chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/18/21 Fatigue, starting ~3pm, slept for 10 hours that night 3/19/21 Extreme fatigue, starting ~2pm, chills, nausea, muscle pain, and fever starting at ~5pm lasted throughout the night. Vomiting began ~8pm lasted throughout the night.  3/20/21 Still chills and slight fever, nausea but no vomiting.
Blisters on full length of left arm, muscle pain and severe tingling all day starting on 8/22/2022   Valcyclovir prescribed
Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction.
Became nauseous and pale approx 5 mins after vaccination. No food prior to vaccination. Gave pretzels and water. Color returned to normal and nausea resolved after 10 mins. left at 1332 with mother.
Pt was at the pharmacy picking up script for Zovirax. She informed me that she had fever chills and fatigue that lasted more than 4 days after she got her vaccine. She currently got fever blisters which her MD suspects may be caused by COVId vaccine. She tried Abreva but that did not help, so she went to her MD who prescribed her Zovirax.
About two weeks later developed cramping in Left leg.  Also has varicose veins. Had the cramping before.  No more cramping but feeling of tightness remains around the calf.  Not hot, not red. but seems like the veins seemed red and now purple.  Seem to have more spider veins.  medial posterior part of calf below the knee.  Didn't think anything about all this until heard about the news about the JnJ vaccine.   Also had a different type of abdominal pain.  Almost felt like she may be constipated but wasn't.  Only lasted a few days.  Has been unable to make an appointment with PCP until may 4th.
This spontaneous report was received from the patient's mother referring to a female patient of unknown age. The patient's concurrent conditions included sulfa based medications allergy. The patient had not concomitant medications and no pertinent medical history. In July 2018, the patient was vaccinated with GARDASIL 9 "1 x 0.5-mL dose at 0, 2 and 6 months", intramuscularly, for prophylaxis (lot # and expiration date were not reported). On an unspecified date in 2018 (reported as "about two weeks after receiving her first dose"), the patient experienced warts on her fingers. At the time of reporting, the outcome of the event was reported as not recovered on an unspecified date. The causality assessment between warts on her fingers with GARDASIL 9 was not provided. This one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA006350: US-009507513-1810USA006397.
Three days after receiving varicella virus vaccine live the pt experienced a mostly papular rash on the arms and face.
Patient had received Flu vaccination in 10/2018 but did not report any adverse reaction until 12/2018. Pt stated that he has soreness in his Arm. Initially patient was showing different area of the upper arm (not Deltoid muscle) but when Rph said it would not be because of Vaccination, pt had switched the area and said pain goes lower and upper arm at different times, Rph has advised patient to go see PCP for evaluation first and then let Rph know of outcome. Patient returns in Feb 2019 and still has not seen PCP and said he was taking Ibuprofen to see if it goes away. Rph advised again to go see Doctor for evaluation. Patient shows different areas of upper arm for pain every time.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (lot number and expiry date unknown) (dosing regimen and frequency unknown) that was not stored correctly. No concomitant medications were reported. No adverse events were reported. No product quality issue was reported. This case is related to case number 1405USA007252 and 1405USA008991 via same reporter link. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to a 2 months old female patient. The patient had no pertinent medical history, concomitant medication or drug reactions/allergies. On 21-FEB-2019, the patient's mother was breastfeeding the patient "just minutes" prior to the patient receiving a dose of ROTATEQ (lot # N030152 with expiration date 01-SEP-2019; strength and dose detail) orally for prophylaxis. On the same day, the patient "projectile" vomited "right after receiving" the dose of ROTATEQ. No treatment was givent to the patient. The patient didn't perform any labdiagnostics/studies. The outcome of vomiting projectile was reported as recovered on 21-FEB-2019. The causality between the event and ROTATEQ was not provided.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route were not reported), lot # J013904, expiration date 30-OCT-2015; lot # K002919, expiration date 26-FEB-2016; lot # reported as K005183, expiration DATE 10-APR-2016; lot # reported as K008880, expiration date 09-SEP-2015 and lot # reported as K023624, expiration date 19-FEB-2016. Total number of doses administered was 37. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pain at injection site, redness and swelling at injection site, chills, slight fever, fatigue, headache.  Onset of symptoms was about 8-9 hours after injection.  Most symptoms cleared up within 48 hours, although some redness and soreness remained.
