chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Positive COVID-19 test result; Positive COVID-19 test result; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 41-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 01May2021 11:00 (Lot number: EW0175) at the age of 40 years as dose 2, single and administered in arm left, administration date 14Apr2021 14:30 (Lot number: EW0164) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cat allergy" (unspecified if ongoing). There were no concomitant medications. No other vaccine in was administered in four weeks. The patient had no other medication in two weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Positive COVID-19 test result". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Oct2021) negative; (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200015479 Same reporter and product; different events and dose
As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.
On the left side of the callers face down to his chest, pain and itching and burning and a rash. The caller went to the ER and the doctors gave benadryl and cream and said it was an allergic reaction.  there is still a rash, and it is burning and painful.
Had trouble urinating ? had to go, but very little came out ? continued for a couple days and then it seemed to resolve
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The nurse reported that, on 16-MAR-2015, the patient was administered with an expired dose of M-M-R II, lot # J003002, expiration date: 14-MAR-2015, albumin status: HSA, 0.5 ml, subcutaneous. No adverse events were reported. Additional information has been requested.
A pharmacist reported that an unidentified pt of a nursing home received flu shield vaccine. The pt developed tingling and a sensation which felt like a vaccine was running down their arms, for a period of 20 seconds. No additional info was available as of the date of this report. The reporter indicated that 6 pts from this facility experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.
Pt had elevated, spotty, rash/hives, on lower limbs and trunk, as well as upper back and neck areas. No airway issues.
Systemic: Fainting / Unresponsive-Mild, Systemic: pt after recived the covid pfizer first vaccine walked to designated areas to sit down for 15 minutes as i direct him to the seat and i did sea him seating comftably and i went back to pharmacy another patient yelled out taht patient is falling off chair-Mild
Shortness of breath, on and off for several days, same with headaches, and slight dizziness
Patient received TD and Hep A intramuscularly separately, left arm.  After receiving Hepatitis A patient stated "I'm going to faint", got pale, sweaty, clammy, lost hearing momentarily, became unconscious for approximately 30 seconds.  Blood pressure 60/30, code blue, called 911, patient continued to be monitored, regained consciousness, walked to couch with assistance, laid down supine, legs up.  Patient recovered fully, refused glucose monitoring and to go with paramedics.
This case involves a patient with unknown demographics who had left out on the counter over nighttemperature out of range with no adverse event while receiving vaccine TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a  dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date the patient developed a non-serious left out on the counter over nighttemperature out of range with no adverse event (product storage error) (unknown latency) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE. Action taken with TYPHOID VACCINE (TYPHIM VI) was not applicable. It was not reported if the patient received a corrective treatment for the event (left out on the counter over nightTemperature out of range with no adverse event). At time of reporting, the outcome was Unknown for the event left out on the counter over nighttemperature out of range with no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
unknown to me at this time. Nurse follow up on 10/29/04 states: "multiple lacunar infarcts in the thalami, (L) caudate head & periventricular white matter; transverse myelitis; hypertension; hyperlipidemia; pain & numbness; weakness of lower extrem; difficulty walking." Autopsy Report received on 12/07/2004 states severe acute CHF, bilateral acute ischemic renal infarcts, severe pulmonary congestion and edema, severe congestion, liver and spleen, and circulatory collapse. 11/18/04 Lab reports received. No new evidence found.
she has swollen lymph nodes under her right arm; patients right arm is sore; patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (she has swollen lymph nodes under her right arm), VACCINATION SITE PAIN (patients right arm is sore) and HEADACHE (patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (she has swollen lymph nodes under her right arm), VACCINATION SITE PAIN (patients right arm is sore) and HEADACHE (patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (she has swollen lymph nodes under her right arm) and VACCINATION SITE PAIN (patients right arm is sore) outcome was unknown and HEADACHE (patient complains of a headache lasting for 3 days/patient continued to have slight headache for a week after her booster dose) was resolving.            No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow up received and contains no new information.
