chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on right arm; hives on right arm; achiness; low grade fever; This case was reported by a nurse via call center representative and described the occurrence of fever in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABX796AZ, expiry date 30th September 2020) for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (received 1st dose on 19th April 2019, refer case US2019143941).   On 16th August 2019, the patient received the 2nd dose of Bexsero. On 17th August 2019, 1 days after receiving Bexsero, the patient experienced fever, rash, hives and pain. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the fever, rash, hives and pain were recovered/resolved.   It was unknown if the reporter considered the fever, rash, hives and pain to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero and next day he broke out in a rash and hives down his right arm which got worse for 2-3 days, he had a low grade fever, and was achy for 48 hours. All events have resolved. The reporter consented to follow up.
7.9 cm mass right upper extremity anterior to shoulder joint read by radiology as being a vaccine reaction. Getting smaller but not entirely gone.
Pt. observed hyperventilating after vaccine.  per daughter she has anxiety issues.  Pt. is alert and oriented and refused emergency care.  Pt. recovered on her own.  She is alert and oriented.  No distress noted at this time.
Booster; Off label use; COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: Fk9895) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre diabetes" (unspecified if ongoing), notes: Pre diabetes; "gout" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: other medical history:  Pre diabetes, gout, high bl, hypercholesterolemia. Concomitant medication(s) included: ATORVASTATIN; OLMESARTAN/HYDROCHLOROTHIAZIDE; ALLOPURINOL. The following information was reported: IMMUNISATION (medically significant) with onset 04May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 04May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
15 minutes following the administering of an influenza shot pt. fell off mother's lap and was unresponsive and became stiff and started convulsing which lasted 15-20 seconds.  Pt did not experience incontinence.  Pt became responsive but dazed and for several minutes was unaware of what had happened or her surroundings.  911 was called and pt was ambulatory with an O2 sat of  99%.  Pt was transported to hospital accompanied by mother and 2 siblings.
Chills started around 4AM while sleeping. Joint pain, malaise, headache, and localize pain at site of injection upon palpation upon awakening and still  continues at the time of this writing (27  hours post-inoculation). No fever noted (99.3 F at 8AM).   ONE Acetaminophen ER 650 mg TABLET was taken at 1PM.
When she woke up, she had a slight fever, about 100.5 F. Shortly after that, it spiked to 104.1. I gave her Tylenol and Motrin, and it brought it down to 103.5. For the next 24 hours, her temperature did not get below 103.5. On 6/1/14, she was awake all night, and I changed her diaper around 3 am. At 8 am, she had blisters covering her diaper area. It was red and very irritated on the small amount of skin that wasn't covered by fluid filled blisters. She has had diaper rashes after each previous vaccine she has had, but never this bad. She had some loose stools the day before, but they were never left on her skin, and she had no stools overnight that would cause such a reaction. We use the same diapers, so she is not having an allergic reaction. Today, 6/2/14, her buttocks are bleeding and oozing. She is in excruciating pain, and screams through each diaper change, every 30 minutes or so. Her fever did decrease to normal yesterday afternoon.
Severe sinus and head pressure and inflammation leading to loud tinnitus. Reduced hearing. Headaches. Light Sensitivity. Extreme thirst. Gastrointestinal issues acid reflux. It has been over  a week, inflammation  seems to be slowly improving. Tinnitus still present. This is a terrible allergic reaction and you should advise those with environmental and chemical allergies to avoid this vaccine.
Nausea - resolved. Fainted right after injection. Dizziness - intermittent. Vomiting 4/16/10 x 2 only. Fatigue - current. Headache sore throat > 4-17-10.
about 12 hrs after, she felt equilibrium problems and nausea but resolved 24 hrs later, today she complains of dizziness and tiredness. Spoke with patient, states that feeling better but will f/u with her ENT for her known equilibrium issues. No longer has nausea. Advised to call us if needed.
MOP reported excessive crying post vaccination and localized redness/swelling 2 hrs post vaccination.
Mother reports that on 1/12/10-the site where the Dtap was given became red, warm to touch about the size of a "50 cent piece" and progressively got more inflamed. Took to MD and was diagnosed with cellulitis. Mom called 01/14/2010 and reports the site looks a lot better after antibiotics.
was positive for covid on 8/21/2021. on 8/23/2021 was given the infusion. on 8/27/2021 began z pack and steroids. was down for 4 weeks. went back to work finally. I have since missed work and continued to be sick with dizziness, faintness, nauseness, headaches, no concentration, depression, fatigue, body aches, cold like systems, something "stuck" in my throat, another round of antibodics, a yeast infections, loss of hair, extreme pain in the bottom of my feet, random break out of hives.
Received 2 of her 3 pre-kindegarten immunizations in her L deltoid (either DTaP, IPV, or MMR).  Two days after administration, she developed marked erythema, induration, warmth, and tenderness of her L forearm- which required hospitalization for IV antibiotics.  She responded well to IV and then po antibiotics as well as benadryl with decreased swelling, redness, warmth, and tenderness.  It was unclear whether this was an infectious vs allergic reaction.
