chrisvoncsefalvay/vaers-outcomes huggingface dataset:
on Sunday  6/1/08 when woke in am. Complaints of severe muscle and joint pain whole body,also slight soreness on left arm at injection site. no reddnes noted at this time. At approx 2pm noted  at injection site small red pimple like mark then clear normal skin then  1 1/2 inchs below site area of reddness and slight swelling size 2"x2" inches irregular marking going down arm. . Also the severe pain whole body and joints. Took Ibuprofen and tylenol all day, with ice/ heat alternating to arm every 2 hours. On Monday 6/2/08 same symptoms and treatments. On Tuesday 6/3/08 Severe pain whole body, arm reddnes spredding down arm now size is 4"x4" irregular mark and swelling and reddness increased. Area at injection site was normal appearring skin. reddness  approx. 1 1/2 in. away from inj. site. On Wed. 6/4/08 Body aches better but not completly gone, More in hip/leg joints. Area on arm same as on Tues. On Thurs. 6/5/08 area of reddness getting better not as big or red.Soreness better joint pain better but still not completly gone. During all this time no fever noted. Was treatment was with ibuprofen and tylenol with ice/ heat to arm alternating every 2 hours and rest ( I slept alot during this time). I did miss 2 days of work due to the severe pain.
This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported similar events for 2 patients. This is the first of 2 reports. A 21-year-old male patient received the first dose TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, reported as Monday, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu symptoms on an unspecified date. The action taken in response to the event for meningococcal group b rlp2086 was not applicable. Outcome of the event of flu symptoms was unknown. The information on the lot/batch number has been requested. Sender's Comments: Linked Report(s): US-PFIZER INC-2018313229 Same reporter and suspect drug, similar events in different patients.
Day 1 shot administered 2 hrs later joint pain. Day 2 all over muscle aches. Day 3 101.5 temp muscular aches. Diarrhea. Day 4 same as day 3. Day 5 temp. fluctuated between norm and 100+. Minor muscles aches diarrhea. Day 6 better, similar to day 5. Day 7 back to work.
Pt had history of receiving Hepatitis B series several years ago. Desired vaccination with Hepatitis A and was given Twinrix. Pt concerned about liver status and wanted maximum  Hepatitis A protection for trip out of country. On 4/8/07 pt denies problems.
At 4:30 a.m. I woke up in sweats with an awful migraine, with a very sore throat, swollen lymph nodes . I am still having these symptoms at this times.
Red bumps now in groups of 2-3 on my chest, back, arms, and legs. More accumulation 8 days later.; This is a spontaneous report from a contactable consumer, the patient.   A 65-year-old male patient received the second dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, in the left arm on 12Feb2021 (at the age of 65-years-old) for COVID19-immunization.  The patient medical history included allergies to sulfa (sulfonamide antibiotics), and levofloxacin.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications included: ibuprofen (ADVIL), paracetamol (TYLENOL), multivitamin, turmeric, and krill oil.  The patient previously received the first dose of BNT162b2 on 22Jan2021 (Lot Number: Unknown; at the age of 65-year-old) for COVID-19 immunisation.  The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 13Feb2021, the patient experienced red bumps now in groups of 2-3 on my chest, back, arms, and legs. more accumulation 8 days later. No treatment was received for the adverse event. The patient had not recovered from the event, red bumps now in groups of 2-3 on my chest, back, arms, and legs. more accumulation 8 days later.
2 day hx of left deltoid pain and hyperemia, fever. Exam: 6 cm hyperemic and edematous patch of skin with sharp edematous demarcation. Plan supportive care, ice compresses, MOTRIN.
Body Aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), CHILLS (Chills) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (Body Aches), CHILLS (Chills) and HEADACHE (Headache). On 20-Mar-2021, PAIN (Body Aches), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No concomitants were reported. No treatment was reported. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  was not applicable.
CHILD WAS GIVEN INCORRECT VACCINE.   PFIZER ADULT INSTEAD OF PFIZER PEDIATRIC.   AT THIS TIME 24 HOURS LATER NO KNOWN side effects or negative reaction has been detected.  Child is feeling fine other than a sore arm.  Confirmed this with the father of patient.
DTaP GIVEN IM RIGHT DELTOID.  IPV GIVEN SUB Q RIGHT ARM.  DEVELOPED APPROXIMATELY 3" AREA OF REDNESS IN RIGHT DELTOID SEVERAL HOURS LATER.  C/O ITCHING, DENIES PAIN,HIVES,WARMTH AT INJECTION SITE.  AREA BEGAN FADING AND DIMINISING IN SIZE AFTER APPROXIMATELY 72 HOURS.
