chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a rash; Raised rash on multiple areas of the body that is pea-sized to half dollar-sized; Red (rash); Itchy (rash); This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Raised rash on multiple areas of the body that is pea-sized to half dollar-sized), RASH ERYTHEMATOUS (Red (rash)), RASH PRURITIC (Itchy (rash)) and RASH (Developed a rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE, CARVEDILOL, ATORVASTATIN, AMLODIPINE and ZOLPIDEM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced RASH PAPULAR (Raised rash on multiple areas of the body that is pea-sized to half dollar-sized), RASH ERYTHEMATOUS (Red (rash)) and RASH PRURITIC (Itchy (rash)). On 11-Apr-2021, the patient experienced RASH (Developed a rash). At the time of the report, RASH PAPULAR (Raised rash on multiple areas of the body that is pea-sized to half dollar-sized), RASH ERYTHEMATOUS (Red (rash)), RASH PRURITIC (Itchy (rash)) and RASH (Developed a rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up received on 19-MAY-2021: Updated product information, events and concomitant medication and reporter information.
Immediate pain upon injection, body aches within 12 hours, massive headache, arm still sore after three weeks.
Moderna COVID was accidentally given to a 16 y/o, who was here to get her first Pfizer COVID vaccine. Pt was observed for 15 minutes without any adverse reaction.
ED to Hosp-Admission Discharged  9/10/2021 - 9/13/2021 (3 days) Hospital COVID-19  Principal problem  HPI: Shortness of breath - Hospital Course: Patient is a 83-year-old male presenting Hospital vaccinated with Covid pneumonia.  Patient was initially started on antibiotics also had a concern for superimposed bacterial infection but patient had 2 - procalcitonin's and the antibiotics were discontinued.  Patient was started on remdesivir, dexamethasone and convalescent plasma.  Patient tolerated therapy well.  Patient improved and was requesting discharge.  Patient be discharged home.  Fortunately patient was vaccinated and likely had mild form of Covid infection.
Reports she received flu vaccine on 10/20/17 in right arm at office. She reports she did not receive a copy of the flu vaccine consent form. Pt reports she looks away when she receives vaccines, but did turn her head while the needle was still in her arm and "felt it was very high up on the shoulder". She reports within 2-3 hours her shoulder became very sore, to the point where she didn't have "any mobility" in her shoulder. She was able to move her arm at the elbow. She reports the pain was so severe her husband had to help her get undressed. She reports she has this pain up until starting prednisone on 11/1/17. The provider is treating her with prednisone through 11/8/17 for inflammation. She has noticed a decrease in pain since starting the prednisone. She reports she is doing in home PT exercises for the next couple of weeks. Spoke to pt, she reports she was not scheduled to work on 11/1/17, her doctor advised her not to work on 11/2 & 11/3. She did return to work her regular FTE status on 11/6/17. Request that pt follow up with this nurse in 1-2 weeks after completing prednisone to report how she is feeling.
This spontaneous report was received from a licensed practical nurse concerning a 17 year old patient of unknown gender. On 10-DEC-2012, the patient was vaccinated with an adult dose of 1 milliliter (ml) VAQTA (lot number and expiry date unspecified) intramuscularly. No concomitant medications were reported. No adverse effect was reported. This is one of two reports from the same source. Additional information has been requested.
4 hrs p/receiving vax pt very pale; no evidence of apnea or dyspnea lasted 30 minutes full recovery;
Pt recvd 1st dose of Hep B vax 06DEC89 & devel gastrointestinal cramping & diarrhea.Later pt exp nausea & loss of appetite that lasted approx. 3-4 days.
pt recvd vax;1 day later exp bouts of v,d, dizziness & hot flashes;
Weird "tightness" in left side of body; muscle tension and soreness immediately after. Following the vaccine, faded overnight. Day 2 after vaccination: severe mental fog and lethargy. Difficulty typing correctly. Day 7 after vaccination: while walking home severe blood rush to left arm. Faded by the time returned home (15 min). All other symptoms gone by Day 12 after vaccine.
