chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FluLaval administered to a 5 months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3K75S, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a Flulaval vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
she often needs a cane to walk; slight headache; muscle pain; A SPOTANOUS report was received concerning a 92 Years old, Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) SECOND dose on 16-feb-2021, batch no:016M20A intramuscular route     The patient's medical history was not provided     Event of Problem : Patient stated that she received her 2nd dose of the Moderna COVID 19 vaccine on 16FEB2021 at pharmacy. About a week ago (unsure of the exact date), she started having slight headache and muscle pain. The muscle pain usually starts in the evening and she often times need a cane to walk. She takes Aspin to alleviate the symptoms. She has not called her doctor because she does not think it is necessary.    Treatment information was ASPIRIN  Action taken with mRNA-1273 in response to the events was not provided.     The outcome of the events were UNKNOWN
I had an asthma attack the following morning after receiving the vaccine. I had to do a breathing treatment.
The left deltoid site of injection, had severe pain with throbbing. Tingling on the surface of the left hand.
left arm became very swollen (1/2 inch thicker); pain; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via Medical Information (Reference number- 00353583) and transmitted to Sanofi on 10-Nov-2020.  This case involves a 35 years old female patient who experienced left arm became very swollen (1/2 inch thicker) and pain, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 04-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [formulation: prefilled syringe, lot number and expiry date not reported] via an intramuscular route at the left arm for prophylactic vaccination.  On 10-Nov-2020, the patient developed a non-serious left arm became very swollen (1/2 inch thicker) (vaccination site swelling) and pain 2 months 6 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that, the swelling initially increased outside of the sharpie marking and then decreased.  Product used: Used  First time product used: Yes  Still using product: No  Details of laboratory data not reported.   The patient was treated with PREDNISONE and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). However, patient tried heat, ice and massage and did not help the pain to go away.  At the time of reporting, the event outcome reported as unknown for events.  There will be no information available on the batch number for this case.
achy all over started about 7pm, woke up in the middle of the night freezing and achy all over, unable to sleep and felt worse than when I actually had covid. unable to get warm and shivering without having a fever for hours. severe left arm pain and aches lasted until the evening of 9/12
After taking the first dose, the right side of my face started to feel tingly and numb. Also, today my right leg felt tingly as well.
Information has been received from a registered nurse concerning an unknown number of dialysis patients with renal failure who on an unknown dates were intramuscularly vaccinated with 1mL of 3 dose series of RECOMBIVAX HB (lot# was not reported), respectively. The nurse reported that patients have failed to seroconvert after receiving a 3 dose series of RECOMBIVAX HB dialysis formulation. Patients sought unspecified medical attention. At the time of the report patients' present status were not recovered, they had negative antibody titers. This is an amended report. Upon internal review, the LLT and PT of the AE "patient have failed to seroconvert" has been changed from "Anti-HBs antibody negative" and "Hepatitis B surface antibody negative" to "Hepatitis B antibody negative". No further information is available.
20 minutes after the injection had numbing and mild swelling of lips, similar to my reaction toward sulfa drugs, but more mild.  Too, had redness on cheeks, again, lar to my reaction toward sulfa drugs, but more mild. the day of the injection, had extreme pain in right arm,  chills, mild fever, tiredness.  this lasted for 3 days. the following week, after the injection, severe headaches began (1 to 2 weekly) combined with neck stiffness/pain in the back of my neck lasting several hours each day, sporadic warmth throughout my body, mild burning sensation in my lungs when inhaling strongly,  but most severe is my extreme dizziness combined with nausea and brain fog.  Dizziness last throughout the day, regardless of sitting, standing, walking, etc. I thought this may be related to my vestibular schwanoma; however, after doing Dr. recommended exercises that fixed dizziness previous, these had no effect.   3 months later (now 7/30), neck pain has decreased drastically but there is still some stiffness, headaches are very infrequent now (1 every other week), burning lung feeling has subsided to almost never (couple of times weekly when breathing deeply), body warmth has intensified however, I've difficulty sleeping throughout the night,  dizziness continues but nausea is subsiding, and brain fog also lingers (I've the constant feeling of disconnectedness - I struggle to stay focused since my mind wonders).
