chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Not long after I got a quick dizzy spell that ended and I was fine About 7 minutes after I noticed a slight rash on my  upper chest and person checking on me did as well. It was very mild (I had a much worse one with my mri contrast) but she wanted to keep an eye on me and said my 15 minutes  wasn?t up for seven minutes . She stayed with me and very close by. I cannot say enough good things about her. Everyone at this facility were great!  I felt fine and told her that. I was not itchy. At the end of my 15 minutes she said I could pull to the side because I asked to use the restroom and wanted to see if I had it anywhere else. It was already looking better and I notice it also on my right upper leg. I had  a thicker diarrhea without stomach cramps or anything.  I didn?t feel bad or great but just wanted to go home. She asked if I wanted to see someone inside and I declined and she suggested I follow up with my healthcare doctor after making sure I was okay. I took a Claritin I had on me before leaving. My mouth got extremely dry and I drank a large water. If I didn?t not my throat kind of had a mild burn to it and cottonmouth.  I didn?t feel bad but I didn?t feel as good as I did going into the first shot. After arriving home an hour and a half later it would come in waves of not feeling great and then feeling okay. I was very worn out and felt had I not tried to push though it would help. I took a Benadryl at 3 am and Advil . Day two just normal side effects. Fatigue headache nausea which I used  zofran and Advil. My skin feels itching from time to time but no rash. Injection site clear with mild soreness.  My left ear keeps feeling like pressure off and on. Nothing severe to me. .
Altered mental status, nonverbal, arouses to painful stimuli, increased ICP. Cerebral edema on CT scan. L.P.: 14.7 WBC / 85% lymphocytes. Sterile at day 43. Required mechanical ventilation.
Awoke during the night 10/18/02 with pain and weakness both arms right arm worse than right. Developed fever and cough over the weekend. Has developed rash around the waist the past 1-2 days. No improvement as of 10/25/02.
I woke up the next morning (1/4/22) with a drooping left eye, my family pointed it out to me. Since then (today is 1/5/22) my eye continues to twitch and my vision is somewhat blurry out of that eye. This is not normal for me.
Hives started day after received flu shot. Hives started resolving 10/25/13 per voicemail left by patient. Cannot return phone call as her phone is not working.
Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 47 years old male patient who experienced received vaccines INFLUENZA VACCINE on Dec-2018 and 0.5 ml single dose of FLUZONE QUADRIVALENT on 15-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if adverse event was experienced or not. 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.
Nausea; Chills; Shakes; Headache; Injection site pain; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021 at 12:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19 and allergy to penicillin and cephalosporin. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknow if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 14Mar2021 at 20:00, the patient experienced nausea, chills, shakes, headache, injection site pain and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, chills, shakes, headache, injection site pain and fatigue was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Symptoms seem to be similar to Reactive Arthritis: severe joint pain and stiffness (knees, ankles, wrists, lower back)
The patient was administered the Fluzone HD Quad 23-24 vaccine via PFS using a fliplock 25gx1" needle. Patient reported and verified NKDA or autoimmune disorders. She is currently well and has not been exposed to COVID in the last 14 days that she is aware of. Patient has received Fluzone HD in the past and has had no issues with any vaccines previously. Upon removal of the needle, the patient began to bleed slightly. This was cleaned using an alcohol swab. Immediately, a knot/bump began to develop. The patient was monitored for several minutes prior to allowing them to shop in the store. By the time the patient left, the "bump" had started to flatten. Patient is a retired nurse. She was informed I would be submitting a VARES report. I recommended she consider taking some ibuprofen or APAP as directed. Additionally, I suggested she try alternating 15min of heat and ice if needed for pain and swelling. I plan to further follow-up with the patient this afternoon. Patient was informed to contact her provider or EMS if symptoms worsened.
Member was carrying a large box and when he went to maneuver through a doorway he felt a stabbing pain through the center of his chest to his back--rated 9/10. The pain lasted for 2-3 minutes and then he felt a persistent dull pain. Patient has been very tired since symptoms began 26 Apr 03. Still feels the persistent dull pain -- 4/10. Patient taking indomethacin 75 mg i bid.
Two days after receiving the dose, I felt nausea and had diarrhea. Two days later (01/08/22), I had phlegm and a sneeze. Today (01/09/22), I awoke with more phlegm, a light cough and continuous sneeze.
Client reported history of lightheadedness after vaccines/needle sticks. Client advised to lay down for vaccine administration. Prior to vaccination, client reported lightheadedness, headache, clammyness, nausea. Vaccine administered. Client remained in prone position x 10 mins post vaccination. Given snack and client reported improvement in symptoms. Client instructed to sit up and after 5 mins began to feel lightheadedness, headache, nausea again. Instructed to lay prone. EMS called. Transported to local ER.
