chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 (DOSE 1, SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2 SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN; Lot number: unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm is still sore". Additional information: Caller stated that he got the 4th shot, the booster, the Pfizer, caller then clarified that he got the 4th dose of the Pfizer Covid vaccine. He wanted to ask a question. His arm was still sore but its was getting better, he would like to know how long would he be susceptible to somebody that has covid and how long does the vaccination take before he was fully covered. Caller confirmed he was trying to find out how long it would take to have immunity. Caller further clarified that he had just been informed that a person that he was potentially going to see today has been exposed to covid, but it had not been confirmed yet if that person has the virus. Caller declined safety report stating that he is only calling for his question. Caller was probed when did he received his 4th dose, caller stated that he was not exactly sure but he thinks it's been exactly a week. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Delayed menstrual cycle by 10 days. Previously very regular, even after multiple live births. Still has not returned to normal.
Starting afternoon after vaccine, extreme fatigue, sore muscles, achy, fever 100%, oxygen level lower than norm (95%).  No appetite.
After receiving second does injection I went to bed at my normal time (10:00pm.  I woke up during the night about 1:00 AM with soreness in arm, dizziness, low grade fever and chills.  Felt lethargic all through the next two days.  Saturday and Sunday my arm was still tender but I had no energy however I was experiencing headaches.  Monday went back to work for 5 hours and returned home with low grade fever, chills, headaches and lethargic.  Not coughing , I have an appetite and have not lost my since of smell.
Child starting with rash on lower legs several hours after vaccine admin. Rash spread to arms, neck, face within 24 hrs. Given BENADRYL 12.5/5ml rx.
pt recvd vax & 3 days p/vax devel necrotizing enterocolitis & antigenemia; pt was transferred to reporter's facility for surgical evaluation of the necrotizing enterocolitis;
the patient has had difficulty walking; patient has not wanted to bear weight on lower extremities; This spontaneous report has been received from a nurse prescriber, concerning a 13-month-old male patient. The patient's drug reactions or allergies, medical history, and concurrent conditions were not provided. The patient's concomitant therapies included cetirizine hydrochloride (ZYRTEC).   On 04-MAY-2022, patient was vaccinated with 0.5 milliliters (mL) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number T037029, which has been verified to be valid, expiration date reported and validated as 03-NOV-2022), as prophylaxis. On the same date, he received 0.5 mL of hib vaccine conj (tet tox) (HIBERIX) injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number U015845, which has been verified to be non-valid (non-company lot number), expiration date reported as 01-APR-2023), as prophylaxis. Also, varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number U015845, which has been verified to be to be valid, upon internal review the expiration date was reported as 21-SEP-2023 but, validated as 19-MAY-2033) as prophylaxis.   On 04-MAY-2022 (since administration), the patient had had difficulty walking (Walking difficulty), has not wanted to bear weight on lower extremities (Weight bearing difficulty), and defaults to crawling after walking attempts. No treatment was given for the adverse events. Patient had sought medical attention. At the reporting time, patient had not recovered from the events.   The action taken with suspect vaccines regarding the events was considered as not applicable.   The causal relationship between suspect vaccines and the events was not provided
Won't move in circles on back and front; won't move forward and back on front, all of which child could do before receiving vaccinations.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unspecified dates, these patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose and route were not reported; lot# K007974 with expiration 03-JUN-2016; lot # L000453 with expiration date 06-JAN-2017; lot # L017998 with expiration 19-MAY-2017). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
The day after the second injection my blood pressure and heart rate became increasingly unstable unstable. It was not until  April 5 that my heart rate increased to 150 during my chemo infusion of caboplatin and taxol. I was taken to the emergency room and prescribed a blood thinner for atrial fibrulation. I was given a cardioversion on May 18. Blood pressure and heart rate have been stable since then.
Back was hurting; No appetite; Has absolutely no energy; Just doesn't feel ok; Pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to the company on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back was hurting), DECREASED APPETITE (No appetite), ASTHENIA (Has absolutely no energy), MALAISE (Just doesn't feel ok) and PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Spinal stenosis. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for Spinal stenosis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back was hurting), DECREASED APPETITE (No appetite), ASTHENIA (Has absolutely no energy), MALAISE (Just doesn't feel ok) and PAIN (Pain). At the time of the report, BACK PAIN (Back was hurting), DECREASED APPETITE (No appetite), ASTHENIA (Has absolutely no energy), MALAISE (Just doesn't feel ok) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-296545, MOD-2021-022507 (Patient Link).
