chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a patient's mother regarding a patient (demographics not provided). The patient's mother reported that the patient was administered dose one of GARDASIL (dosage and route of administration not provided) on 03OCT2013. Dose two of GARDASIL (dosage and route of administration not provided) was administered on 31OCT2013. The doses were administered less than one month apart, which is other-than-indicated in the prescribing information. The reporter confirmed that the patient had not yet received her third dose in the series. No adverse effects were reported. Follow-up information was received from a physician's assistant regarding a female patient, age unknown. The physician's assistant reported that the patient came into the office on 02APR2014 to receive a dose of GARDASIL (dosage and route of administration not provided), and that the patient had not reported any adverse experiences. Additional information has been requested.
This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date, (Oka/Merck) VARIVAX underwent a temperature excursion and on an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous. No adverse effect report. At the time of the report the action taken with (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
About 1-2 weeks after receiving my third dose, my urine was darker, and I passed blood at a point in time. I knew there was a problem, so I contacted my Urologist. I went in and we went into a procedure where I was on an antibiotic. It seemed to clear it up, but then I noticed that it came back. I called him again. While getting ready for my back surgery, they drew blood to check my panels and noticed that there was an infection in my blood. I am now on two antibiotics. When I went to my appointment yesterday 11/10, everything looked better. I'm going back today for another checkup and hopefully I can have my back surgery on 11/23.
Took HBV on 8/23/02 at 10, at about 6:30-7:00pm "started having troubles breathing and throat was swollen and was very hot. Took Benadryl-2 pills and started feeling better, breathing better and swelling of throat went away. PHN advised to check with her MD before taking HBV #3.
The patient had a swollen left thigh, red, hard, warm.  Treated with Keflex for 5 days.
Received vaccine aprox 0745 am 12/22/2020, aprox 09:00pm 12/22/2020 while at work onset tachycardia at rest 140's-150s, , chills, flushing, and light headiness. Employee continued to work through her 12 hr shift, she advised tachycardia persisted throughout the night 140s.  She reported taking Tylenol at 3am, and chills resolved. She reported to Employee Health at 0730am 12/23/2020, vitals HR 142, BP 103/72 (she advised that was her normal BP), resp 14, Temp 97.2. She denies chest pain, shortness of breath, weakness, headache, cold symptoms, n/v/d. Advised the chills, flushing and light headiness had resolved, but the tachycardia continues. Employee denies any medical history, takes no daily meds, reports recovered from COVID early November. Discussed with Employee the need to seek higher level of care, she was escorted to the ED.
Pt devel a pruritic skin rash following vax w/1st dose of Hep B vax & no further details were provided;
Patient stated that her arm was sore to her elbow and up to her neck after she had the vaccine. It lasted for about 3-4 weeks. Patient didn't seek any medical treatment and it resolved on its own
Patient had a stroke and was taken to hospital on 1/25/2022. tested positive there at hospital
I was in a store a week after the vaccine, and I sat down and took a BP reading and it was 150s/high 80s and I was wearing a sweater and I was hoping it was incorrect. I went home and took my BP again and it was still in 150s/high 80s. in the past, I've never had a reading over the low 140s for the top number. So I monitored it for a couple more days and asked my doctor for an appointment. I went to see the NP on Monday 4/18/2022 and she prescribed blood pressure medication hydrochlorothiazide.
Nausea/vomiting Headache "Foggy" feeling in head 98.9 temp, 122/90 mmHg, 81 bpm
1 of 2 pts who exp an inject site react following immun; red, warm, swollen down to elbow @ inject site; treated w/DPH;
Information has been received from an MD concerning a 9 year old black male who on  08/19/1996 was vaccinated with a 2nd dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 05/08/2004, the pt broke out with severe chickenpox in his mouth, eyes, and rectum. The child was taken to the ER. No other information is available. The outcome was reported recovering with sequelae. There was no product quality complaint. There were no relevant diagnostic tests or lab data. Follow up information indicated that the pt recovered on 05/13/04. No further information is expected.
