chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches/ Pain; Fever; Rash; This case was reported by a physician via sales rep and described the occurrence of pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, fever and rash. On an unknown date, the outcome of the pain, fever and rash were recovered/resolved.   It was unknown if the reporter considered the pain, fever and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The field representative reported the doctor mentioned a colleague of the doctor's received unknown dose of Shingrix vaccine at an unknown time, but experienced aches, pain, fever, and rash for approximately 4 to 5 days. The reporter did not give consent to follow up. The doctor who reported adverse event to field representative did not want to be contacted.
developed a headache the next day while she was at work. The pain feels like a pressure on the eyeball itself, periorbital area. The focus of the pain is right above her L eyebrow. Has had a headache 24 hrs a day following the vaccine shot. Vision has also been affected---unable to focus diagnosis----Intractable episodic cluster headache.
pt recv vax 28MAR97 & pt mom noted that on 29SEP97 pt devel a rash & 30 pox, one of which crusted over;3OCT97 pt recovered & did well w/no problems;
Left arm began hurting and continued and  early evening started swelling, hot to touch and redness down arm.
Lump in arm,  little swelling down inside of left arm and swelling, tenderness in left breast.
With day my right arm became numb every night to where I couldn?t feel it. It progressively gotten worse. A week later my left arm started becoming numb with sleep. 2.5 weeks later bilateral lower extremities. I wake up unable to move them and it?s painful.  Once I force movement it gets better. During the day I only have mild tingling in all 4 extremities but it?s getting worse. I did not get my second vaccination today.
The pt experienced redness, warmth to the touch at the injection site. Treated with Benadryl for 3 days. Redness resolved.
This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA010633:
Event occurred after 2nd dose. Patient was diagnosed with COVID 19  Ascorbic acid, Tylenol  Discharged home
tired; achy; arm very sore; nausea; feeling unwell; throbbing injection site that was very hot; throbbing injection site that was very hot; She woke up twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 11:00 (Lot number: ER8732) at the age of 86 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: From 40 years. There were no concomitant medications. Vaccination history included: Flu vaccine (Adds after getting the flu vaccine she contracted the flu. When ask for information regarding the flu vaccine that she took and then got the flu she states that was many years ago and she was working for a hospital and it was required.), for Immunisation, reaction(s): "then had the flu". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "tired"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "achy"; PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "arm very sore"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "nausea"; MALAISE (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "feeling unwell"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 25Mar2021, outcome "recovered" (26Mar2021) and all described as "throbbing injection site that was very hot"; MIDDLE INSOMNIA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "She woke up twice".  Additional information: There were no additional vaccines administered on the same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated she had a history in reacting to a long list of unspecified medications that were mostly heart medications. Patient reported she was fine until evening on the day of vaccination (25Mar2021) and then she was tired, achy, her arm was very sore, she had nausea and was feeling unwell. During the night, she woke up twice with throbbing at injection site that was very hot. She mentioned she has a very high pain tolerance so it was pretty bad to wake her up. Adds all of her symptoms went away by the next morning. Events did not result to emergency room visit and physician office visit.  No follow-up attempts are possible. No further information is expected.
Began turning white (pale) and sweating. Had a headache and could not focus. SOB and wheezing. She took a Medrol dose pack and Benadryl.
Patient is 48yo, presented 48h after 2nd Moderna vacccine with an acute right MCA stroke, required IV tpa and thrombectomy. Only known risk factor is active cigarette smoking.
Narrative:  diarrhea resolved w/o txt or other intervention. Patient had recent treatment with antibiotics(augmentin 875mg bid)that was completed 3 days prior to event, diarrhea
The first dose less than 6 months prior had no adverse reaction other than a sore arm.  This time the area turned bright red and about the circular size of an egg. It was raised slightly and  was very hot and sore.  This lasted for probably about 4-5 days.
It was reported that a 47 year old female patient received a Fluzone SV 2001-2002 vaccination, administered on 12/12/01. The patient experienced itching immediately and redness (8cm) at the injection site.
Patient reports of not feeling well, clammy, dizziness, and ringing in ears. Patient has had reactions to antibiotics previously. Patient reports of above symptoms and was placed on a cot, given water, and cool packs. Patient's symptoms improved without further treatment.
On 10/2/21, I began with the normal reported symptoms of chills, fever, body aches.  I wear a  constantly and noticed that my heart rate was elevated.  It became very elevated and stayed so all day...my heart rate varied from 105 to over 138 throughout the day.  I took a cold shower, drank cold water, did deep breathing exercises and held my breath for a beat before exhaling as attempts to lower the heart rate.  These attempts would work just for a very few moments (the time of the breath and approximately 5 minutes after getting out of the shower).  However, none of these methods kept my heart rate down.  I went to bed with the intention that if my heart rate did not slow by 10/3/21, I would go to the hospital to be checked out.    My heart rate stayed high overnight from 10/2/21 to 10/3/21.  I spoke with the nurse hotline for my insurance and she advised that I go to the emergency room as, when at rest, my heart was at 105 to 110 bpm and when walking around the house it would rise to over 120.    I went to the  Medical Center Emergency Room on 10/3/21 where tests were conducted and I was released with a diagnosis of sinus tachycardia.    As a baseline for the heart rate, my normal resting heart rate is between 73 and 75 bpm.  On a normal day, I will register only approximately 70 to 120 exercise zone minutes  and that is with specifically trying to exercise.  On 10/2/21, when my heart was racing, I was not able to do anything but lie down.. registered 458 exercise zone minutes.  Additionally, my normal daily calorie burn is between 1900 to 2500 calories with exercise.  On 10/2/21 with no exercise and just lying down, my calorie burn was 3,525.
