chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylactic reaction. Hives and swelling on face and mouth, itching. ER Gave IV fluids, Benadryl, Pepcid and steroids.
swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away; swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away; inflammation; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0173 and expiry date was not reported), via an unspecified route of administration in right arm, on 01May2021 (age at vaccination: 50 years), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were none. On 05May2021, 3-4 days after the patient presented swelling of her legs, that was painful/ legs were like swollen and hurting a lot, and it did not go away and inflammation. The patient queried what she should take to reduce inflammation. The patient used cold water as treatment. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Product supply issue; itch, starting at both wrists, then down to her ankles; had dose number 3 of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Due to the shortage the patient was not called for a 2nd dose until November 2018. When the patient went in for her 2nd dose, she was told by the person at the pharmacy that she only needed to get 1 dose, so she did not get the 2nd dose.   Follow up information received from Consumer on 2nd March and 9th March 2020:  The consumer stated that after receiving the third shot (in March of 2020) of Shingrix, she had itching of the ankles, wrists and moved around her upper body and on the back of her arms.  She stated her physician recommended CeraVe cream and Cortisone which she has been using and also a steroid cream that she administered for seven days twice a day.  She stated that the itching around the ankles and wrists subsided some, but she was still itching under her upper arms and behind her thighs. She stated that the day of reporting, she started to itch on the outside of her ears.  She stated that she did not have a rash and that it was just itching.  She said she got the first Shingrix shot at a Hospital pharmacy, the second shot at a Medical Practice and the third at a pharmacy.  She said she had never had allergies before and that she has not changed detergents.  She said her physician had now given her Claritin.  She stated that she never got soreness or redness of the arm with Shingrix, only the itching and the itching only started after the third dose. No other information was provided.
Swelling near injection site along with redness.  No pain but warm and tender to the touch.  Still had normal range of motion and had no difficulty performing everyday activities.
pt sister was vax on 7/10/98 & devel lesions on 11th. on 7/24/98 pt devel chickenpox & slight fever. had 40-50 vesicles & papules over body. f/u from MD indicated pt had simple case varicella.
around the injection site is swollen, itching, hurting, red with a big patch; around the injection site is swollen, itching, hurting, red with a big patch; around the injection site is swollen, itching, hurting, red with a big patch; around the injection site is swollen, itching, hurting, red with a big patch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (around the injection site is swollen, itching, hurting, red with a big patch), VACCINATION SITE SWELLING (around the injection site is swollen, itching, hurting, red with a big patch), VACCINATION SITE PAIN (around the injection site is swollen, itching, hurting, red with a big patch) and VACCINATION SITE ERYTHEMA (around the injection site is swollen, itching, hurting, red with a big patch) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain in arm (had a reaction to the flu shot when it first came out and her arm was real sore for almost a month). Previously administered products included for an unreported indication: INFLUENZA VACCINE.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (around the injection site is swollen, itching, hurting, red with a big patch), VACCINATION SITE SWELLING (around the injection site is swollen, itching, hurting, red with a big patch), VACCINATION SITE PAIN (around the injection site is swollen, itching, hurting, red with a big patch) and VACCINATION SITE ERYTHEMA (around the injection site is swollen, itching, hurting, red with a big patch). At the time of the report, VACCINATION SITE PRURITUS (around the injection site is swollen, itching, hurting, red with a big patch), VACCINATION SITE SWELLING (around the injection site is swollen, itching, hurting, red with a big patch), VACCINATION SITE PAIN (around the injection site is swollen, itching, hurting, red with a big patch) and VACCINATION SITE ERYTHEMA (around the injection site is swollen, itching, hurting, red with a big patch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included unspecified blood pressure pills and depression medication for an unknown indication.  No treatment related information has been reported.
sinus infection; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sinus infection in Dec2020. The patient wanted to know the efficacy of the covid vaccine after getting the first dose. The 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.
