chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number 1637651 with expiration date in 09-JUN-2022 (dose, route of administration, strength and anatomical location not reported) that underwent a temperature excursion.  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a temperature of 35.6 degrees Fahrenheit (°F) for the time frame of 3 hours and 15 minutes. There was a previous temperature excursion and the call was because of a data logger. 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: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
post 2nd vax & exp swelling in legs-worsened-dx w/kidney problems renal biopsy;poss r/t hep B vax, heavy edema;
This spontaneous report was received from a licensed practical nurse refers to a 17 year old patient (gender not reported). Patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, frequency and route not reported), lot # N020943 (expiry date: 26-OCT-2018) instead of VARIVAX (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis (wrong drug administered). No adverse effects were reported. No additional information was provided. A product quality complaint (PQC) was not filed.
Pt's left thigh is swollen - measured in circumference 34 cm. Right thigh (unaffected) is 31.5 cm - Area surrounding injection measures 8 cm W x 7 cm long. Area is indurated and painful to touch. Temp on admit 100.3. MOTRIN given. temp on D/C 99.5. Vaccine area is warm to touch. Very tearful. Unable to bear weight at this time due to pain.
Patient recieved 1st booster after 3 dose primary series after only 2 months.  No adverse effects reported
About 2 minutes after receiving the vaccine, the patient had a complete syncopal event, causing him to hit his head/face on the ground.  He regained consciousness immediately afterwards.  His blood pressure was low and he had a HR in the 30s, which improved slowly over time.  We asked that he go to the hospital for further evaluation, but he refused to go.
"Fainted" 1635 unconscious about 1 minute, couple of "jerky" arm movements. 98/64 BP HRR 64. Lowered to floor & elevated legs. 1647 Sitting up, drank water BP 92/68 HRR 60.
Patient presents for admission  from J-tube dislodgment.  Tube was later replaced without incident. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
All joints ached a ran a fever for 7 days high of 102 degrees on Sunday & went to the hospital.
He had a Tmax of 102.5 on 2/28 and had a 10-15 min seizure episode of shaking arms and legs w/ rolling of eyes.
On November 24, 2022, I woke up from a dead sleep with a fever of 100.5. I tried to rest but felt super sick and woke up dizzy and nauseous. I slept most of the day. The next day I felt better but contacted the doctor to let them know I tested positive for COVID-19. I was prescribed an anti-viral. A week after I finished the anti-viral I got a rebound case of COVID-19. I still feel "dumb" like I am not getting things quite right when I am trying to do stuff, like "COVID Brain". I am also still pretty fatigued.
Swollen lip, hives everywhere especially chest area, dizziness, faint feeling, heart racing within under a minute of receiving vaccination. Today I feel heavy and swollen, along with flu type symptoms and an arm that hurts worse than the tetanus shot I received this past July 2021.
Patient presented to ED o for evaluation of R flank pain and fever in the setting of known UTI. She has been on po Ciprofloxacin as OP but due to worsening symptoms, came into ED for evaluation. Found to have low grade fever, CRP 13.6, hypokalemia 3.0 and CT AP concerning for findings seen with acute pyelonephritis. She was started on empiric IVFs for GNR sepsis, IV Ceftriaxone 1 gm and admitted for further treatment. She received total of IV Ceftriaxone 3 doses and was feeling much better. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Weakness in legs.  Severe burning sensations in hands and face.  Also, stabbing pain in hands.
Patient received 2nd primary Pediatric Pfizer dose on date above. However, first primary shot was on 11/20/2021, so earliest patient should have received 2nd dose is on 12/7 and the correct 21 day period between the two is 12/11/2021. Error found in data mining. Safety officer has requested patient's parents come in for a 3rd dose since 2nd vaccination was given too soon.
swelling started in evening; SAT am went to MD very red & swollen, warm-pain in elbow, swelling in lower arm returned to MD;
Patient complained of redness and itching on her arm where vaccine was administered about 5 days after the administration.
itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and ERYTHEMA (red) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (itchy) and ERYTHEMA (red). At the time of the report, PRURITUS (itchy) and ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment information information was reported.
Stated symptoms started 2/16/08; After 14 days low grade temp.. Rash on stomach in A.M.; later by noon rash on face then later on thighs and arms. Swollen glands of jaw (mumps) 2-21 and 2-22-08 totally down with water retention hands, fingers, legs; Felt all joints painful; Could not walk! Took husbands Glucosamine Tabs (felt better)
This spontaneous report was received from a healthcare worker refers to a patient of unknown age who on 13-AUG-2012, was vaccinated with the second dose of GARDASIL (dose, route and lot number not reported) that could have been improperly stored. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
Pt recv vax on 1/6/99; on same day pt exp hyperactivity
Four days after vaccines were given, child developed diarrhea, fever of 101F, would not bear weight and was inconsolable for four days after onset of symptoms. No local reactions to vaccines occurred. Child was seen by Pediatrician and treated for diarrhea illness and fully recovered.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL (dose and route were not reported, lot # K010215, expiry date: 05-MAY-2017). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date (also reported as when the patient was 64 years old) the patient was vaccinated with ZOSTAVAX, (dose, route and frequency were not reported). Concomitant medications were not reported. The reporter stated that on an unknown date (a couple of weeks ago and also 6-7 yrs ago) the patient was diagnosed with shingles. The outcome event was unknown. The causality of events was not reported. The company representative stated that she did not have much patient specific information, therefore many fields remain unspecified by reporter and NA. VZV packet declined. Patient sought medical attention required. No product quality complaint (PQC) was reported. No further information was reported. Additional information has been requested.
