chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; every bone in her body is aching; head is plugged up (head congestion); stomach is cramping really bad; eyes are puffy; She was miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 26Nov2021 02:30 (Lot number: 330308D) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "Thyroid issue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 27Nov2021, outcome "unknown", described as "chills"; BONE PAIN (non-serious) with onset 27Nov2021, outcome "unknown", described as "every bone in her body is aching"; HEAD DISCOMFORT (non-serious) with onset 27Nov2021, outcome "unknown", described as "head is plugged up (head congestion)"; ABDOMINAL PAIN UPPER (non-serious) with onset 27Nov2021, outcome "unknown", described as "stomach is cramping really bad"; PERIORBITAL SWELLING (non-serious) with onset 27Nov2021, outcome "unknown", described as "eyes are puffy"; FEELING ABNORMAL (non-serious) with onset 27Nov2021, outcome "unknown", described as "She was miserable".  Additional info: Patient stated she had never been so miserable in her life. The caller's symptoms started Saturday, the day after she got the vaccine. Then on Saturday and Sunday the caller stayed in the bed all day. The caller went to work Monday and dragged through it. Yesterday the caller had a doctors appointment so she went to that. Then today the caller couldn't even get out of bed.  No follow-up attempts are possible. No further information is expected.
Got the shot Monday, Jan 10, 2005 at noon. By late evening of the 11th I had aches, skin sensitivity, headache. Heavy cough started the next day. Hives developed Wednesday night. I took Tylenol. I was able to function relatively well until Saturday afternoon. I've stayed in Saturday afternoon and all day Sunday. Still have a headache, cough (from post-nasal drip?), and sore throat from coughing. I've had a moderate muscle pain all throughout.
Patient was running a low grade fever since the shots. However on July 3rd 1/3rd  to 1/2 of her upper arm turned really red and was extremely hot to the touch.
ARMPIT WAS SWELLING; BARELY COULD MOVE AROUND; BACK WAS HURTING; ARM WAS HURTING; KNEE AND LOWER HIP WERE HURTING; FEELING TIRED; This spontaneous report received from a patient concerned a male 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, batch number: 105604, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced armpit was swelling. On APR-2021, the subject experienced barely could move around. On APR-2021, the subject experienced back was hurting. On APR-2021, the subject experienced arm was hurting. On APR-2021, the subject experienced knee and lower hip were hurting. On APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling tired, armpit was swelling, arm was hurting, barely could move around, knee and lower hip were hurting and back was hurting was not reported. This report was non-serious.
diarrhea; dizziness; headaches; feeling little nauseous; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (dizziness), HEADACHE (headaches) and NAUSEA (feeling little nauseous) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (dizziness), HEADACHE (headaches) and NAUSEA (feeling little nauseous). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. On 03-May-2021, DIZZINESS (dizziness) had resolved. At the time of the report, DIARRHOEA (diarrhea), HEADACHE (headaches) and NAUSEA (feeling little nauseous) had not resolved. Not Provided          Concomitant medication was not reported.
pt recv vax 10FEB97 & 23FEB97 t102 ax high temp cont 24FEB97/25FEB97;rash on face-red blotches w/white bumps in middle;APAP given w/mod temp reduction;26FEB97 temp 100-101 now;
Large red area surrounding injection site noticed at 8PM 10/31/2018; swelling, pain, redness, hot-to-touch area below injection site above elbow, noticed 7AM 11/1/2018.