Patient complained of severe pain & swelling at the injection site on the day following vaccination. In-office assessment 2 days after vaccination  revealed   "L anterior and superior shoulder significant swelling and tenderness. No redness or warmth of the joint. no redness @ injection site, injection site- injection was given too high. Severely decreased ROM due to severe pain." Patient was prescribed a methylprednisolone dose pack, opioid pain medication and referred to orthopedics. Was seen by ortho 4 days later.  Symptoms were still present at that time but improved.  No further treatment provided.  Patient scheduled for follow u pin 6 weeks.
got the flu; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who got the flu (illness), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient reported that patient got a flu shot about 10 years ago for the last time. That winter patient  got the flu 4 different times in a 3 month period.   No relevant laboratory details were provided. It was not reported if the patient received a corrective treatment.   Outcome of the events were reported as unknown.   There will be no information available on the batch number for this case.
I have reactive arthritis; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received the first dose of BNT162B2 (Pfizer COVID 19) via an unspecified route of administration on the right arm on 11Aug2021 at 12:00 PM (Lot Number: EN0198) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included allergy to sulfa drugs. COVID prior vaccination was unknown. COVID tested post vaccination was none. The patient didn't received other vaccine in four weeks. Concomitant medication was received (not specified). On 30Aug2021, the patient had reactive arthritis. Ankles, feet , hands, back and wrists. The patient blood work twice. The government should push to check for Covid antibodies PRIOR to giving a shot. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included 2 different doctors visits, blood work twice. The outcome of events was not recovered.
Multiple dew drop lesions, some ruptured on trunk, face. Red macules on extremities after 24 hours. Fever 102 about a day ago, sore throat, chicken pox at school. Diagnosis-post vaccination Varicella.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-NOV-2015 13:41, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.1 (1 hour 54 mins) and 2.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Chills, headache, vomiting and fever during the first 18 hours.  Tingling hands and feet from  3/16-3/26.   Fluid behind eardrums 3/24 & 3/25.
pt recv vax 22OCT97-no allergies, no adverse rxn to other vax;presented self in ER on 24OCT97 w/local rxn (red & swollen lt deltoid);also rash (blotchy) on both arms & back, some edema lt hand w/numbness & tingling, sore throat & cough;tx A
Headache, Myalgia, Arthralgia & NauseaVomiting Narrative:  Injection site pain for 5 days. day 2- started with fever, nausea and fatigue, day 5 nausea resolved-fatigue until day 6,
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Mar 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Mar 24, 2021, she developed a rash all over her body. It itched. She kept on scratching. On Mar 28, 2021, she went to a clinic. They prescribed her a steroid to take along with Benadryl. The physician informed her the steroid would interfere with the COVID-19 vaccine; so she took Benadryl, and put on Cortisone-10, which helped with the itching. At the time of report, she still had the rash. That day was the first day the itching was not so bad as before. She had a scheduled appointment for a second dose due on Apr 12, 2021. She asked if this would happen again or worst if she got her second dose. The patient has tested for COVID-19 several times, and results were negative. The outcome of the events: recovering. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
cold chills; neck pain; Headache; feeling dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Liver disease" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TRULICITY; ROSUVASTATIN; LOSARTIN. Past drug history included: Keflex [cefalexin], reaction(s): "Hypersensitivity". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 5; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 6; MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: HEADACHE (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering"; CHILLS (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering", described as "cold chills"; DIZZINESS (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering", described as "feeling dizzy"; NECK PAIN (non-serious) with onset 10Nov2023 at 19:00, outcome "recovering". Therapeutic measures were not taken as a result of chills, neck pain, headache, dizziness.  Additional information: horrible cold chills in the early evening with neck pain. Headache to the point of feeling dizzy. Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting?: No. Did the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting?: No.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Injected on the top of my left shoulder? incorrect postision? After 3hours my left arm ?not injection area?very pain? weekness? unable to move? no fever?pain did not resolve after  motrin and cold compress? Pain scale #10? seen doctor on 1/11/2021? pain released after Predisone?but returned when decrease predisone dosage? pain consistant ?unable to move?  muscle weekness? seen neurolgist on 1/26/2021? EMG done? Dx Myositis? restarted Predisone and Gabapentine? MRI done? result negative?Pain resolved after Rx? Now pain and weakness  decrease a lot, but still on Gabapentin once/ day.
Severe Rash on Sept 15, vomiting and refusal to eat, diarrhea. It is now 15 days after the vaccine and the rash is looking better but the vomiting and diarrhea continue. We have been to urgent care and also the Pediatrician who are recommending just treating the symptoms.
PATIENT FELL AT HOME AFTER VACCINATION; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 70.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, every 1 day, frequency, and therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: ZE019B0101) dose, start therapy date were not reported, for prophylactic vaccination. Concomitant medications included riociguat. On an unspecified date, the subject experienced subject fell at home after vaccination. The action taken with covid-19 vaccine was not applicable; and dose of macitentan was not changed. The outcome of patient fell at home after vaccination was not reported. This report was non-serious.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L048237, expiration date reported a 08-MAY-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 32.7 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter. Additional information has been requested.