Rash and flushing face, chest and legs immediately after receiving immunization in the legs. Benadryl 10 mg IM given immediately. Signs/ Symptoms resolved within 15 minutes.
4 hours later, fever of 101, chills , muscle aches, nausea, continues 24 hours + later
Left upper arm warm to touch; reddened and raised at injection site; hard knot at injection site. Rash to upper and lower extremities.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in left arm, on 27Apr2022 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in left arm and on 16Dec2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) or other medication in 2 weeks included: SYNTHROID; LOSARTAN; COZAAR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Treatment of COVID-19; (2022) Positive, notes: Recurrence of symptoms on day 10 with a positive COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19. For covid-19, the patient was given anti-viral Paxlovid from 23Jun2022 to 28Jun2022. Treatment also included Remdesivir.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient went into urgent care with fever, cough, and rash on right arm legs, and body.  She had been on amoxicillin since 1/8/15 for ear infection.  Lesion noted on right arm where varicella vaccine administerd.  Dr described as a cyst like lesion on posterior right arm.  Rash on Right Posterior Arm: 2.5cm X 1cm. Erythematous. Indurated. No vesicles, pustules or crusts. No red streaks. No discharge. No obvious breaks in skin. Mildly tender to palpation. She was diagnosed with cellulitis and given oral Clindamycin.
All information obtained through the Database report. Client presented to the emergency room via EMS after he was found down in the bathroom by his wife unable to move his left side of his body with altered mental status. On exam in the emergency room, the patient is altered with aphasia therefore unable to provide any history.
left eyelid began to twitch and to this day has been off and on everyday; This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) solution for injection, intramuscular on left arm on 18Dec2020 08:00 at a single dose for COVID-19 immunization. Medical history included seasonal allergies. Concomitant medication included liothyronine. On 19Dec2020 at 23:00, patient reported his left eyelid began to twitch and up to this day it has been off and on everyday. No treatment was given. The event was reported as non-serious. The patient was not diagnosed of Covid-19 prior to vaccination and has not been tested for Covid-19 since vaccination. Outcome of the event was unknown.  No follow-up activities are needed. No further information is expected.
t104, listless, irritable x 3 days; adm to hosp on 3rd day; MD called to report react & request to note on chart not to receive pertussis in future;
After give immunizations instructed Mom to wait for 15 minutes. Baby was asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping.; Cry and was easily aroused; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2425360-1. The original narrative from the sender is the following:  After giving immunizations instructed Mom to wait with both children for 15 mins in our vaccination room and when returning to give mother the visit summary at 11:40am , baby was sitting in infant seat sound asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping. Mother reported that baby's nap time is usually around this time of day and she had been up since 6 am and last feeding was at 10:30am . Asked RN to please hold baby and stay with mom , retrieved our NP and our volunteer to please help assess baby in vaccination room. Applied child size bp cuff on left thigh to obtain bp reading and then baby began to cry and was easily aroused. Baby was then placed in mother's arms and baby was smiling and awake. Informed with help from translating RN that should mother see any changes in baby's respirations or behavior to please go to er or call emergency services for evaluation . Let her know that usually in the first 15 mins post vaccination that is when a reaction is likely to occur. Baby Awake and alert and responding to her mother. Discharged in stable condition with mom.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "After give immunizations instructed Mom to wait for 15 minutes. Baby was asleep, tired to arouse baby with sternal rub- baby still sleeping, checked pupils with bright light, baby still sleeping." and "cry and was easily aroused".  No further information is expected.
On 4-26-11 pt was given PENTACEL & varicella vaccines. On 5-6-11 mother noticed redness & a few bumps on right lateral thigh. Brought to ER 5-7-11 to have a Dr. look at. Advised Ibuprofen children no distress.
We have a patient who swears that she is now in Hospital (january 2007) for "Bilateral Lobal Pneumonia" due to her recieving Fluzone from us on 10/25/2006.  She has always gotten her yearly flu shot with no complications, but felt tired and/or lethargic weeks after this years vaccination.  Her daughter relayed all this info to me.  1/26/07 Received medical records from hospital which reveal patient experienced respiratory distress & was admitted 1/8-1/11/07.  Treated w/antibiotics, bronchodilators & steroids.  Improved significantly & was d/c on tapering prednisone & close f/u. FINAL DX: Multilobar pneumonia in a smoker; possible bronchogenic neoplasm which will be worked up as outpatient; hyponatremia; COPD; multifocal atrial tachycardia, short duration; tobacco abuse; & hyperlipidemia.