pt recv vax 28APR98 approx 5min later pt became very lethargic, pale, barely responsive;911 alerted, BP stable 86/50, P88, R20;became more alert, 02 & epi ready but not given;
pt recv vax & pt exp fever & rash;f/u hlth care professional indicated pt exp was not r/t therapy w/MMR vax;
Patient is a 83 y.o. female patient of MD with history of essential pretension, CAD, hyperlipidemia  presented to Hospital with right hip pain secondary to ground-level fall found to have right femur fracture. Had R hip intramedullary nailing on 3/12/23 with no complications.   Acute intertrochanteric fracture proximal right femur due to mechanical fall Fracture of right femur due to trauma alone S/p R hip TFN 3/12/23 S/p mechanical fall, x-ray right hip fracture Ortho consulted, taken to OR 3/12/23, tolerated procedure well.  Recommend WBAT right lower extremity Lovenox for DVT prophylaxis PT/OT recommend up to 5 days of ST for 10 to 30 days SW following for DC needs.  Pre-CERT approved.  Plan for DC to SNF today as patient stable. Pt advised to f/u with her PCP   Acute hypoxic respiratory failure Covid-19 virus infection Date of covid positive test: 3/12/2023 Vaccination status: vaccinated Imaging: Chest x-ray bronchitis, bronchiolitis Completed IV Remdesivir Continue Decadron Placed initially on 2 L of oxygen via NC, then weaned down to room air Hypoxic on 3/16 so placed on 3 L of oxygen Repeat CXR unchanged from previous  Continue to wean down oxygen at the SNF   Hypotension due to medications Primary HTN SBP 84 on 3/15, required 500 cc bolus, 110 after bolus Home BP meds held Will continue to hold coreg and lisinopril on discharge. Can be resumed out-pt as deemed appropriate by physician at SNF/PCP   Stage 1 pressure injury of left heel present on admission Wound care consulted.  Appreciate input.
Pt admitted to hospital.  Chief complaint: Shortness of breath, hyperglycemia   History of Present Illness:  Patient is a 46-year-old male who presented to the ED with increased heart rate, difficulty breathing and confusion.  He has a complex past medical history of diabetes mellitus, hypertension, hyperlipidemia.   Patient is he is oriented x3 but a poor historian. Patient reports that increased glucose values is the chief reason he is in the hospital.    In the ED, he was tachycardic, tachypnoeic, hypertensive, febrile, hypoxic (SpO2 86% on room air).  Labs revealed WBC >10.8, elevated neutrophils, low sodium of 117, acidemia, elevated BUN/Cr, elevated CRP/ Ferritin. He was started on 60 L 80% HFNC. CT Chest and CT Abd & pelvis were done.   Off note, he received his 1st vaccination of Pfizer COVID-19 on Wednesday 7/21 and started feeling bad right away.  He also reported that his blood sugars have been up and down in the past few weeks.
Extreme leg swelling (4 months); neurological changes:  balance, ability to communicate, mood change (6 months)
HEADACHE; FATIGUE; NAUSEA; FEVER OF 102F; TERRIBLE MUSCLE ACHES; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 41A21A, and batch number: 41A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 09-APR-2021 18:30, the subject experienced headache. On 09-APR-2021 18:30, the subject experienced fatigue. On 09-APR-2021 18:30, the subject experienced nausea.  On 09-APR-2021 18:30, the subject experienced fever of 102f. On 09-APR-2021 18:30, the subject experienced terrible muscle aches. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, fatigue, nausea, fever of 102f, and terrible muscle aches on 11-APR-2021 09:00. This report was non-serious.
on arising had difficulty speaking, h/a, numb rt arm & leg w/pins & needles sensation in hop; had IV Solumedrol & Pred taper-little improvement;
Per RN- At 1350 client stated "Slight numbness and tingling in both arms". No redness or swelling at injection site.  At 1355, a coke was provided and tolerated well. At 1359, BP in left arm was 176/94, HR- 74, Lungs clear, Respirations- 20. At 1415, Numbness decreased to only in hands. At 1418, BP- 173/89, HR-71, Respirations- 18, Lungs clear, Client escorted to car by EMT.