Tinnitus; Gestational period: 30; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jul2021 (Lot number: ER8736) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient was 30 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Oct2021. Concomitant medication(s) included: ENALAPRIL MALEATE; LEXAPRO in two week. Past drug history included: Known allergies: calcium channel blocker, reaction(s): "Known allergies: Calcium channel blocker". No other vaccine taken in four weeks. No covid prior to vaccination and no covid tested post vaccination. The following information was reported: TINNITUS (disability) with onset 31Jul2021, outcome "not recovered", described as "Tinnitus"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious), outcome "unknown", described as "Gestational period: 30". The event "tinnitus" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus. Clinical course: Last menstrual date: 25Dec2021 (as reported). Facility type vaccine was Pharmacy or Drug Store. Dose 2 administered in left arm, administration date was 20Aug2021 with lot no. FD8448 and Vaccine location for dose 3 on left arm, administration date was 17Feb2022.  No follow-up attempts are possible. No further information is expected.
From initial information received on 15Nov04 from a physician regarding an adverse event occurring. It was reported that a 12 year old female pt received TD ADS adult, lot number U1340AA, and MMR, lot number 09549 on Oct04. The routes of administration were not reported. The next day on 09Oct04, the pt developed swelling, redness and peeling skin on both hands. She then developed pain and tingling in both hands with clumsiness. This progressed to bilateral leg pain with increased sensitivity to the touch. The pt was hospitalized on 10Nov04. She had a positive ASO titer which was treated with amoxicillin, dose and dates of administration not reported. The physician reported that the pt's condition is improving with physical therapy. It is unknown if the pt recovered from this event.
Patient called 8/7/22 reporting residual pain at injection site. She describes the site as tender and sore and has never had any pain after injection that has lasted this long (going on 7 days).
Worst headache of my life impairing my vision and all daily activities. Lasted for 3 days after shot. Extreme fatigue, diarrhea, injection site pain, nausea lasting 3-5 days after shot. Dizziness and off balance causing me to fall over on day 5. Lasted through the day and into the next Elbow pain still (going into one week after shot) and injection arm feels tingly   Took extra strength Tylenol and it seemed to help, but not fully take symptoms away
Patient received dose #3 too early.  Dose #2 was given on 8/4/22
First Reaction: Three minutes after receiving injection felt lightheaded and dizzy. Symptoms resolved with food, water, and time Second Reaction: About 36 hours later while doing dishes, felt prickly on both sides of my neck. Both sides of my neck turned pink as though I had a sunburn. Broke out in profuse sweating.  Called my doctor who was on call that night. He told me to get Benadryl  right away and to keep taking it until symptoms subsided. If they did not subside or got worse I was to go to urgent care, or ER. Treatment: Benadryl every 4-6 hours for 2 days. As each dose wore off I waited to see if the symptoms came back and then took more Benadryl. Issue lasted until Saturday night - 2 days.
Pre - V/S WNL T. 98.3 P. 69 R. 16 BP. 110/73. Approx. 2-3 mins after receiving 5 immunizations, student became faint, weak & pale, for approx 25-30 mins. Oral glucose given stabilized within 30 mins. Transport to ER.
A serious spontaneous report of daughter got H1N1 and then a nose bleed has been received from a registered nurse/healthcare professional concerning her eight-year-old daughter, subsequent to H1N1, Intranasal. The patient does not have a history of nose bleed and bleeding disorders. Concomitant medications have not been reported for this patient. The patient received H1N1, Intranasal on 15-Nov-2009 for an unknown indication. On 16-Nov-2009, the patient experienced severe nose bleed lasting for about 30 minutes. On 17-Nov-2009, she experienced another severe nose bleed that lasted 1.5 hours. The blood was gushing and they were unable to stop the bleed. She was taken to the emergency room. The doctor did a full work up to ensure that she does not have any bleeding disorder. The outcome of this event was unknown.
Severe vertigo; nausea; within 4 hrs. had oral temp of 100.9, fatigue, aching in muscles, mostly in upper back. Symptoms continued for 1 1/2 days then disappeared after extra rest. No other symptoms.  No rash.
Fever, chills, fatigue, nausea, vomiting 19 hours post vaccine.  Severe headache, muscle and joint pain, back pain and fatigue continues at 42 hours (present).
The pt was seen in the ER on 1/28 and diagnosed with Bells Palsy.
