chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the last 2 vaccines that I had from you I had a lot of protein in my urine from the vaccine."; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Transplant" (unspecified if ongoing), notes: I am transplant patient. The patient's concomitant medications were not reported. The following information was reported: PROTEIN URINE PRESENT (non-serious) with onset 2021, outcome "recovered" (2021), described as "the last 2 vaccines that I had from you I had a lot of protein in my urine from the vaccine."". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reason for no lot number of COVID-19 Vaccine: Other: LOT number: Consumer stated that they did not knew what the number was would it be on their card. As they did not had their card with them right now, they would had to call Pfizer later and then tell him for options 3? Consumer stated that they knew about having the Pfizer Vaccine and were thinking about taking a booster. Consumer was transplant patient (Further clarification was unknown). The last 2 vaccines that patient had from you they had a lot of protein in their urine from the vaccine. Consumer asked whether that was okay. When informed about the role of Pfizer Drug Safety and Pfizer medical information department, consumer stated that they cannot really understand you, you are gonna, they mean they could ask another one in your department if that was alright? Consumer was again informed about medical information department and was provided with the number, was provided with the number and told to press number 3. Consumer stated that was what they called now. Consumer stated: You are the pharmacist. Okay, after few days it disappeared, patient did not had protein. Consumer confirmed the vaccine as Pfizer COVID-19 Vaccine. Consumer stated that they would call that number again? When asked to file a safety report. Consumer was provided with the timings of Medical information department 8 am to 8pm EST and stated they will call. When asked for further probing: Consumer stated that they just cannot understand what you are saying and asked to call that number later. Further probing could not be done as the consumer was not willing to provide further information. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Abnormal mammogram images; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jul2021 17:30 (Lot number: FA6780) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, lot number=EW0217, lot unknown=False, administration date=16Jun2021, administration time=07:15 PM, vaccine_location=Left arm), administration date: 16Jun2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: MAMMOGRAM ABNORMAL (non-serious) with onset 25Aug2021, outcome "unknown", described as "Abnormal mammogram images". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of mammogram abnormal.  Additional Information: The patient did not receive any other vaccines within 4 weeks. Patient received other medication in 2 weeks was Sertraline. Patient did not received treatment for AE. The patient did not had COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient had no known allergies and other medical history.  Follow-up attempts are completed. No further information is expected.
Menstruation for June and July extremely heavy bleeding, large blood clots and severe cramps. At 53, I have had zero history with any of these issues prior to COVID vaccine (42 years). My periods were regular, no cramping, and regular clotting. Clotting now is large in size.
Muscle aches in legs and arms, lightheadedness/dizziness, and headache the night following the injection. Fever and runny nose the next morning. Ibuprofen was taken in 6 hour intervals and cleared headache and reduced fever but did not affect muscle aches. These symptoms were all gone 2 days after the injection.
This spontaneous report as received from a female consumer of unknown age reporting on herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The consumer reported that on an unknown date, 3-4 days after getting ZOSTAVAX, she experienced itchiness and a red, hard area at injection site. At the time of the report, the patient's outcome was unknown. Additional information is not expected.
Chills, fever, headache roughly 16 hours post injection and lasted about 6 hours. This happened after dose #2.
Vomiting started at 11:00 PM and continued until 8:00 AM when I went to hospital. I was severely dehydrated causing temporary kidney damage.  Blood pressure was extremely low. All of my numbers were alarming.  I was admitted to ICU where I stayed for 5 days, followed by 6 days in PCU.   Diagnosis was acute allergic reaction to vaccine.
No additional AEs; Caller reported expired dose of RECOMBIVAX was administered.  No other information provided.  No additional AEs or PQC reported. See related AEs 02342091, 02342106, 02342109, 02342114, 02342123.; This spontaneous report was received from Medical Assisstant and refers to a patient of an unspecified age, and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 05-DEC-2022, the patient was vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #U019135, expiration date: 22-NOV-2022, administered intramuscularly (IM) for prophylaxis (anatomical location, and strength were not provided) (expired vaccine used). No additional adverse events were provided. ; Sender's Comments:  US-009507513-2302USA008289:
Slight local reaction, erythema with axillary adenopathy.  Nausea with vomiting and diarrhea 24 hours also abd cramping.  Generalized achiness.  Home from work in bed 1 1/2 days.
flu; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case is linked to cases 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173, 2020SA294125 and 2020SA294145 (same reporter).  This case involves a patient of unknown demographics who got flu (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu (Influenza) (non-serious event) 12 hrs following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information on the batch number for this case.
05/15/2017 Diverticulitis of colon-given CIPRO and FLAGYL for 11 days. 5/26/2017 given PREVNAR 13 also CIPRO and FLAGYL for another 4 days. 5/28/2017 itching and rash started and continued. 6/7/2017 started on steroids. 6/12/2017-returned for evaluation by PCP.
