chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irritation of joints on same arm as injection:  elbow, wrist and middle finger.  No signs of irritation in shoulder of this arm or other parts of the body.  Irritation is constant and ongoing, without decrease since its onset.  This irritation leads to limitations on use of the arm for weighty objects (5 pounds or more) and any major pressure down onto the arm.
pt recvd vax 28DEC95 & devel rash on chest, & lt shoulder 31DEC95; then rash cleared 1JAN96 & lt elbow became swollen & red on 1JAN96;Keflex started 1JAN95 elbow better by 2JAN96;1JAN96 generalized joint/muscle aches
Patient reported having flu like symtpoms, fever chills, muscle aches in the shoulder and legs, stomach ache, feeling foggy, and redness around the site of injection.
Severe allergic reaction unable to breath passed out; Severe allergic reaction unable to breath passed out; Severe allergic reaction unable to breath passed out; Headaches; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), HYPERSENSITIVITY (medically significant), DYSPNOEA (non-serious), outcome "unknown" and all described as "Severe allergic reaction unable to breath passed out"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches". Therapeutic measures were taken as a result of loss of consciousness, hypersensitivity, dyspnoea.  Clinical course: Had to be transported and had medical intervention. Still was having reactions to other environmental reactions. Headaches after the vaccine had persisted. Was immunized before thanksgiving possibly the 10Nov.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and the reported  events Loss of consciousness , Hypersensitivity, Dyspnoea, Headache  cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Dry cough, chest tightness, rash covering entire left arm, chest and left side of abdomen, fever, Fatigue, nausea.
red area on upper left arm and knot 2cm by 2.5cm monitored for 20 min no change
Heart rate resting 130, walking around up to 160 for 36 hours after vaccine. Currently 5 days later still resting is in the mid 90s instead of mid 70s. Shortness of breath, especially when talking which causes a dry cough persisting for the past 5 days. Sometimes have palpitations. Pain in left arm lymph nodes on occasion. Fever of 101 with chills and sweats for 36 hours has since resolved. Slept for 14 hrs, fatigue has resolved. No appeptite at all, still persisting after 5 days. Tsh is low now showing HYPERthyroid (was last tested on 7/20/21 and was right in the middle of normal where it has been for 2 yrs). Esr is high. Crp is high.
No further adverse events.; MMR and VARIVAX were administered to 2 patients in the deltoid area; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.     On 21-APR-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX), both intramuscular in the deltoid area (incorrect route of product administration) for prophylaxis (strength, dose, frequency, lot number and expiration date were not reported). No additional details available. No further adverse events. No product quality complaint.
Fluarix Quad was administered as opposed to high dose vaccine for patients 65 and older.
Redness and inflamation of the injection site. No other signs or symptoms of allergic reaction.
Very swollen, hot, painful reaction started 2 days after the vaccine at the shot site.  It is very itchy also? like an allergic reaction.
Left sided Facial droop effecting Left eye and Left face muscles, concern of Stroke  ambulance to  Hospital Emergency   Examined neurlogicaly  Cat Scan done neg, Glucose normal    REPORT BY DR "BASED ON MY ASSESSMENT AND RESULTS OFEXAMS< LABS< IMAGING IT WAS DETERMINED   TO LIKELY BE BELLS PALSY MEDICAtions ordered VALTREX 3 times a day for 7 days, PREDNISONE 60mgs for 7 days   EYE GTTS for Dry eye relief 3-4 times a day
This case was reported by a physician and described the occurrence of generalized swelling in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included HIBERIX; GlaxoSmithKline; unknown given on 29 July 2011; PEDIARIX; GlaxoSmithKline; unknown given on 29 July 2011; PREVNAR (non-gsk); Wyeth Labs; unknown given on 29 July 2011. On 29 July 2011 at 12:00 the subject received 2nd dose of ROTARIX (oral). On 30 July 2011, 20 hours after vaccination with ROTARIX, the subject experienced generalized swelling and irritability. The events were reported as a systemic reaction. The physician considered the events were clinically significant (or requiring intervention). The subject sought medical attention at the Emergency Room. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with ROTARIX.
