chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt c/o calf pain/myalgias, bilaterally sine Td booster on 3/23/04. No prior intolerance of Td booster. Denies weakness/paresthesias/strength changes.  to see PMD for hypothyroid w/u May 2004.
Arm turned red from shoulder down to elbow, skin was hot to the touch, itchy, and muscle was swollen and hard.   Lasted 3 days.
This spontaneous report as received from a licensed practical nurse refers to a 4 years old patient. On an unknown date the patient was vaccinated with a dose of PROQUAD (Merck) (lot#, dose number were not provided), 0.5 ml, intramuscular. The licensed practical nurse stated that she had a patient who received a dose of PROQUAD (Merck) and came in with injection site reactions that were red and swollen. The outcome of the event is unknown. No lab diagnostics studies were performed. The patient sought medical attention by office visit. This is one of several reports received from the same source. Additional information has been requested.
Patient received flu vaccine for the first time. While being monitored after vaccine she began to feel nauseated. She had 2 episodes of vomiting. No hives, rash or shortness of breath. Glucose fingerstick was 92. She rested in Health Center and observed for 45 minutes and felt much better. Upon follow up the next day she stated she had a slight headache the night of the vaccine that resolved. States she was feeling well with only minimal soreness at the injection site.
Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body; elbow is a little sore; Injection site soreness; Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt; Pinky is a little numb; Shaking uncontrollably; First dose administered 10-Mar-2021, second dose administered 16-Apr-2021; Headache; Chills; This spontaneous case was reported by a patient and describes the occurrence of BURSITIS (Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt), HYPOAESTHESIA (Pinky is a little numb), TREMOR (Shaking uncontrollably), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 10-Mar-2021, second dose administered 16-Apr-2021) and MYALGIA (Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included GABAPENTIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced TREMOR (Shaking uncontrollably), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 10-Mar-2021, second dose administered 16-Apr-2021), CHILLS (Chills) and HEADACHE (Headache). On 23-Apr-2021, the patient experienced BURSITIS (Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt) and HYPOAESTHESIA (Pinky is a little numb). On an unknown date, the patient experienced MYALGIA (Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body), ARTHRALGIA (elbow is a little sore) and VACCINATION SITE PAIN (Injection site soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 17-Apr-2021, TREMOR (Shaking uncontrollably) and CHILLS (Chills) had resolved. On 18-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, BURSITIS (Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt), HYPOAESTHESIA (Pinky is a little numb) and ARTHRALGIA (elbow is a little sore) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 10-Mar-2021, second dose administered 16-Apr-2021), MYALGIA (Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.            Treatment also included Ice applied to left elbow  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-101917 (Patient Link).
after an hour had metallic taste in my mouth, felt faint.  as fast as it came it disappeared as fast.  Eyesight reading letters were blurry, an memory for spelling not good.  Then got tired my usual reaction to preservatives, took a couple of naps most of the afternoon.   Whole body started to ache.  Around 8pm  site started to hurt, got swollen and red.  Now today the only problem is the site is warm and red and hard to raise my arm.  Otherwise seem ok.   Was concerned as i have A fib with a pacemaker.  Cardiologist said they could not see any a fib episodes for yesterday and this morning.
significant pain in the arm where the vaccines were administered; chills; extreme fatigue; experienced low grade fever; This spontaneous report as received from a consumer refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 milliliter, intramuscularly (anatomical location, lot # and expiration date were not provided) as pneumonia prevention and influenza virus vaccine (unspecified) dose 0.5 ml (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On the same date, she experienced low grade fever, chills, extreme fatigue and significant pain in the arm where the vaccines were administered. The patient recovered from the events on 25-SEP-2020.  Causality assessment was not provided.
Expired vaccine. No temperature excursion occurred. Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration." Patient reported no adverse reactions.
Rash on both thighs, forearms and beltline.  dx in ER with hives on 1/11/00, Tx with Benedryl and Prednisone.  1/12 - seen in MD office, rash increased, some were open and bleeding apparently due to scratching.  1/13 rash worse, and some wheezing began, pt also had upper right quadrant abdominal tenderness. 1/14 pt states very ill, admitted to hospital.