I was symptomatic and tested positive for Covid.  Symptoms began with fatigue and nasal drainage and congestion.  This proceeded to low grade fever and body aches.  It progressed to loss of sense of smell and taste, and loss of appetite.  The fever only lasted a few days but I was extremely tired for 10 days.  Sinus symptoms continued another week.  I am coughing some now, worse at night and with exercise.  I didn't cough so much during the active covid. But the cough is persisting.
Sore lymph nodes; Aches; Headaches; 101.6 Fever; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0162) via an unspecified route of administration in the left arm on 09Apr2021 at 13:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medication included citalopram hydrobromide (CELEXA) for depression from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6204) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 09Apr2021 at 20:00, the patient experienced sore lymph nodes, aches, headaches, 101.6 fever and fatigue. On 09Apr2021 the patient underwent lab tests which include body temperature and the result was found to be 101.6 (unspecified units).The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ADVIL. The clinical outcome of sore lymph nodes, aches, headaches, 101.6 fever and fatigue was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
erythema macular lesions, low grade temp 100;inc lesions c/w urticaria vs erythema mult
pt presented w/purpura & petechiae;adm to hosp & given 2 doses IVIG for ITP;
Patient second dose outside of 42 days; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient second dose outside of 42 days) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient second dose outside of 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient second dose outside of 42 days) had not 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.   No Concomitant medications were provided No Treatment information provided    This case was linked to MOD21-061829, MOD-2021-056417 (Patient Link).   Reporter did not allow further contact
sz (2-3)mins-prolonged h/a, muscle spasms lt side face 23OCT;eye strain, sleeping problems, nervousness, chills, facial pain, tension, sleeping diff, fever, weakness, lack of sleep, sz;lack of energy;spasms;exhaustion;h/a while sleeping
SHOULDERS PAIN; RIGHT ARM GET SORE SO FAR/FULL ARMS PAIN; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. The batch  number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced shoulders pain. On 21-JUL-2021, the subject experienced right arm get sore so far/full arms pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm get sore so far/full arms pain, and shoulders pain. This report was non-serious.
pt was healthy for his well baby exam at 1 mo 9/10/07 He slept for approx 3 hrs when he got home, and awoke crying inconsolably and was refusing to nurse. He was brought to dr's office 6:30pm 9/10/07. There was no fever, some swelling of left high was observed: exam was otherwise normal. Crying persisted through evening. Treated w/acetaminophen 0.8mg Ibuprofen 25 mg.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves Elderly patient (age and gender was not reported) who had skin red and irritated, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced skin red and irritation skin. Lab data not reported. Final diagnosis was skin red and irritated. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Rapidly beating heart that woke me from sleep. 2-3 hours duration. Slight tingling in fingertips on 1-15-2013 short duration.
Information has been received from a licensed practical nurse concerning a 20 year old female patient with no medical history and drug reactions who on 26-FEB-2009 was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number 0947X, site not reported).  There was no concomitant medication.  The patient developed muscle weakness radiating from her right arm to the right legs two hours after vaccination.  The patient stated that the muscle weakness began radiating to left side.  She was sent to the neurologist on 26-FEB-2009.  An unspecified neurological exam was negative for findings.  On 27-FEB-2009, the patient recovered from the event.  Additional information has been requested.
Large round red circle at injection site developed 11/12 days after receiving first shot. Described as "Covid arm" or ?delayed cutaneous hypersensitivity.? Hot to the touch. Still present (day 13)
severe chills and shaking- bundled up, no other treatment, symptoms abated after a few hours, muscle aches and malaise next day treated with naproxen
I am continuing to feel bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I am continuing to feel bad) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I am continuing to feel bad). At the time of the report, FEELING ABNORMAL (I am continuing to feel bad) outcome was unknown.            No concomitants were provided. No treatment was provided.