Allergic reaction; This case was reported by a pharmacist and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th November 2020, the patient received Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th November 2020, less than a day after receiving Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported patient was administrated with Fluarix QIV-Shingirx and had allergic reaction. The reporter consented to follow up.
Mouth ulcers that later progressed to face swelling with large blisters and body blisters.
pt recv vax & 11 days later pt awoke  c/o gen malaise, h/a, t102;PMD gave pt ATB;next day had a gen fine maculopapular rash;seen by MD;dx measles;
Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Concomitant therapy included VARIVAX (Oka/Merck). It was reported that the patient experienced an adverse reaction following vaccination with GARDASIL. The reporter stated that the patient had an adverse reaction (possible seizure) when VARIVAX (Oka/Merck) was administered concomitantly with GARDASIL. The details of the adverse reaction were not provided, thought it may have been a seizure. On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention or not. Upon internal review, seizure was considered to be other important medical event. Additional information has been requested.
Information has been received from a physician and from Emergency room medical records concerning a 16 year old female with  no pre-existing allergies or medial condition, who on 24-APR-2007 was vaccinated intramuscularly into left deltoid with the first dose of GARDASIL (lot# not reported) and on 10-JUN-2008 was vaccinated with the second dose of GARDASIL (lot # 656051/0244U). On 12-JUN-2008 the patient went to the emergency room and had complaints of headache to the right temporal area, described as constant. The symptoms were aggravated by standing or laying for too long. The patient had right neck pain into her shoulder. Examination was positive for right trapezius, pain at rest, pain with movement. The symptoms began two days ago. Chest pain was also noted (onset not reported). The emergency room report noted that there was no dizziness, fever, nausea, paresthesis, sinus congestion, vision changes, vomiting. The severity of the pain in the emergency department was a "10" out of "10." The patient had not had any similar episode in the past. Physical examination in the emergency room showed that the patient was oriented to person, place, time and her mentation was appropriate for stated age. She had excellent breath sounds in all fields with symmetrical chest wall movement and no wheezing, rales of rhonchi. Her heart sounds were normal with no murmurs, rubs or gallop. Vital signs included: B/P 130/93; pulse 81; respirations 18; temperature 98.7 and pulse oximeter 96& on room air. Impression was tension headache. In the emergency room the patient was given MOTRIN 800 mg orally and FLEXERIL 10 mg orally. Her symptoms improved and she was discharged to home in stable condition with instructions on headache, tension muscle contraction headache. Discharged medications included prescriptions for PHENERGAN (twelve) tablets 25 mg, 1 every 6 hours as needed for nausea; TORADOL 1O mg (twelve) tablets, 2 tablets by mouth to start then 1 tablet every 6 hours as needed. She was to follow up with her physician in 2-3 days. The physician reported that the headache and chest pain were not related to the GARDASIL. On an unspecified date the patient recovered from the headache, chest pain and shoulder pain. Additional information is not expected.
Became very unsteady walking; Became very unsteady walking; Have fallen several times; took 1 extra pill of amantadine after the first dose by mistake; balance became bad; This is a spontaneous report from a contactable consumer reported for self. This 79-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284) via an unspecified route of administration on 08Jan2021 at 14:30 PM as a single dose in right arm for COVID-19 immunisation. Co-suspect medication included amantadine from an unspecified date at unspecified dosage for Parkinson's Disease. Medical history included Parkinson's, penicillin allergy and ongoing unsteady. Concomitant medications included medications for Parkinson's disease. The patient had no vaccine in four weeks. The patient became very unsteady walking, had fallen several times 09Jan2021 at 07:30 AM. Patient was already unsteady before the vaccine, but not falling down which started soon after receiving the first dose of vaccine. The patient was scheduled for the second dose on 30Jan2021. Patient also took 1 extra pill of amantadine after the first dose of vaccine by mistake and balance became bad and remained so since. The patient suspected that maybe combo of the vaccine and Parkinson's Disease medication is an issue. The patient purchased walker and was recommended to physical as treatment. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had no COVID prior and post vaccination. The action taken of amantadine was unknown. The outcome of the events was not recovered.
Cold chills began at 100am 2/4;  severe nausea and vomiting (could not hold down water) , 8/10 pain in headache, extreme fatigue began at 8am. Intensity resolved around 2pm 2/4. Head fog, variable chills and headache persisted through afternoon of 2/5.
