chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an approximately 19 year old male patient who in 1992, was vaccinated with 3 doses of Hep B (manufacturer unknown) (route, dose and lot number not reported). On 28-JUN-2011, the patient had an antibody test which reported failed to seroconvert. It was also reported as no adverse effects. It was unknown if the patient sought medical attention. At the time of the report the patient had not recovered. No further information is available.
Itching all over, nausea for about 10 hours -BENADRYL 100mg (total) and 1 PEPCID - symptoms relieved with medication.
Booster; Curious how much may have been related to the change in  vaccine type for me (Moderna to Pfizer); Curious how much may have been related to the change in  vaccine type for me (Moderna to Pfizer); Got a bit feverish 24 hours after the  booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received third dose of bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: MODERNA (Dose No: 1), for Covid-19 immunization; MODERNA (Dose No: 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Curious how much may have been related to the change in vaccine type for me (MODERNA to PFIZER)"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "Got a bit feverish 24 hours after the booster".  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt began influenza type sx: h/a, cough, sore throat, low grade temp, fatigue, inability to eat on 25OCT; 4NOV had lost approx 15 lbs-h/a (sever), muscle aches, weakness; trouble keeping eyes open;
This spontaneous report was received from a nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with an expired dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 (dose and route were not reported), for prophylaxis. No adverse effects was reported. The outcome of expired product administered and no adverse event was unknown. Additional information has been requested.
After the vaccination the level of my tinnitus increased quite a bit. In other words, it?s much worse than it was.
Follow up information pertaining to patient's medical history was received from a physician. Information regarding Flumist was received from a healthcare professional regarding a 9 year old male who experienced malaise and fever. At 9 years of age, the patient received his first dose on 11/19/03. Relevant medical history: none. Indication for Flumist was immunization. Product was administered on 11/19/03. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 11/24/03, approximately five days after receiving Flumist, the patient developed fevers of 102-104 that lasted for about three days. The patient also experienced malaise. All symptoms resolved in about five days. It was reported that the patient's brother received the Flumist on the same date and did not experience problems. The physician additionally noted in his follow up that it is unknown if the fever was vaccine related or whether the patient had some other illness since he did not have a chance to examine him. No additional information is was available at the time of this report.
rash; This is a spontaneous report from a contactable consumer reported in response to Non-HCP follow-up letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation causes pain, right knee-could barely walk and all of her joints that had been previously hurt in the past started killing her. The patient experienced rash on 16Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was recovered.  Information on the lot/batch number has been requested.
This spontaneous report was received from other health professional refers to an unspecified patients of unkonwn age and gender. On an unkonwn date, an unspecified number of unspecified patients received improperly stored oral, ROTATEQ (lot # K015841 and expiration date 01-MAY-2016 and lot# K013861 and expiration date 18-MAY-2016 and lot  # K011947 and expiration date 07-JUN-2016) (dose and route were not reported). No adverse effect reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a female with diarrhea for 4 days prior to vaccination who on 31-MAR-2008 was vaccinated PO with her second dose of Rotateq (lot# 660289/188U). On 01-APR-2008 the patient experienced severe abdominal pain and was subsequently hospitalized for "several days." During hospitalization it was determined that she had ileus which resolved spontaneously, and then she was released from the hospital. No labs or diagnostic studies were performed. On 04-APR-2008 the patient recovered. No further information was available. There was no product quality complaint. Ileus was considered to be immediately life-threatening by the physician. Additional information has been requested.
Information has been received from a health professional concerning a male patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced breakthrough chickenpox with 50 lesions. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
After I had left the pharmacy my neck became tingly and numb and trouble swallowing but could continue to breath through my nose. Did not go the hospital. It passed after perhaps 30 minutes. I talked with a doctor and will follow the cdc guidelines and get the JandJ shot now since it?s been after 28 days. Had a similar but milder experience after my hep shot  6 years ago. Just didn?t think about it since I wanted a vaccine.
