chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a bachelor of science in nursing concerning a 74 year old male with "cardiac status problems" and glaucoma who in February 2010 also reported as about "1 year ago", was vaccinated with ZOSTAVAX (Merck) (dose, route and lot # not reported) (from another provider). In approximately May 2010, "about three months post vaccine", the patient began to develop a rash-fine, red, "extremely itchy all the time". Amount of body surface covered by the rash unspecified. The rash had become extremely debilitating to the patient's quality of life. The patient had visited a dermatologist and immunologist, who prescribed prednisone (steroids). The steroid treatment did seem to help the rash, but when it was discontinued, the rash reappeared. The patient also stated that he was instructed to use a sunblock, with higher SPF, however, he burned extremely easy and the burns were painful. The patient had been experiencing this rash for "about nine months". Biopsy was performed (results not provided). At the time of the report, the patient's status was not recovered. According to the nurse, the patient's rash was considered to be disabling with lifestyle affected. No further information is available.
Muscle aches, chills, feeling weak, feeling tired approximately 9 hours after injection. After a night of sleep, the next day I woke still with muscle aches, feeling weak and tired in the morning. I seemed fine the rest of the day and the next. Three days after injection, I felt nauseated, but unsure if this was related to the vaccine.
Information has been received from a health professional concerning an 8 year old white male, with no medical history and no allergies, who on 12-JUL-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 25-OCT-2007 the patient was sent home by the school nurse who diagnosed chickenpox with less than 50 lesions. On 01-NOV-2007 the patient recovered. Medical attention was not sought. There were no laboratory or diagnostic tests performed. Additional information has been requested.
tired, sore muscles, aches throughout body, fever of 100 lasting 12 hours +; overall symptoms ongoing for 36 hours.
Information has been received from a physician concerning a 71 year old male patient with no pertinent medical history who on 05-JUL-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 658081/0743U; exp. 08-NOV-2008), 0.65ml. The physician mentioned that in March-2012 the patient had been diagnosed with acute retinal necrosis, which was later deemed to be zoster retinitis. This AE started in his right eye, then spread to his left eye, and his retina had since detached in his right eye. On approximately 22-JUN-2012 (reported as "now") the patient had some vision loss, but the doctor did not specify the extent of the loss. The patient went to the ER visit at an unspecified hospital for treatment and was given oral valacyclovir hydrochloride, prednisone and intraocular ganciclovir. The patient sought unspecified medical attention. The AE improved after stopping therapy. Therapy was not reintroduced. At the time of the report, the patient was recovering. Additional information was received from the registered nurse who indicated that the physisican has no further information to provide. Additional information is not expected.
Initial report received from a consumer on 03 Dec 2009: This patient was vaccinated with H1N1 vaccine (manufacturer not specified) in 29 Nov 2009 and received another dose of FLUVIRIN on 02 Dec 2009. The outcome of the event was not reported.
Patient could not walk, run, play.  She complained of her legs hurting badly.  She had difficulty climbing stairs and would sit down and cry.  She attempted running and playing with her cousins and I would see her get frustrated and give up.  She limped.  She would not wrap her legs around us when we picked up; they'd hang like dead weight.  She was diagnosed with an autoimmune disease-dermatomyositis.  Something triggers this response, we believe it was theLive virus Flu Mist she received at school.
Mild tinnitus SEVERE vertigo (leading to a trip to Urgent Care  where they prescribed meclizine and home Epley maneuvers, diagnosis of BPPV).  Nausea  Muffled hearing in left ear  As days progressed- vertigo lessened, no just constant but slight dizziness and fogginess. Muffled hearing persists.  Some relief was found with osteopathic manipulations of the neck. Began taking vitamin D, vitamin B complex, zinc, vitamin C, and magnesium.
I had chills, fatigue, headache, and bilateral calf and thigh muscle pain that started about 6 hours after the vaccination and lasted about 36-48 hours. I took Tylenol 500mg after the onset of symptoms and three times a day. The symptoms went away by mid-day on 4/13/2021. Since then, I have been experiencing bilateral calf muscle pain off and on. I also had an enlarged axillary lymph node n the left side (side of vaccination). I reported it to urgent care on 4/18/2021 and was told the muscle pain was unlikely to be a clot since it was bilateral and there was no swelling or discoloration. I was told to hydrate and follow up with my primary care provider if it continues.  The calf muscle pain has continued - almost every other day - and responds to Advil. I have an appointment to talk to an MD tomorrow (May 5th)
About 30 hours after vaccination, patient noticed a sunburn type redness all over his body.  Rash was apparent face, neck, chest, stomach, arm, legs, and tops of feet.   Rash was warm, but not itchy.  Rash was not raised.  Resembles a sunburn
HEALTH DECLINING/STRUGGLING WITH HEALTH; ACHES/PAIN; This spontaneous case was reported by a consumer and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (HEALTH DECLINING/STRUGGLING WITH HEALTH) and PAIN (ACHES/PAIN) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis and Rheumatoid arthritis.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced PAIN (ACHES/PAIN). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (HEALTH DECLINING/STRUGGLING WITH HEALTH). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (HEALTH DECLINING/STRUGGLING WITH HEALTH) and PAIN (ACHES/PAIN) outcome was unknown.            No concomitant medications were reported. Physician advertently wrote prescription for every two weeks but requiring Humira once weekly/provided incorrect directions, might be from electronic Submission. No treatment medications were reported.
