chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist via company representative and refers to a unspecified number of male patients over the age of 15 years old. On an unknown date, the patients were vaccinated with GARDASIL 9 (dose and dose number and anatomical location were not reported. On an unknown date, the patients experienced inappropriate schedule of vaccine administered. No adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.
"Knot" at injection site since injection. 13 days past vaccination (10/17/09) has swelling, redness and knot size of silver dollar at injection site.  15 days post vaccination (10/20/09) arm really sore and says cannot lift it very high.  Doctor visit 10/20/09.  Prescribed PREDNISONE and BENADRYL and 0 more flu vaccinations.  11-6-09 no signs of redness or swelling.
Neuropathy peripheral; pt developed flu-like sx w/in 24 hrs of receiving vax; third day, low grade fever developed which has persisted to date; Also aches, pain & weakness in her rt arm, & peripheral neuritis-dx branchial plexus neuropathy;
Developed malaise and fever of 101.2 approx 20 hours after vaccination. Entire upper surface of left arm swollen, blotchy red, and sore. Gradual improvement over the next three days.  Missed 2 days work.  Took ibuprofen, aspirin.
Lethargic, Headache, and Nausea. I took two Tylenol Extra Strength. The symptoms lasted for 5 or 6 hours.
This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient woke up out of the sleep and can't move it (arm), and described that it hurts like it's broken or some on an unspecified date. Outcome of the events was unknown.
A non-serious spontaneous report of we gave H1N1 to 56 year old female was received from a registered nurse/health professional concerning a 56-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 22-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
A few days after vaccine, not long after, my symptoms started with frequent loose stools and couldn't figure out why and changing my diet didn't help. I had incontinence as well and went to my doctor and she had me stop taking medications just in case and I did some blood work, and she didn't find anything wrong. I think once all those tests came back negative, I was referred to gastroenterology and they took my history and did more tests and a colonoscopy including a biopsy and everything was clear. With process of elimination, they went with a diagnosis of IBS.
DELUSIONAL AND CRAZY; SUSPECTED COVID-19; GOT SOME FAR OFF STRAIN; This spontaneous report received from a patient concerned a male of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2023, the patient experienced suspected covid-19, and got some far off strain. On an unspecified date, the patient experienced delusional and crazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from delusional and crazy, and the outcome of suspected covid-19 and got some far off strain was not reported. This report was non-serious.
Work up noted that she had a cecal volvulus and she underwent emergent operative intervention - s/p lap converted to open right hemicolectomy with ileocolic anastamosis. Recovery in hospital. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
She was due to get the second dose on 07SEP2021 and she was out of town and missed it.; So far asymptomatic for COVID-19 Disease; Exposed to COVID-19 infected person; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person), PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.) and ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person). On 13-Sep-2021, the patient experienced ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person) and ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Pt called on call phone 1/17/07 at 8PM C/O tenseness and spasms to left neck increase spasms when turning head to left. Went to ER that night and was told a nerve may have been hit. Given inj of Valium and anti inflammatory was RX'd Naproxen.
This spontaneous report as received from an unspecified healthcare worker refers to a 11 year old patient of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
other zoster-related conditions; shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/ or administered by a healthcare provider at the medical office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by healthcare providers at the medical office for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Per father "within minutes" post her first Pfizer vaccine, pt developed a red, raised, circular rash to various areas of L upper arm that extends down to just above her L elbow. Pt denies any chest pain/palpitations/SOB/wheezing/dizziness. No stridor noted. Pt also denied any other discomforts or distress, she was very calm and cooperative, answering all questions appropriately. RN noted swelling the size of a silver dollar to the same injection arm. Area is also red and very warm to touch in comparison to R arm. Pt has full range of motion to L arm and no other complaints. RN made contact with ER MD and pt was given po Ceterizine 10ml and tolerated it very well. Ice pack also provided to L arm. Pt's swelling to L arm dissipated and pt did not develop any worsening of her rash to the L arm.
Pt has been walking for 2 wks a/vax; p/vax mom states pt stopped walking; pt bears wt & walks holding on & crawls, but not walking alone; pt taken to MD who felt wait 2 wks & if not walking will refer to neurologist;
Localized erythema/firmness at injection site (2cm-4cm in diameter).