LEFT LEG PAIN BEHIND THE KNEE AND HURTS TO WALK ON IT; TIREDNESS; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no medical history, no allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 22-JUL-2021, the subject experienced tiredness.  On 01-AUG-2021, the subject experienced left leg pain behind the knee and hurts to walk on it. Laboratory data included: Pain scale (NR: not provided) pain 3/10 to leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tiredness and had not recovered from left leg pain behind the knee and hurts to walk on it. This report was non-serious.
Patient received moderna vaccine on 2/12/21, 3/13/21 and 11/23/21. COVID positive 5/16/22. Presented to ER on 5/18/22.  Presented to the ed for chest pain, described as pressure x3 days, admitted for chest pain r/o. Patient tested positive for covid at home 5/16. Vitals remarkable for hypertension. Labs with negative troponin x3, iron deficiency anemia and b12 deficiency. cxr unremarkable. Initial EKG in ED with repol abnormality. Repeat EK 5/19 NSR. Discharged on 5/19/22
Cardiac arrest Narrative:  An 82 year old, male, resident of a facility, received his first dose of the Pfizer COVID vaccine on 12/30/20 (time of dose not known). On 12/31/20, patient was reported to be febrile with increased lethargy and UTI was suspected so patient received a dose of ceftriaxone and levofloxacin. Within 30 minutes he became wheezy and short of breath, developed hives and tongue swelling. He required intubation and admission for treatment of acute respiratory failure, acute kidney injury and significant lactic acidosis. Treatment included epinephrine, H1 and H2 blockers, and steroids. He recovered and was extubated on 1/3/21 and discharged back to the facility on 1/6/21. Attending physician noted that antibiotics were most likely contributor to event, but recommended that patient not receive the 2nd COVID vaccine dose. Patient was referred to an allergist to assess this event, with an outpatient visit on 1/14/21. Patient expressed interest in receiving the 2nd dose. Allergist determined that the antibiotics were the cause of anaphylaxis, and recommended skin testing to take place 6 weeks after his reaction. Allergist determined the reaction was not due to the COVID vaccine and advised patient that he could receive the 2nd dose. Patient received the 2nd dose of the Pfizer COVID vaccine on 1/9/21 (time not known). Notes from the facility indicate patient was lethargic and running a fever the morning of 1/20/21. At 1500 on 1/20/21 patient was noted to be lying supine in bed, visiting with aides. At 1508 nurse entered room and noted patient to be lying on floor supine and nurse was unable to get patient to respond to shaking or calling his name. Breathing was noted to be labored, and nurse was unable to detect a pulse. At 1509, 911 was called and CPR initiated. Spontaneous pulse and breathes resumed just before ambulance arrived at 1522. On arrival at the ED patient was responsive and breathing spontaneously, however, hemodynamically unstable. Patient went into cardiac arrest and code blue called at 1535. Received treatment with epinephrine, methylprednisolone, diphenhydramine, amiodarone, atropine. Patient was intubated. EKG obtained and showed acute MI. At 1622 he again went into cardiac arrest and time of death was called.
On 01/11/2023 I noticed my thyroid P.S.H. had went up to 6.390 after being at 1 for approx. a year. I had to increase thyroid medication.
Redness at injection site. Soreness at inject site. Swelling and itching at injection site size of palm of hand.
Pt received injection in rt leg (thigh). Next day mother noticed redness and swelling. Went to ER Dx with cellulitis given antibiotics. Recovered 8/12/2015.
arm became red; warm to touch; a big area, 3 by 4 right below the injection site; scratchy throat; Little cold; runny nose; m low grade fever 98; m low grade fever 98; sore arm; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (arm became red), VACCINATION SITE WARMTH (warm to touch), INJECTION SITE SWELLING (a big area, 3 by 4 right below the injection site) and THROAT IRRITATION (scratchy throat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included MULTIVITAMINS & MINERALS PLUS LUTEIN and Synthroid                                                      Levothyroxine for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Feb-2021, the patient experienced INJECTION SITE SWELLING (a big area, 3 by 4 right below the injection site), THROAT IRRITATION (scratchy throat), NASOPHARYNGITIS (Little cold), RHINORRHOEA (runny nose), PYREXIA (m low grade fever 98) and NASAL CONGESTION (m low grade fever 98). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became red) and VACCINATION SITE WARMTH (warm to touch). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (ZICAM COLD & FLU) for Cold, at an unspecified dose and frequency. On 17-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (arm became red), VACCINATION SITE WARMTH (warm to touch), INJECTION SITE SWELLING (a big area, 3 by 4 right below the injection site), THROAT IRRITATION (scratchy throat), NASOPHARYNGITIS (Little cold) and RHINORRHOEA (runny nose) outcome was unknown and PYREXIA (m low grade fever 98) and NASAL CONGESTION (m low grade fever 98) had resolved.        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.