chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Was unable to walk about 30 hours after the vaccine. Went to the Emergency Room about 36 to 40 hours after the vaccine. Diagnosed with rhabdomyolysis, with CPK blood level of 11,600. Was admitted to the hospital for 4 days, with IV fluids to flush the body of the CPK enzymes. My mother still has leg pain and muscles weakness, is using a walker, and has to have physical therapy to regain her leg muscle strength. Prior to this, she used to take daily walks and was otherwise independent.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "Seizure"; BLOOD GLUCOSE INCREASED (medically significant), outcome "unknown", described as "blood sugar was in the 500's". The patient underwent the following laboratory tests and procedures: blood glucose: 500's. The lot number for bnt162b2 was not provided and will be requested during follow up.
Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/droop 4 days post vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination/Tingling to lower extremities; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; This is a spontaneous report from a contactable consumer (patient herself).  A 36-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EK9231), via an unspecified route of administration in the left arm on 04Jan2021 13:00 at single dose, for Covid-19 immunisation. The vaccine was given in a Nursing Home/Senior Living Facility. Medical history was none. No known drug allergies. No other vaccine in four weeks. No Covid-19 prior vaccination. Concomitant medication included naproxen sodium (ALEVE). The patient experienced tingling in injected arm and facial tingling in cheeks/lips same day of vaccination (04Jan2021). Tingling to lower extremities the day after vaccination (still continuing). Slight left sided facial weakness/droop 4 days post vaccination (04Jan2021). Tingling to left arm continuing on and off. No treatment reported. On 04Jan2021, she was negative to PCR covid test post vaccination. She went to the Emergency room/department or urgent care. The outcome of events was not recovered.
This case was reported by a physician and described the occurrence of not responding to therapy in a 15-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hep B. On an unspecified date the subject received 3rd dose of ENGERIX B (.5 ml, unknown), 2nd dose of Hep B (unknown). On an unspecified date after vaccination series completion with ENGERIX B and Hep B, the subject experienced not responding to therapy. The physician reported the subject tested negative for hepatitis B antigen and antibody on a recent test. The subject completed the vaccination series "years ago", but the mother was antigen positive. Relevant test results included Hepatitis B antigen and antibody negative. The healthcare professional reported another case regarding ENGERIX B, see case A0890090A. Follow-up information was received on 16 November 2010 via physician who refused to be contacted. At the time of the report no other information was provided.
Developed eczema and rosacea both on my face one week after getting the 1st dose of vaccine. I?ve never had any skin problems before. Since April 2021 until now  October 2021 I?ve been to many different dermatologist appointments and other doctor appointments.
7 days after receiving Covid vaccine developed subclavicular lymphadenopathy on side of injection. Swelling developed and decreased. Due to area of lymphadenopathy, had to have breast exam, lab work and will need to schedule diagnostic mammogram and ultrasound. If that comes back clear there are discussions of CT scan.
Fever above 102, fatigue, severe body aches and swelling and pain at injection site. Feel worse after vaccination than I did when I had Covid back in January 2021
10 minutes, post vax, child developed a generalized urticaria. He was alert and active with no wheezing. He was given IM Benadryl and urticaria resolved. He was sent home on a 5 day course of po Benadryl.
Information has been received from a physician concerning a 15 year old female with no pertinent medical history or known drug reactions or allergies who on 03-JAN-2007 was vaccinated with Gardasil 0.5 ml injection. In February 2007, the patient experienced heavy menstrual bleeding, nose bleeds and eye problems and was hospitalized for four days (admittance and discharge dates not reported), and while hospitalized was diagnosed with Evans syndrome. The patient needed a blood transfusion. The patient's Evans syndrome persisted. There was no product quality complaint. Additional information has been requested. 06/06/07-records received from facility for DOS 5/7-5/10/07. DC DX: Evan's Syndrome, immune thrombocytopenia and anemia. Prolonged episode of epistaxis. HX: Nosebleeds frequently since age of 3 or 4. In last 4 weeks have increased in frequency 6-7 times per day, harder to stop. Prior to admission nosebleed from 21:30 through 9:30 with nausea and bloody emeses. HX of bruising easily. Menses 3 days longer in duration and heavier with clotting and clumps. Petechia on lower extremities, more tired or fatigued. Feels faints if she stands up too quickly. Black out this morning. Fell.  Follow up visits 5/17/07: Impression Evan's Syndrome, Strong family history of autoimmunity. Abnormal labs including positive ANA, low complement.