A non-serious spontaneous report of "I gave a child H1N1 and it got in my eye", irritation, scratchiness and blurred vision has been received from a registered nurse concerning herself who is a 52-year-old female, subsequent to administration of H1N1, Intranasal to a child. Neither relevant medical history nor concomitant medications were reported for this patient. The nurse herself did not receive H1N1, Intranasal. On 05-Nov-2009, the nurse had administered the vaccine to a child, and the child subsequently sprayed the vaccine from his nose into her eye. Immediately after this she flushed her eye with an eye wash. On 05-Nov-2009, she experienced irritation, scratchiness and blurred vision in the evening. The outcome of the events "I gave a child H1N1 and it got in my eye" and blurred vision was resolved. The outcome of irritation and scratchiness was recovering.
tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570).  A female patient received BNT162b2 (BNT162B2), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. MANUFACTUERER UNKNOWN.), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN.), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset Sep2022, outcome "unknown", described as "tired". Additional information: The reporter reported girlfriend received the 2nd Pfizer booster last Friday and was still very tired today which was Wednesday. She works in a nursing home and since she recently started working they are requesting a Tdap and MMR Titer. Reporter feel this was too soon to get these with her recent booster. Could you please let me know your thoughts about all these shots just a week or so apart from each other.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Beginning in early April I got sick with a Sinus infection that last for approximately 2 months, and after two rounds of antibiotics, an inhaler, Tessalon pearls, and other medication to ease my symptoms, finally got over this. Then in June 2021, I noticed some white patches on my vaginal area and went the the doctor and these turned out to be HPV warts.  I have never in all of my 63 years, had I EVER had a breakout of warts from this disease. They were on the outside as well as on the inside of my vagina. Was sent by my local OB/GYN to see an oncologist/Gynaecologist for treatment of these warts.
I have not had a menstruation since the administration of the vaccine, when I urinate and dry myself I see pink blood. There are days that I stain a little and there are days that I don't.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 71-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included SYNTHROID, Cerefolin with Nac, ZONEGRAN, WELCHOL, TRILIPIX, CRESTOR, Bisoprolol,  BONIVA, NIASPAN, Baby aspirin and CoQ-10. On 15 December 2010 the subject received 1st dose of FLUARIX (.5 ml, unknown, left arm).  On 15 December 2010, two hours after vaccination with FLUARIX, the subject experienced injection site redness and swelling injection site. The subject was administered FLUARIX by her daughter, who is also a nurse practitioner. Approximately two hours later, the subject reported redness at injection site and swelling at the injection site. The subject was treated with ice on the site. At the time of reporting the injection site redness and swelling injection site were improved in approximately five days. Follow-up information was received on 07 January 2011. It was reported that the subject experienced a site reaction with injection site redness and swelling. The events began on 15 December 2010 and resolved on 20 December 2010. The events were considered possibly related to treatment with FLUARIX. The subject had no history of drug allergies and no history of alcohol or tobacco use.
Pt should have been given the regular dose of the flu vaccine, because she is under the age of 65. Pt was given high dose flu vaccine.
Recvd 3 doses of Engerix-B & did not respond; recvd 2 booster doses & still did not convert;
Pt. received HEPATITIS A vaccine in clinic only vaccine she received.  Within 30 min. had one hive on lip and lip swelling no respiratory troubles.
there was a needle malfunction and some of the dose leaked out, the leakage was from syringe the needle may not have been attached properly/screwed in tight, unsure if patient received full dose/No AE; Poor connection with luer lok caused Fluzone syringe leakage/ no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographics patient who received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in which there was a needle malfunction and some of the dose leaked out, the leakage was from syringe the needle may not have been attached properly/screwed in tight, unsure if patient received full dose, lot UJ242AA, expiry date: 04-MAY-2020 via intramuscular route in the right deltoid on 20-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   It was a case of vaccine underdose and syringe leak.  At the time of report no adverse event was reported.  Poor connection with luer lock caused Fluzone syringe leakage.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Progressive headache,  Urticaria and itchiness  in arms, palms, hands, thigs, abdomen, back with onset 30-60 minutes after vaccine. Symptoms Alleviated after 1 dose of Xyzal 5mg.  Symptoms progressively worsened after 24 hours +  xyzal dose.  Went to the hospital were vaccine  it was administered  and took Xyzal 5mg another dose after with symptoms improvement, although urticaria and rash persist.
admitted to pediatric unit of hospital June 7th 2am with high fever over several days; severe headaches; projectile vomiting; started night of June 6th and symptoms ended June 9th. Triggered intense emotional distress as well requiring psychiatric hospitalization once medically stable.