Nauseous; Did not want to eat; Stomach pains; Vomited; Temp at 99.6; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 9-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Dec2021 (Lot number: FK5618) at the age of 9 years as dose 2 (tris), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: ZYRTEC and MOTRIN. Vaccination history included: Comirnaty (DOSE 1 (TRIS), SINGLE, Lot Number: FK5618, Route of Administration: Intramuscular), administration date: an unknown date in Nov2021, when the patient was 9 years old, for COVID-19 immunisation.  The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 18Dec2021 at 07:00, outcome "unknown", described as "Stomach pains"; VOMITING (non-serious) with onset 18Dec2021 at 07:00, outcome "unknown", described as "Vomited"; NAUSEA (non-serious) with onset 18Dec2021 at 11:30, outcome "unknown", described as "Nauseous"; DECREASED APPETITE (non-serious) with onset 18Dec2021 at 11:30, outcome "unknown", described as "Did not want to eat"; PYREXIA (non-serious) with onset 18Dec2021, outcome "unknown", described as "Temp at 99.6". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper, vomiting, nausea, decreased appetite and pyrexia.  Additional Information: It was reported that, a 9 year old boy received 2nd dose of COMIRNATY approx. 5:00pm on 12/17. Woke up around 7:00am on 12/18 with stomach pains and vomited. Around 9:00am reported feeling better, but at 11:30 was nauseous and did not want to eat. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Excessive sleepiness, vomiting, headache, hot itchy painful rash at injection site and surrounding tissue traveling up to shoulder and down to arm.
REPORTS HEADACHE, NAUSEA, REDNESS AND SWELLING AT INJECTION SITE, SORE WHEN LIFTING ARM -- STARTING 2 HOURS POST DOSE. PT HAS TREATED W/ ICE, IBU, AND BENADRYL
chills 11 hours later, lasting 3 hours. Body and joint aches and fatigue the day after
Patient was given 1 vial of un-reconstituted vaccine or the equivalent to 6 doses
This spontaneous report has been received from a medical assistant referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
about 5-10 minutes after injection i had phlegmy feeling in my throat and had to keep clearing it. Very uncomfortable and felt like if i didn't clear it I couldn't breathe.   Lasted about 1 hour 15 minutes.  Also felt very nauseous but didn't throw up.
Within an hour of the second dose, I was so tired that I fell asleep and slept over 24 hours.  When I awoke, I had soreness in my muscles and cramps.  The cramps migrated to my chest area and I have had severe chest pains, soreness in the back of my neck on the left side and in my left chest with occasional tingling in my right arm.  The pains have slowly subsided and went away for about 5 days and returned fiercely last Friday in the middle of the night.  It hurt so bad I couldn't sleep, so I took an Advil and after 30-45 minutes, the pain subsided.  When the Advil wore off, the pains returned, so I attempted to contact a walk in clinic, they referred me to an urgent care facility.  The urgent care facility took my vitals, asked about my symptoms and then hooked me up to an EKG.  They told me I have an abnormal T-wave and sent me to the emergency room.  The emergency room triaged me, took blood samples, reviewed my EKG and took chest X-rays.  After several hours, they ruled out heart conditions and sent me home with a prescription for heartburn medicine.  I do not have heartburn, I have symptoms that mirror Myocarditis/Pericarditis.
Information has been received from the authors in a published literature article. This case concerns a retrospective analysis that studied the impact of 7-valent pneumococcal conjugate vaccine (PCV7) on the incidence of invasive pneumococcal disease (IPD) in cancer patients, along 20 years. The patients included were registered with =1 visit(s) between 01-JAN-1992, and 31-DEC-2012. Unique patient-visits (UPV) (inpatient or outpatient) per calendar year, age, and cancer type were obtained from hospital databases. However, non-cancer patients were also included. Patients <15 years were considered "children," and =15 years were "adults." Children 04 years were referred to as "vaccinees," and patients =5 years were "non-vaccinees."  Three IPD cases "before 7-valent pneumococcal conjugate vaccine (PCV7)" had documented vaccination with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) prior to IPD diagnosis. IPD was caused by pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) serogroups (serogroup 6 in 1 patient and serogroup 15 in 2 patients). No patient's identifiers were provided. The outcome of pneumococcal infection was unknown. Upon internal review the event pneumococcal infection was considered to be medically significant.
Seconds after injection my left arm had an icy numb sensation from injection site to my fingers. Today Three weeks later I experienced same icy sensation  plus numbness/weakness, decreased  sensation in fingertips. 2. Still have bad Headaches still after 3 weeks 3. Extreme Fatigue still after 3 weeks 4. Last few days, three weeks after shot, I have worsening/ Increased joint pain, spiky pain in joints, chills and entire body aches like I have the flu. No fever, no runny nose, etc. Just the body aches, joint pain like people experience with the flu. 5. Decreased  mental sharpest last 2 weeks since shot.  6. Light headedness, dizziness. 7. Immediately after shot I experienced metal taste in my mouth. Since the shot, I still experience occurrences of metal taste every day.  8. Today experiencing slight numbness in right foot. 9. Swelling in fingers
Asthma attack at vaccine facility - breathing treatment at home.    Beginning morning of 03/15/2021 - hair loss on head, fingernails sore day after filing them, sensitivity to caffeine, extremely dry eyes.   As of 06/21/2021 still have all symptoms.