Customer returned to pharmacy 4 days after vaccination was given. There was a small lump in the proximity where the shot was given, but no redness. Patient indicated feeling of "pins and needles" down her arm after a workout at the gym, did not indicate what day this was though. Not other affects or symptoms though.
10 spontaneous nosebleeds (left nostril only) Muscle Weakness Nausea Dizziness Swollen Lymph Nodes (only on left side of body)
intense nausea and migraine before leaving  clinic.  Left a call to physician re: all symptoms.   3/31/21 was given Zofran,  Sumatriptan, Tylenol.  Zofran was the best.  Had to call off from  work ill.  had trouble eating or drinking anything.  Stayed in bed.  after about a week was able to go back to work with the medications but still sick.  4/14/21  went to urgent care as migraine worse and nausea back.  Given Ketorolac Inj 30 mg (TORADOL), and Trimethobenzamide Inj 200 mg (TIGAN). Again off from work for a couple of days.  Had migraines but manageable on and off after.
Pt developed urticaria on abd and back.  Tx:  antihistamines  Zyrtec once daily, Benadryl at time of hives and q6 hr prn for breakthrough hives and itchiness.  Referred to allergist.
Patient developed redness in the arm after 1st dose administration; Patient developed swelling in the arm after 1st dose administration; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3B55B, expiry date 18th December 2022) for prophylaxis.   On 24th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was unknown. The patient receive dose of Shingrix vaccine and experienced redness and swelling in the arm. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Patient experienced flushing and racing heartbeat within minutes after receiving vaccines. This resolved without intervention after about 5 minutes. Patient was given 650mg of acetaminophen for back pain (unclear if related to vaccination or if pre-existing).
Edema and erythema, warmth approximately 6 cm in diameter. Lasted 3 days. No treatment.
no additional adverse events reported; improperly stored Varivax; This spontaneous report was received from an office manager and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported.   On 27-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021926, expiration date 15-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 1.2 degrees Celsius for 3 hours and 9 minutes. There was no previous temperature excursion reported. Data logger was involved. There was no adverse effect reported.
Large asymmetrical rash over 1 inch radius at injection site warm, mildly painful.
Patient given bivalent instead of second dose in inital series. No adverse effect reported or noted. Date of first vaccine was 10-26-2022
After the vaccines, a serious rash appeared on both legs. The rash is extremely inflamed and itches significantly. It looks like Measles and the rash has blisters that pop open and cause scabs when healing.
Tested COVID-19 positive, resulted in  hospital admission. Symptoms include fever, sore throat, cough, shortness of breath, chest pain, and diarrhea.
mild pain at the injection site of vaccine; after diarrhea, she had blood dripping in the toilet; pain in kidney area; pains in abdomen/soreness in lower abdomen; nausea; throwing up; chills; A spontaneous report was received from a consumer, concerning a female patient of 58 age , who received Moderna's COVID-19 vaccine and experienced after diarrhea, she had blood dripping in the toilet (diarrhea haemorrhagic), pain in kidney area (back pain), pains in abdomen/soreness in lower abdomen (abdominal pain), nausea, throwing up (vomiting), chills, and mild pain at the injection site of vaccine (vaccination site pain).  History of the patient was not provided. Concomitant product use was not provided by the reporter.  On 26Feb2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (lot number 025A21A) via intramuscular route in her right arm for COVID-19 infection prophylaxis.  On 26Feb2021, after first dose of vaccine, the patient  had intense  lower abdominal pain, cramping, nausea, vomiting and diarrhea. Patient reported chills with a temperature of 98.9. Patient noticed blood dripping after diarrhea, until 2 days after vaccination (Sunday). Patient states she has less cramps today, but pain in the loin (kidney area). she also had mild pain at the injection site of the vaccine.   Action taken with mRNA-1273 in response to the event Abdominal pain, Muscle spasms, Nausea, Vomiting, Diarrhoea, Chills, Tremor, Haemorrhage, Renal pain, and Vaccination site pain was reported as unknown.  The outcome of the event Abdominal pain, Nausea, Vomiting, Chills, Haemorrhage was considered to be unknown. Renal pain and Vaccination site pain was considered to be recovered/ resolved at the time of this report.  Haemorrhage was considered to be medically significant.  No treatment medication was reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
developed symptoms 03/04/10 a.m. Symptoms of swelling R side of face in front of ear R cervical lymph node swelling.