patient received an expired dose of IPOL, no AE; Initial information received on 10-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 9 years old male patient who was inadvertently vaccinated with an expired 0.5 mL second dose of IPV (VERO) [IPOL] (frequency once) lot N1J451M, expiry date: 05-Oct-2019 unknown route in the Right Thigh on 10-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and HIB VACCINE CONJ (OMPC) (PEDVAXHIB).  It is an actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from an other referring to a 13 month old patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 17-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX injection (strength, dose, frequency and route were not reported) (lot # N020013 and expiry date: 17-JUL-2019) for prophylaxis. The administered dose of VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiry date were not reported). The vaccine was stored in between -14 degrees Celsius (C) to -10 C (-14.37 C) for 15 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA008334.
Itching, followed by swelling and redness that spread over days until it reached from the shoulder to the elbow. The redness and swelling took about 9 days to disappear. It still itches. Some pin point scabs appeared near to the injection site. Also have dark splotches appearing on other arm.
For two weeks following application of booster, inabiity to complete full night sleep due sensitive reaction to left shoulder when sleeping on left side.  Doctor prescribed Tizantine HCL 4 Mg to be taken at bedtime.  recieved slight relief.
Coughing, congestion, and fatigue on morning of 4/2/2023. Fever started next day. Three home covid tests; first two (4/2 and 4/3) were negative. Third (4/4) was positive.  (Note: I sang in a choir of ~120 people for the 3 days prior to developing symptoms. I know that at least 12 other singers also tested positive for Covid within 5 days of the same event.)
Side effects included: Constant muscle spasms all over body; numbness in right hand twice; right side jaw pain; and headache. I took IBprofen for a couple days every 8 hours, but discontinued use after headache and jaw pain dissipated. However,  The muscle spasms are still present three weeks after vaccine was administered.
Chills and very mild nausea within 12 hours of the vaccine. Swollen lymph nodes under my left clavicle, and multiple lymph nodes along the left side of my neck. Vaccine was received in the left arm.
3 patients may get 3rd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 patients may get 3rd dose) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 patients may get 3rd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 patients may get 3rd dose) outcome was unknown.        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 treatment and concomitant medication provided by the reporter.   Reporter did not allow further contact
Communal Living / SNF Placement (Asymptomatic) ED to Hosp-Admission  Current   10/21/2021 - present (14 days) MD  Last attending  Chief Complaint Patient presents with ? Shortness of Breath     1. Severe sepsis 2. Acute encephalopathy 3. Pneumonia 4. Chronic systolic CHF 5. Stage 3 CKD 6. Hypertension 7. Type 2 diabetes   Plan:   This is a little bit of a confusing case so far in terms of whether there is truly an infection or not.    This is a gentleman with a history of stroke, CKD, DM, HTN who came in with SOB from nursing facility. In the ED, he was febrile initially. However, WBC count and procalcitonin are both normal.    I am treating this like pneumonia. He does have a history of CHF but the BNP is lower than previous and clinically he looks quite dry.    Otherwise, I considered other causes of fever and altered mental status/SOB - he does have a history of stroke - CT head doesn't have anything new. But I have ordered a stat MRI brain as well. Neuro checks.    Type 2 diabetes mellitus without complication   Spoke to ED physician personally and agree with admission.    Called and updated son. Confirmed for now code status is DNR/DNI - he will call back if this changes at any point - he is going to discuss again with his mother Patient is an 88 y.o. male.       I personally interviewed patient, reviewed chart, and reviewed emergency room resident history and agree with it in its following entirety unless otherwise noted below.  "Patient is a 88 y.o. yo male presenting to the ED with recent left MCA stroke with resultant right sided deficits, discharged from rehab 3 days ago to nursing facility now presents with reported O2 saturation on room air in the mid 70s.  Patient reportedly had rales bilaterally.  Of note, the patient had developed new onset CHF on his last hospitalization.  Troponins have been chronically elevated.  Per nursing facility, at baseline the patient is able to talk and is alert and oriented with some difficulties with speech fluidity after the stroke.  They deny history of fever.  They state that he became altered in association with his difficulty breathing."   In the emergency room he underwent a CAT scan of the head.  This was unremarkable for anything new but does have a lot of chronic findings on it.  The patient cannot contribute much to history.   He was febrile.  He was given antibiotics out of concern for pneumonia.   Otherwise history is incredibly limited given the patient's altered mentation
1/26 VARIVAX. That night after shower, she had a generalized blotchy rash all over body not hives. 1/27 rash gone, developed swollen tender ill defined area at TRICEP Region. Injection site negative. 2/2/09 no fever, sl tender, better.