Problem was with shoulder area (left arm) went to primary physician diagnosed with arthritis in rotate cup.
received Havrix that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 37-year-old male patient who received HAV (Havrix) (batch number 5816082643, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 26th August 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-AUG-2022 Reporter's Comments: The health care professional (HCP) reported that patient received Havrix that was expired on 14th Jun 2022. No other reactions reported. The vaccine administration facility was the same as Primary Reporter The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
RECEIVED VACCINES AT 11:30 AM; BECAME VERY LETHARGIC AND SLEEPY WITHIN 30 MINUTES OF RECEIVING VACCINES.  SLEPT FOR 26 HOURS; AROUSABLE FOR ONLY 2 FORMULA FEEDINGS OF SMALL AMOUNTS.  MOTHER STATES THAT SHE WAS LIKE A "RAG DOLL".  HAD NO FEVER AFTER VACCINES.
2 doses of the liquid adjuvant only given at one time; 2 doses of the liquid adjuvant only given at one time; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number 9K2MA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: the patient received 2 doses of liquid adjuvant and no lyophilized antigen.  Additional Supportive Information: the patient received 2 doses of liquid adjuvant and no lyophilized antigen of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Pfizer Dose 1 3/12/21 (EN6208) Pfizer Dose 2 4/18/21 (ER8734) Pfizer Dose 3 10/5/21 (lot NA) COVID Positive 3/9/22  3/8/22: 86-year-old lady presented to the emergency room via the EMS with history of generalized weakness for 2 weeks.  Patient also reports some episodes of dizziness, has been having difficulty ambulating. Patient was diagnosed with UTI yesterday and started on Cipro.  However, symptoms have persisted, so decided to come to the emergency room for further evaluation.  She denies any focal neurological deficit. She denies chest pain.  She denies abdominal discomfort.  She has also subjective chills.  3/12/22: Patient was admitted on the 9th with complaints of generalized weakness, episodes of confusion.  Patient was diagnosed with urinary tract infection.  Patient was started on IV ceftriaxone.  Also COVID PCR came back positive but patient was asymptomatic, no treatment needed. Patient had episodes of confusion on and off during her stay in the hospital.  Patient's urine cultures came back positive for E coli sensitive to ceftriaxone and Augmentin. Today patient is alert and oriented, hemodynamically stable.  Discussed about COVID status being positive and patient being asymptomatic.  Advised isolation only at this time.  IV ceftriaxone switched to oral Augmentin and patient being discharged, family okay with the discharge plan.  Patient has plenty of family support at home.
that he tested positive for the Covid virus; that he tested positive for the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "that he tested positive for the Covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had my vaccination on 09/12/2022. On 12/13/2022 I had a feeling in my chest and called 911. I was admitted and stayed for approximately 4 days and 3 nights. I was determined that I had a cardiac event and listed as having coronary artery disease. I am currently being followed with my cardiologists.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805483 was cross linked to the original case 201804863 due to same reporter.
Swollen bottom lip, swelling started the next morning after and lasted all day, went down by the next day. Ever since then I get a swollen lip or eye every time I take Advil. I believe I have developed an Advil allergy, which I took ibuprofen after taking my shot to manage fever. I was menstruating when I took the shot and was also nursing at the time.
Initial report received from a physician on 26 Aug 2010: On 25 Aug 2010, this patient inadvertently received a intramuscular dose of MenA lyophilized conjugate component of MENVEO (batch number not reported) that was reconstituted with a sterile diluent. The patient had not received the MenCWY-135 liquid conjugate component of MENVEO. No adverse reaction had occurred following this administration. Follow up physician report received on 13 Oct 2010: The patient had received powdered constituent of MENVEO (batch number: 023011) by reconstitution rather than liquid component, intramuscularly in upper arm. The patient did not experience any adverse event following this drug administration error.
Atypical chest/between shoulder blade pain, tightening of throat on Thursday,  14Jan2021, became clammy,  started in back and wrapped around to chest.  Last about 10-15mins, mod to severe increasing pain.  Mod-severe fatigue had been ongoing.  Was not COVID tested at Emergency Dept visit, appeared to be isolated event.