Rash, swollen feet, hands & feet tingling. Benadryl 1 1/2 tsp, Orapred 2 tsp,  Epi-pen 4.
subcutaneous nodule lt thigh consistent w/fatty necrosis d/t infiltration of vax;redness @ site of injection for 4-5 days following vax;
On 5-30, 2022 I started having a sore throat. On 5-31, I began having upper respiratory congestion, cough, fatigue and elevated heartrate (92bpm). On 6-1, I took a Covid home test and it was positive so I called the doctors office for a telehealth visit. He prescribed PAXLOVID and recommended OTC MUCINEX and TYLENOL. I followed up with another Covid home test on 6-8, 2022 and it was negative. I still have some upper chest congestion but feel much better. I am reporting a breakthrough case of Covid.
This spontaneous report as received from a nurse refers to two patients of unknown demographics. On an unknown date, the patients were vaccinated with a dose of GARDASIL (Lot number, expiry date and dose were not reported), intramuscularly. On an unknown date, the patients experienced syncope. The healthcare professional present also agreed with the nurse who works for the same practice. It was not stated as to where in the dosing schedule the event syncope had occurred. The outcome of syncope was unknown. Additional information has been requested.
Severe headache for about 10 days, later pain in legs and unable to walk, couldn't lift arms to shoulder level, couldn't move neck right to left approximately 30 degrees, difficulty in standing up.
After receiving the vaccination, could not walk due to muscle spasms in back. No have fibromyalgia and severe pain throughout body. Chronic migraines with aura and now a racing heart rate. Blood pressure is significantly high now. Treated with PERCOCET after the incident and then TOPAMAX, Propranolol, EFFEXOR, CYMBALTA, and extensive amounts of BOTOX injections. Received multiple injections in back and hips. Directly after the injection, could not walk and was put on a profile from the doctors.
61 Y/O male diabetic diagnosed with COVID last saturday states became progressively SOB He was hypoxic when evaluated in ER. He was placed on ventinask and now maintainig normal O2 sat. States received J&J vaccine in april. PMHX T2D, Depression, Anxiety  8/6/2021 tested positive
pt recvd vax & 1 day p/vax exp an itchy, swollen arm; same day as dose 2 exp an itchy swollen arm & face, & paresthesia of tongue;
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer-BioNTech Vaccines on 3/5/2021 and 3/25/2021. Presented from nursing home, admitted for acute hypoxemic respiratory failure due to COVID-19 PNA, lactic acidosis and NSTEMI. Received: oxygen supplementation, dexamethasone, antibiotics, and heparin. Patient had bloody bowel movements, hypotension, and respiratory status decline. Suffered cardiac arrest without ROSC. Expired on 2/4/2022 at 0458.
4 x 5cm, erythematous, raised induration on (L) thigh, irregular borders with central clearing, no color, NTTP, no pruritis.
Covid-19.  Doctor prescribed Paxlovid.  Now I test negative for the Covid-19 virus
Strong body aches. Muscle soreness, chills, mild fever, diarrhea. 2nd shot was at 2pm. Body aches started at 7am the following day and lasted 14 hours. Chills and fever started about 2pm the day after 2nd shot. Lasted about 4 hours. Diarrhea started at 8am. Lasted till 8pm
Sustained deep soreness in muscles x 10 d post - FLUZONE HD and PREVNAR; No redness or swelling; Knot like sensations recommended ibuprofen, see MD if not relieved.
Malaise; Body aches; Fever of 101 degrees; This case was reported by a physician via sales rep and described the occurrence of malaise in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a month after receiving Shingrix, the patient experienced malaise, general body pain and fever. On an unknown date, the outcome of the malaise, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the malaise, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced malaise, body aches, and a fever of 101 degrees.  All symptoms resolved within two days. The field representative indicated that the reporter provided this information to her during a Congress she was attending.  The field representative was unable to provide any additional details.  This was report 1 of 4 cases, reported by same reporter.
Small pin point area of redness and hardness at injection site and then 2 days ago became larger area of redness warm to touch size: 3x2 1/2cm on 10/06/2011
Information has been received from a certified medical assistant (C.M.A.) concerning a female patient between the ages of 11 to 15 years old who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. This is one of several reports from the source. Additional information has been requested.