Patient is a 37 yo female new patient referred by the ED for allergy consult on delayed urticarial/angioedema 2 days following the initial dose of Pfizer Covid19 vaccination.   Timeline:  4/19/21 Received her first Pfizer immunization at clinic.   4/21/21: She woke up with a systemic itchy rash. Worst in flexural regions like the folds of her groin, elbows, knees and where her bra meets her skin. The hives didn't stay fixed and didn't respond to benadryl. She also was experiencing joint pain in her hands and ankles.   4/23/21: Increased benadryl dose to 50 milligram Q4 hours which initially helped but then the hives returned.   4/27/21: Seen at a local urgent care and was prescribed a medrol dosepak. She didn't fill this immediately given pharmacy wait time.   4/28/21: Woke up with upper lip swelling. Went back to urgent care and was given epinephrine which didn't help. She was referred to the ED where she was given an IV, IV benadryl and more epinephrine. Tryptase was not obtained. At no time did she have dizziness, throat swelling, or difficulty breathing. Her lip swelling resolved and she was discharged home. Her blood pressure and respiratory exam in the ED were normal.   She continues to have itching and rare hives.   She is currently on day 3 of the medrol dosepak and is taking benadryl 50 mg. Q6H    She denies a history of medication/vaccine allergies/reactions.   She had recent IVF retrieval on 3/29 and is currently taking birth control pills for ovarian suppression.
Pt started having sign of SIRVA after vaccine was administered. Vaccine was administered in Left deltoid. Pt is having ongoing treatmetn with Ortho.
8-10 scattered papular-vesicular-crusted lesions on trunk and scalp. Rash 1st appeared 23 day after the administration of Varivax vaccination.
First it was dizziness, light headed, nausea, and vomiting, headaches, and extreme weakness. Went to the Hospital received IV fluids  and sent home.  Wasn't any better and lost my taste and smell for 3 days. Went to the Clinic, was tested for Covid-19 and the flu both negative. Went back to the Clinic and had chest x-ray, diagnosed with right middle lobe pneumonia.  Sent home with doxycycline and zofran. Took the Medication as directed. Still feeling dizzy and lightheaded, and still winded and extremely tired after doing the slightest bit of house work, whether it would be sweeping the floor, doing dishes, or laundry. I get extremely after doing one activity. I still have not driven.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. In July 2013 the patient was vaccinated with first dose of GARDASIL (dosing details, lot and expiry date not reported). No concomitant medication was reported. The patient was administered with the second dose in series of GARDASIL (dosing details, lot and expiry date not reported) in July 2015 (inappropriate schedule of drug administration). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Information was received from a chief researcher through an online article via a company representative referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date, dose and route were unknown). On unknown dates, the patients experienced adverse events included Guillain-Barre syndrome (paralysis), lupus erythematosus, thrombus and encephalitis (cerebral palsy). The outcome of the events was unknown. The causality assessment between the events and GARDASIL was not reported. Upon internal review, all the events were determined to be medically significant events. This is one of several reports received from the same reporter. Additional information is not expected.
The patient experienced redness, warmth, induration, and itchiness in a 7-8 cm diameter area at the injection site with associated axillary adenopathy.
The pt developed erythema multiforme hive like reaction 6 days after the vaccinations. The pt also ran a fever of 104. The pt has recovered without sequelae.
Developed a ?rash? which started on the face, onto the neck and slightly on the torso. The rash was composed of tiny pink-red dots. They did not itch or ooze. After 3 days the rash subsided and the skin returned to normal. Felt generally run down.
Increased fatigue Short of breath Easily sore Vertigo Constant ache in spine Constant issues with gallbladder Nausea Abdominal pains Gas Occasionally feel feverish Forgetting more Random coughing fits  I had some issues with my back and gallbladder, but I could manage them. I work at a pharmacy store, and we were pushing vaccines, etc. I waited a while before getting them, the first one I got a fever but was okay. Second one was kind of the same. Symptoms started mild not long after the second and just got worse.
RA redness, slightly swollen, warm to touch, slightly firm, no c/o tenderness, no fever, advised to see child's pediatrician. 3/22 Mom states he prescribed antibiotic and OTC Benadryl.
Arm pain started 1/28 lasted 4 days Swollen and painful lymph nodes, left armpit, left supraclavicular, also in groin -started 1/29/21-  still happening Abdominal pain and diarrhea on 1/30/21 Spleen swelling/swelling just below left rib front and back and pain started  and no appetite 1/31/21- still happening
Laying on L side to sleep, felt pain to armpit, feeling for lymph nodes, did not find any one particular but discomfort seems more on the 3rd day.
sensory changes and weakness started on 2/25/03 patient presented to the ED on 2/27 with left sided numbness, head CT and MRI of brain and spine were performed and came back normal, discharged on 2/28/03 presented to ED again on 3/4/03 with increased weakness, fatigue, and difficulty walking, was treated with Solu-Medrol and discharged on 3/7/03 on oral prednisone
Weakness; Chills; Aching; Nausea; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received Shingrix. On 10th September 2019, 1 days after receiving Shingrix, the patient experienced chills, pain, nausea, fatigue and weakness. On an unknown date, the outcome of the chills, pain, nausea, fatigue and weakness were unknown.   It was unknown if the reporter considered the chills, pain, nausea, fatigue and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient demographic details were not provided. The age at vaccination was not reported. The patient reported that, after vaccination with dose of Shingrix, currently experienced chills, aching, nausea, fatigue and weakness. The reporter did not consent to follow up.
Severe itching, redness, sores on back, arms, torsal, upperlegs, buttocks.