Went to ER on 12/26/20 due to change in vision in left eye (flashes and floaters). Retinal specialist did dilated eye exam and found vitreous detachment occurring. Then, on 1/2/21, lost small part of vision and returned to retinal specialist with diagnosis of retinal detachment.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 13-DEC-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
An expired vaccine vial was administered from previous day -since the old vaccine vial was not discarded and mixed with the current vial
I did not feel well the morning following the injection.  I attributed it as a mild side effect and went to work on 9-6.  Early in the afternoon I began experiencing severe chills and by 5:00 pm I was on the couch.  My arm was sore and had a large red lump.  I checked my temperature at approximately 9:30 pm and had a fever of 102.4.  I treated the fever with ibuprofen and it persisted throughout the night.  My temperature came down to around 99 by 8:00 am on 9-7.  I phoned the clinic and advised medical staff of the problem.  I was told to use ice on the injection site and continue with ibuprofen if needed.  The redness and swelling in my arm continued to increase and remained hot to the touch. By the morning of 9-8 redness began developing in a secondary area of my left arm approximately 4" below the injection site.  The initial spot was approximately the size of a quarter and continued to spread throughout the day.  Both areas remained red, sore and hot to the touch.  I continued applying ice to the arm as instructed.  On the morning of 9-9, I awoke to find the secondary area had grown in size to be approximately 4" wide and 2 1/2" to 3" tall.  The areas were still very red, sore and hot to the touch.  I phoned the clinic once again to advise the medical providers of the change in the condition and was told I should be seen.  I visited the clinic that morning and was seen by two providers.  I was told that this was merely an injection site reaction and that it was "normal".  I was told to take antihistamines and continue icing.  An appointment was made for 9-13 if needed.  The pain in these areas did not subside and remained hot to the touch throughout 9-11.  The initial injection site was less red on 9-12 and I cancelled the appointment with the clinic.  The secondary site has been slow to recover with the lump and redness persisting through 9-23.  The skin then became flaky and discolored and there is an indentation approximately 1" high and 4" wide across my bicep with a lump directly below.  It appears there has been some type of tissue damage in this area and I do have continued pain and discomfort at this secondary site on my left arm.  I do not believe proper protocol was utilized in the administration of this vaccine.  The person administering the vaccine brought an uncovered syringe into the room, set it on the counter to look for a band aid, and stuck the opened band aid on her finger.  She was not wearing gloves and did not swab the injection site.  My deltoid was pinched tightly and the vaccine administered.  It was painful from the outset.  This was a stark contrast to the easy painless experience I had with the first vaccine two months prior.  I do not believe that large red hot areas encompassing most of the upper arm can be deemed a normal injection site reaction.  I was repeatedly told that the reaction was "better than having the shingles".  I disagree - I have had the shingles twice in the last four years and the fever and lingering pain in my arm has been worse.
Increased redness and swelling of left upper arm and generalized malaise after receiving tetanus toxoid x48 hours ago for cat bite. Feeling tired (fatigue), nausea, rash. Cold compresses observe for increased erythema tender lymph nodes or fever.  Tylenol for fever, prednisone 60mg daily x 5 days.
Hospitalized (2.25.22 - 3.5.22);  COVID positive;  Fully vaccinated PLUS booster Discharge Provider: MD Primary Care Provider: DO Admission Date: 2/25/2022 Discharge Date: Mar 5, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Unintentional weight loss Pneumonia due to COVID-19 virus COVID-19  HOSPITAL COURSE: 70-year-old female with past medical history for follicular lymphoma status post chemotherapy (last treatment 12/2021), depression, history of Roux-en-Y bypass.  She presented to emergency department with failure to thrive, nausea, diarrhea, inability to tolerate oral intake.  Incidentally tested positive for COVID-19 pneumonia.  Patient was vaccinated and boosted.  On arrival to emergency department she is hemodynamically stable and breathing comfortably on room air.  Labs notable for leukopenia (stable), mild anemia, thrombocytopenia as expected.  Metabolic profile showed hypokalemia, indeterminate procalcitonin, normal lactic acid.  She was given some potassium and admitted to a HCF for assessment management.  Hematology-Oncology were consulted recommended supportive management.  Felt failure to thrive was related to COVID-19 pneumonia.  However patient did not develop worsening symptoms for COVID and still despite that had poor oral intake and weight loss.  A CT abdomen pelvis showed findings of mild positive fluid balance otherwise no acute findings in abdomen pelvis.  Speech therapy evaluated patient, recommended VFSS which showed esophageal dysmotility.  Gastroenterology was consulted patient underwent EGD which was relatively unremarkable.  Biopsies were taken and pending at the time of discharge.  During her stay in the hospital patient did receive Corpak in tube feeds, tolerated these well.  Corpak was removed and nutrition was monitored.  She was started on Remeron.  Patient was able to meet caloric intakes by oral intake.  Nausea diarrhea had resolved.  Patient was also hospitalized for syncope/orthostatic hypotension.  Improved with supportive measures, hydration.  She was started on Florinef with improvement in her symptoms.  She is being discharged in stable and improved condition with instructions follow-up with primary care physician and primary hematologist.  Of note patient's sodium did rise towards the end of her hospital stay, attributed to tube feeds that were previously running.  Recommended patient encourage oral hydration/intake and outpatient follow-up with blood work.  She expressed understanding.
Pt had a large induration hot to touch 4" x 3 1/2".  Dx: Cellulitis.
Fever for more than 24 hours Bruise at injection site is still visible after 4 weeks
severe back pain/ back aches; body aches; inflammatory reaction; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable female nurse (patient) of unknown age reported that she received BNT162B2 (COVID VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got the Covid vaccine on Thursday (date not specified). She was taking ibuprofen (MOTRIN) (later clarified as ibuprofen) for anti-inflammatory. She went to a doctor visit yesterday (18Dec2020), and then her doctor told her that because ibuprofen was an anti-inflammatory, she shouldn't be taking it during, right after the vaccine because of inflammatory reaction and so patient stopped taking it and switched over to paracetamol (TYLENOL), now she was in severe back pain/ back aches and body aches, but anyways she was just going to end up taking it if this took much longer. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: From the information provided it is unclear which event is the intended subject of this spontaneous report and what is the reporter's perceived relationship to the vaccine. In addition, the lack of critical information (e.g. immunization date) makes a global medical assessment impossible. 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.