Individual called the Student Health department where she received both of her doses of Covid-19 (Moderna) vaccine. She noted that approximately 1 week after receiving her second dose that her hair began to "fall out" in a dramatic way. She notes that it has fallen out "by the fist full" and is currently about 1/2 as thick as it had been previously. Nurse has not seen the individual to confirm her statement. She denies any other changes of any nature within her health, diet or nutrition since receiving her two doses of vaccine (first dose given 1/5/21 and second dose 2/2/21).  She denies any other symptoms or concerns other than ongoing hair loss.
pt recv vax & became diaphoretic;rhythm on cardiac monitor was noted to be atrial fibrillation w/a ventricular response rate of 180 beats per min;pt had a syncopal episode;pt placed in trendelenberg position & given addtl IV & 02
Information has been received from a nurse practitioner concerning a female (age unknown) who, on an unspecified date, was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. The patient was administered Gardasil in one arm ant Tetanus vaccine in the other arm on the same day. On approximately 02-FEB-2007 the patient developed a rash on her whole body. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. At the time of this report, the outcome was unknown. No product quality complaint was involved. no additional information is available.
Information has been received from a nurse practitioner concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, the patient developed breakthrough varicella.  The patient did not go to the hospital and recovered.  A product quality complaint was not involved.  No further information is available.  The nurse practitioner also reported a male patient that had a similar experience after therapy with varicella virus vaccine live.
Patient reports hives on both arms and on her back.  Recommended oral non-drowsy antihistamine like zyrtec or allegra as well as tylenol or ibuprofen if pt is in pain.  Discussed monitoring for swelling in face or mouth area.
The patient noted that he felt moderate and sharp pain from the flu vaccination at the time of vaccination.  The pain is progressively severe over the past 3 weeks after receiving his immunization.  Patient had chills, nausea and fever for one day after the injection, and persistent pain with overhead activities.  No previous issues with the vaccine.    From this visit the provider prescribed diclofenac sodium 75mg twice daily.  The provider recommended that after 2 weeks of the medication if there is no improvement he will likely need imaging.
Hives, wheezing, itching,rash chest tightness and respiratory issue. I was treated at the hospital. Treatment medications were Prednisone, metoprolol succinate, Benadryl.
I did not clarify if cancer developed before or after Prevnar 13 shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "I did not clarify if cancer developed before or after Prevnar 13 shot". The patient got the Prevnar13 in 2020 and she was going 77 years old two weeks. The patient was not sure if this is a forever shot or not. She stated she only ever got Prevnar 13, not a Pneumovax23. Her oncologist is telling her its okay and then the pharmacist says she should get a forever shot. The action taken for pneumococcal 13-val conj vac (dipht CRM197 protein) was unknown. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
This report describes arthritis in a vaccine of unspecified age and gender who received Lyme disease vaccine recombinant OspA (Lymerix). The medical history, concurrent conditions and concurrent medications were unknown. The vaccinee had "no problems" following the first injection of Lymerix. Information regarding the second injection was not provided. On an unspecified date, the vaccinee received the third Lymerix injection. Subsequently, the vaccine experienced arthritis with joint pain. The vaccinee was seen by a physician. The reporter stated that these events were possibly related to lymerix. As of 05.03/02, the outcome of the event was unknown. The adverse event "arthritis" does not meet serious criteria, but is  being submitted as an expedited report  by special FDA request per the 06/28/00 letter.
Patient reported Flu-like symptoms and achiness at 12:00 PM on 1/4/21. There was bilateral neck pain and headache at 2:00 AM on 1/5/21, and a hacking cough throughout the day. Patient experienced chills at 6:00AM. Patient called in sick to work on 1/5/21. Patient alternated between ibuprofen and tylenol, and symptoms have seemed to resolve by 3:15 PM on 1/6/2021 3 hours after taking 2 grams of tylenol.
got shingles even after got the shot/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles even after got the shot/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-MAR-2023 This case was reported by a patient's cousin via interactive digital media. The reporter stated that, the patient got shingles even after receiving shingles shot.  The reporter stated that getting the shingles shot did not actually make you immune unfortunately. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
I received my first Pfizer/BioNTech vaccination at 1:00 PM on March 21, 2021.  I was fine all day, but near bedtime felt like something was beginning to happen.  My upper left arm was also sore from the injection.  I fell asleep at 11:30 PM and awoke at 1:00 AM with body aches and chills.  I was never able to get back asleep the entire night.  The following morning, March 22, I had body aches, chills, shaking and a terrible headache all day.  All of these symptoms continued throughout the day and evening.  I stayed hydrated with Gatorade and Sprite and ate very light foods.  By the next morning, March 23, the headache was gone, but still have a little remaining of the body aches.  No more chills or shaking.  Moving slow still, but getting better.