Sleepiness and fatigue the following day, 28 hours after administration Sore arm at site of injection
Developed redness, swelling & fever up to 101 within  24 hours of vaccination. Treated with oral tylenol, Benadryl  25mg po Qx2 and ice application with improvement  of erythema & resolution of fever
After 1 day or two, began to develop pain and itching near the skin surface on my right abdomen.  After another week a rash developed; my GP believe that it is consistent with shingles.
awakened from nap & was playing then got a little restless then began having period of high pitched crying for about 1 hr; refused nursing; mom took to MD;
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed in VAOS is 12/31/2069.  To find the expiration date, look up expiration date tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine. Patient contacted on 12/4/2021 and no adverse effects reported.
Adverse event: Pt began to experience nausea and vomiting approximately 7 hours post vaccination.  Has been vomiting every day since then (3 days).  Worse yesterday than today.  Mother estimates 4 times yesterday and twice today. Diarrhea onset 07/28/21 night.  Other s/s include generalized fatigue and sore arm. Has been drinking plenty of fluids.   Pediatric patient's not seen at this clinic, her PCP is closed.  Recommended ER or Urgent care.
Info has been received from a physician concerning a 16 month old female with no pertinent history and no allergies who was vaccinated, SC with a 0.5ml dose of varicella virus vaccine live (on an unspecified date). There was no concomitant medication. Subsequently, the pt experienced breakthrough varicella (date unspecified). Unspecified medical attention was sought and no diagnostic or lab tests were performed. The present status of the pt was not reported. No product quality complaint was involved. Additional info has been requested.
Hives, increased temperature; went to ER X 2. On 8/16/00 and 9/20/00; seen by physician and ER. Missed 8 days of school. Exemption from MD for Hep-B #3. Adverse reaction to Hep-B.
Patient received her first dose of covid vaccine on 3/17 who comes to the hospital on 3/31 for increased fatigue and decreased appetite which began 3d after vaccine. In ER she tested + for covid and CXR was unremarkable, pt was discharged home. Patient returns to ER for increasing shortness of breath causing her to increase her home 02 to 3L and then ultimately 4L prior to EMS arriving. She notes she is dizzy and fatigued. She denies chest pain, n/v, but did have 1 episode of diarrhea PTA. This morning patient requiring 5L NC 02 and ID asked to evaluate for recommendations.  Remdesivir withheld as symptom onsent > 2 weeks ago. Tocilizumab 8 mg/kg and dexamethasone 6 mg daily initiated.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose number, lot number, expiration date, route of administration and anatomical location not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
red irritation oval on injection site; red lump on injection site; red irritation oval on injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red irritation oval on injection site), INJECTION SITE IRRITATION (red irritation oval on injection site) and VACCINATION SITE MASS (red lump on injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medication history reported).    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red irritation oval on injection site). On an unknown date, the patient experienced INJECTION SITE IRRITATION (red irritation oval on injection site) and VACCINATION SITE MASS (red lump on injection site). At the time of the report, INJECTION SITE ERYTHEMA (red irritation oval on injection site), INJECTION SITE IRRITATION (red irritation oval on injection site) and VACCINATION SITE MASS (red lump on injection site) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: No specific follow-up information recorded.
Info has been received from an RN concerning a 4 year old male who on 1/2/04 was vaccinated with a dose of varicella virus vaccine live. On 11/30/05, the pt developed a mild case of breakthrough chickenpox with less than 50 lesions. Subsequently, the pt recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Follow-up info from the RN indicated that there was no further info available. Additional info is not expected.
on the second day after getting the Pfizer second shot, my skin was extremely sensitive and was very painful to do anything, hurt to sit, couldn't sleep cause laying in bed was just so painful. even the clothes i had on hurt to ware.
Covid arm. On day 8 I developed an itchy red rash with swelling, heat, and tenderness at the injection site. I have a picture if needed.
Pt received covid19 vaccination approximately 1355 hours. While PT was in observation, PT stated that her mouth and throat were feeling "weird". PT allowed EMS on scene to evaluate PT's condition. Fire/Rescue also arrived on scene to assist. PTs vitals were stable. PT's symptoms were better during evaluation. PT declined transport and stated she was going to walk to CVS. PT cleared observation at approximately 1430 hours.  End