Headache, Myalgia, Fever, t 101,arm sore Felt like flu symptoms Narrative:
Tiredness; Headache; bone and marrow pain; Nausea; Mild flu-like aches; Extremely dry skin; Flakey skin; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non- pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an unspecified route of administration in right arm on 08Mar2021 at 09:15 (at the age of 70-year-old), as a single dose for COVID-19 immunisation. Medical history included mild COPD, asthma and diet-exercise controlled diabetes. The patient was allergic to sulfa, cephalexin, neomycin, nickel, banana, soy & soy lecithin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications received within two weeks of vaccination included umeclidinium bromide (INCRUSE), azilsartan kamedoxomil (EDARBI), vitamin D3 (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), ubiquinol (MANUFACTURER UNKNOWN) and ELLIPTA. All concomitant medications were taken from unspecified dates for unknown indication. On 09Mar2021 at 10:00, the patient experienced bone and marrow pain. On 10Mar2021, the patient experienced headache and tiredness. After a few days on an unknown date in Mar2021, the patient experienced nausea and mild flu-like aches. These last lasted on and off for a few days. She thought in that week her skin was extremely dry and flakey. It was reported that the patient had taken acetaminophen as a treatment measure for the reported event and took rest. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of bone and marrow pain, headache, tiredness, nausea, mild flu-like aches, dry and flakey skin was resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
drowsiness, chills, stiffness and soreness all over. 2 inch red blotch appeared at vaccine site about 10 hrs after injection--slight itching. On the second day could hardly get out of bed..very stiff and sore overall, slept most of the day, on awakening I was groggy and confused. Perspired thru the night as though a fever was breaking and when I awoke I felt slight headache but otherwise NORMAL! tHIS WAS THE 2ND DOSE.
Got shingles after the Shingles booster/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after the Shingles booster/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that almost all he/she knew got shingles after the shingles booster. The reporter further stated that what's that told you. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
legs were in pain/sharp pains on the right side of my thigh; had trouble swallowing; my thighs were tight and very hard, I could barely walk; my thighs were tight and very hard, I could barely walk; pain in her thighs which feels muscular; chest pains here and there; have not gotten my period; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 21Sep2021 at 17:00 (Batch/Lot Number: Fc3181) (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. Medical history included anemia and mitral valve prolapse. Concomitant medications included vitamin d nos and unspecified multivitamins; both taken for an unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot: FF8839), administered in the left arm in Aug2021 at 16:30 (at the age of 39-years-old) for COVID-19 immunisation and experienced heart palpitate, tongue went numb and have not gotten her period. The patient also has known allergies to acetylsalicylic acid (ASPIRIN). On 22Sep2021, after the second dose, patient reported that her legs were in pain. Patient felt sharp pains on the right side of my thigh and had trouble swallowing. The pharmacist suggested that patient should go to the ER. Patient was given pain meds and told it was an effect from the vaccine. Patient was told to take Tylenol and follow up with her doctor. Patient also reported that her thighs were tight and very hard that she could barely walk. Patient had to take rest constantly because of the pain. Patient followed up with the doctor, had an ultrasound, waiting on results. It is now mid-October and patient still have pain in her thighs which feels muscular, but she is not sure and cannot walk for a long period of time. Patient now have to see a rheumatologist. The patient get chest pains here and there but the doctor said her heart is ok. Patient also have not gotten her period since the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient was given IV pain medications and Tylenol Extra Strength as treatment for the events. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101371429 same patient/drug, different dose/events
Moderna COVID?19 Vaccine EUA Hives/raised bumps formed initially at injection site, approximately 5 days after injection. Bumps joined to form a large 3? diameter area of rash (red, raised slightly itchy) at injection site the next day. Accompanied by fatigue (2-3 days) and GI issues (about 1 week). Symptoms resolved in about 10 days.
Redness, firm to touch Rt upper arm - 11 cm length x 10 cm. Notice small redness. Child began to scratch Rt upper arm. Enlarged in size by evening. C/O pain eating (2-3). Instructed parent to apply cool compress, Tylenol 1.5 tsp Benadryl ointment.
Rec'd vax IM lt deltoid 20mcg-c/o soreness in lt arm on the day of administration. Had chills & sweats 13OCT90 in PM. 15OCT90 had temp of 101 degrees F, chills & sweats, & arm is still sore.
Went into A-Fib.  Had not had an A-Fib episode since an ablation in November, 2018. Saw cardiologist on Feb. 22, 2021.  Had a cardiogram. Scheduled for a cardioversion  on Feb. 26, 2021.
12 hrs after vaccination, developed chills, total body muscle aches, fever/sweating, intense headache. Symptoms persisted throughout night, with no relief from multiple doses of acetaminophen.  After taking 2 ibuprofen in morning, muscle aches and headache subsided.