SOME JOINT PAIN/VERY FATIGUED/BAD INJECTION SITE PAIN/ HEADACHE
Vaccine was given on 5/26. Pt came back on 5/27 and complained about pain on arm. Rph consulted pt on soreness on 5/28 am, pt returned to pharmacy with a swollen elbow. Later on that day on 5/28, pt fell and went to ER and was diagnosed with cellulitis.
Patient was given a 0.25 Flu vaccine at 4 months. Recommended age is 6 months.
Information has been received from a pharmacist referring to a 49 year old male patient with high blood pressure. The patient's medical history included unspecified nasal problem. On 07-OCT-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L017265 with expired date 10-FEB-2017; 0.5 ml, intramuscular) (inappropriate schedule of drug administration). Concomitant therapies included FLONASE, lisinopril (manufacturer unknown) and clopidogrel. The reporter also stated that the patient received an unspecified flu vaccine (unspecified manufacturer) every year (unspecified dates). A week after receiving PNEUMOVAX 23, on approximately 14-OCT-2015, the patient developed an unspecified fever, "achiness all over his body" and unspecified swollen glands. On 18-OCT-2015, the patient went into the pharmacy for medical attention and was informed to take TYLENOL 500mg every six hours for the fever. No lab test was performed. At the time of reporting, the patient did not recover from the events. Additional information has been requested.
Pt received the flu vaccine on 1/21/16 at 1101. Parents first noticed that his lips were swollen around 1845 that same afternoon. Was taken to the ER, where he was triaged at 1920. By this time, he had also developed a splotchy rash on his face. VS at the ER were T 97.9, HR 116, R 38, and O2 sat 98% on RA. At 1958, he was given 12.5 mg of Benadryl IV and 2 mg of Decadron IV. Dad stated that this helped his symptoms greatly, but did not completely get rid of rash or swollen lips. States that symptoms had completely disappeared by about mid-morning the next day.
MENVEO given in (R) deltoid. 2 days later with 2.5 in x 2.5 in red swollen area.
Patient stated that she received a headache and arm soreness from the first vaccine. Patient stated that she received pain all over body. The pain feels that it is in her bones.
Flu like symptoms about 8 hours after injection with crushing headache.  Most flu like symptoms ended after 30 hours after injection with the exception of the headache which remained( but not crushing) for 3 days second day after injection I suffered from a rapid heartbeat. This lasted a couple of hours with heart rate going between 100-135 while sitting or standing.  My normal resting heart rate is around 70 and standing between 80-90.  I found this unusual for me
Sever body aches last 2 weeks, extreme SOB, fatigue and prolonged menses that lasted 3 weeks. This is unusual as my cycle is very regular and never exceeds 5 days
Patient continues to complain of pain at the injection site at second dose. Pain comes and goes. No numbness or tingling, but occasional pain. Pain eased by rubbing injection site. No redness, swelling or tenderness noted at time of visit.
nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown. Not Provided          He has been taking tums for his nausea.
reaction at the injection site/ with underlying hardness at the site; genera and malaise; large area of redness / at the site/ local reaction has gotten larger; with underlying hardness at the site; severe body aches; low grade fever; This case was reported by a consumer and described the occurrence of injection site reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On 24th June 2021, the patient received the 2nd dose of Shingrix. On 24th June 2021, 12 hrs after receiving Shingrix, the patient experienced injection site reaction, malaise, general body pain, low grade fever, injection site erythema and injection site induration. On an unknown date, the outcome of the injection site reaction, injection site erythema and injection site induration were not recovered/not resolved and the outcome of the malaise, general body pain and low grade fever were recovered/resolved.   The reporter considered the injection site reaction, malaise, general body pain, low grade fever, injection site erythema and injection site induration to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's wife. The patient had taken second dose of Shingrix and had mild side effects and they thought might be a reaction at the injection site. After vaccination beginning about 12 hours patient had genera and malaise, Severe body aches and low grade fever. The patient had also developed a large area of redness with underlying hardness at the site. The patient symptoms resolved over about 2-3 days but local reaction had gotten larger.