Patient given 1st dose of Pfizer vaccine to right deltoid by vaccinator on 1/14/2021 at 1322. At 1325 patient reports the following symptoms: shaky and also visibly noted shaking of bilateral hands, reports verbally not feeling nervous beforehand of vaccine or needle, throat felt closed at first after vaccinated but then felt improved, states throat felt different, feels heart beat fast and then not. Reported to nurse, writer and once assessed: alert and oriented to person place and time, speech clear, patient sitting at the time, oxygen saturation 98% on room air, pulse varies from 98 to 118. Gave 1 capsule of 25mg Benadryl orally and 911 called. EMS arrived and they evaluated patient, left clinic with EMS at 1410. Writer called ED RN and gave report. Patient left sitting in a wheelchair.
3-4 days following immun devel red rash on chest & abdo; no urticaria or fever; seen by MD;
LADY SAYS WITHIN A HOUR OF VACCINATION SHE EXPERIENCED NUMBNESS IN THE EAR AND PAIN IN HER JAW (TOOTHACHE TYPE PAIN). SHE ALSO HAD THE SORENESS IN THE ARM FOR 3 DAYS. ALL SYMPTOMS HAPPENED ON HER LEFT SIDE (INJECTION SIDE).
Pt states that approximately 24 hours after receiving his first dose of the Pfizer vaccine he began having 8/10 chest pain and feels like he cannot take a deep breath.
Was seen 9/5/17 for well care. Had HPV, MENVEO in left arm, Tdap and FLULAVAL in right arm. Mom noticed redness and swelling last night 9/6/17 in left upper arm. Was tender and itchy this morning 9/7/17. Site red and warm to the touch. 9/7/17 School nurse marked it at around 12:00, redness grew outside the lines when we saw it around 2:30PM. Felt dizzy and nauseous while in school nurses office, had resolved by the time she came in for her appointment. No fever or chills, able to move arm. Diagnosed with local reaction to immunization. Advised by Dr to continue to apply ice 3-4 times per day and use BENADRYL every 6 hours as needed. Instructed to call if any increased tenderness, pain, fever. streaking or chills.
This case was reported by a healthcare professional via a sales representative and described the occurrence of sore arm in a 54-year-old female subject who was vaccinated with Boostrix (GlaxoSmithKline). On an unspecified date the subject received 1st dose of Boostrix, the subject experienced sore arm. At the time of reporting the outcome of the event was unspecified.
cough; spitting of phlegm to clear lungs; runny nose; grogginess; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 17:45 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COUGH (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "cough"; PRODUCTIVE COUGH (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "spitting of phlegm to clear lungs"; RHINORRHOEA (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "runny nose"; SOMNOLENCE (non-serious) with onset 03Dec2021 18:00, outcome "not recovered", described as "grogginess". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, productive cough, rhinorrhoea, somnolence.  Additonal information: It was reported that there was no Covid prior vaccination and was tested for Covid post vaccination. It was also reported that there are no other vaccine in four weeks and it was not available whether there are other medications in two weeks. Lot unknown reason was misplaced/discarded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
neuropathy symtoms  feet, hands numb and burning.  testing by neurologist shows no neuropathy but still stympstoms.   artheritis symtoms arms hands neck,   swollen fingers , dropping things neck pain and wrist pains.   Had similar reaction to shinrix vacccine but not senior flu shots.
Pt. states that after receiving the 3rd Booster of Moderna 11/15/2021, started experiencing symptoms 11/16/2021 of feverish, chills, and muscle aches. Self-treating with Tylenol, no noted Primary visit/communications. Symptoms have subsided. 11/15/2021 Influenza Quad Flu Vaccine given.
01/22/2013 Noticed redness and swelling the following morning with itching. That morning the area measured approx 2 inch dia to 6 inch diameter by the second day. The area still has redness, swelling, heat, and itch on 4th day 01/25/2013.
PATIENT HAD MODERNA VACCINE ON 04/23/2021 and 05/21/2021, AND TESTED POSITIVE TO COVID.
Itching in the arm; Redness 3 inches wide in the arm; A spontaneous report was received from a consumer concerning a 59-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching in arm/pruritus and redness (3 inches wide) in the arm/erythema.  The patient's medical history, was not provided by the reporter. No concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : 027L20A)  for prophylaxis of COVID-19 infection.   On an unknown date, some days after receiving the vaccine the patient experienced itching and redness (3 inches wide) in the arm.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, itching and redness (3 inches wide) in the arm are unknown.