Sore arms for 2 days. Severe fatigue. Dizziness. Abnormal and extremely heavy menstrual bleeding with large clots.
When I came home from work patient stated his arm was hurting, which is normal for a shot.  He came up a few minutes saying his arm was swollen.  I looked and he has a hard, red, hot area starting at the vaccine site almost 5 inches long and 2 inches wide.  It is hurting to lift his arm.  I had 2 children receive this shot yesterday, and of 3 children I have never seen a reaction like this.  It looks like cellulitis.
Rash, papules on trunk and extremities, 10 days after varicella vaccine.
Information has been received from a case in litigation from information obtained from a published literature article concerning an 8 week old female who in September 2002, when she was 2 days old, was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  On 14-NOV-2002, the patient was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown).  On approximately 14-NOV-2002, "within hours," the patient developed a low grade fever, became lethargic and developed a rash.  Within 24 hours she developed vomiting, diarrhea and became fussy.  On 07-DEC-2002, she was diagnosed with Kawasaki disease.  At the time of the report, the patient's outcome was unknown.  Upon internal review, Kawasaki disease was considered to be an other important medical event.  The reporter felt that Kawasaki disease was caused by RECOMBIVAX HB.  No further information is available.
5-6hrs p/vax temp elevated to approx 99-100 degrees; around 10PM temp 103; APAP had been given since vax 1030AM, q 4 hrs;awake all noc Monday and all day Tue; slept some Tues night; WedT104.9, slept all day, @ 1:05pm had sz & called 911
15 minutes after administration, pt collapsed and seized. Was able to moan after 10 seconds, slurred words after 30 seconds. Then was able to sit up. Pt lost control of bladder and rolled eyes during seizure. B/P 88/60, Sa O2 99%, pale. Laid down and had B/P checked. Ambulance called, pt refused; family took pt to hospital.
34 year old male patient received Flucelvax Quadrivalent flu shot on 12/26/19 at 11:42am. Patient fainted after flu shot was administered and immediately the 911/ambulance was called. Patient was evaluated by the 911 paramedics/EMTs and stayed in the pharmacy for 20-30 minutes until he felt better and was able to go home. Upon inquiry after the patient fainted, the patient stated they have not eaten prior to the flu shot and have a history of fainting in the past and feels better after eating foods with sugar in them. Documented in patient's pharmacy profile that they fainted after flucelvax shot.
Patient is a 56 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot EW0161 on 5/4/2021.  1008:The patient experienced the following reaction(s) during the immediate   of observation: pt reports feeling nauseous, generalized itchiness and numbness in arm and lips.   Pt denies trouble breathing or difficulty swallowing.   1024:Patient was treated/managed as follows:    Pt brought to treatment area and given water, and kidney basin for symptoms of nausea. VS performed: BP- 130/86, HR-77, R-18, 02-98% RA. Pt symptoms have lessened at this time. Pt refuses to take benadryl on site and is advised to take benadryl once home. Pt escorted out of lobby safely by RN. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
Patient c/o knee pain x 1 week then went to ER and dx w/ ataxia at Medical Center.  Seen by Peds ID.
Pt recvd vax 4FEB93 & the next day pt exp abdo cramping & constipation which lasted approx 2 wks;
Syncope, pale, cough, mouth foam.  2 minutes  before start to recover. EMS activated on arrival assessment diagnosis for vasovagal. Pt taken home with no other adverse effects except mild fatigue.
I received my first Moderna shot April 11th and am not allowed my second shot until August 1; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my first Moderna shot April 11th and am not allowed my second shot until August 1) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my first Moderna shot April 11th and am not allowed my second shot until August 1). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my first Moderna shot April 11th and am not allowed my second shot until August 1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Fever. Dizzy. Nauseous.  Body aches.  Soreness.
Headache, more intense over the last few days, still has it, loss of appetite, brain fog. Couldn't  answer simple questions, extreme fatigue, bowel changes, diarrhea. Still experiencing all symptoms except brain fog. no fever.