chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of necrotic lesions in a 6-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline.  Concurrent vaccination included HIB, ROTATEQ and PREVNAR all given on 1 November 2007.  There were no concurrent medications.  On 1 November 2007 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left thigh.  At an unspecified time after vaccination with PEDIARIX, the subject developed a rash in the injection site area.  The rash worsened and developed a large necrotic lesion.  Swelling was reported.  The subject was hospitalised and the physician considered the events were life threatening and clinically significant (or requiring intervention).  The subject was diagnosed with cellulitis and treated with oral clindamycin.  The subject had the area exised and drained and was negative for cellulitis.  The symptoms continued to worsen.  The area was large with a "brown necrotic, depressed center."  The differential diagnosis was a spider bite.  The subject was seen on 8 November 2007 and the area was healing.  She had restarted oral clindamycin after leaving the hospital.  The necrotic lesion and swelling eventually resolved although there was permanent scarring.  The subject suffered a systemic reaction.  The physician considered the events of necrotic lesion and swelling to be possibly related to vaccination with PEDIARIX.
Pt was admitted to the hospital on 7/4 and tested positive for covid. Pt died 7/6
The first night I got the vaccine, and I had a fever of 103 degrees for about six hours and 101 degrees at the 24 hours. I had all over body aches for two days but my hands still ache after tree weeks. I woke up in the morning an noticed a big bulging blue vein in my right eyelid right above the outer part of my eye. One week later my thumb started to throb and then a big bulging blue vein in my left thumb. It felt like it had been injured but it looked better within hours. I called my doctor and he advised that I go to the ER. I also had trouble with my head throbbing for a week after the shot.  My eye was painful and lasted a little over a week and my eyes were a little blurry. Both problems have resolved but I still have an ache in my hands after three and a half weeks. It is a deep bone ache which makes it difficult to work with my hands.
Tiredness; No energy; cannot stay awake; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced tiredness, loss of energy and somnolence. On an unknown date, the outcome of the tiredness, loss of energy and somnolence were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, loss of energy and somnolence to be related to Shingrix.  Additional details were provided as follows: On 6th May 2019, the patient received the vaccine. On 8th May 2019 at the time of reporting the patient had no energy and could not stay awake. The patient asked how long tiredness lasts.
Patient received vaccine at 3:04 pm 7/31/2021.  At 3:30 pm pharmacist was notified that patient was experiencing a knot in the throat (similar to when he consumes shellfish).  Patient could still talk and breath normally with no outward signs of distress.  Patient was given 10 ml of Diphenhydramine and monitored for the next hour by the pharmacist.  Patient reported the knot going away within 5 to 10 minutes of diphenhydramine being administered.  No itching or hives or dizziness experienced by patient.  Patient did not report any tongue swelling or throat closure.  Blood pressure and pulse were 142/90 and 64 4:37 pm on 7/31/2021.   Rechecked at 4:44 and BP was 133/85.
Persistent red rash on both sides of the face, 1cm below the eyes, and extending outward from the nose 4cm in width and 3cm in height.The rash never goes away. The skin is dry and flaky. I never had any skin issues before the covid shots.
Headache, Myalgia, NauseaVomiting, Fever, fatigue Narrative:
On 1/22/21 at 6:30 pm both arms from shoulder to hands felt numb, mostly in the back of the arms.   I tried to pick up a spoon  with my right hand and my fingers would not wrap around the spoon or anything.   I could touch my thumb to pointer finger but other fingers turned inward like a cramp but did not hurt.  Could not feel my right hand.  This lasted about 1 1/2 minutes.  My arms were tingling for about 25-30 minutes.  Called my heart doctor and he told me to get to hospital.  When I arrived at about 7:05 pm I told them I had a COVID vaccine 2 days prior.  They preformed and EKG, a CT scan and a chest x-ray, did blood work, took a urine sample and everything came back normal.  They said it was probably a side effect of the COVID vaccine, sent me home and told me to take 2 Benadryl when I got home.  Also to take Ibuprofen for pain if I had any.  My hands, especially my right still feels a little tingle at 10:28 am on 1/22/2021.