102 degree fever, serious headache, full body aches, chills, ringing in ears
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot# L013428, expiry date 03-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to separate temperature excursion (dates unspecified): lasting for 24, 136 and 32 hours, with the lowest recorded temperature of 34, 31 and 30 degrees Fahrenheit, respectively. No adverse effects were reported. there was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt reports on 1/30/07 7 PM - was itching all over and had fine red raised rash on chest, both forearms, both thighs, denies fever. Rash and itching lasted 3-4 days - gone by 2/3/07. Also had localized swelling at injection site.
Pain and swelling in left arm ~12hrs after shot Swelling of left armpit and lymph nodes in left arm put ~ 36hrs after shot Mild Asthma  symptoms (use of prosit inhaler required ~67hrs after shot Mild Edema -right side of face and nose; right palm, right forearm
I got my shot and she said, "oops, I missed the muscle." Then, my arm swelled up, my lymph nodes swelled up, I had nausea, vertigo, and vomited. I took TYLENOL, methocarbamol, meclizine, and went to sleep the rest of the day. I may or may not have taken and edible. I can't remember. I was coughing so hard that my chest and ribs started to hurt. Everything else has cleared up but the chest and rib pain.
40 cm length 50 cm width red and swollen. Temp 98.7, O2 sat 97%, P 84. ATARAX Rx admin.
Hives for 3 days, psoriasis on scalp felt like on fire for 11 days, constant body (ALL OVER) itchiness (going on for 9 days now), difficulties breathing (still current), coughing attacks persistent and lasts for 13 minutes with sometimes urinating clothing because it gets so bad (still current), coughing up phlegm every morning after waking up (still current), internal ear canal itch (12 days)
Severe muscle pain, severe joint pain in ankles, knees and hips, joint pain in fingers back and shoulders. Temperature up 4.5 degrees F.
Severe Spinal Aches - Mid Back to Hips - 3days HeadAche - 3days Elevated temperature - 2days (101.4, 101.2) Left Ear pressure and loss of hearing - 3days Left Collar Bones Ache - 3days Memory Loss - ongoing - couldn't remember personal phone number, names of shellfish eating, loss of being able to complete sentences because couldn't remember words to complete thought, loss of focus while driving forgetting destination point Left side of Jaw ache and lower teeth ache Eye tear ducts - sappy sticky fluid at tear ducts
My arm was sore and it was black/bruised for a week and half. Two weeks later on August 17th, I develop a ringing in my ears. And it has not stopped.
Inpatient- 1/23/10 - 4/8/10, transferred to another hospital with encephalopathy of unknown etiology.
Muscle stiffness on left side of neck, left jaw locking, nausea, headaches, fatigue, itching,  breathing discomfort
pt recvd vax & was presented w/lower extremity & lt arm paralysis for 1 yr; No dx has been established; grandmother had never been immunized;
Next day post vax, the pt developed an injection site reaction characterized by 4.7 cm by 3.5 area of redness and warmth.
Headache, NauseaVomiting, itchy throat Narrative:  itchy throat, headache , nausea - resolved without intervention
About 2 days ago, patient started to feel numbness at the lips, uncontrollable eyelid movements, heaviness in eyeball, right ear pain and inability to raise right eyebrow. Patient said her PCP diagnosed the symptoms as Bell's palsy and prescribed meds for her. Patient did not provide name of meds to staff on-call. Patient was advised to follow-up with her PCP to assess if she should receive dose 2.
Extreme pain in joints (all) and all over muscle soreness. Started at 10:30pm on 9/27/15 and lasted until 3am on 9/28/15 teeth chattering, chills, sweating, urinating profusely.
One week after vaccination. The vaccination site became red itchy and swollen.  Went to see the doctor they said to watch it and put warm compresses on it. The next day it continue to spread. I did decide to take some Benadryl on the Second night. Today is day three the injection site looks a little lighter in color it is still itching. My concern is should I take that second dose?