Verbalize at 1:02 pm feeling light headache, blurred vision like vertigo.  He was evaluated by Fire Rescue and released home feeling better at 1:05 pm.
Sever lymph node tenderness.  Progressed into Rash morning of day 2.   On injection arm.   We have a picture of needed
Extreme arm soreness within 2 hours lasting 5 days. Body aches, fever, chills, shakes, extreme fatigue,  headache lasting 24 hours. Large red, warm non raised rash on the right arm below site of injection starting day 3 and lasting 2 days.
Shingles, none, went away after several weeks. Pain, aches, chills, discomfort at shingles location.
Patients MD advised them to get "new shingles" shot, patient was unaware this was the same shot she received in 2018 so patient got a 3rd dose of shingrix. Incident wasn't discovered until pharmacist went to log the vaccine into system. Patient feels fine.
Immunization given and client immediately got pale, diaphoretic, sweaty, and fell to floor. Mother in room and assisted to floor, but had quarter-sized bump to right head area.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
First symptoms within two weeks were weakness in shoulders and itching eyes. Evolved within days into anxiety and high blood pressure, inability to sleep and fast hard heart rate. Continuous fast, heavy heart rate and high blood pressure. Extreme anxiety and loud heart beat in ears. Inability to regulate body temperature.  Extreme fatigue and unable to maintain walking at worse. Until medication was prescribed, beta blockers  was almost unable to sleep at all. Testing showed hypothyroid levels changing to hyperthyroid.
8/8/15 low grade fever 100.2, muscle aches, headache, nausea, baseball sized lump at injection site-hard, hot and painful. 8/10/13-other symptoms resolved-only baseball sized lump, hard, hot and painful persists.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-FEB-2017, the patient was vaccinated with improprerly stored dose of M-M-R II lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with the improperly stored doses of VARIVAX (lot # M032495, expiration date 06-JUL-2018; dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Fahrenheit for 48 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter.
Left upper arm red and swollen.  Give Tylenol or Advil as needed for pain.
INJECTION GIVEN AT 1:47PM AND CLIENT REPORTED FEELING LIGHT HEADED AT 1:52.  CLIENT ASKED TO SIT BACK IN CHAIR AND BREATH NORMALLY.  REMOVED SWEATER AND REQUESTED WATER. OBSERVED IN CHAIR AND FAINTED IN CHAIR AROUND 1:55 P.M. FOR 1 OR 2 MINUTES.  IN PROCESS OF CALLING 911, CLIENT REGAINED CONCIOUSNESS, AND CLIENT SAID FEELING OK, SO 911 CALL WAS CANCELLED.  AT 1:57, SPO2 92, PULSE WAS 62.  BP WAS TAKEN AT 1:58 AND 115/71.
my body felt like it was on fire inside, it felt like i was being poisoned inside,  i started getting a metallic taste in my mouth that never went away, it has been going on for months and i have been having right sided flank pain that has been going on since the shot also, my uric acid levels are high, i am now having to take medication for the uric acid.
Reports achey on Wednesday after the shot, by midnight reports severe pain in the neck, down into chest, down arm and down scapula. Sought treatment Thursday morning around 8:30am at ER in. Patient was admitted. Discharged Tuesday 5-4. Hospital tried pain medications and muscle relaxants (chewable baby aspirin, morphine, benadryl (after reaction to morhphine) norco, dilaudid, toradol, valium, oxycodone and flexeril. Sent home with diclofenac gel, and hydrocodone/apap.
Client had completed Moderna series (first dose 2/2/2021, second dose 3/2/2021). Received Pfizer on 4/16/2021.
Petechial rash developed on the lower extremities from the toes to the thighs within 2 hrs from the time of the MENACTRA vaccination spreading up the legs for 6 weeks.