Left Shoulder Pain,left shoulder stiffness,weakness. Treatments include anti inflammatory medications,physical therapy,etc
Every time sick for a day or a week every time; Initial information was received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer .  This case involves a patient (an unknown demography) who every time sick for a day or a week every time (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious every time sick for a day or a week every time (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that it may not be the flu but it sure feels like it.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Atypical chest pain after COVID-19 vaccination.- resolved and s/p cardiac cath yesterday and negative. MRI, MRA brain with out contract and labs looking for vitamin deficiencies.  11/06 mri/mra done, all unremarkable except a small 3.5mm aneurysm that he will follow up with. Hospital admission within 6 weeks of receiving the COVID vaccine.
Redness, pain, warmth, swelling and urticaria at vaccine site. Given halobetasol 0.05% cream and Prednisone 20 mg q 6 days PRN (if patient presenting respiratory symptoms of allergic reaction), treated today at 1400.
Approximately 10 minutes after receiving the second dose Pfizer vaccine, pt collapsed. Pt was able to regain consciousness within a few seconds without external factors/help/medication. Pt was orientated to location/name/age upon regained consciousness. EMT was called. Upon checking his blood pressure, EMT was concerned about hypotension and transported pt to hospital.  Pt stated that he feel hot and his hands were shaking. Per pt, this reaction did not happened with the first vaccine but happened a few years ago with another vaccine.
Pt developed temp of 103R about 3hrs post vax; W/APAP & cool baths temp dec to normal by noon the next day;
Patient received Moderna vaccines on 03/10/2021 and 04/07/2021. Patient presented to the ED on 11/02/2021 with complaints of respiratory distress. Patient found to be COVID-19 positive.
Complained of left arm pain after flu shot. Took Tylenol/Motrin/Aleve for relief. Saw MD. Rx for Naprosyn, PT, and x-ray. Told she has tendonitis. Thinks shot was given too high.
** NO LOT # PROVIDED FOR THE FIRST DOSE** I couldn't move my arm for 3-4 days. I had body aches, fatigue.  I also broke out in hives, I called my Dr. she advised me to take Benadryl. I had a spot under my arm (size of a quarter), looks like a bruise- she gave me medication to help with it.
Patient reports a spreading rash on his neck, face, scalp and today 6/27 starting to spread downward and outward to his chest and back. The rash itches and burns, particularly on his scalp. He also reports severe left arm soreness for 3 days and general myalgia, low grade fever and lethargy for about 24 hours after receiving SHINGRIX. The rash has resulted in the need for a KENALOG 40 injection and a clobetasol scalp solution for itching (from a dermatologist).
Systemic: Body Aches Generalized-Medium, Systemic: lower back pain-Medium, Additional Details: Patient called on 6-29-21 complaining of lower back pain that started and has continued since receiving his first dose of pfizer vaccine.
Information has been received from a pharmacist concerning his 66 year old wife with diabetes, high cholesterol, hot flashes and a penicillin allergy who on Friday 27-APR-2007 at 10:00 was vaccinated SC with a dose of Zostavax (Oka/Merck). Concomitant therapy included insulin lispro (HUMALOG), estradiol (ESTRACE), atorvastatin calcium (LIPITOR), ezetimibe (MSD), quinapril HCl (ACCUPRIL), aspirin, calcium (unspecified), docusate Na (COLACE), vitamins (unspecified) and lorazepam (ATIVAN). From the middle of the night on 27-APR-2007 until late Sunday night (29-APR-2007) her glucose increased to 300-400 mg/dL. From late Sunday night (29-APR-2007) to Monday morning (30-APR-2007) her glucose had gone down to 109 mg/dL. It was reported that medical attention was not sought though lab studies performed included protein, A1c, ALT, AST, cholesterol (results not reported) and a nuclear stress test (results not reported). On 30-APR-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
The patient developed diffuse body itching and diffuse body (trunk and extremities) red rash throughout that was not clearly urticarial. This began about an hour after vaccine administration. He denied any symptom of allergy. Symptoms began to improve within 28 hours without intervention but did not resolve. He was advised to trial benadryl and monitor closely.