Upon waking the day after the 2nd vaccine dose (3/25), I experienced unusual heightened energy.  Was not jittery and did not have increased heart rate, just extremely energetic (same happened to my father from J&J vaccine).  The following evening, 48 hours after 2nd dose,  (3/26), I noticed a round red spot the size of  an egg on my upper left arm, but not at the injection site. It was at the base of the same muscle.  The next day (3/27) the red spot began spreading towards the injection site in the afternoon. The spot was always warm and felt sore only when touched like a bruise. This same day I also experienced: Entire face tingling Itchy spots over entire body (as if I were getting hives but I did not get any other rash spots) Dizziness when standing and walking around Dizziness was moderate for about 48 hours and I chose to rest during that time to avoid injury Dizziness became mild after 48 hours and I was able to move around carefully Dizziness ended after 4 days total Red arm rash faded after about a week, 8-9 days I applied an expired steroid cream only once after 48 hours of the rash betamethasone dipropionate Also experienced hard stools and bowel cramps for 12-13 days after 2nd dose Note arm was never sore at injection site after 2nd dose, only after 1st dose.
Moderna vaccine administered to an unauthorized age group (patient 13 years old); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to an unauthorized age group (patient 13 years old)) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to an unauthorized age group (patient 13 years old)). On 20-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to an unauthorized age group (patient 13 years old)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter Treatment information was not provided.
Vaccine admninsitered at 1604 on 10/22/08 and individual began with nausea, fever ( 101) , chills, diarrhea, generalized body aches.  Symptoms lasted through 1600 on 10/23/08
This patient present with a Swollen and red upper left arm that felt hot to the touch.  She denied having a fever but stated her arm really hurt a lot.  Shots were recieved on 01/30/09 and  pt presented on 02/09/09
Approx 14 hours after injection, woke up with heavy chills and body aches..flu like symptoms. Very high resting heart rate (110bpm, while in bed). I average around 50bpm, according to my Apple Watch. Lasted for approx 18 hours.  Slept for almost 11 hours and felt much better. However, had a very swollen lymph node under left arm pit, same side where injection took place.  Woke up the next morning (approx 62 hours after injection) with upset stomach and chills, again. Developed high heart rate, again. Had to take LORazepam 0.5MG, then another 0.5MG tablet to help calm my heart rate. Now over 72 hours since injection and still have weakness, fatigue and swollen lymph node under left arm.
Redness, heat, swelling from upper arm to elbow. CIRPO, BENADRYL; Loratadine.
This spontaneous report was received from a physician referring to a 2-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Generalized weakness, worse in bilateral legs with blurred vision,  dizzy and lightheaded and tripping when he is walking. It occurred for a week before presenting to the ED. Today, he is still complaining of pain in his legs and unable to get up on his feet.
Severe debilitating headache, shaking chills, fever, aching joints, lethargy.  Lost time from work.
Blood sugars in the 400 to 500 range. Administered 94 units of insulin. Blood sugars still in the 300 range.; Nausea; diarrhea; Extreme fatigue; This is a spontaneous report from a contactable other HCP (patient). A 58-years-old non- pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262, via unspecified route, in right arm on 27Jan2021 at 14:00 (at 58-years age) as single dose for covid-19 immunization. The patient's medical history included diabetes, hypertension, hypercholesterolemia, previous heart attack, heartburn. The patient had no allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received other medications in 2 weeks Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 18:00 the patient had experienced blood sugars in the 400 to 500 range. Administered 94 units of insulin. Blood sugars still in the 300 range and the patient experienced nausea, diarrhea and extreme fatigue. The patient had undergone the lab test which included blood sugars (blood glucose) 400 to 500 range on 27Jan2021 and 300 range on an unspecified date in Jan2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event blood glucose abnormal and the suspect vaccine BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient received vaccines on Monday 4/9/18 and started having reaction on 4/10/18. Rash spreading from legs, feet, arms, stomach, and face (described to be itchy and look like welts.) Parent giving BENADRYL to patient, no fevers.