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis.  It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 16 years. It was also confirmed that on 07-AUG-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA005738: US-009507513-1709USA005739: US-009507513-1709USA005748: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005747: US-009507513-1708USA001768: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005740:
Entire upper arm from shoulder to elbow is swollen, red and warm to touch. Pt states very tender to touch. No itching. No fever or generalized symptoms. Temp = 98.6.
PATIENT'S LEFT ARM GOT VERY SWOLLEN AND PAINFUL AND SHE WAS UNABLE TO MOVE IT UPON WAKING THE DAY AFTER INJECTION WAS GIVEN.
Headache which got worse 2 hrs after vaccine and then worse at 10 hrs after vaccine. Dizziness for 2 days after vaccine, slight fever overnight 8 hours after vaccine and into the end day.  MAJOR DEPRESSIVE AND ANXIETY SYMPTOMS. CRYING ALL DAY FOR 2 days. Stomach anxiety. Feeling of dread and doom and fear of going to hell for 2 days and is still not resolved as of 04/10/2021
Patient became light headed, pale, and diaphoretic immediately after receiving vaccine.  Patient had a syncopal episode and recovered after 3 minutes.
MILD SWELLING, ERYTHEMA, AND PRURITUS LOCALIZED TO THE AFFECTED ARM IN THE VICINITY OF INJECTION SITE (LEFT DELTOID). PATIENT STATES NO PAIN AND NO OBVIOUS SIGNS OF INFECTION (STREAKING, ETC). PATIENT DESCRIBED THE INFLAMMATION AS GETTING A BIT BETTER EACH DAY, BUT NO MEDICATION TAKEN. I RECOMMENDED LORATADINE OR FEXOFENADINE AND TOPICAL HYDROCORTISONE AS NEEDED AND TO CONTACT PHYSICIAN WITH ANY QUESTION, CONCERNS, OR IF CONDITION WORSENED OR NEW PAIN OR REDNESS DEVELOPED.
the dose that was administered had expired on 06/23/2021 and has had a previous temperature excursion; No additional adverse events reported; an expired dose of GARDASIL 9 was administered today, 06/30/2021, to a patient; This spontaneous report has been received from a registered nurse and refers to an 11-years old patient of unspecified gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 30-JUN-2021, the patient was vaccinated with a 0.5 milliliters (mL) expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (lot number R027577, was verified to be valid for syringe formulation, expiration date reported and verified as 23-JUN-2021) (dose number, vaccination scheme frequency, route, and anatomical site of administration were not provided) (expired product administered). Additionally, the expired administered vaccine had experienced a previous temperature excursion on an unspecified date (product storage error).  No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R027577; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Congestive heart failure, currently in hospital. 1st dose while pregnant, 2nd dose 2 months after delivering twins via c-section. Symptoms began around the week of 2nd dose.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unspecified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L051099, expiry date: 17-JUN-2017; lot # M002058, expiry date: 11-JUL-2017; lot # L046510, expiry date: 19-MAY-2017; lot # L044058, expiry date: 02-MAY-2017). Nurse reported that the vaccine underwent a temperature excursion in a freezer at -3.2 degree Celsius for 2 hours 13 minutes, which came back to its temperature range. No adverse events were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Registered Nurse (R.N.) refers to a 70 year old female patient with concurrent conditions of hypertension, hyperlipidaemia, gastritis, hypercalcemia, osteoporosis, chronic tubotympanic disease and drug reaction allergies to Niacin, MYCELEX, Iodine, Penicillin, BIAXIN, NEMBUTAL, rash after taking VIOXX, achiness after taking VYTORIN and headaches after taking FOSAMAX. On 27-FEB-2013, the patient received the first dose of PNEUMOVAX23 (lot number H017801, expiration date: 09-JUL-2014) (dose, frequency not reported, intramuscular route in teh gluteal muscle). No other co suspect medications were reported. Concomitant therapies included VALTREX, TYLENOL, NORVASC, RECLAST, omega-3 marine triglyceride, red yeast rice, calcium (unspecified) and ATIVAN (also reported as ATAVAN). On 02-MAR-2013 the patient reported that on 27-FEB-2013 redness, pain and swelling at the injection site. The site was warm to touch and the patient had trouble sleeping. On 03-MAR-2013 the reaction was worse and the patient spoke to the on call physician at the office. The patient went to the emergency room and was given intravenous LEVAQUIN and oral LEVAQUIN to take at home. At the time of the report, the patient's outcome for all adverse events was unknown. This case is linked to MARRS cases #1303USA010401, #1303USA010402, #1303USA010403. Additional information has been requested.