Injection site is swollen; Injection site is red; Hurt initially, Injection site is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE PAIN (Hurt initially, Injection site is very painful) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (Hurt initially, Injection site is very painful). On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site is swollen) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE SWELLING (Injection site is swollen), VACCINATION SITE PAIN (Hurt initially, Injection site is very painful) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Product was stored in refrigerator after expiration; they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients) and PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered expired doses of the Moderna Covid-19 Vaccine from 2 vials to 2 patients) and PRODUCT STORAGE ERROR (Product was stored in refrigerator after expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Date the vial was initially stored in the refrigerator on 28 Mar 2022. The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-528254 (Patient Link).
Patient experienced tinnitus starting one week after first dose and intensified after second and persisting tinnitus.
Minor injection site pain was present the afternoon  of vaccination,  approximately 7 hours after receiving the vaccine.   I woke up about 2:15 am the next morning with chills and was unable to get warm.  When I got out of bed, the morning of the 13th, I started to feel unwell and became overly warm.  I had to go back to bed and lie down.  I did not have a fever.  Through the rest of the morning I alternated between feeling chilled and overly warm.  I was feeling better by about 2:00pm.   No additional problems were noted except for continued injection pain site
Red spots/ rash on chest; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient previously took KENALOG for an unspecified indication and experienced drug allergy. Concomitant medications were not reported. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced red spots/rash on chest. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event red spots/rash on chest was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
WRECKED ALL DAY; HORRIBLE ACHES OVER MY WHOLE BODY; MUSCLE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced wrecked all day, horrible aches over my whole body, and muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrecked all day, horrible aches over my whole body and muscle pain was not reported. This report was non-serious.
Family had flu vaccination.  When mom had flu mist had bad reaction.  Sore throat and headache/fever.  Concerned that will give to children.  Does have fever. Cough. No trouble breathing.
Breakthrough case admission after 2 vaccines Moderna 2/15/21 Lot# 013M20A;  Moderna 4/9/21 Lot# 037A21B
p/vax pt became fussy & irritable & devel an inj site rxn characterized by a quarter size area of erythema & swelling;seen by MD 4/23/99;pt recovered;
RSV Virus with a booster; her back is broken; she cannot get out of the bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "RSV Virus with a booster"; BACK INJURY (non-serious), outcome "unknown", described as "her back is broken"; BEDRIDDEN (non-serious), outcome "unknown", described as "she cannot get out of the bed".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information was received on 11-JUL-2017 from a pharmacist who reported that a patient (age and gender not reported) received a dose of ZOSTAVAX subcutaneous (lot# reported as N012092, expiration 31-MAR-2018) reconstituted with sterile diluent (lot# K021919, expiration 30-SEP-2017) on 11-JUL-2017. The pharmacist reported that, after this dose was administered, the patient's wife stated that the patient had already received a dose of ZOSTAVAX (lot#/expiration unspecified) on an unspecified date "4 years ago". No adverse effects were reported. Additional information has been requested.
Myalgia, Arthralgia fatigue, polyuria and soreness in shoulder 12/27. weakness 12/28. pain upper UE is better, mild soreness conts in LE 12/29
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received KINRIX (batch number 935RF, expiry date 17th September 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to KINRIX. Additional information received: Vaccine administered to a 2 months old infant. No symptoms were reported.
15 min after admin. of HPV vaccine, mom reported client had jerking motions of arms as if having "seizure", then slumped over onto mom while in sitting position. Nurse found pt. awake, pale, diaphoretic in sitting position. Pt states "I blacked out". Placed pt's head down between knees. Within 2-3 min color pinked up. Client moved to supine position on floor. Ambulance called. Assessed and counseled by paramedics. Mom declined ambulance ride to ER. Client walked out of clinic w/mom in satisfactory condition. Per follow up call on 5/22 mom states doing well and has consulted w/MD.
Rapid onset of hoarseness & fast irregular heart rate. Treated in emergency room for atrial fibrillation. Kept in ER for several hours. Released home. 12/2/09 ER records received for date 11/18/09. DX: Presented to ER w/ c/o irregular HR, hoarseness pt states had H1N1 vax this day. Assessment: (+)irregular HR.
Patient lost his hair- all of it over the course of 3 months and became completly bald. He has not had any new growth.
Information has been received from a health professional concerning a 24 year old female who on approximately 08/16/2001 was vaccinated with a dose of varicella vaccine. In August 2001, over the last five days since the vaccination, the pt developed a generalized rash. No description of the rash was available. No other symptoms were reported. Unspecified medical attention was sought. Additional info has been requested.