Information has been received from a nurse practitioner referring to a 1 year old male patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 2 oz. Concomitant therapies included VARIVAX and hepatitis a virus vaccine (unspecified). On 12-MAY-2016 at 12:08, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 1, subcutaneously in the right arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Data digital logger was involved. No adverse effect was reported. This is one of several reports received from the sane reporter. Additional information has been requested.
Site of MMR injection became red, swollen and tender, and warm to touch 5/7/13. Afebrile. No lymphangitis. Two arms of deeper induration each size of peanut. Entire area size of orange.
Treatment of COVID-19; Treatment of COVID-19; Pfizer- 22Oct2021/ Moderna- 18Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 at 13:00 as dose 1, single (Lot number: El3248), in left arm, on 12Feb2021 at 13:00 as dose 2, single (Lot number: El3249), in left arm and on 22Oct2021 at 13:00 as dose 3 (booster), single (Lot number: Ff2590) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: Ouzm21A), in left arm and on 21Sep2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Iodine dye" (unspecified if ongoing); "Known allergies: NSAIDS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Apr2022 at 13:00, outcome "unknown", described as "Pfizer- 22Oct2021/ Moderna- 18Apr2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received Paxlovid from 13Mar2023 to 20Mar2023 for treatment of COVID-19. On 26Mar2023 at 13:00 pm, ten days after negative test, chills and aches, positive test.
3x5 " hive type swelling on inner arm.  Well below injection sight. Hot, burning and itchy. Lasted a week at this size and then reduced gradually.  At 4 weeks there is no longer a red area.  Still itchy on that spot on my arm.
Patient called today and stated that she aches all over her body and hasn't been able to sleep since 9/28. She specifically says aches, not pain. She had received the Fluzone HD last year as well and now remembers that this happened to her last year as well.
Uveitis, following a small pox vaccination by 1985. I lost the sight of my right eye-after several surgeries. MD who treated my uveitis, told me that in the 40's there was a small pox scare and of those who were vaccinated, many were subsequently diagnosed with uveitis. President should be made aware that this small pox vaccinations could do a lot of damage to people's sight. Floaters, photophobia-eye drops to reduce intra-ocular pressure. Finally lost sight of ret. eye to uveitis secondary glucoma. *F/UP report on 3/31/03: PT lost signt in her right eye to uveitis - triggered by a smallpox vax*. I finally became blind in the one (right) eye.
On 9/22/16, it noticed an uneven amount of diluent vs vaccine, when discussed with new injection nurse, it was found that she was not mixing the two. And only giving diluent.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot#, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting with in 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA001616, 1209USA003022, 1209USA003023, 1209USA003024). Additional information has been requested.
tiredness/fatigue; went pale; numbness in arms; sweating; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALLOR (went pale), HYPOAESTHESIA (numbness in arms), HYPERHIDROSIS (sweating), CHILLS (chills) and FATIGUE (tiredness/fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (preservatives), Contrast media allergy, Lactose intolerance and Gluten intolerance.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PALLOR (went pale). 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in arms), HYPERHIDROSIS (sweating) and CHILLS (chills). On 06-Apr-2021, the patient experienced FATIGUE (tiredness/fatigue). On 31-Mar-2021, PALLOR (went pale), HYPOAESTHESIA (numbness in arms), HYPERHIDROSIS (sweating) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (tiredness/fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Electrocardiogram: abnormal (abnormal) EKG abnormality persisted for 3 hours from her time of arrival to the hospital. On 31-Mar-2021, Heart rate: decreased (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details were not provided.
