provide any information. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry: ; devicelotnumber: R025730; expirationdate: 18-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
R57.9 SHOCK, UNSPECIFIED 1/19/2023 ALCOHOLIC CIRRHOSIS
6:00 pm onset of profound fatigue and moderate pain at the injection site 7:45 pm onset chilling/rigors lasting 90minutes, even under 5 blankets 9:15 pm fever up to 100.8, headache, bodyaches, unable to sleep 3:30 am 1/7/2021 took 800mg ibuprofen 4:00 am fever broke, went to sleep 6:30 am awoke with temp 97.4, tiredness and mild headache due to lack of sleep. Got up and went to work.  -Fatigue, mild malaise, and injection site discomfort fully resolved after 72 hours with no further intervention.
swelling of wrists & hands-severe pain-severe pain in joints;moves to different joints & back;severe aches in joints;rt knee joint stiff;hands sl numb;neck pain;both hands swelled & pain;fingers sl swollen;
8 days later I collapsed. 6 days later I had a 4 inch very red and itchy elevation, it was very swollen and itchy and black and blue at the site. My skin, I had a rash, I was weak, chilled, nausea and I felt feverish. I had aches.
COLD; CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced muscle ache. On MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, headache, cold and chills was not reported. This report was non-serious.  Additional information was received from patient on 26-MAR-2021 following information was updated and incorporated into case narrative: Cold and chills event added
This spontaneous report as received from a doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed injection site redness an a small rash 5 days after she received the vaccination. The patient sought medical attention by contacting the pharmacist. No treatment was given for the events. The outcome of injection site redness and small rash was unknown. The relatedness for injection site redness and small rash was not provided for ZOSTAVAX. Additional information has been requested.
Dizziness followed by extreme achiness, chills and skin sensitivity to the touch.  Nausea followed.
low grade fever (98.8°F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever (98.8°F)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever (98.8°F)). At the time of the report, PYREXIA (low grade fever (98.8°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.8 (High) 98.8 degree F.         No concomitant medications were reported. Patient received their second booster shot and was experiencing a low grade fever. Treatment information was unknown.
Fever of 101.8 for two hours on first day of fever. Tylenol controlled to 100.3 for remainder of day and next. Three doses of maximum dose Tylenol first 18 hours, then let low grade fever run it's course. Third day temperature was normal. Intermittent Chills for about 12 hours  and constant  muscle cramping body wide from about 12 hours after shot, through third day.
Within 3 days of vax, had "flu-like" illness, temp 102, diarrhea, nausea, ringing in ears, bodyaches everywhere; exacerbation of FM beyond bearing-extreme pain in hip, knees impeding walking. Had headache, 5/2, chills, aches.
It was the pfizer vaccine, got a little tingly and light headed which I am accustomed to.  I got very tired  but I was able to drive home.  At home I fell asleep for an hour or two, swelling started in my legs mostly but also arms and all over.  They were swollen like balloons and it was difficult to bend the knee. Swelling was visable, white, no redness,  Next day my face was swollen and dark bags under my eyes.  I have had this swelling before and another bad episode was after surgery with anesthesia.  It is still very tight and sore mostly in my knees.  Not sure if it is autommune reaction or allergy.