Given DTaP3/Hib3/Prevnar 3 immunizations on 12/1/03 12:15 PM. Very fussy starting at 2 hours. After shots noticed dime size red/hot to touch area on right thigh last night - quarter size today. T 100 R.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 03 NOV-2012 at 17:36, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient c/o R sided myalgia in arms and leg and lower back pain. This started 4 days after receiving the JE vaccine. She actually received the vaccine in the L deltoid, which is opposite of where she is having pain. She cannot recall any other reason why she would be having discomfort. She has no fever or other symptoms. She still has full function of her extremities and denies numbness/tingling however she does have signifcant pain. She tried taking Ibuprofen which did not help.
I administered RSV vaccine to 56 years old patient due to not calculating the patient's age based on the date of birth. The vaccine was given at the clinic. I noticed the mistake that I made when I returned to the pharmacy and started to enter the vaccine consent form to the pharmacy system. I call the patient immediately and informed him that I have administered the vaccine that is only approved to individuals above 60 years old with risk factors. At this time, the patient does not have any adverse events. However, I have informed the patient to report it to VAERS when he gets any adverse events from this vaccination.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received expired Moderna COVID-19 vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 007C21A) for COVID-19 immunization. No medical history reported. On Aug 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 27, 2021, patient experienced administered expired product (patient received expired Moderna COVID-19 vaccine). On Aug 27, 2021, administered expired product (patient received expired Moderna COVID-19 vaccine): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vaccine was placed in the refrigerator from the freezer on Jul 12, 2021. There were a total of 5 ten dose vials expired past the beyond-use-date of Aug 11, 2021 in the refrigerator.
Day 2 - itchy nose, need to take deep breath 15-30 minutes Day 3 &4 - less than normal energy level, heaviness in chest Day 5 - heart racing: 107 BPM resting, dizziness, vertigo
Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting.; This is a spontaneous report received from a contactable consumer (patient himself). A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: Ew0164) via an unspecified route of administration in left arm on 05May2021 10:00 for COVID-19 immunization. Patient medical history included High blood pressure and acid reflux. Concomitant medications included amlodipine besilate, benazepril hydrochloride (LOTREL) and esomeprazole magnesium (NEXIUM) 40mg. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE and lot number: Ew0164) administered in left arm on 01May2021 10:00 for COVID-19 immunization. On 29May2021 06:00 patient was experienced with Extreme vertigo, uncontrolled eye movement like pendulum left and right, full feeling behind both years, nausea, vomiting. Patient was went to physician office/clinic visit, Emergency room/department or urgent care. Patient was treated with Steroid shot and prednisone 50mg from urgent care. Outcome of events was not recovered.
Initial information received on 27-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 months old patient (gender unknown) who was inadvertently given vaccine ADACEL, lot number, expiry date, dose not reported via unknown route in unknown administration site on an unknown date. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender - none.
Narrative: 68 yo F with h/o recently diagnosed serous adenocarcinoma of mullerian/gyn origin, history of CVA with no residual deficits besides some memory loss, hypertension, hypothyroidism, GERD, MDD and PTSD died on 06/25/2021 died at home in home hospice care. Pt had received covid vaccinations on 03/08/2021 and 04/05/2021. Death unrelated to vaccinations.
Pt was to have 3 vaccines administered from the 317 stock. Meningococcal, Pneumococcal, and TDap. I did not intake the patient. However, was asked by my co-worker if I could give the vaccines, since she needed to attend another patient. I responded, "Yes, but tell me which goes where, because I don't know," and she pointed out that Pneumo. and TDap were IM, and Meningococcal was SubQ, she had them separated in a tray. Vaccines were administered by me. Pt did not have any reaction to the vaccines.
10/2/21 patient received covid19 booster vaccine 10/3/21-10/4/21 patient didn't feel well ( headache, chills ) 10/4/21 patient started to feel worse and developed diarrhea and nausea 10/5/21 had doctor appointment and nurse noticed pulse was erratic 10/6/21 went to the doctor for an EKG - was normal but referred patient to the heart institute 10/8/21 at appointment with the cardiac doctor - patient was experiencing chest pains, heart pounding, and bradycardia. A longer EKG was performed and showed a PVC every other beat.  An ambulance was called at the cardiac doctor's appointment and patient was taken to hospital and admitted over the weekend. 10/10/21 Patient was discharged 6:30pm.  Metoprolol was added to patient med list and she is currently wearing a heart monitor.