Symptoms started 2 weeks after booster vaccine. Itchy scalp, intense itching of the ears, hot flashes and sweating, itching of neck, back, torso, palms and soles of the feet. Hives appear in areas of itching and upon scratching. Dermatographia present. Started taking Claritin, some relief, went to doctor on 1/11/22, prescribed Zyrtec 1x daily and Pepcid 2x daily for symptoms. Only taking Zyrtec and it?s managing hives and itching, but if I stop, itching and hives return. Hot flashes are starting to diminish.
pt recvd vax & had swelling & redness at inject site; PMD stated treatment w/DPH & n ot take another TD inject;
Two minutes after injection, patient stated he felt light headed. He started breathing heavily and turning red in the face while clenching his fists. Patient's eyes were open but he was unresponsive for 30-45 seconds. Patient then became responsive and started breathing normally and returned to normal facial color. He was then alert and feeling normal. Patient was given water and observed for 30 minutes. He walked out on his own with no problems. Was given our contact information and told to call with any issues.
Fever  of 101.1 dropped to 99.5 by 9pm and broke at 4am on 5/1. Mild body aches and nausea.
Immunized at 11AM 10/18/08. 2PM - low grade fever-did not check temp, entire body aching-pain arm took ALEVE and heat to arm. 10/19-arm extremely painful-redness. 10/20-arm v. red, tender to touch -felt hard to touch. Continue with ALEVE. 10/21 Felt much better, fever gone, arm still tender to touch.
1455 1ST DOSE PFIZER VACCINE ADMINISTERED 1457 PT WITH LOSS OF CONSCIOUSNESS, WITH ARMS AND LEGS JERKING MOVEMENTS. AMMONIA INHALANT USED, PT AROUSED AFTER STERNAL RUB AND INHALANT. ORIENTED TO SITUATION PROVIDED. PT STATES "I'M SO EMBARRASSED, I FELT THAT COMING ON" 911 CONTACTED AND PT ASSISTED TO STRETCHER. 1458 BP 137/81 HR 72. PT DENIES ANY OTHER COMPLAINTS. DOES CONFIRM HE WAS ANXIOUS ABOUT INJECTION AND WAS SCARED HE WOULD FAINT. 1500 EMS HERE, BP128/80 HR 92. PT REFUSED TRANSPORT WITH EMS AFTER DISCUSSION WITH EMTS.  1530 PT STATES FEEL OK TO LEAVE WITH GIRLFRIEND DRIVING. BP 165/64 HR 65. DENIES ANY COMPLAINTS. INSTRUCTED TO CALL 911 OR SEEK MEDICAL ATTENTION IF NEEDED. VOICED UNDERSTANDING.
Info has been received from a doctor of pharmacy concerning a "healthy" male who was vaccinated on an unknown date with one dose of pneumococcal vaccine 23 polyvalent (lot #641114/1387L). A day or two after his vaccination, the pt had blood work drawn for HIV which returned positive for ELISA and negative for Western Blot. Additional info was received on 07/17/2002, from the doctor of pharmacy, who stated that the pt had a history of "risk factors for HIV" and was vaccinated "because of his diabetes." He further clarified that the blood work was drawn on the same day, within a few hours post vaccination. The reporter felt that it "was just coincidental that the Pneumovax 23 vaccination and the serum ELISA were positive on the same day." The pt sought unspecified medical attention. Additional info has been requested.