Pt called clinic stating that 12 hours after getting vaccine she noticed swelling of left breast and left arm. States that left breast noticeably bigger that the right. Almost double the size from the swelling. Left arm having swelling that started on the inner aspect of the upper arm and has spread down to the elbow. Stated it is tender to the touch and having pain in muscle with moving arm. Not hot to touch. No redness, rash, bruising, shortness of breath, or tightness in throat. Offered an appointment for evaluation at the clinic, but patient declined and preferred to continue to monitor at home. Discussed that if swelling increases or persist to contact the clinic fo an appointment.
Cough approx 10 min after vax. Pruritic, wheezing w/decreased 02 sats-90%,2 1/2-3 cm hives over inject site. Given 02, Benadryl,epinephrine, albuterol with improvementof sx but sent to ER for observation.No tx in given in ER.
Information has been received from a registered nurse referring to a 16 month old patient of unknown gender. On 30-JUN-2015 the patient was vaccinated with ROTATEQ (oral, lot # K011952, expiration date and dose were unknown) which was excursion the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Had DTaP Tues 11/08/05 developed 16x7 cm area of redness and warmth around injection site.
It has been 10 days since I had the vaccine.  I felt sick within about 24 hours, aches, chills, skin hurt, tired.  That subsided within a day and then joint pain, muscle pain in legs, hips and rear end, shoulders and pain behind eyes started and lasted for about a week.  I have had a steady headache for probably the past 6 days or so.  No fevers, just significant muscle pain and headache, low energy and difficulty sleeping.
Swelling at injection site with redness that became visible within 12 hours.  At 72 hours site is larger,  measuring 2 inches in diameter. Area is also swollen, slightly sore, periodically itchy.
Soldier c/o itchy whelp with redness and hardness on left deltoid. Soldier received Anthrax.
Large, blotchy red hives all over back, arms, and bottom; swollen, red, inflamed bump at injection site all lasting over 3 days.
She developed a fever, chills, rigors, muscle aches , lost taste and smell ,headache runny nose, cough, wheezing ,shortness of breath diarrhea and congestion and felt weak.
Needle retracted prior to the nurse administering the full dose and received 0.1 mL of the Pfizer vaccine on the left deltoid.  0.2mL observed in the needle cap by the nurse.  Agency guidelines reviewed.  Repeat dose recommended and given  on the right deltoid IM. Patient informed and verbalized understanding of recommendations. Observed for fifteen minutes and discharged with no adverse reactions noted.
I am very active, healthy person & within 6-7 hrs of flu shot, had significant pain and muscle spasms from (R) hip to mid lower (R) leg. Could not walk without holding on, knee would buckle without warning. Was not able to exercise (treadmill, swimming). After 6 wks sxs slowly resolving but still debilitating at times.
A non-serious spontaneous report of administration of expired product was received from a certified medical assistant in a physician's office concerning a child of unknown age and gender. On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient became lightheaded and dizzy after vaccination, passed out briefly and came to within minutes.
fever of 103, fatigue, headache, chills.  Symptoms lasted for approximately 24 hours
Erythematous, blanchable, itchy maculopapular rash on left upper extremity and abdomen appeared the following day after vaccine administration. No anaphylactic reaction reported. Treated with Benadryl cream with very mild benefit noted for 4 days. Prescribed triamcinolone 0.1% cream to use BID for 14 days on day 4 of rash.
Initially developed fever in early morning; had fever off and on during course of day with associated voice hoarseness, cough and headache. At 10 PM developed stridor and mild respiratory distress.  Was taken to local emergency department and treated with intra-muscular dexamethasone and inhaled albuterol/ipatropium.
Breakthrough Covid-19 infection which lead to lingering respiratory distress, long fatigue, cessation of menstrual cycle and menopause. Treatment has been vitamins D, C, NAC, and zinc, along with herbs.
Gionatti-Grosti Syndrome (confirmed on 10/6/09) -Chicken pox like spots on 9/6/09 and rash on legs. 9/12/09 = rash spread to arms and hands. 10/5/09 =rash on entire body and face starting to dry out. Still recovering.
After receiving the Vaccine, patient waited 15minutes in Immunization section. Upon standing became light headed-dizzy, increase anxiety and Palpitations. Patient denied any SOB, nausea vomiting, tingling in his throat. Disclosed medical history of hypothyroid and mild anxiety. Upon assessment patient wasn't diaphoretic pulse 77 normal RR. ER staff escorted patient to ER for evaluation.