Case number PHEH2013US022744 is an initial spontaneous report received from a pharmacist on 28 OCT 2013 and a follow up report from the pharmacist received on 28 OCT 2013. This report refers to a 14-year old patient of an unknown gender. The patient was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly on 26 OCT 2013. No more information was available. No adverse event reported following this medication error (inappropriate age of vaccine administration). Follow up report from the pharmacist received on 28 OCT 2013. The age of the patient was updated. The report type changed from other to spontaneous report.
The next day I experienced  bring feverish to becoming chilly.  Additionally, I had a lose of appetite, the smell of food made me nauseous and I was lethargic. I sleep nearly the entire day.
Rash on belly, pt treated with 1 tsp of Benadryl 3-4 times daily and also use Motrin 1 tsp four times daily to decrease inflammation.
6:50 PM child developed 104 degrees fever and eye lids swelled. 1:50 PM child complained that back, legs, neck and left arm hurt - given 1 1/2 tsp Tylenol elixir - developed dry mouth and sore throat - Tylenol every 4 hours - saw MD 9:10 AM on 6/12/03.
Information has been received from a healthcare worker referring to 3 patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the 3 patients might have possibly been vaccinated with 3 doses of improperly stored PROQUAD (Merck) (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse effect reported. It was unknown whether the patient sought medical attention. Additional information has been requested.
BEGAN WITH BEING TIRED, NEXT DAY BUMPS ON FACE LIKE BEING BITE BY A SPIDER, TIREDNESS, WEAKNESS & ACHES, ON 10/9 EYES STARTED ITCHING, FACE WAS GETTING ITCHY AND TO FEEL LIKE A SNAKE SKIN DAY TO DAY, ON NIGHT OF 10/11 WOKE UP @ MIDNIGHT EYES EXTREMELY ITCHING, BY THE AM FACE FLAKEY ALL OVER, EYES & FACE SWOLLEN & ITCHING, PLUS HEADACHES, BACKACHES, HOT SWEATS, CHILLS.
A year after my 2 vaccines (no boosters) I have swollen lump nodes under my arm pit.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 0.5 ml (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and type of excursion (R/F) for each time were 72, 29 and R; 112,30 and R; 24,31 and R; 104, 33 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
1hr p/vax had fever of 101.5, hoarseness, congestion, cough, unable to sleep; given motrin 4x throughout weekend;
no adverse event; a dose of MMRII which expired on 18Aug2022 was given; This spontaneous report was received from a register nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 23-AUG-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) virus vaccine live (rHA) subcutaneous injection, 0.5 milliliter/ once, lot #T027935, expiration date: 18-AUG-2022, administered for prophylaxis (strength and route of administration were not provided) (expired product administered) with sterile diluent (MERCK STERILE DILUENT) (lot #T003595, expiration date: 03-NOV-2022). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had no history of temperature excursions. No other adverse event was reported (no adverse event).
Started noticing upper left arm pain 4 hours after injection, around 6pm. Left arm too painful to move for 24 hours. Pain was mostly in deltoid where shot was given. Injection site seemed unusually high on shoulder. Injection site never felt worse than a mild sports bruise. No visible inflammation or other external symptoms. After 48 hours still painful, but full motion of arm possible. After 96 hours most pain was gone, but not comfortable to lie on left side.
the muscles in my neck is achy and sore; painful to turn but not excruciating; fever; chills; My body is achy; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (the muscles in my neck is achy and sore), PAIN (painful to turn but not excruciating), PYREXIA (fever), CHILLS (chills) and PAIN (My body is achy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced NECK PAIN (the muscles in my neck is achy and sore), PAIN (painful to turn but not excruciating), PYREXIA (fever), CHILLS (chills) and PAIN (My body is achy). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (the muscles in my neck is achy and sore), PAIN (painful to turn but not excruciating), PYREXIA (fever), CHILLS (chills) and PAIN (My body is achy) outcome was unknown.            Treatment medication included Tylenol and ibuprofen.
family stress; depression; drug effect decreased; Walking difficulty; Rheumatoid arthritis flare up; Activities of daily living impaired; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 30-Mar-2021, 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. In May 2021, the patient experienced FAMILY STRESS (family stress) and DEPRESSION (depression). In 2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty). The patient was treated with METHOTREXATE at a dose of 1 dosage form. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired), THERAPEUTIC PRODUCT EFFECT DECREASED (drug effect decreased) and GAIT DISTURBANCE (Walking difficulty) had not resolved and FAMILY STRESS (family stress) and DEPRESSION (depression) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccine on Saturday at 10:50. Evening and next day Saturday I had regular symptoms of second dose (fever, headache, chills). By Monday I felt better, but woke to see that my chest above my breast line and neck seemed red. It did not bother me at the time. Tuesday I woke up and felt a prickly feeling on my throat, looked in the mirror to find a very localized rash on my throat. It itched a little, but was very intense and localized only on my throat when I thought about the day before. My husband confirmed this was also the case. I took a picture and started taking allergy medicine immediately and some old steroid cream I had for anti-itch. I have now been doing this diligently for three days and it is finally getting better but still definitely not resolved.
Patient reported dry, itchy rash around ankles - started 2 days after vaccination; worsening for 8 days.