This spontaneous report was received from a nurse and refers to a 12 month old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. The reporter stated that on 01-FEB-2019 the patient was vaccinated with PROQUAD lot # R012417, expiration date: 28-OCT-2019, for prophylaxis and during the same office visit received a dose of VARIVAX 0.5 ml, once, subcutaneously, lot # N027628, expiration date 04-OCT-2019. Both vaccines were reconstituted with sterile diluent, lot# R006344, expiration date: 13-DEC-2020. No adverse effects were reported.
pt recvd vax 23NOV93 & 23NOV93 12 hrs p/ vax devel a full body rash; each rash lesion was approx 3 cm across w/a flat central core of 3 to 4 mm; it had the appearance of a bulls-eye; No further details were provided
SHOULDER PAIN, FROZEN SHOULDER, STABBING PAIN CLAVICAL AREA, INJECTIONS SITE IRRITATED DAYS 2- 14 SWOLLEN, ITCHY WITH HARD LUMP. DAY 14 CHILLS , DAY 1-14 STOMACH PROBLEMS, DIARREHA DAYS 2-6, FATIGUE OFF AND ON
The first dose I received I received in the left arm. I got a very sharp pain in my wrist. It came on a bit slow really hard and only lasted about 15 mins. After 15 mins it went away. Upon my 2nd dose I got a fever the same day an hour after my shot that I got in the right arm. The fever was 100 degrees. I was tired and also got the chills. I also got a fever the next day of 100 degrees. I also got the chills.  After taking ibuprofen it went away.
a eleven year old female patient inadvertently received her booster dose of VAQTA nine days before the six month spacing interval; No adverse effect; This spontaneous report as received from a pharmacist regarding to a 11-year-old female patient.   No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On approximately unknown date in 18-OCT-2018, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) first dose for prophylaxis. On 09-APR-2019, the patient inadvertently received her booster dose of with hepatitis a vaccine, inactivated(VAQTA) 25/0.5 (lot # R010369, expiry date:  25-MAR-2019) second dose of 0.5 milligram nine days before the six month spacing interval noted in information for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported. No product quality complaint (PQC) was reported.
headache; neck pain; This is a spontaneous report from a contactable consumer, on behalf of his wife via Pfizer-sponsored program. A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient slept wrong and experienced neck pain. Patient also had headache. Reporter was asking ibuprofen could be taken for the headache due to the wrong sleeping position. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever & malaise on 02/26. Had an annual follow up with cardiology for known aortic insufficiency & stenosis. Possible vegetation seen on heart valve. Because of fever & malaise the day prior, he was admitted to hospital for endocarditis workup. Blood cultures and transthoracic echocardiogram all negative to date. Broad spectrum IV antibiotics initiated
Allergic reaction to Modern Covid Vaccine including swollen tongue and lips. Was monitored for 45 minutes, took another 50 mg tablet of Benadryl at 11:10 am. Called PCP on-call doctor and was instructed to go to ER and I went to the ER.
pt recv vax 1MAY97 & 7MAY97 pt devel a rash consisting of less than 50 lesions;
Sever local reaction.  Arm in which shot was administered quickly ballooned up and turned bright red over a patch approximately 8 inches in length.  Extreme pain and restricted mobility for two days, accompanied by unremitting severe headache and dizziness.
patient received a 3rd vaccination of Pfizer unknown to administrator at clinic. pt received doses on 1/8/2021 01/29/2021 and now 2/19/2021  per pharmacy records
CROHN'S FLARE; This is a report received from contactable reporter (Consumer or other non HCP), Program ID: (FACILITATED COLLECT). The reporter is the patient.  Report from a consumer of a female with events of and non-serious and with Single-Dose Pen, Adalimumab Solution for Injection. A 66-year-old female patient received BNT162B2, on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160836), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1; Route: Intramuscular), administration date: 01Mar2021, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2; Route: Intramuscular), administration date: 01Apr2021, when the patient was 64-year-old, for Covid-19 Immunization. The following information was reported: CROHN'S DISEASE (medically significant) with onset Aug2022, outcome "not recovered", described as "CROHN'S FLARE". It was also reported that on an unknown date, the patient experienced Humira was not working as expected. The action taken for adalimumab was unknown. Assessment Results: HUMIRA: Crohn's aggravated not reported per Non-Health Care Professional via Global Introspection, and for drug effect incomplete was probable per non-health care professional via global introspection. Pfizer Biontech covid-19 vaccine: drug effect incomplete and Crohn's aggravated were not reported per Market Authorization Holder (MAH).  The reporter's assessment of the causal relationship of "crohn's flare" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event CROHN'S FLARE Cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
12 days after vaccination I have a red itchy ring around the inject site about 5 inches in diameter and raised on the edges. Site is hot to the touch, even through clothes. It is itchier and more sore now on day 13.
about 2 hours after getting flu shot, he started getting red all over and itching and developed hives. This lasted about 1.5 weeks. He self treated with benadryl
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN4890780.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "frequent urination" (ongoing); "High blood pressure" (ongoing). Concomitant medication(s) included: AMANTADINE; GABAPENTIN; AMPYRA; GEMTESA; AMLODIPINE; SOLIFENACIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Covid-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300165822 same patient/ product, different event;
Information has been received from a 41 year old female social worker who in May 1999, was vaccinated with 1 dose of Hep-B vaccine recombinant and a couple days, post vax, she experienced "stuffed up nose." She sought unspecified medical attention. No further information is available.