Currently have Tinnitus since 1992, upon taking the shot and booster Tinnitus severely elevated each time.
Symptoms started a week after receiving the booster shot. Severe hives and swollen joints. These symptoms were reduced with several rounds of prednisone. Still breaking out in hives/rashes/swollen 3+ months later. The severity varies.
A knot  on her  one arm; Achy arm; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (A knot  on her  one arm), PAIN IN EXTREMITY (Achy arm), PYREXIA (Fever) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Aug-2021, the patient experienced NODULE (A knot  on her  one arm), PAIN IN EXTREMITY (Achy arm), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, NODULE (A knot  on her  one arm), PAIN IN EXTREMITY (Achy arm), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, Body temperature: 106 f (High) 106 F.         Concomitant- A medication for migraine   This case was linked to MOD21-128456 (Patient Link).
1) on 01/04/21, around 1:30 pm received vaccine to left arm, 2) 01/05/21, around 4 am, woke up with headache, sore throat, temp 99.1, left arm slight numbness and tingling 3) 01/05/21, 6am,  symptoms worsening, temp 100.1, severe body ache, headache, sore throat, chills, nausea, diarrhea,severe weakness, left arm more numb and tingling. Symptoms were consistent and as severe as covid infection that I experienced in August,2020. On 01/05/21 tested negative for covid and flu ( tested at nursing facility where I work) Today, 01/06/21, I'm still bed resting, no fever today, and less headache and body ache. Left arm is just sore- no numbness or tingling. I do realize that most of these symptoms are listed under side effects,  but my side effects are as intense as my covid infection. Beck in August, last year, I couldn't get out of the bed for 8 days, due to aches, and all the other mentioned symptoms ( except arm problems). I was not hospitalized, but I was never that sick in my life. Based on severity of reaction to vaccine, I'm not planning to take second dose.
DRY HEAVING; BUMP; BURNING SENSATION; BRUISE AT INJECTION SITE; CHILLS; SORE ARM ALL THE WAY DOWN TO MY ELBOW; HIGH FEVER; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced dry heaving, bump, burning sensation, bruise at injection site, sore arm all the way down to my elbow, high fever, chills, headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from high fever, sore arm all the way down to my elbow, chills, and headache, and the outcome of burning sensation, bruise at injection site, bump, dry heaving and tiredness was not reported. This report was non-serious.
Pt's cheeks got very puffy and swollen 15 days after his MMR vaccine. His face was swollen around his eyes and between his eyes at the top of his nose, his skin on his face was red and itchy, then later got rough and had raised bumps on it.
Patient received flu vaccine in left arm. That evening, she felt feverish and chilled. These symptoms were gone by the next morning. Her main complaint was pain in the left arm, into the left axilla and left lateral breast. The pain in left arm extended to just beyond her elbow. She stated the elbow joint was achy. TYLENOL relieved discomfort some what, but not completely.
I all of a sudden had a loss of balance and my left side of my body stopped working.  I could not support myself with my left side of my body.  I could not push myself up with my left arm.  I met with my cardiologist because they thought it could have been a mini stroke and they ruled that out.  I am waiting to get an appointment with a neurologist to see if I have something going on in with my nervous system.   The symptoms has happened about 4 times.
patient was administered Fluad instead of Fluzone High Dose, no AE; Initial information was received on 30-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a male patient who was administered with INFLUENZA VACCINE INACT SAG 3V [FLUAD] (lot number and expiration date not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (wrong product administered) via unknown route at an unknown administration site for prophylactic vaccination in Sep-2020 (exact date was not clear).  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to wrong vaccine administered (same day).  Patient was wondering if he should get re-vaccinated because he wanted the High Dose vaccine.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
red patch on my upper leftarm that has developed in the days since the shot was given. It's about 2 inches wide and feels warm to the touch. The red patch is located where I received my injection.; red patch on my upper leftarm that has developed in the days since the shot was given. It's about 2 inches wide and feels warm to the touch. The red patch is located where I received my injection.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 at 09:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, asthma and irritable bowel syndrome. The patient had no allergies to food, drug or other product. 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 fluoxetine (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and oral contraceptive nos (MANUFACTURER UNKNOWN); all for unknown indication, from an unknown date and unknown if ongoing.  On 08Mar2021 at 12:00, the patient experienced red patch on her upper left arm that was developed in the days since the shot was given. It was about 2 inches wide and felt warm to the touch. The red patch was located where the patient received injection. 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. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event red patch on her upper left arm that was developed in the days since the shot was given, it was about 2 inches wide and felt warm to the touch and the red patch was located where the patient received injection was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt stated she completed the Moderna vaccine series on 3/13/21 and 4/13/21.  She has been in bed for the last 3 days.  The first day she was unable to move from the bed and had a fever of 102, headaches, incontinence.  She is able to move some today but states her legs are rubbery which is a feeling she has never felt before.  She said she has been very confused the last few days and dreaming a lot more than usual.  She is improving but still not back to herself at this time and plans to discuss with her neurologist later today.