I had an area on my right wrist that was almost healed from eczema that started after the first vaccine as I previously reported. That area became inflamed and itchy. My lower right arm became covered with eczema as a couple of days progressed. I have since ended up with it on the left side of my face.
p/vax pt started having nose bleeds;pt stated nose bleeds cont off & on through next day & would bleed 2-3hr @ a time;pt had inc body temp but not checked w/thermometer;face started to break out w/small bumps;h/a, stuffy nose & lips swell
Side effects started as flu symptoms the day after the vaccine, but then on Thursday, there was an extremely swollen lymph node under my left arm - it was visible and I couldn't put my arm down all the way. There was also pain around my kidneys / flank area that wrapped to the front near the bottom of my ribcage, extreme fatigue and loss of appetite. On Friday, the about the same. Then on Saturday I felt great, went to the grocery store and had a terrible episode where I had intense shoulder pain that shot down deep plus an extreme faintness that I could not get rid of - even while sitting. I have neurocardiogenic syncope, so I know what helps you prevent fainting but this was different - so intense that even sitting wouldn't stop it. I went to the ER, where my blood pressure and pulse were elevated but all blood work came back normal. I was released in a few hours. I continued to feel fatigue and faintness upon being up and around too much the following day. It's now almost gone, but I still feel the fatigue. I tire so easily.
Vertigo, motion in brain, loss balance, headache, nausea.   Been over a month.
SOB shaking and anxious @ 3:30 pm. 911 called taken to local ED. Rxed with Benadryl 50 mg and prednisone x 5days. Pt c/o hives on both extremities, generalized itching and throat closing.
I only had a sore arm for a day or two after receiving the vaccine. The first of August 2022 I started experiencing headaches in the front of my head. I contacted my doctor, and I had a brain MRI and a brain CT scan. After that I was referred to a neurologist and she reviewed the test and diagnosed me with fibromuscular dysplasia. The doctor was not concerned about it at this time but advised to take baby aspirin and magnesium every day.
Patient became dizzy and fell to ground. Patient has HX of seizure disorder and possibly had small seizure emergency called and EMS arrived to check her out. Refused ambulance. Walked out on her own.
Client received first dose of Moderna Vaccine at 15:31. 15:32--sat down in observation area F.  Without warning, client lost consciousness, fell from chair and hit head/left side on concrete floor. Was unresponsive x 1min.  Used Syncope protocol. APRNs  assessed client and local on-site paramedics notified  Client denied difficulty breathing, or any other symptoms typically associated with anaphylaxis. 15:36: BP 87/57, pulse 67 15:37--client awake and talking. Complaining top of head hurts. Client reports she has not eaten today, as she indicated she was very anxious about getting the covid immunization and reports she did not sleep last night. Next page15:39: BP 110/65, pulse 87 15:41: BP 119/77, pulse 91 15:47: BP 110/77, pulse 88 15:50--paramedics started IV and checked blood sugar at 103. Client very anxious, but agreed to be tranported to ER due to hit to head. Local transport unit called. 16:01: BP 98/64, pulse 76. 16:03: EMS transport unit arrived/transported to Emergency Room.
My leg started swelling and it kept getting worse by the day. At night it was scary so i went to the doctor. Before i went i tried icepack and keeping my leg up and wrapping it but nothing help. When i went to the doctor she gave me a steriod and anitboticis she thought it looked like cellulytics. The meds did help but i didn't make it go away she sent me a doctor to get a scan of my leg and no clot was shown on the scan. They then put me on a medication that is used for gout. They didnt think it was gout but they thought that it will help the issues with the swelling and it did help. And i now do still have some slight swelling and had to wear compression shorts for a few months. And it did go away.
9/20/2021 Vaccination *Sharp ribbon of pain in front of L ankle and left calf. 12/29/2021 I only experienced side effects the day I was hospitalized. Chest pain, very sharp, very localized. I had sharp pain in L posterior Calf. SOB. I am in the healthcare field. I went back to bed after self evaluation. I was very SOB getting ready for work, pushing thru. I got out of the garage and stopped in the driveway. The SOB was not going away, quite pronounced, pain in calf, ankle. I couldn't get out a whole sentence. I sat in chair by doorway, put my head down, and sat there for about 10 minutes. My husband wanted to take me to the ER. After awhile, I went to work. Between home and work, I had to stop 3 times as I was extremely SOB. It took me another 2 stops to get to the garage to catch breath. I told self I had to stop being in denial and went to the ER with SOB, chest pain; admitted to the Hospital. I had to wait 4 hours for hospital bed as they were so busy. L lateral chest, pain occurred again. Nitroglycerin and heparin drip on me. I developed heparin induced thrombocytopenia. Started another IV Argatroban drip; frequent lab draws and vital signs; therapeutic. I was hospitalized for 7 days. Hematologist diagnosed me with 'vaccine induced immune thrombocytopenia'. *Brand new syndrome vaccine related syndrome to the booster. Hematology appt 1/13/2022;  PCM is 1/6/2022; Cardiologist is trying very hard to free a appt time for me in the next week. *1st & 2nd dose, fever of 102-103 w/ chills and body aches.
