chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As reported, a 42 year old Caucasian with history of arrhythmia after ASD repair developed stiffness followed by pain of his knees and all proximal interphalangeal (PIP) joints starting day 5 after the first anthrax vaccine dose (lot FAV064). Chills, fever, joint and neck pain with nodule at injection site occurred with Dose 2 (lot FAV066). Dose 3 associated with fever, chills, nausea, vomiting, neck, hand and shoulder pain. Doses 2 and 3 were coupled with Typhoid VI and Yellow Fever respectively with no known prior adverse reaction to either vaccine. Symptoms of pain and stiffness persisted for 9 months with anorexia and 6.8 kg weight loss. Physical exam revealed swelling of bilateral PIP joints with presence of Bouchard's nodules. Vaccination was terminated after the third dose.
Fatigue-loss memory-skin rashes, muscle pain-headache-loss vision-high pressure-cramps on arms-sleep disturbances
55 year old staff physician, active duty and in generally excellent health, predeployment, who finished the 4-dose oral typhoid vaccine (starting 9 Jul 09, every other day with no other vaccines as prescribed). After the 1st dose, in retrospect but at the time not associating it with the vaccine, he noted reduced exercise tolerance that evening doing his usual run and with each passing day, as he took the rest of the doses, he noted worsening malaise, fatigue with new onset headache that worsened with lying down, temperature to 100.6 degrees F, some chills and night sweats but NO RIGORS or GI symptoms, generalized myalgias, and sleep disturbance due to headache pain. HE DENIED ANY nausea, vomiting, diarrhea or abdominal pain. Temperature resolved by day 6 but headache continued, myalgias and fatigue decreased but spouse noted increased irritability. By day 7, the headache severity was >8/10, "unrelenting", without photophobia, and myalgias, fatigue was continuing to improve. Physical exam was normal. Day 8 received a lumbar puncture and brain MRI to rule out meningitis (normal). By day 10 all symptoms were resolved. By 31 July, all laboratory abnormalities had normalized (transient anemia, thrombocytopenia, transaminitis (with normal bilirubin and muscle enzymes). Had measurable (low level) anti-smooth muscle and anti-CCP. Cultures and ID serologies non-diagnostic. COMMENTS: Extensive external consultations: Concurrence of infectious disease, special experts and manufacturer representative provided information that makes cause of clinical presentation as a vaccine strain infection highly improbable if not impossible, particularly in a non-immune suppressed individual. To date, infectious disease testing for other concomitant causal infections has not identified a potential cause but some still pending.
Injection site redness and swelling appearing 7 days after vaccination. Arm feels numb. Otherwise, I feel fine.
This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient's historical drugs included penicillin. The patient's concurrent conditions included penicillin allergy, anxiety, unspecified respiratory problems and unspecified urinary problems. On 12-OCT-2017 at 09:15, the patient was vaccinated with a dose of ZOSTAVAX lot # N021170 with expiration date 27-OCT-2018, subcutaneously, for prophylaxis (dose was not reported). Concomitant therapies included nortriptyline 25 mg, vitamin D, LEXAPRO, "cholecystramine powder", and albuterol. On the same day at 12:30, the patient developed "symptoms of urinary tract infection". No treatment was provided for the adverse event. At the time of reporting the outcome of the event was reported as not recovered. A product quality complaint was not involved. The causality assessment between urinary tract infection and ZOSTAVAX was not provided.
Patinet c/o of dizziness and looked pale, ammonia inhalent was opened, pt felt nausea but did not vomit. Pt with normal pulse and no other symptoms. After about 3 mins, patient reported feeling better, no dizziness and no nausea, and paleness improved. No syncope or LOC.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL, lot number was not provided. A week later the patient developed atypical aggressive behavior. The patient did have some tests (unspecified) done and was diagnosed with having an ovarian cyst but that since has resolved. The patient sought unspecified medical attention. the patient will not receive the second and third dose of GARDASIL. Additional information has been requested.
Purple toenails and fingernails. Headache. Symptoms just started 45 minutes after 2nd vaccine.
pain in back of neck, shoulders, fingers, hands, knees, toes-especially joint;
Excruciating pain, could not turn, move arm or touch shoulder. Pain radiated down to elbow. Could not lift arm for several days. As of 4/30/18, still does not have full range of motion.
This spontaneous report was received from a physician's assistant, via company representative, referring to a 24-year-old non-pregnant female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (strength, dose, frequency, lot# and expiration date not reported) for prophylaxis. On an unknown date, after receiving the first dose of GARDASIL 9, the patient experienced hallucinations. It was unknown if the patient received any treatment for the event. The outcome of the event was not reported. The causal relationship between GARDASIL 9 and the event was not reported.