Pain in joints, pain in muscles, headache, tired, continued for five days, then on 11/24/2014, the sixth day after, the injection site became inflamed with itching and swelling.  The injection site problems are just now easing somewhat on 12/01/2014, but it is still red, swollen and itching.  This area on my left arm is about two inches by three inches.
Information has been received from a foreign legal firm concerning a female who on 12/12/95 was vaccinated with MMRII. Subsequently, the pt experienced learning problems, autism and language problems. Upon internal review, the pt's learning problems, autism and language problems were considered to be other medical events. No further information is available.
She had a low grade fever of 100.6 at max. She also had congestion.
THE PT RECIEVED A SINGLE DOSE OF FLUZONE FROM A MULTIDOSE VIAL USING THE NEW PHARMAJET NEEDLE-FREE MACHINE ON FRIDAY SEPTEMBER 9, 2011 AND BY SATURDAY HER ARM HAD A LARGE HOT RED RASH FROM ABOVE THE SHOULDER TO ABOUT 7 INCHES DOWN AND IT WAS PAINFUL AND THE INJECTION SITE HAD A ROUND HARD LUMP ABOUT A CENTIMETER IN DIAMETER.  THE RASH WAS GONE BY MONDAY BUT THE HARD LUMP WAS STILL PRESENT AT THE INJECTION SITE AND THE AREA WAS STILL HOT.
Spoke with patient regarding incorrect age vaccination given. Patient states she has no adverse reactions. Informed patient to return to clinic for appropriate dosage.
No other information provided; Pediatric patient was inadvertently given PUENMOA VX 23 the patient was 7 months of age; This spontaneous report was received from a medical assistant, referring to a 7-month-old pediatric patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 23-JUL-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration were not provided) for prophylaxis (product administered to patient of inappropriate age). No other information provided.
6" x 4" edema, erythema, hyperemia, tenderness, typical of urticaria rxn around inj site;
Information has been received from a registered nurse for ZOSTAVAX a Pregnancy Registry product refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, dose, route and indication were not reported). The patient that may have received ZOSTAVAX on an unspecified date may have had a case of shingles on an unspecified date while pregnant. Nurse could not confirm whether patient had a possible history of ZOSTAVAX administration. The LMP and EDD were not known. The pregnancy outcome and the outcome of adverse event were not provided. It was noted that the patient also who was immunocompromised and pregnant again may also had a diagnosis of shingles in 16-AUG-2013 (MARRS number 1308USA008620). Additional information has been requested.
0.25ml influenza vaccine was administered as a first dose for the 2017-2018 flu season. The recommended dose for this vaccine was 0.5ml. No adverse reaction was observed. Parents have been notified and asked to return to clinic for revaccination at no cost.
He got his vaccine and had his boots on he had a burning sensation in both ankles around 10:00 PM.  Then when he got home at 1:00 AM and removed his boots he saw what looked like chicken pox on both his feet and ankles.  It was a very strong itch and he started scratching them.  He has one on both inner thighs, but  it has not progressed any further.  They are red and really itchy.  The next morning he started scratching and noticed that thy were breaking and there was clear liquid coming out of some of them.  He has not taken anything for them or put anything on it.  They are still as bad as they were on Monday but are not getting any better.   He went to the ER on Tuesday and said that it was not shingles or chicken pox and that it was just an allergic reaction and was given steroids which he has not taken.
Papules, pustules, malaise, headache, pruritis- started 3/11/04- papules appeared 3/12/04 treated with antihistamines
headache; nauseous; soreness at the site; extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN5318, expiration date was unknown), via an unspecified route of administration in the left arm on 24Jan2021 at 12:15 at a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hyperactive thyroid; known allergies to penicillin, eggs, and cashews; and severe allergy to all dairy products; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin, ezetimibe (ZETIA), acetylsalicylic acid (BABY ASPIRIN), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. She had not tested for COVID post vaccination. On 24Jan2021, after 2-3 hours of receiving the vaccine, the patient became very nauseous, which lasted for three days. It had eased at the time of the report. On 24Jan2021, the patient also had soreness at the site, extreme fatigue, and headache. The patient had headache for about one day; however, she managed to deal with it without pain killer. The patient drank a lot of warm water with fresh ginger and lemon (with peel) to control the nausea. The patient was very fatigued for three days following the vaccine. Therapeutic measures were taken as a result of nauseous. The patient did not receive treatment for the events "soreness at the site, extreme fatigue, and headache." The patient was recovering from the events "nauseous, soreness at the site, extreme fatigue, and headache."