Approximately 45 hours post-2nd Pfizer COVID-19 vaccination, first signs of a shingles vaccine rash, sore joint and leg pain on the left side of the body, as well as a headache were experienced. Later the same day, additional rash spots (2) were seen. Online urgent care used four days post-vaccination and shingles was diagnosed by nurse practitioner on duty at Virtuwell clinic.
Within hours became disoriented, thirsty and achy.  Next morning, arm was numb and fingers tingly,  Achy, fever, nausea, headache, extreme thirst, disoriented.  Extremely sore arm that I couldn't lift to my waistline without extreme pain..  Hard to dress/undress.  Never felt so sick in my life!
Information has been received from a pharmacist via a company employee referring to a 42 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were reported as none. On 26-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N014188, expiration date N014188, single 0.5 ml, intramuscular for prevention of Pneumococcal disease. On the same day, the patient experienced redness/swelling of skin and pain at injection site. The outcome of the events was reported as resolving. Unspecified treatment was given for the events.
Mother of infant reported that infant had a low grade fever on 10/24/2008 with a spike to 105 degrees Fahrenheit on 10/25/2008, slight clear rhinorrhea. Tylenol every 4 hours decreased fever to 100 degrees Fahrenheit through 10/27/2008. No fever after second dose of influenza vaccine on 11/24/2008.
Localized Reaction.  On 10-19-2016 2020, it was and is 5 cm (or 2 inches) wide, red, and indurated. It was accidentally touched early in the day that set it off to itching. I am fighting the urge to rub it like when I had the chicken pox when I was in 6th grade.
Fall/syncope admission.  Tested + for COVID 1 week PTA, confirmed at admission 12/5 by NP PCR
The mother states that this child had a seizure at 1:30 AM, and states the child felt warm to touch. He had a 2nd seizure at 6:30 AM, his temp was 102 (ax). At 7:30 the child was taken to the hospital, the temp was 103 (rect), he was given Motrin, Blood work was done. He had a 3rd seizure at 2 PM some day 04/03/01 none since. The patient was in the clinic on 04/12/01 to inform of the seizure activity with the child.
BRUISE ON TOP OF RT KNEE; TINGLING ON HAND AND LEGS; FEELS LIKE LEGS ARE SWELLING; ARM FROM INJECTION SITE FEELS LIKE A HEAVINESS AND PAIN; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808986, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced bruise on top of rt knee. On 17-JUN-2021, the subject experienced tingling on hand and legs. On 17-JUN-2021, the subject experienced feels like legs are swelling. On 17-JUN-2021, the subject experienced arm from injection site feels like a heaviness and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise on top of rt knee, tingling on hand and legs, feels like legs are swelling, and arm from injection site feels like a heaviness and pain. This report was non-serious.
Both had some tummy issues after receiving it; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it). At the time of the report, ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it) outcome was unknown.     No concomitant medications were reported. Patient and patient's daughter received booster shot on Monday and both had some tummy issues after receiving it.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681730 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681730:MOD-2022-681730 -Daughter case
Swollen lymph nodes under right arm extending towards chest. At largest point, probably half the size of a softball. Advised to use an icepack on it and take benadryl for the swelling. Started this treatment on March 13 in the afternoon. Swelling seems to be subsiding slowly each day. Was told by doctor's office if swelling didn't start going down by March 17, to call them back.
Having a slight pain in chest didn't thing anything of it , it went away until a few days later on June 4th the pain didn't go, went into the bathroom and almost passed out go the ambulance rushed to the hospital where they had to put a stint in the leg and stayed 4 days in the ICU before being able to come home. Has to take medicine everyday now for heart.
4"x4" erythematous indurated area on left deltoid no flucturance appreciated. Symptomatic treatment.
This is a spontaneous report from a contactable consumer (patient). A 56-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 56, via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient has no known allergies to food, medications or other products. The patient received unspecified medication within two weeks of vaccination. Prior to vaccination, patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On Feb 23, 2021, patient felt worse than she did when she had COVID for 3 weeks. She had extreme body aches, headaches, brain fog and extreme tiredness. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included treatment with prednisone from an unknown date. Since the vaccination, patient has not tested for COVID-19. The outcome of the extreme body aches, headaches, brain fog and extreme tiredness resolved with lasting effects on an unknown date in 2021. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
- Developed DVT left calf; unknown if related to air plane flight with increased risk related to vaccination with history of thrombosis with thrombocytopenia syndrome (TTS) in patients. Understand it is predominately a concern with women, but just want to include this data point in case it is being seen in others. Received blood thinners at one dose for 20 days and then 69 days of a lower dosing.