Feverish, chills, swollen glands under tongue, stuff nasal passage, throat tightening, lots of phlegm, body aches.
Muscle pain along hip and back, injection site pain  Fever spiked to 100.5 (current) about 39 hours after vaccine received.
8 cm erythema and swelling at injection site 6-8 hours after injection - right anterior thigh.
A report was received from a consumer on 10/24/2003 concerning a 54 year old vaccinee who experienced flu like symptoms with bad headache, fever, muscle aches, cramps weakness, congestion, sneezing, stiff neck and stiff should 1 day after receiving Fluvirin on 10/10/03. On 10/11/03 the vaccinee experienced flu like symptoms with bad headache, fever muscle aches, cramps, weakness, congestion sneezing, stiff neck and stiff shoulder. At the time of the report the vaccinee continued to have a headache, weakness, congestion and sneezing. the vaccinee took diphenhydramine hydrochloride and aspirin for relief of symptoms, neither of which was very effective. The vaccinee had not recovered at the time of the report. Update 1, 03/30/2004: a follow up report was received from a consumer indicating that he had experienced influenza, coughing and a stiff neck/shoulder almost continually since receiving Fluvirin on 10/10/2003. On 3/4/2004, the vaccinee attended an emergency room for chest pain du to excessive coughing. The reporter indicated that the doctor came to the conclusion that the vaccinee's chest wall had gone into spasm due to coughing. The vaccinee also attended a doctor on 02/19/2004 for should spasm and pain. Update 2, 05/11/2004: A follow up report was received from a health care professional indicating that he had seen the vaccinee in the emergency room for other reasons. Follow up pending.
On 10/21/99, the pt developed varicella and sought unspecified medical attention. No further information is available.
Patient reported that on 1/7/2021 she began to experience symptoms of feeling flushed, warm and nauseous. Shortly after she began to develop hives to her chest, arms, face and thighs and felt itchy. She then took a 25mg Benadryl tablet. She denied experiencing any difficulty swallowing, facial /throat swelling or difficulty breathing during this episode. Symptoms began to improve after taking oral Benadryl 25mg.   Patient then contacte her tele-health doctor and was prescribed the following medications: Allegra, Medrol dose pack and Famotidine. Pt reports that she had not yet started these additional medications but notes improvement in her initial reported symptoms at this time.
Shot given 11/3/09. On 11/9/09 pt continues with sore arm with swelling from injection site to elbow. Injection site "bright red". Describes arm as "very sore". Advised to use ice and ibuprofen.
Early on in the day of 1/6/21, I felt very sluggish and spaced. My boss asked me early in the day if I was okay because she said that I seemed "out of it." It wasn't to the point that I was unable to work, but it was a noticeable difference from my typical state. At 11:31 AM, I texted my wife and said "I feel gross and weird today." When she asked me how so, I replied, "I just feel run down, my neck hurts, and I can't focus." My arm was more sore than it typically is from the flu shot, but it wasn't unbearable.  As the day went on, I felt the cloudiness in my head start to dissipate a bit and I started to feel a little better. By dinnertime, I was feeling sick to my stomach and was not able to eat very much. I chose to head to bed around 9 because I was feeling pretty ill (my neck had really started feeling sore again and my stomach was very upset.) At 1:30 AM on 1/8/21, I woke up with a horrible headache. I get migraines from time to time, but this was unlike anything I had ever felt before. It felt like my head was in a vise and I was very close to asking my wife to take me to the ER. I never go to the doctor, but it legitimately scared me. My neck was extremely sore and my head hurt so bad that even laying it on a pillow hurt. I was extremely nauseous as well. I took a few extra strength Tylenol and laid my neck on a heating pad with an ice back on my forehead. The sound of our humidifier was too much for me, so I also out in earplugs. After an hour or so, I fell back asleep. When I woke up this morning, I still had a headache and I took an Excedrin. To this point, I have felt a little sick to my stomach, but the intense headache has been kept at bay. My neck is still sore but it is also somewhat better.
Rash about half inch to 3/4 inch in diameter and bulge appeared at the site of injection (right upper arm).  so far it has persisted on the arm since Friday.
No additional adverse effects reported; patient was administered an expired dose of PROQUAD; This spontaneous report was received from nurse and refers to a 5-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 30-JUL-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, injection, lot # S002925 and expiration date 28-JUL-2020 (exact dose and route of administration were not reported) for prophylaxis. No additional adverse effects were reported.
mom gave APAP a/getting vax & began w/fever w/in 2-3 hrs p/vax; fever kept rising even though pt cont w/APAP & it went to 102, pt fussy w/high pitched cry & very lethargic;
STARTED HAVING BELL'S PALSY SYMPTOMS AROUND NOVEMBER 9TH. PT DOES NOT KNOW WHICH INFLUENZA VACCINE SHE RECEIVED.