Large red swollen itchy patch on upper arm at the site of injection that started 7 days after injection and lasted for 3 days
Large nodule on left side of neck; Lymphadenopathy; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; Some pain occurs when straining neck, but mostly just very uncomfortable; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 13:00 (at the age of 32-years-old) at a single dose for COVID-19 immunization. Medical history included penicillin allergy and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included ibuprofen (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable on 16Jan2021. The clinical course was reported as: The patient woke up the morning after being vaccinated and had a large nodule on left side of neck, which appeared to be lymphadenopathy. There was some pain that occurred when straining neck, but patient was mostly just very uncomfortable. The patient did not receive any treatment for the events. The clinical outcome of large nodule on left side of neck, lymphadenopathy, and some pain occurs when straining neck, but mostly just very uncomfortable was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Information has been received from a published article, concerning "a patient who was vaccinated with two doses of ATTENUVAX (manufacturer unknown). In approximately 2004, the patient experienced measles related death. The cause of death was measles." The article also discussed the experience of 1 other patient who died while on therapy with ATTENUVAX (manufacturer unknown) (WAES# 0903USA01794). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
presented to clinic on 27AUG96 c/o runny nose, cough dec appetite, crying outbursts & loss of use of arms;referred to hosp ER;
I felt bad immediately afterward, headache. Treated with Tylenol. By the next day, a very large tongue ulcer appeared or the front right side of my tongue, and that night I felt the beginnings of Bells Palsey.  On Monday 3/8 I went to the clinic and explained that I have Ramsey Hunt and could feel Bells Palsey starting. They began me on antivirals, steroids, and topical lidocaine because of the extreme pain of the ulcer.
itchy hives; feeling hot; This is a spontaneous report from a contactable consumer or other non-health care professional.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced itchy hives and feeling hot on an unspecified date. The outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Heart palpitations; Shortness of breath; May be I have an enlarged heart; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and DYSPNOEA (Shortness of breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke since 2012. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations), DYSPNOEA (Shortness of breath) and CARDIOMEGALY (May be I have an enlarged heart). The patient was treated with ROSUVASTATIN ongoing since an unknown date at a dose of Daily. At the time of the report, PALPITATIONS (Heart palpitations), DYSPNOEA (Shortness of breath) and CARDIOMEGALY (May be I have an enlarged heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood cholesterol: high (High) Dose of rosuvastatin was increased from 5 mg to 10 mg daily.. In May 2021, Cardiac stress test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had the events after 1 month of second vaccine. Patient had 2 stress tests that did not had a clear results. Stress test performed.  It was reported that, palpitations and shortness of breath was occurring 4-5 times a day and though she might have enlarged heart. After receiving the vaccine, Rosuvastatin was increased to 10 mg daily. An angiogram was schedule on the Tuesday following this report.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Event description was updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
VACCINE LEFT IN FRIDGE MORE THAN SIX HOURS ( ABOUT 12 HOURS); USE OF EXPIRED JANSSEN COVID-19  VACCINE/DID NOT CHECK THE VIAL OR TIME AND  JUST FOUND OUT ABOUT IT JUST NOW; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 203A21A, and  expiry: UNKONWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine left in fridge more than six hours ( about 12 hours), and use of expired Janssen covid-19 vaccine/did not check the vial or time and just found out about it just now.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine left in fridge more than six hours ( about 12 hours) and and use of expired Janssen covid-19 vaccine/did not check the vial or time and just found out about it just now. was not reported. This report was non-serious.
SQ SITE RIGHT ARM SOLLEN WITH ITCHING,MILD PAIN, LOW GRADE FEVER,DIZZINESS POST VACCINATION. NO BLISTERS OR VESICLES.
This spontaneous report as received from a pharmacist refers to a 63 years old female patient with sulfa allergy. On 15-AUG-2012, the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # 0422AE Exp: 27/MAR/2013). No concomitant medications were reported. The pharmacist stated that on 18-AUG-2012, the patient developed shingles rash after receiving ZOSTAVAX. The patient had painful rash on right inner thigh. The patient saw the physician. Laboratory studies were not performed. At the time of the report the patient was recovering from shingles rash and painful rash on right inner thigh. Additional information has been requested.
devel 3cm area eythema @ site w/ 7/10 tenderness & 3cm swelling; devel lymphadenopathy axillae & groin & medmarked myalgias;
Child seen in clinic on Aug 3 for 5 yr WCC and received KINRIX via right thigh and MMRV via left thigh. Child was brought to clinic on Aug 5 for c/o right inguinal/femoral lymphadenitis, fevers and discomfort. Child had been c/o the past week of right groin discomfort with some limping. Child placed on AUGMENTIN. Did well for 5 doses and then developed fevers, increase in inguinal lymph node size, returned to clinic for ROCEPHIN. Subsequently did well for a few days again and the redeveloped fevers. Brought to ER where US showed possible necrotic inguinal lymph tissue, CT done, multiple labs and testing to determine cause of issue. Child ended up in the OR with inguinal lymph node dissection and inguinal node removal.