I had difficulty in breathing after I took the first one; If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I had difficulty in breathing after I took the first one) and INTENTIONAL PRODUCT USE ISSUE (If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I had difficulty in breathing after I took the first one) and INTENTIONAL PRODUCT USE ISSUE (If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021). At the time of the report, DYSPNOEA (I had difficulty in breathing after I took the first one) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (If I decide to take the second vaccine is it still going to be effective like if I took it when I supposed to take it on April 10, 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
Patient presented with gross hematuria and vasculitic rash/ulcers on bilateral lower extremities.  She was continued on IV methylprednisolone inpatient was transitioned to p.o. prednisone upon discharge. She was also started on trial of lisinopril by nephrology. Wound culture was positive for Pseudomonas aeruginosa. recommended ciprofloxacin x14 days. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Small, itchy bumps on forearms and shins. Less severe on upper arms and thighs.  Leg rash ended after 5 days. Arms still affected.
This case was reported by a other health professional via sales rep and described the occurrence of adverse event in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case has been linked with US2018GSK195619 and US2018GSK111832, reported by same reporter.
02/07/22 presents to ED for "covid infection that was discovered 1-27 -22 with worsening shortness of breath and chest pain". PMHx of "ILD, multisystem sarcoidosis, PBC, DM2, GERD, and glaucoma"
Stroke; numb left lips; numb fingertips; balance issues. Still going on.
Initial pain at injection location stopped on this day, but later in the evening, I began experiencing INTENSE pain in the shoulder/collarbone region on the side of the injection. Could barely lift arm, could not lay or stand comfortably. Pain has lessened slightly, but increases throughout the day. Still suffering pain on 10/16/2016 PM.
A non-serious spontaneous report of positive influenza B test manifested by fever has been received from a health professional concerning an eight-year-old male, subsequent to FLUMIST. Neither patient's medical history nor concomitant medications were reported. The patient received FLUMIST on 09-Sep-2011. The patient received a total of one dose before onset of the event with the last dose before onset of the event given on 09-Sep-2011. After receiving FLUMIST, the patient had fever of 103F and tested positive for influenza B on 15-Sep-2011. The outcome of positive influenza B test manifested by fever was not recovered.
Blurry Vision; Headaches; Left ear pain; Loss of taste, smell; Loss of taste, smell; Insomnia; Fatigue; Joint pain; Neck pain; This is a spontaneous report from a contactable consumer reporting for himself. A 51-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunisation. Medical history included allergies to penicillin and COVID-19 prior to vaccination. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Concomitant medication included unspecified drug. On 09Jan2021, the patient experienced blurry vision, headaches, left ear pain, loss of taste and smell, insomnia, fatigue, joint pain and neck pain. The patient received meloxicam as treatment medication. The events were considered as non-serious. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Rash-fine/pink/ papular. Evanescent about 24 hours.  Fussy, low grade fever to 101.
fever and shivering from 8 PM until about 4:30 AM. Finally went to sleep and awoke at 10 AM. Other than being tired today, I feel normal with no side effect symptoms lingering.
Dizziness started around 230pm in the afternoon on Saturday, 3 days after the first does (i also felt a brief wave, Friday around the same time,  2:30pm only 2 days after my shot). Sunday morning when I woke up I felt full on vertigo (forward and back) and a disoriented feeling due to feeling a really strong pulse consistently in my head and whole body. This dizziness and vertigo caused naseua. I treated it with meclizine and ondansetron but it only mildly helped symptoms. I went to urgent care and got a steroid shot. They also measured that my blood pressure was high. The steroid shot also did not do much to change the dizziness. Today is Wednesday, a full week after my first shot, and I am still feeling dizzy, with pulsing pressure in my head and full body causing vertigo. I went to an ent today and was started on a z pack. I'm not sure what else to try or how long to expect this or if this is considered an allergic reaction and I should skip my second dose?
Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 23-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, not instead of 0.3 ml. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
Received MMR vaccine September 18, 2007. Noted rash on anterior and posterior trunk, mildly itchy. Seen by Employee Health Physician October 2, 2007.
102.5 Fahrenheit for the first 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102.5 Fahrenheit for the first 24 hours) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PYREXIA (102.5 Fahrenheit for the first 24 hours). At the time of the report, PYREXIA (102.5 Fahrenheit for the first 24 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Body temperature: 102.5 (High) fever. On 12-May-2021, Body temperature: 100 (High) fever.         Patient has not seen a primary care provider in the last four years and does not have one as well. Patient is not on any other medications. Patient would like to know how long the symptoms will last  Patient consent to document this call Patient provided local pharmacy contact information Patient granted permission for Safety to follow-up if needed
Seen in office 7/22/19 for erythema to R arm  approx. 3x5 inches.  Provider recommended ice pack, Tylenol prn.
caller stated a few days after he got the vax he started getting a sore arm. On 3/2 he lost voice, had runny nose and head congestion.  On 3/4 he had difficulty breathing and chest congestion.  On 3/5 he was transported from (hospice patient) home to Hospital where he later died.
Information has been received from a 70 year old male with asthma and a history of back surgery and with no known drug reactions/allergies, who on 02-FEB-2008 had an outbreak of shingles. The patient mentioned that it was a bad case on his right leg and he had severe nerve pain. On 25-MAR-2008, the patient was vaccinated with a single dose of ZOSTAVAX (route and administrating site not reported) at a hospital. Concomitant therapy included montelukast sodium (MSD) (dose, duration and indication not reported), AZMACORT, INTAL, AZOR, ADVICOR and allergenic extract. Thereafter, the patient had three separate episodes of shingles. On 19-MAY-2008, the patient developed shingles on his right arm and right side. On 02-JUL-2008, the patient had shingles in his right leg and on the right side of his nose and face. Subsequently, the patient fully recovered from all of these outbreaks of shingles. The patient sought unspecified medical attention. Additional information has been requested.
Dull headache and stayed in bed for 2 days, fatigue like a building fell on top of me. 2nd dose. Saw Pulmologist, trouble breathing in 30Apr2021 with shortness of breathe even doing laundry and was diagnosed with asthma, and difficulty breathing. Back in Feb2021, I was diagnose with sleep apnea.
Nurse inadvertently injected Td instead of PPD skin test on 06/13/08. Induration and erythema developed on (L) arm. Tx warm soaks/Tylenol.
According to son, mom began to feel bad in the evening after receiving both the Fluad flu vaccine and Moderna COVID vaccine on the same day. He did not give us any information than that at the time and hung up on the technician before she could get any information. When he contacted our corporate office, he stated she was having seizures and in the hospital.
I began feeling dizzy, nauseous, weak in legs, blurred vision in early May which continued throughout the month.  On June 3 I experienced an event like no other.  My legs felt like rubber and  tried but could not speak.  My husband carried me to the sofa, when I sat down I felt disoriented, and saw a circle in front of my eyes.  I felt as if I was about to pass out.  I saw my cardiologist a week later.  He is concerned that the neurological symptoms are new.  He suspects I had a mini stroke despite being on blood thinner for my CHF and referred me to a neurologist.  He suggested I report this sudden change to VAERS.
2d after PNEUMOVAX 23 SQ given (10-11-11), pt. developed 2 1/2" circle of redness, warmth at site. Also complained of "not feeling well" w/ fatigue, malaise, Treated w/ TYLENOL, BENADRYL 50mg BID.
Day1 - intense itching in neck, jawlines, fingers, palms of both hands, abdomen Day 2 - intense itching in jawlines, fingers, neck
After pt received the 2nd dose of Shingrix, she had a new outbreak of shingles; Shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient experienced new outbreak of shingles in the same place after receiving 2nd dose of Shingrix. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case was linked with US2020AMR012069, reported by same reporter.
Body aches, low grade fever, shaking chills, sore arm.   Had to leave work. Lasted about 16 hours.