Patient was originally vaccinated with the Moderna vaccine on 8/20/21 (lot 025C21A) for his first dose, and inadvertently received his second dose with the Pfizer formulation on 10/4/21.  No adverse event occurred - submitting this since a vaccine administration error occurred.
Raised pink rash started near vaccination site 10 days after. Grew to about 5 inches. Warm at site. No fever no pain. Some itching. Called doctor. Said to keep an eye on it   If fever or shortness of breath to come in. Went away in4 days
24 hrs later, my right ankle where I had surgery, ached and swollen from my knee to ankle hurt really badly. Had it elevated. Bad right foot, 11 pins and 2 plates in foot in surgery in the past, 5 years ago and still had a bone simulator. That leg swell and became huge and lasted for 7 weeks. I had to use the cane. I felt it might be a good thing. Didn't call doctor because my doctor moved away and didn't have a new doctor yet. I was tired for 3-4 days and the arm was a little sore and it was no big. ER visit was not for this event, went to ER for a dog bite.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:02 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Age of patient was reported as 78.97 for dose administered on 31-Mar-2021.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM. These vials were moved to fridge on 23- Mar-2021 and beyond use date for the vials was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021 Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported
Extreme headache all week. Fatigue, nausea, intestinal problems, heart palpitations, heaviness of chest at first 3 hrs indigestion, sleepiness all time. Took off 1/2 day Tuesday.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included immunocompromised, infections, and flare up.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. Laboratory data (dates unspecified) included: Blood culture (NR: not provided) not reported, and COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Was vaccinated on 3/20/2003, scab fell off the last week in May, about 8-9 weeks after vaccination.
GI FLU LIKE SYMPTOMS; LOOSE STOOLS; UPSET STOMACH; 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, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced GI flu like symptoms.  On 12-MAR-2021, the subject experienced loose stools. On 12-MAR-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gi flu like symptoms, loose stools, and upset stomach. This report was non-serious.
injection site pain; headache; fatigue; muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 19-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0179), via an unspecified route of administration in the left arm on 18May2021 at 09:15 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. Medical history reported as none. The patient did not take any concomitant medication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0162), via an unspecified route of administration in the left arm on 27Apr2021 at 09:15 as a single dose for COVID-19 immunisation. On 18May2021 at 12:00, the patient experienced injection site pain, headache, fatigue and muscle pain. On 15May2021, the patient underwent saliva covid test and the result was found to be negative. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events injection site pain, headache, fatigue and muscle pain was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Shortly after vaccines were given, Patient's eyes rolled back in her head.  Mom laid her down on the table and she passed out.  She had a brief tonic clonic seizure that involved all 4 extremities and lasted a few seconds.  By the time the physician entered the room, she was awake and crying.  Within 15 minutes, Patient was able to walk out of the office with her mom.
Itchy; broke out in a rash all over body; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Itchy) and RASH (broke out in a rash all over body) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy) and RASH (broke out in a rash all over body). At the time of the report, PRURITUS (Itchy) and RASH (broke out in a rash all over body) outcome was unknown.            Concomitant medication and treatment information were not reported.  The patient reported that after about a week and half from the second Moderna vaccine the patient had broke out in a rash all of body and was very itchy.  Action taken with mRNA-1273 in response to the event was Not Applicable
Knee has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee has gotten worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (She had been diagnosed with arthritis of the knee years ago.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Knee has gotten worse). At the time of the report, ARTHRALGIA (Knee has gotten worse) outcome was unknown.            No concomitant product use was provided by the reporter. Treatment information was not provided.  The consumer stated that she was having a knee replacement surgery in September 2021 due to arthritis. The patient received 2nd dose of Vaccination in February 2021.
4 1/2 yr old child 25Jun90/w positive blood culture for h. Influenzae type B. Child received immunization on 9Dec87
trouble holding bladder; sick; body pain; sore and ache; arm sore; threw up; fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache) and PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache), PAIN IN EXTREMITY (arm sore), VOMITING (threw up) and PYREXIA (fever). At the time of the report, URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache), PAIN IN EXTREMITY (arm sore), VOMITING (threw up) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Adverse Event  outcome were updated.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Site: Pain at Injection Site-Severe, Additional Details: Patient's caregiver called to state that after patient received the Moderna covid 19 vaccine, she had severe shoulder pain and she went to the ER where she was diagnosed with adhesive capsulitis.  Patient is wondering whether store will reimburse her the cost of the ER visit which was between $1800 and $2000 per her caregiver.