Headache; body aches; fatigue; low grade fever; SOB; This is a spontaneous report from a contactable physician (patient). A 38-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0177, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 09Jun2021 (age at vaccination 38 years old) at 14:45 as dose 1, single for COVID-19 immunization administered in hospital.Medical history included migraine, PCOS from an unknown date and unknown if ongoing. Concomitant medication included topiramate (TOPAMAX); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); thiamine hydrochloride (B1); cyanocobalamin (B12-VITAMIIN); escitalopram oxalate (LEXAPRO); beta-carotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. The patient previously took phenergan [promethazine] and experienced drug allergy (phenergan). The patient was not pregnant at the time of vaccination. On 10Jun2021 at 09:00, the patient experienced headache, body aches, fatigue, low grade fever, sob. The patient underwent lab tests and procedures which included fever: low grade on 10Jun2021 at 09:00. No other vaccine is administered in 4 weeks prior vaccination. No covid prior to vaccination and was not tested positive for covid post vaccination. No treatment was taken in response to the events. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On 14 October 2011 and 16 April 2012 the subject received 1st dose and 2nd dose of HAVRIX (unknown). On 30 May 2012, 44 days after vaccination with 2nd dose of HAVRIX, 8 months after vaccination with 1st dose of HAVRIX, the subject experienced not responding to therapy. The subject had a titer performed on 30 May 2012 and showed non reactive. The healthcare professional reported several subjects did not respond to Hepatitis A vaccine; seven with HAVRIX and three with TWINRIX. For the other subjects please see OCEANS cases A0994236A, A0994238A- A0994240A, A0994242A - A0994246A.
Patient reported pain and numbness in deltoid region of arm. She also reported limited mobility and extreme pain in the injected arm. Symptoms started 2 weeks after first vaccination in January. She received a second dose in the same arm on May 23, 2019. Symptoms have not improved several months later. Patient has limited movement of arm, numbness in the deltoid muscle, and stabbing pain in arm with movement. According to patient, the deltoid muscle is in constant contracting state.
This spontaneous report was received from a registered nurse and refers to a patient (gender and age unknown). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-MAR-2017, the patient was vaccinated with an expired dose of injectable PNEUMOVAX23 (Lot # L017406 and expiration date 26-FEB-2017) intramuscularly for prophylaxis (dose, frequency and anatomical location were not reported) (product use issue). There were no known adverse effects.  Additional information has been requested.
23AUG96 extremely elevated fever & aches, spoke to MD;24AUG96 pt seen by MD;25AUG96 redness started called MD & started on ATB;26AUG96 followed up w/MD;
Tested positive for COVID; This is a spontaneous report form a contactable consumer (patient). A 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) dose 1 via an unspecified route of administration, administered on 19Apr2021 (at the age of 37-year-old) as a single dose for covid-19 immunisation. Medical history and concomitant medications of the patient were not reported. On 19Apr2021, 12 hours after receiving the shot, patient experienced soreness throughout body and had little bit of chills. On an unspecified date in 2021, patient experienced cough, lethargic, had no fever until a couple of days later and he did not lose his sense of taste or smell. Caller was certainly not expecting to have COVID and the timing made perfect sense that the symptoms were from the shot. Patient started experiencing symptoms that were normal with getting the vaccine and then things started getting worsened on an unspecified date in 2021 and at that point he was tested positive for COVID, seven days after administration of vaccine on 26Apr2021.  Patient was scheduled to get the second shot on 10May2021, but he cancelled it and he had received differing education from an urgent care as far as whether or not to get second shot as scheduled or to wait in between. It was reported that chills stopped sometime around the change of the months, confirmed that it stopped around Apr2021 or May2021. The patients cough and being lethargic were the only symptoms he had left. The soreness throughout body, this also stopped around end of Apr2021 or beginning of May2021. Patient was calling now to ask if he should reschedule the appointment that he had cancelled for 10May2021. Patient asked if it was safe to get the shot now or should he wait. Reporter considered all events as non-serious. Outcome of the event unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient reported feeling  itchiness in throat. Denied shortness of breath, trouble breathing,  throat constriction. No rash forming.  BP 156/104 HR79   Patient was provided water,  loosened constrictive clothing, rested comfortably for 30 minutes.  Symptoms improved.  Patient verbalized she felt ok to go home and take a Benadryl.
Woke up early morning with chills and a slight fever (99.8), sinus headache and very tired for entire day after vaccine.
experienced sporadic chest pain; on day 8 he developed Shingles; Pain in his  back; Pain in his left side; This case was reported by a nurse via call center representative and described the occurrence of chest pain in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2020, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced chest pain, shingles, back pain and pain. On an unknown date, the outcome of the chest pain, shingles, back pain and pain were unknown.   It was unknown if the reporter considered the chest pain, shingles, back pain and pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. On day 5 and 6 after vaccination he experienced sporadic chest pain, on day 8 he developed Shingles and he now has mild pain in his left side and back. Nurse did not provide lot number and expiration date but she provided the mailing address of where her husband received the dose. She mentioned that they went to the hospital and checked his kidneys and they were okay. The reporter consented to follow up.