Pt recv vax and a few hours later exp soreness of muscle underneath her arm.  Pt developed cellulitis which went up her arm.  Pt tx=unspecified antibiotics.
Olecranon Bursitis (left)-given Voltaren Gel to use 3 times a day, pending outcome
Information has been received from a physician concerning a 13 month old asian-american male pt with left otitis media since 09/02/03, and no medical history who on 08/22/03 was vaccinated SC once in the right anterior thigh with a 0.5mL first dose of varicella virus vaccine live (Lot # 645290/0326N).  Concomitant vaccine administered in the left anterior thigh on 08/22/03 included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197)(Prevnar, Lot # 492-402). On 09/19/03 the pt "broke out in a zoster/shingles like rash on his left buttock". The physician further described the Zoster as located on the L2 dermatome, the left superior buttock had approximately 30 confluent tiny papule vesicles, and the pt was asymptomatic. Therapy with varicella virus vaccine live was discontinued on 08/22/03.  The physician reported that he did not see the pt until 09/24/03 and by then most of the lesions had healed. It was noted the adverse event abated and the pt recovered on 09/24/03 at 12:00AM. No prescription drug was required. There was no product quality complaint reported. Unspecified medical attention was sought. Follow up information received from the physician reported that photographs had been taken of the pt, but the photographs were not readily available at the time of the report. The physician indicated that he would forward the pictures at a later date when they were made available. Follow up information received from a physician on 11/19/03 included the photographs of the pt's zoster/shingles like rash on his left superior buttock area. Follow up information contained the following adverse experience: Left otitis media onset 09/02/03.  Additional information is not expected.
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a patient who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction but was not sure if it was from the PEDIARIX. The reporter denied providing any information regarding the patient or reaction the patient had.
Too young..  Mom reports child experienced chills and was tired the next day but never had a  fever.   Symptoms lasted no more than one day.  Voices she is happy her child was able to receive the 2 dose series of Moderna.  "He did great!"
Patient reports his symptoms initially started on Tuesday (11/9) with nausea, vomiting, and diarrhea.  He reports that he first began to feel his heart race yesterday morning (11/13).  He states that his pulse has remained elevated from 163-165 bpm since he had first noticed the symptoms. Patient also reports that he has not been able to take any of his medications since yesterday.  He states that it has been hard to maintain p.o. intake.
On 10/15/2022, at approximately 1150, patient presented with his parent to the vaccination site for Infant Pfizer, age 6 months-4 years, COVID-19 Vaccine. At approximately 1205, the client did not receive the dose (0.2 ml) of Infant Pfizer, age 6 months-4 years, 3rd dose COVID-19 Vaccine (Lot# FT9142). The patient moved the arm before EMT started pushing the syringe plunger into the patient's deltoid muscle. The RPh, submitted a medical consult via phone and text message to Dr. MD PRIVATE, regarding the patient's vaccination status after this incident. Since Dr. MD PRIVATE, did not respond back, the RPh, spoke via the phone with Clinical Project Coordinator RN, regarding the patient's vaccination status after this incident. Clinical Project Coordinator RN, recommended, per CDC Interim Guidelines for COVID-19 Vaccine, that since the patient had not been administered the dose (0.2 ml) of Infant Pfizer, age 6 months-4 years, 3rd dose COVID-19 Vaccine, the vaccine should be administered. Patient's parent requested that patient receive the dose on the opposite arm. At 1225, the patient received the Infant Pfizer, age 6 months-4 years, 3rd dose COVID-19 Vaccine (Lot# FT9142) on his left arm (deltoid) by the EMT. The EMT, educated the patient and the patient's parent on the signs and symptoms of adverse reactions when to seek medical care and suggested the patient to register on V-Safe. The patient and the patient's parent both verbalized understanding. At approximately 1240, the patient left the facility with his parent with unlabored respirations and a steady gait.