UTI-like symptoms (irritation and burning); UTI-like symptoms (irritation and burning); This is a spontaneous report from a contactable consumer (husband reported for his wife). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an intramuscular route of administration, administered in Arm Left on 08Apr2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were none. Family medical history Relevant to AE(s) was none. Patient medical history (including any illness at time of vaccination) was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route (injection) of administration, administered in Arm Left on 21Mar2021, as single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer Suspect were none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. AE(s) following prior vaccinations was not provided. On 28Apr2021, the patient experienced UTI-like symptoms (irritation and burning). The clinical details of the events as follows: Reporter stated that he and his wife received their second Pfizer Covid vaccine doses on 08Apr2021. They have both been experiencing UTI-like symptoms including irritation and burning) that have not resolved. Reporter stated that his wife symptoms began around the same time as his. It was pretty much identical. Started at the same time and are ongoing and persisting. Reporter stated she mentioned something to him about it just in the past Sunday. The patient went to the gynecologist for Urinary tract infection symptoms, where no blood work or urinalysis were performed. She was trying to go to her regular doctor for testing. No Relevant Tests performed. The events did not result a visit to Emergency Room. No Investigation assessment provided. The outcome of the events was not resolved at the time of this report.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Information has been received from a registered 35 years old female pharmacist who reported that she thought her right eye could had inadvertently been exposed to ZOSTAVAX (Merck), unknown dose, once, on 14-JAN-2009.  The pharmacist reported no relevant medical history, concomitant medications or past drug history.  On 14-JAN-2009 at around 14:00 while preparing some ZOSTAVAX (Merck) for two of her patients, as she went to inject the air to draw out the reconstituted ZOSTAVAX (Merck) she thought that some of the "back spray" from the vial might had hit her brow, but some of the ZOSTAVAX (Merck) may have inadvertently gotten into her right eye.  She further stated that it was a fluke, and that she could had sworn that something flew up underneath her glasses, but that she did not feel anything go into the eye itself, but then her eye started to bother her.  There was no relevant laboratory data. On 15-JAN-2009, her eye was not red or watering, but it "sort of hurt but not real bad", the inner corner of the eye was a little bit inflamed, but she stated that it could just be irritation from getting something in there, or because the air in the pharmacy had been very dry.  At 8:00 on 15-JAN-2009 she went to see her doctor and he did an eye wash to flush the eye out.  The doctor told her that her eye looked fine, and recommended that she used a moisturizing eye drop for the irritation.  As of 15-JAN-2009, she had no stinging or blurred vision at this time, and was currently using GENTEAL moisturizing eye drops for the irritation.  This was originally reported by a Drug Center.  Additional information has been requested.
Within 10 minutes of the injection, I started experiencing tingling and numbness of all my fingers, then started to experience blurred vision, I work in a medical office and had experienced difficulty in reading the words on my computer screen and could barely read the VIS read the VIS sheet provided to me by my pharmacist,  then I started to feel a bit of nausea coming on, no vomiting occurred. The adverse events lasted about 2-3 hours, but I did notice some trouble with my vision for a day or so afterwards. My doctor was informed of these adverse events, but no medical attention was deemed necessary.
No adverse event; lower than authorized dose of Moderna bivalent vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, 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 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (lower than authorized dose of Moderna bivalent vaccine administered to patients).    Concomitant product use was not provided by the reporter.  Patient received 0.25 mL dose instead of 0.5 mL dose. The patient had not reported any adverse reactions at this time.   Treatment information was not provided.  This case contains information for the 11th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280, US-MODERNATX, INC.-MOD-2022-666286, US-MODERNATX, INC.-MOD-2022-666063, US-MODERNATX, INC.-MOD-2022-666248, US-MODERNATX, INC.-MOD-2022-666249, US-MODERNATX, INC.-MOD-2022-666250, US-MODERNATX, INC.-MOD-2022-666295, US-MODERNATX, INC.-MOD-2022-666278, US-MODERNATX, INC.-MOD-2022-666252, US-MODERNATX, INC.-MOD-2022-666255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666284:Patient 9 US-MODERNATX, INC.-MOD-2022-666280:Patient 16 US-MODERNATX, INC.-MOD-2022-666277:Patient 11 US-MODERNATX, INC.-MOD-2022-666286:Patient 10 US-MODERNATX, INC.-MOD-2022-666063:Patient 1 US-MODERNATX, INC.-MOD-2022-666248:Patient 2 US-MODERNATX, INC.-MOD-2022-666249:Patient 3 US-MODERNATX, INC.-MOD-2022-666250:Patient 4 US-MODERNATX, INC.-MOD-2022-666295:Patient 12 US-MODERNATX, INC.-MOD-2022-666278:Patient 14 US-MODERNATX, INC.-MOD-2022-666252:Patient 6 US-MODERNATX, INC.-MOD-2022-666255:Patient 13