It started from the chest and went abnormal serve pain couldn?t walked. Went to the emergency room and gave me pain.
Heart murmur detected 7/5/2021. No previous history of this condition, including up to previous medical visit in February 2021.
Patient did not visit a healthcare professional until 10/28. He said a rash was noted the evening of the immunization(6 hrs. later). On 10/28 he presented to a clinic with a body rash, swollen eyes,swollen rt. hand and SOB. He was treated with Prednisone 20mg BID for 5 days and Allegra for 7 days.
Dizziness. Mild injection pain, redness and swelling, muscle pain.,  Nausea, fatigued, Headache, joint pain, Hot Flashes ,
Received Jan 27, and as of today Feb 9  2021 I am still having symptoms low grade fevers, night sweats, sever headaches, little appetite, fatigue, coughing.  Comes and goes, has not disappeared as of this date Feb 9 2021 I have notified my Primary Doctor to the above and am waiting his call
The injection site (upper arm) was swollen and itchy the next day, and I ran a fever of 100 (not unexpected, per the drug information I was given).  Two days later, without any warning , I passed out, hit my head on a doorway and got a mild concussion.  The only other time in my life I have passed out was in the 1970's when I was getting the flu, so I am not prone to syncopal episodes.  It took several weeks before I felt normal again.  I did report the episode to my Dr..
pt has experienced pain in left arm- noticable swellingn and redness today 2 days after immunization
Swelling at injection site and upper arm leading to burning sensation and occasional sharp pain in upper arm that radiates from injection site and lasts about 15 minutes. Pain still occuring after 5 weeks and getting more frequent. Hard to sleep. Pain responds to ice. Dr. prescribed Meloxicam & Cyclobenzaprine ( started 4/21/2021)
Patient received the covid vaccine on 01/14/2021. She continues to breadfeed her 22 months old son prior to and post vaccination. She reports that her son had a fever of 101.1 started 10 hours after vaccination (2 am on 1/15/2021). Son had another fever with temp. of 101.1 at 9 pm. Son is eating/drinking well. Normal BMs. Behaved normally. Very active. Patient reports that she tolerated the vaccine without any problem.  But wants to report because of her lactation status.
left arm pain at site of vaccine immediately afterwards, a few weeks later pain traveled into left forearm, clinically diagnosed with lateral epicondylitis
Symptoms started 10/22/2021 with a fever of 101.0. Measles like rash appeared 10/25/2021.
Fever started around lunch time at 99 went up to 101.9F several times & lasted for 5 days.  Treated with Tylenol. Rash started on 4 & spread to cover entire body with raised rash & bright red hives by day 6. By day 7 (today) started subsiding but not gone. Treated with cool water & aloe. Loss of appetite, cranky, & lethargy started on day one & continues. Probably eats half of what he did a week ago.  Just started eating baby food again on Day 6.
Pt. visit school nurses office with elevated blood sugars.  It was then discovered pt. had type 1 diabetes and received the Flumist. Vaccinator was not informed of diagnosis.
The 1st of May all of a sudden my ears feel full of fluid like I have to pop them. I couldn't hear well and I went to my PCP on the 3rd and gave me steroids plus a Flonase. I went to an ENT doctor on the 14th and he gave me Afrin which helped a little bit on top of a 10 day supply of steroids. I went to another follow up and hearing test which they gave me the diagnosis of Sudden Hearing Loss on June 10.
Pt. states that after receiving the 1st dose of J&J 10/01/2021, started experiencing symptoms 10/04/2021 of fatigue, nausea, severe headache (lasting a week), hot flashes, chills, irritability, random pain in both legs, severe pain from the back of shoulder blades to the back of the head. Physical Therapist visit 10/14/2021 loss of right shoulder mobility/Tension. 10/07/2021 Primary visit prescribed Zofran for nausea, continuing to experience symptoms of "heart pain" 10/10/2021 Hospital visit/ EKG, Blood Work, and Ultrasound. 10/18/2021 Blood Work , recommendation of PT *Shoulder Mobility, and observation. Still experiencing symptoms.