This case was reported by a consumer and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced headache, generalized muscle aches, pain, fever, tiredness, injection site pain, injection site swelling and poor sleep. On an unknown date, the outcome of the headache, generalized muscle aches, pain, fever, tiredness, injection site swelling and poor sleep were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the headache, generalized muscle aches, pain, fever, tiredness, injection site pain, injection site swelling and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 4:00 pm, on Tuesday, the patient received SHINGRIX. Wednesday, when the patient woke up, she was experiencing headache, whole body muscle pain, poor sleep (woke up due to pain and fever), tiredness, (the typical viral infection symptoms) with injection site reactions (pain, swelling, tenderness). The patient was still experiencing the above side effects till the time of reporting and the pain symptoms were getting better. As per reporter the event headache was from 7 to 2, and muscle pain was from 6 to 4 (NRS 11 scale).
on 20AUG93 mom noticed a small bruise size of pencil eraser & long marks on neck that appeared scratches & bruises/splotches;
I had extreme pain in my shoulder at the vaccine site; then I had extreme pain - my whole upper back (especially my right side) - like someone had taken a hammer and beaten my back. I exercise a lot and I'd exercised cross country skiing and downhill skiing the day of the vaccine and the next day I worked. I could barely use my right arm to treat my patients. I was sore and as the days went on I was really fatigued. I felt like I had a low grade fever. I usually have lower than normal temperature and it was 99.4-99.7 range. So on Monday I called the Occupational Health Dept of the Hospital - and they told me stay off work. And they had me test for COVID -  negative. It took about a week until I started to feel better. To treat during the course of it I just took Advil.  Recovered before my second dose on January 20th, 2021.  I did not exercise before that second dose vaccine or work the next day and I stayed very hydrated and went into it rested.
This spontaneous report was received from a pharmacist referring to an unspecified patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis. On an unknown date, the primary reporter heard from other pharmacist that unspecified patient "got shingles", additionally it was stated that the sterile diluent (manufacturer unknown) was missed. At the time of the report, the outcome of herpes zoster was unknown. The reporter did not assess the relatedness between herpes zoster and ZOSTAVAX.
Moderna Vovid-19 Vaccine EUA  Got Vaccine at 10am that morning and by 9pm patience  was having chills, fever, balance issues, muscle aches.  It felt like a bad case of the FLU.   It lasted until the next day about 8pm.
Swelling redness in (L) deltoid. Rash-erythematous rash on face, hives on chest and back, pruritus.
Severe abdominal pain, rash, hair loss, black spots before eyes, body temperature being too hot, constant illness, weak immune system, vomiting, dizziness, fatigue, depression.