Headache; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; She was pregnant at the time of vaccination; This is a spontaneous report from a contactable nurse (patient). A 38-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) solution for injection, via an unspecified route of administration on left arm on 01Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included diabetes, and depression. Concomitant medications included escitalopram oxalate (LEXAPRO), ascorbic acid, biotin, minerals NOS, nicotinic acid, retinol, tocopherol, vitamin b NOS, vitamin D NOS (PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS]), progesterone (PROGESTERONE), and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported she was pregnant at the time of vaccination on 01Jan2021 15:00. She was at 9 weeks gestational period and will be due to deliver on 01Aug2021. The patient experienced headache on 02Jan2021 16:00 but did not receive any treatment. Outcome of the event headache was recovering while for the other event was unknown.  No follow-up activities are needed. No further information is expected.
11/9/09 - given 2009 H1N1 on 11/6 - got headache took ALEVE  - felt nauseous next day.
About three weeks after the vaccine, I started to experience an inability to concentrate. I had Diarrhea and a low grade fever for one day and I couldn't concentrate. I started to have symptoms of depression that I do not normally have. I felt restless and I had trouble sleeping. I was very aggravated, and I was having repetitive thoughts. I had trouble working and my brain was a little.  It went on for two weeks. I have had a few more episodes since then but it is much better.
FEVER; HEADACHE; DIZZINESS; WEAKNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022) dose was not reported, once a total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced weakness. On MAR-2021, the subject experienced headache. On 13-MAR-2021 23:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, dizziness and weakness was not reported. This report was non-serious.
Diffuse maculopapular urticarial eruption, hives, not including oropharynx; no anaphylaxis, no abdominal pain or dizziness or vomiting
Hep A vaccine was given early, second shot should have been given at 6 months not one month
Fever of 101.3, flushed face, holding breath slightly before exhaling, fussiness, vomiting, stuffy nose from vomit coming up through nose. All symptoms lasted about 12 hours. Vomiting lasted 2+ days.
Was to receive SARS-2-COVID booster dose of 0.25ml instead received 0.50ml dose. Denies any symptoms.
pt recv vax in SEP95 & devel a hard lump @ inj site;
Good afternoon patient wanted me to inform you of a couple of symptoms I have been experiencing, the injection was in my right arm and since then my entire arm has felt like it is asleep.  also the right side of my neck has more stiffness and pain than usual.  pain in my neck is nothing new due to my motorcycle accident long ago however since the injection it has gotten worse.
Patient vaccinated with 3rd dose of Pfizer COVID Vaccine. First Pfizer COVID 5/2021. 2nd Pfizer COVID shot 06/11/2021. Dr. made aware of booster shot to 16 year old with no PMH.
Approximately 15 mins after receiving COVID vaccine began c/o headache, cough and itchiness. Took 2 25 mg Benadryl that she had with her. Was then administered 25 mg IV Benadryl by EMS. By 4:30 pm reports itching and headache improved. Encouraged to take Benadryl q 6-8hours prn. Discharged home. Phone call on 1/17-No symptoms. Has f/u w/PMD 1/20
could not move her arm at all as it felt like a huge heavy weight on her; Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm; small black and blue bruise the size of nickel at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.   This case was linked to MOD-2021-250952 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant FU was received on 07-jul-2021: Dose 2 details updated
Small hive patches on body and tightness of face. Lasted 2.5 hours.
red rash; low grade fever; joints hurting; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PYREXIA (low grade fever) and ARTHRALGIA (joints hurting) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included GABAPENTIN, LISINOPRIL, ESCITALOPRAM OXALATE (LEXAPRO), BUSPIRONE, CLONAZEPAM (KLONOPIN) and BUPRENORPHINE for an unknown indication.    On 17-Apr-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 ERYTHEMATOUS (red rash), PYREXIA (low grade fever) and ARTHRALGIA (joints hurting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red rash), PYREXIA (low grade fever) and ARTHRALGIA (joints hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took Benadryl few night and helps until morning
SUSPECTED COVID-19 (LOSS OF TASTE, LOSS OF SMELL, BODY ACHES, CHILLS AND FEVER); This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced suspected covid-19 (loss of taste, loss of smell, body aches, chills and fever). Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 (loss of taste, loss of smell, body aches, chills and fever) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as case assessed as non-serious.
Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain and Fever. Concurrent medical conditions included Sjogren's syndrome and Osteoarthritis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Made Sjogren's Syndrome better/autoimmune disease gone after the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.   Patient was a retired teacher who has Sjogren's syndrome where her white blood cells attack her. Patient was enflamed everywhere all the time. The vaccine has made her Sjogren's syndrome better and was reporting a positive side effect. Patient can move without pain. Patient has osteoarthritis from her syndrome and it's usually debilitating, but now she can move without pain. Patient had Sjogren's syndrome and that syndrome was lupus kind autoimmune disease. Patient used to have pain and fever, now she has no pain no fever.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up received on 23-04-2021 added second dose and reporter details. On 13-Jul-2021: Follow-up received on 13-07--2021 contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The patient's Sjogren's syndrome and osteoarthritis have improved with positive side effects, she can move without pain.
Patient was administered the Pfizer-BioNTech vaccine 5-11 years formulation (orange cap) resulting in a lower-than-authorized dose.
Fever above 100 and painful and very tender arm to slight touch. This extended through the following day along with swollen hot andneed upper arm.