systemic autoimmune conditions with serum testing, MS was diagnosed;   A 29-year-old female patient received bnt162b2 (Formulation: Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS (hospitalization, medically significant), outcome "recovering", described as "systemic autoimmune conditions with serum testing, MS was diagnosed". The event "systemic autoimmune conditions with serum testing, ms was diagnosed" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: 0.71; csf test: pleocytosis (8 leukocytes/ul), an elevated igg, notes: index (0.71), and 10 oligoclonal unmatched bands in the CSF; investigation: negative diagnostics for systemic autoimmune, notes: conditions; investigation (normal high range 5): 5, notes: with positive orbiting sign and mild pronator drift; 4; magnetic resonance imaging head: multiple brain lesions, including several, notes: periventricular and juxtacortical white matter lesions with one enhancing lesion in the right centrum semiovale; magnetic resonance imaging neck: multiple brain lesions, including several, notes: periventricular and juxtacortical white matter lesions with one enhancing lesion in the right centrum semiovale; neurological examination: noted to have weakness in, notes: her left arm (power 5/5 per scale), with positive orbiting sign and mild pronator drift), and left leg (power 4/5 per MRC scale); white blood cell count: 8, notes: /uL. Therapeutic measures were taken as a result of multiple sclerosis.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported multiple sclerosis and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : PFIZER INC-202200012202 Same article/drug/event and different patient;PFIZER INC-202200012201 Same article/drug/event and different patient
rash; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and INJECTION SITE PAIN (Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash) and INJECTION SITE PAIN (Injection site pain). At the time of the report, RASH (rash) and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax 8FEB96 & 25FEB97 pt devel gen chickenpox on stomach, back, & groin consisting of less than 50 lesions;
Sore arm. Began within the first 15 minutes; Joint pain (shoulder, elbow, wrist) didn't begin until 6pm that same day, still occurring; Swollen hand,  noticed at 10am on August 4th(morning after)
10/29/99:Pt. received Pneumo shot and later that evening developed syncope,became light-headed, & had arm pain at injection site.11/26/99:pt presented w/ swollen autecubital area & slight numbness.Tx w/ Keflex
His sister had blurry vision with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (His sister had blurry vision with the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (His sister had blurry vision with the vaccine). At the time of the report, VISION BLURRED (His sister had blurry vision with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Spike in blood pressure noticed around one week after injection; treated by doctor by adding amlodipine besylate 5 mg on 4/15/21; follow up appointment on 4/21/21 showed normal blood pressure Pulsatile tinnitus in left ear - scheduled MRI MRA for 5/13/21; referred to ENT; hearing test on 5/4/21 revealed no hearing loss in left ear and mild nerve loss in right ear; no other issues noted with nose, throat or carotid artery noise; follow up scheduled for 5/18/21 to review MRI MRA results Pulsatile tinnitus remains in left ear, along with minor episodes of dizziness and mild headaches in front and back of left side of head starting around 4/30/21
Dizziness the afternoon after the second shot on 23 Feb 2021  On  8 Mar 2021 experienced extreme dizziness.  Call 911.  Went to Hospital.  Dr treated a brain stem stroke.
Raised, reddened, severe itching that has not resolved even with prescription strength 2.5% hydrocortisone applications at site of injection that was noticed on day 7 after injection. On days 1-2 or days 1-3 soreness and pain were noted, but these had resolved.
Case number PHEH2014US003610 is an initial spontaneous report received from a consumer on 21 FEB 2014. This report refers to a 14-year-old patient of unknown gender. The medical history and concomitant medication of the patient was not reported. On an unknown date, the patient was vaccinated with FLUCELVAX (batch number: unknown). No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This is a (possible) case of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/22/2021, 02/19/2021, and 11/19/2021. They presented to emergency department on 08/302/2022 with a chief complaint of generalized weakness. COVID-19 test in emergency department on this day was negative. The individual reported to the physician that they had taken "a couple of home COVID tests that were faintly positive." The individual was not admitted to hospital at that time. They then presented again to emergency department on 09/02/2022  for shortness of breath. A second COVID-19 test on this day was also negative. They were admitted to hospital at this time. The individual was found to be in respiratory distress. Assessments indicated pneumonia as well. The individual refused to be transferred to another hospital and declined intubation and aggressive measures. They were also a DNR. Due to poor prognosis, they were transitioned to comfort care only and died on 09/11/2022. Despite the 2 negative COVID-19 tests, COVID-19 pneumonia is on the death certificate.
Patient inadvertently received vaccine after published expiration date. Moderna analyzed batch/lot# 007B21A and advised vaccine maintained activity needed to protect against COVID-19 on date vaccine administered. Also patient did not call in to complain of adverse event. This is administrative error without adverse event.