several strokes; This is a spontaneous report received from a contactable consumer. A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 08Jun2022, for Covid-19 immunization. This information combined with the negative (near death) reaction that patient has suffered in Jun2022 (several strokes two weeks after receiving his second Pfizer vaccination) has any future injections on hold.  Event resulted in doctor or other healthcare professional office/Clinic Visit. It was unknown if covid prior vaccination or if covid tested positive post vaccination. The event "several strokes" required physician office visit. It was unknown if therapeutic measures were taken as a result of cerebrovascular accident. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
p/recvd vax pt became limp & pale & vomited; Pulse 60; BP 64/42; this occurred 2 minutes p/all vax were given; mom stated pt did same thing p/fingerstick for blood work 2 months prior to this; pt fully active in 2-3 minutes;
PT BROKE OUT IN AN OVERALL BODY RASH ON 3RD DAY AFTER RECEIVING SHOT, SHE ALSO BROKE OUT WITH HERPES AS WELL, IT IS ONGOING AND HAS NOT RESOLVED, PATIENT SAYS SHE HAS NOT HAD A HERPES OUTBREAK IN OVER 2 YEARS, IT HAS BEEN CONTROLLED WITH THE VALTREX
was given expired Pentacel with no reported adverse event; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00811243).  This case involves a two-month-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  On 11-Oct-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ402AAA and expiry date: 10-Oct-2021) (frequency: once) via intramuscular route in the right thigh for prophylactic vaccination.  It was reported "nurse told him it may not be necessary to re-administer because it is only one day expired, however, to follow-up with manufacturer."  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A little background... in 2021 I received my first two doses of Moderna. A couple of weeks after vaccination I developed strange sensations and tingling throughout my body, severe fatigue and difficulty concentrating, increase in dropping things, a feeling of weakness in my arms. An MRI showed non specific lesions in my brain and a few lesions in my cervical spine. A nerve conduction study, blood work, and a lumbar puncture showed insignificant findings. The symptoms seemed to disappear around Oct 2021, with the exception of tingling in my upper left back and odd sensations in my right thigh, which I still have on occasion to this day. My doctor did not think the vaccine was the cause of my symptoms, so I decided to get a booster last week. It was Pfizer this time. The afternoon of my vaccine there was an increase of odd sensations in my right thigh. 5 days post vaccine I started getting small short lived tingles and pricks in my arms and legs, and tingling in my scalp, which I haven't had for several months. 6 days post vaccine I felt a sudden feeling of fatigue and arm weakness, which is what happened me to last year. Today is day 7 - no fatigue or weakness, but still occasional tingles throughout my body.
Patient reported that the day after receiving the Zostavax injection he had a "very swollen arm that hurt and itched" which he reported lasted for 1 1/2 weeks. Patient reported this after symptoms had already resolved and did not report receiving any treatment. Reported symptoms in the arm Zostavax was given (left arm).
Light hives come and go.  Appear as light red blotches and streaks.  Started on 124-2021.  Reactions appear in small areas on neck, back, arms, hands, upper leg, and chest.  Skin can feel warm.  Ears get hot.  Symptoms go away.  Only a slight itch.  No particular rhythm to timing of the appearance of red marks.   used hydrocorticone cream and Benadryl before going to the doctor.  Was prescribed Prednisone.  Completed 21 tablet prescription starting 12-7-2021.  Symptoms still present after completion.  Still using hydrocortisone cream.  No Benadryl since taking Prednisone as of 12-14-2021.
Pt devel scaly erythematous patch of eczema @ inject site which lasted x 1 mo; dematologist felt it might be a hypersensitivity reaction to HIBTITER;
When they got their shot the person was not good at giving it and they shot a blood; hemotoa apparently caused by person injucting; Rash, upper arm swelling to elbow with rash; huge area that was hard; huge area that was red; huge area that was very painful; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (When they got their shot the person was not good at giving it and they shot a blood), HAEMATOMA (hemotoa apparently caused by person injucting), RASH (Rash, upper arm swelling to elbow with rash), INJECTION SITE INDURATION (huge area that was hard) and INJECTION SITE ERYTHEMA (huge area that was red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy. Concomitant products included RIZATRIPTAN BENZOATE (MAXALT) from 01-Jun-1985 to an unknown date for Migraine, LEVOTHYROXINE SODIUM (LEVOXYL) from 03-Jun-2000 to an unknown date, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 01-Jun-2017 to an unknown date, MAGNESIUM, BOTULINUM TOXIN TYPE A (BOTOX) and DENOSUMAB (PROLIA) from 01-Jun-2017 to an unknown date for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE INDURATION (huge area that was hard), INJECTION SITE ERYTHEMA (huge area that was red) and INJECTION SITE PAIN (huge area that was very painful). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (When they got their shot the person was not good at giving it and they shot a blood), HAEMATOMA (hemotoa apparently caused by person injucting) and RASH (Rash, upper arm swelling to elbow with rash). On 15-Feb-2021, INJECTION SITE INDURATION (huge area that was hard) and INJECTION SITE ERYTHEMA (huge area that was red) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (When they got their shot the person was not good at giving it and they shot a blood), HAEMATOMA (hemotoa apparently caused by person injucting) and RASH (Rash, upper arm swelling to elbow with rash) had resolved and INJECTION SITE PAIN (huge area that was very painful) had not resolved.        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.   This case was linked to MOD-2021-096853, MOD-2021-096933, MOD-2021-096853 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional info
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Within 4 hours caused fibroid to spasm. Fever/chills/extreme body aches  afternoon and through next day Extreme fatigue for 2-3 days, with continued fatigue more than week later
Erythema multiforme rash started as hives on feet, then spread to heels & elbows, then knees. Topical steroids & OTC antihistamine.