Paresthesia of the lower extremities, described as pins & needles feeling & also had a chilled feeling & a kind of a shuttering sensation. Occurred several days after the 14th shot & persisted for several days, wore off; pt now asymptomatic
Pt received 2nd dose of GARDASIL and TB skin test became pale, eyes rolled upwards and was briefly unconscious but responded quickly, BP decreased 42/10 but gradually became WNL. Last BP 100/58. She also c/o dizziness. Color gradually returned and pt remained responsive.
VERY PAINFUL THROAT PAIN; SLEEPING  RANDOMLY NOT WHOLE NIGHT/INSOMNIA; VERY VERY BAD, LIKE SOME SICKNESS; HEAVY HEADACHE; FEELS VERY TIRED AND STILL WANTS TO  SLEEP; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced very painful throat pain. On 09-JUN-2021, the subject experienced sleeping randomly not whole night/insomnia. On 09-JUN-2021, the subject experienced very very bad, like some sickness. On 09-JUN-2021, the subject experienced heavy headache. On 09-JUN-2021, the subject experienced feels very tired and still wants to sleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy headache, very painful throat pain, and very very bad, like some sickness, and the outcome of sleeping randomly not whole night/insomnia and feels very tired and still wants to sleep was not reported. This report was non-serious. This report was associated with product Quality complaint: 90000182408. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
Patient started on the evening of 04/28/2021, same day as vaccine administered, with feeling warm, headache, right arm and neck hurting. The right arm had some swelling but no redness at site. Site was painful to touch. She was evaluated and noted to have significant tenderness noted in the mid/upper arm on the right, small amount of swelling noted but no redness or streaking.
significant local swell, fevers, chills  family reports similar reaction after last year's influenza vaccine given  10/3/18 Fluarix lot 794A3 left deltoid
Arm was sore 2 days after injection, over 2 weeks later arm was swollen, hot to touch and sore. taking advil & Benadryl
Patient asked about numbness that was about 1-1.5 inches above and 1 in towards back of where the vaccine was given.  Stated that every once in a while it feels like the muscle is tearing and it get a burning sensation.  Going  to have checked out 11/3/23 by her doctor.
Shot site became red, swollen, and painful. By 11/3/2010, patient developed a fever of 103 which returned to normal on 11/4 am. Dr has been diagnosed with cellulitis and erythema. He prescribed warm compresses, Advil, Keflex, and a Medrol dose pack.
Nausea, chills, severe headache, joint pain, pain at injection site along with itching.
After injection in her left arm, locally really by 8:00 PM. Then the next day, she didn't feel good all day, listless.  Went to MD at 0930 on 12-21-09. Had a fever of 99.5 degrees F. He prescribed antibiotic cephalexin 500 mg TID. He also prescribed benedryl to take 2 hrs after antibiotic. By mid-afternoon on 12-18-09, she had developed hive looking blotchy hot welts. Moved from shot site down toward elbow. Still a swollen site on 2-21-09 which is tender to the touch which is the size of a tablespoon.
While waiting at the observation line after receiving a vaccination, the patient reports lightheadedness, no other symptoms. VS stable. The patient looks well and in no acute distress. Has a history of asthma and eczema. Has eczema rash back of neck, which was present before vaccination per patient. No new rash after vaccination. Zyrtec given orally. Symptoms improved in a few minutes and resolved before leaving the site. Stable throughout.
Pt recvd vax & exp visual spots, chest tightness, breathing difficulty, dizziness & a severe throbbing h/a for 4 hrs; also lost peripheral vison; sx resolved completely w/no treatment;