Immediately upon completion of inject white welt size of dime noted surrounded by area of redness 2" x 2" - area warm to touch. No wheezing or problems breathing. MD examined liquid Benadryl given pt was watched for 10-15 min w/no other sx.
I had terrible inflammatory reaction; my right injection arm was sore; then site was swollen up; numbness and I couldn't put my arm or hand down, it throbbed, literally; I had right wrist swelled up; fingers turned into bluish; I don't feel right; This is a spontaneous report from a non-contactable consumer (patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included varicos veins. Reported that patient had lots of inflammation in me, varicose veins, during covid, I haven't been to have them cut and redirected during Covid. My heart doctor said I have inflammation in me, he didn't know if I had a massive mold inflammation, or if it was from my heart or mold infection. The next vaccine scheduled on Thursday, I really want to have this protection, I don't know if I am having a stress attack over this. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced i had terrible inflammatory reaction, my right injection arm was sore, then site was swollen up, numbness and i couldn't put my arm or hand down, it throbbed, literally, i had right wrist swelled up, fingers turned into bluish, i don't feel right. It was reported that patient was fine the day after right injection arm was sore, like normal, then site was swollen up and then I had the 3rd day after I had right wrist swelled up and I couldn't use it, and I couldn't put my arm or hand down, it throbbed, literally unusual. I got supports for wrists and oh no, that was worse. I actually massaged it to get vaccine around and got it going. It lasted 4 to 5 days and along with that I had some, once in a while, 2 or 3 times where is happened, I got up from the chair and stepped down and my right foot gave out. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 25-30 minutes, patient began having "itching in her throat" and tachycardia on assessment
bump, red, raised, warm; To ER DPH given; rash lasted 2 1/2-3wks chest, back, bad;no problems @ this time
Info has been received from an RN concerning a 9 year old male who on 1/2/98 (also reported as in 1996) was vaccinated, SC with a 0.5ml 1st dose of varicella virus vaccine live (lot 624063/0958E). Concomitant vaccination included a 1st dose of MMRII (lot 622896/0740E) given, SC. There was no illness at the time of vaccination. On 1/3/06, (previously reported as 1/2/076), the pt presented with about 50 vesicular lesions on his trunk and face. No other symptoms were noted. Unspecified medical attention was sought. It was reported that the pt recovered 4 or 5 days later on approximately 1/7/06. No product quality complaint was involved. Additional info has been requested.
PT DEVELOPED INTENSE PAIN ON HIS FACE THAT FELT EXACTLY THE WAY IT FELT WHEN HE HAD SHINGLES ON HIS FACE SEVERAL YEARS AGO HOWEVER, THE PAIN WAS ON THE OPPOSITE SIDE OF HIS FACE THAT HE HAD HAD SHINGLES ON. PAIN DEVELOPED WITHIN 24 HOURS OF VACCINATION AND CONTINUED FOR 3 DAYS.
Extremely tires about 9pm normal soreness to left arm started developing  Wike up at 1:00 shaking, temp 101.3 Ibuprofen 600 mg taken.  Its 3:55  temp is 101 1
Vertigo, confusion, dizziness, mottling at injection site, and neuropathy starting roughly 1-2 days after vaccination and lasting 2 days. symptoms still persist at the time of reporting
pt recvd MMR vax on 19JUN90 & pt became pregnant; conception was thought to have occurred on 22JUN90; delivered a nl infant by C-section on 17MAR91;
Evening 12/30  chills with temp 102.3-100.1 , severe headaches . symptoms persisted for 3 days then disappeared
I came home and found my father on the floor in his bedroom just after 8am.  He was disoriented and unable to get up.  I had to lift him up and he was still off balanced.  I asked him if he had fallen and how long he was on the floor.  He couldn't give me a clear answer and I don't know how long he was on the floor.  I noticed he seemed very weak and I asked him when was the last time he had something to eat and he wasn't sure.  He said maybe 1 or 2 days.  I asked if he didn't have an appetite and he couldn't answer me or give me a reason.