Day after Vaccine I had a redness, burning feeling in my left arm. The second reaction returned 10 days later with a bulls eye erythema measuring approx. 2 Inches in diameter this lasted two days and then faded to a red area about an inch wide.
Pt with complaints of headache, painful legs, fatigue and died within 48 hrs of taking 2nd dose. Found in her bed.
39 year-old (current age) ARNG WM who was in his usual state of good health prior to deployment to foreign country in 2004. Based on patient recall, he received 9 anthrax vaccines over a 28-month period due to lack of documentation of immunizations in medical records. He reports receipt of doses 1-3 over a 3-month period in early 2002; receipt of doses 4-6 over a 3-month period around March 2003, and receipt of his last 3 doses (doses 7-9) over a 3-month period between June and August 2004 (documented), within 3 months of deployment to foreign country. Starting the day of his "second doses" (#2, 5 and 8), he noted headaches, joint aches, fatigue and urgency to have bowel movement following meals. He denies worsening of these symptoms with subsequent doses and denies occurrence of these symptoms following doses #3, 6 and 9. These symptoms resolved after 3 days. He denies any unusual local reactions at anthrax vaccination sites until his last dose (#9) of anthrax vaccine in Aug 2004; he noted an area of about 2-3' of redness, swelling and tenderness, which lasted < 1 week. SM reports that he was told after receipt of his smallpox vaccine in July 2004, he did not have "a good reaction", so he was given a 2nd dose. SM reports he had a robust response to the second dose with normal site progression and no prolonged systemic or local symptoms. He denies rashes or other systemic symptoms (other than those symptoms listed above) within 30 days of anthrax and smallpox vaccine receipt. He denies prior history of, or subsequent history of vaccine reactions. He was well on the days of vaccine receipt, without recent antecedent illnesses. He denies antecedent travel, animal or tick exposure, food, insect or latex allergies. At that time, his past medical history was negative and he was not taking any prescription or OTC medications on a routine basis. He was smoking a cigar or pipe about once per week and drank about 2 drinks daily. Family history is significant for diabetes, sarcoidosis, and hyperlipidemia. At that time, his exposure history included working at 9/11 site x 3 week activation. During his deployment to foreign country between Nov 2004 and Nov 2005, SM reports the onset of a number of symptoms, but due to mission priority, he did not seek evaluation, or if he was evaluated and treated, there are no records accessible. He is unable to recall the exact timeline or details of symptom onset. The following symptoms occurred during SM's deployment to foreign country: 1) Joint pain and generalized muscle aches 2) Swelling of extremities 3) Fatigue 4) Diarrhea, dyspepsia 5) Bronchitis, episode of pneumonia 6) Sinus infections, with associated headaches 7) Nosebleeds 8) Rashes, skin peeling
Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) 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) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that there was no product complaint associated. No treatment medications were reported.   This case was linked to MOD-2022-501363 (Patient Link).
PRE TREATED  WITH 25MG BENADRYL PO DUE TO A PREVIOUS ANAPHALACTIC REACTION WITH A TETNUS VACCINE.
Janssen COVID-19 Vaccine EUA  Headache started around 5:30PM and progressed into migraine by 7:30PM. Full body aches, severe bone pain (low back/neck), sensitive skin, hot/cold flashes, dizziness and sleep difficulties continued all night even after 1000mg of tylenol. Symptoms continue this morning (8:00AM) but to a far lesser degree. On a scale of 1-10, the level of pain was ~8-9, and unrelenting.