This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patient's medical histories were not provided. On an unknown date in 2014, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration and lot # were not reported) which were exposed to an unsupported temperature excursion since 02-NOV-2014. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
having wrist pain/not much of the pain is in her elbow anymore/pain extends into the lower arm and up into the shoulder/pain and aches in her wrist, lower arm, the elbow, upper arm and shoulder; left wrist and went up the inside of her hand/shooting pain up to her fingers; first shot on her left arm/pain extends into the lower arm and up into the shoulder/all of this was occurring in her left arm only; itches and hurts like crazy; Inside the palm area it was very tender; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) on 21Jan2021 at 10:30 (Lot Number: EL3302) as dose 1, single and on 10Feb2021 12:45 (Lot Number: EL9265) as dose 2, single both intramuscular, administered in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation from an unknown date diagnosed 7 years ago. Concomitant medications included apixaban (ELIQUIS) taken as a blood thinner, start and stop date were not reported. The patient stated that on an unspecified date in Jan2021, 10 days after getting the first shot on her left arm, she started experiencing some symptoms and after getting the second shot, these symptoms haven't stopped. She started having wrist pain. It started in her left wrist and went up the inside of her hand. Inside the palm area it was very tender, it itches and hurts like crazy if she tries to scratch it. If she scratches at all and if she scratches in her sleep or something, it is very painful. The pain extends into the lower arm and up into the shoulder. From there, it went down to the top part of her hand and she experienced shooting pain up to her fingers. She hasn't had the pain shooting from her fingers recently. She has this pain and aches in her wrist, lower arm, the elbow, upper arm and shoulder. The patient explained the elbow hasn't been bothering her as much. It does if she is sleeping on it wrong or something but it is not just aching or throbbing. The patient has not contacted her doctor yet. She was wanting to know if these were signs or symptoms of the vaccine before she called her doctor. The patient clarified that all of this was occurring in her left arm only. The patient explained that it did improve some because not much of the pain is in her elbow anymore, just a little bit, but the pain is still there when it hits. She does take a couple of Tylenol Arthritis. It gets very painful if she doesn't take something. The patient stated that she will call her doctor and see if the doctor can prescribe some kind of medication to get her through. The outcome of the events itches and hurts like crazy and itches and hurts like crazy was unknown while the outcome of the other events was not recovered.   No follow-up attempts are possible. No further information is expected.
Dialysis treatment started at 06:36.  Vaccine given at 10:07.  At 10:12 patient c/o feeling hot, had burning sensation throughout his body, became very diaphoretic. Pt was placed flat, Normal Saline 200cc given and O2 started per nasal cannula at 3 liters.  Did not loose consciousness, was not short of breath, did not get hives. Patient refused IV Benedryl and Solumedrol.  Symptoms completely resolved in 10 minutes.  BP after normal saline given was 106/60.  Pt completed dialysis treatment and went home with stable vital signs and feeling well.
fever more than 24hr p/vax-101 lasted 4 days;T101-103, hives started 2 days p/vax;stated hives hurt to touch;son had just got over chickenpox;mom told during pregnant did not need to worry about getting chickenpox;sero pruritic vesicular ra
Prior to giving vaccines and discussing aftercare, I asked whether the client had eaten and had fluids, and his mother said he had just eaten half an hour prior. After instructing client to relax his arms and breathe normally, I administered the vaccines. The client began to tense up and become nervous. I asked him to let me know if he became dizzy, and he did (within a few minutes). I notified (Supervisor) and we administered the ice pack to his forehead and back of neck, moved him to a flat bed in the wheelchair and took his vitals. 12:47 pm BP 98/51 P 57 R 18 T 96.6 F. He remained lying down for about 10-15 minutes and raised his legs by bending his knees in the supine position. He stated he was beginning to feel better. 12:56 pm BP 109/60 P 63 R 16. He sat up on the side of the bed for a few minutes before standing. We had him drink a bottle of cold water and eat some crackers. Had him sit in the lobby while his mother paid at the checkout and stay until they were sure he was ok.
small ecchymosis on deltoid area where injection was given 9/17/19. Below there is an approx 5cm x 5cm area of erythema that is warm to touch. No drainage or bleeding as of 9/25/19. Pt advised to continue Tylenol or Advil PRN pain, apply cool compresses, and continue to monitor sx. Call or go to ER if increasing redness, pain, drainage from area, fever, chills, N/V/D, myalgias, weakness, lightheadedness. Pt voiced understanding and agreement with plan.
Information has been received from a Registered Nurse (RN) concerning a 12 year old female patient who was currently being examined for juvenile rheumatoid arthritis due to leg pain who on 29-AUG-2007 was a first dose of Gardasil. On 29-AUG-2007, concomitant therapy included Menactra, DTaP. On 29-AUG-2007 the patient experienced syncope, nausea, and developed vomiting after getting her first injection. She also had impaired vision and difficulty hearing. She reported feeling hot and her temperature was checked and recorded as 99.1 degrees. In less than a minute, temperature went up to 99.8 degrees and then back down to 99.3 degrees. The office called 911 and the paramedics arrived. The outcome was unknown. The reporter believed calling 911 and paramedics and arrival of paramedics was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.