I was diagnosed with Depression in September 2021.  It's hard to say exactly when it started.  Appx. June 2021.  I don't think it has anything to do with the vaccine, but I answered the question on the V-Safe check-in about a new conditions so I think that is why I was contacted. I started taking Zoloft on October 1, 2021.  I am feeling better.
Suspected vaccination failure; My cousin has had the shot and had them three times..twice after the shot....; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows. The patient had reported for his/her cousin. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151420:Same reporter. Reporter's case. US-GLAXOSMITHKLINE-US2021AMR151421:Same reporter. Other people's case.
mild urticaria covering whole body; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration on 07Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hyperlipidaemia. She is not pregnant at time of vaccination. Concomitant medications included atorvastatin calcium; and esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]). The patient experienced mild urticaria covering whole body on 09Jul2021 with outcome of recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment hydoxizine and famotidine were received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
P/MMR arm turned red @ site approx 40 mm, whelps developed. No other sxs. Give DPH 10 min later redness down to 25 mm, no whelps. Sent home w/DPH. Contact w/mom 1 wk later no further problems.
Went to ER 2 days after injections. Dx. Cellulitis. Treatment-KEFLEX TID x 10 days doing well.
Approximately five days after administration of vaccine, patient started experiencing chest pain and heart palpitations. Followed up with healthcare provider approximately two weeks after, and was prescribed 500mg naproxen twice per day.  Symptoms subsided and returned approximately two weeks later. Patient was seen at ED and diagnosed with pericarditis using ultrasound approximately 3 months after administration of first dose, prescribed 250mg Naproxen twice per day.  Symptoms continued. Patient seen at ED on 8 July 2021, EKG, ECG and stress test conducted. No sign of pericarditis, however patient still experiencing chest pain and heart palpitations. Prescribed 500 mg Naproxen twice per day, and 0.6mg colchicine once every two hours, as needed.
Really bad pain and swelling in arm. Hard lump at injection site (could not touch area).
A report was received from a healthcare professional on 10/03/2003 concerning a 73 year old female vaccinee who experienced hyperglycemia in the evening of 10/02/2003 after receiving Fluvirin vaccine in the afternoon of 10/02/2003. On 10/02/2003, the vaccinee was administered Fluvirin vaccine in the afternoon and later that evening the vaccinee noted that her finger stick blood sugar tests were reading 400mg/dl.  The tests were repeated twice and they all yielded a result in the 400mg/dl range.  The vaccinee self administered an extra 10 units of insulin subcutaneously as a result of her hyperglycemia.  The vaccinee did not exhibit any outward signs or symptoms of hyperglycemia.  The vaccinee did not exhibit any outward signs or symptoms hyperglycemia.  On the morning of 10/03/2003, the vaccinee's fasting blood glucose was approximately 50mg/dl.  Her normal fasting blood glucose is between 50mg/dl to 80mg/dl.  The vaccinee's normal dose of insulin of 40 units subcutaneously every morning was resumed.  The vaccinee has had perfect control of her diabetes for 5 years.  The outcome of the event was not reported.   There was insufficient information to determine the reporter's causality assessment. Update 1, 11/10/2003: Further information received from a healthcare professional on 11/10/2003 indicated that the vaccinee developed a fasting blood glucose of 400mg/dl on 10/03/2003, which resolved the following morning on 10/04/2003 following an extra insulin dose. No follow up pending.
Chest pains for two days, irregular EKG, diagnosed with Pericarditis, will take 600mg x 3 for 14 days, follow-up with Cardiologist in 2 weeks.