chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature report as received from the authors of a published literature article, refers to 59-year-old male patient with a history of squamous cell carcinoma of the larynx and squamous papilloma of the right tonsillar pillar, both treated with laser resection, presented during routine follow-up with multiple nasopharyngeal papillomatous lesions on the posterior soft palate. His lesions were resected en bloc with CO2 laser via both transnasal endoscopic and transoral approaches. Final pathology revealed lesions consistent with squamous papilloma, and sequencing analysis showed the lesion to be positive for HPV 11. On a 3-month follow-up visit, the patient complained of mild nasal congestion. Endoscopic exam showed a recurrent papilloma of the nasopharyngeal surface of the soft palate. On an unknown date, the patient began vaccination with GARDASIL for recurring nasopharyngeal papilloma (dose and route were not reported). The patient's vaccination course was interrupted by the discovery of a symptomatic patent foramen ovale, which required surgery. The patient's nasopharyngeal lesion increased in size during that time, becoming visible by direct sight. After the patient resumed and completed the three-dose vaccination with GARDASIL, the lesion appeared subjectively smaller on exam. The patient underwent CO2 laser en bloc resection of this lesion. Surgical pathology confirmed the 1.7 x 1.2 x 0.6 cm lesion to be squamous papilloma. In the 6 years since the patient's second resection, the patient had no recurrences. This is one of the two cases from the same article (linked with MARRS # 1705USA000105). Additional information has been requested. Sender's Comments: US-009507513-1705USA000105.
had a positive test for COVID; had a positive test for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable physician who reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient had a PCR COVID-19 swab performed on 23Dec2020 which returned positive on 26Dec2020. The action taken in response to the event for bnt162b2 was not applicable. Outcome of the event was unknown.  Information for lot number has been requested in follow up activity.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Pneumonia; chronic coughing; wheezing; Information has been received from a lawyer referring to a female patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 03-JUL-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered pneumonia and subsequent chronic coughing and wheezing. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events pneumonia and subsequent chronic coughing and wheezing was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event pneumonia and subsequent chronic coughing and wheezing to be disability.   Upon internal review, pneumonia was determined to be medically significant.
Right eye lid drooping, could not raise right eye brow, could not blink right eye, could not smile on right side of face, could not eat on right side of mouth, pain behind right ear.
pt recv vax & 3-4 days post vax pt exp pain, myalgia, malaise & sensation which lasted 10 days;sx resolved w/o tx;
Patient reports lower back pain and pelvic pain that started the day after her second dose of Moderna Covid-19 vaccination. She also reports that this pain has not improved.
29JUL95 felt very tired; 30JUL95 stiff neck, pain behind lt ear that worked around the head causing severe h/a-tolerated if laid in bed very still; 31JUL95 had sensation of wearing tight hat
Case previously recorded as MA2009-4156. Initial case report received from a health professional via MedCom on 11 NOV 2009. A 3 year-old female patient was inadvertently vaccinated with 0.5 mL i.m S-OIV FLUVIRIN (batch no. 1008146P) on 11 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007993.
Rash; This is a spontaneous report received from a contactable consumer (mother).  A female patient (reporter's youngest daughter) of an unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Colitis; pain in the stomach; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0MJ20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach). At the time of the report, COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach) 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 concomitant medications were reported.  No treatment medications were provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.
5/30/06 PAC reports swelling/redness at injection site approx. 4" diameter. Tx with Benadryl po. Last TD 5 yrs ago-foot injury 5/15/06, reason for TDAP update. General Comments: 5/25/06 Client reports red, hard area size of a lemon at site of injection. Denies discomfort, itching. States prior TD almost 5 years ago and she received TDAP due to injury. Suggested Motrin/Tylenol and ice to area. Call or follow-up with PMD if no improvement. Client to call 5/29/06 if continued concerns.
I am an internal medicine physician. I experienced a classic syndrome for acute influenza. I had sudden severe cough and fever to 102.5F. Fever spikes occurred repeatedly over next 60 hours. Diarrhea, nausea, anorexia, prostration, severe myalgias. Started Relenza 24 hours after symptom onset, and I think it did help. Was able to return to work today 11-2-09 with some residual cough and diarrhea.
Nausea,  headache,  chills,  stomach ache,  hot flashes,  arm soreness
Got leg ulcers. Sharp shooting pains in his legs - both legs and then he started getting weepy runny sores in his legs. They started getting bigger and bigger and wetter and wetter. Urgent Care  - August 6th. The doctor there treated him, bandaged his legs and said to make an appt at the Wound Care facility on the 10th. He has been going there every week. We have nurse that comes in twice a week to change his bandages and I change them the other days. One has healed up nicely on his left leg. He has two on his right leg that are terrible - they say they are getting better but they are not gone yet. We have Mupirocin 2% ointment to put in it at home. His bandages have to get changed every day. He has compression wraps to put on and he has to keep his legs elevated. He has never had this before.
Lymphadenopathy; Patient that was 13 weeks pregnant did receive the first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) at a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was 13-week pregnant when the first dose of the vaccination was received. On an unspecified date, the patient had lymphadenopathy. The outcome of the events, '13-week pregnant when the first dose of the vaccination was received' and 'lymphadenopathy', was unknown. The patient was asking about the second dose of the vaccine.  Information on the lot/batch number has been requested.
Pt became pale, wanted to lie down about 45min. after vaccine. Pt returned to good color and strength by 1:30pm 1/7/11 (about 1 1/2h after vaccine).
diffuse, pruritic red, raised papular hives on back, abd & axilla/shoulder junction;inj site unremarkable;pt was treating self w/DPH cream;atarax prescribed;rash resolved;
Watery loose stools W/O mucus or blood started approximately 4 hours after rotavirus vaccine was given orally. Continues with increased watery stools now 3 days later. No fever, fussiness, emesis or other signs of illness. No ill contacts. Breastfeeding with no new food given, Mom has not made any changes to her die which might have effected baby.
Had usual symptoms on March 12, the day after the vaccine -- headache, sore arm, temperature of 99.5, achy muscles..  On Saturday, March 13, I had a rash on my trunk (stomach, chest, neck, parts of my back, and some on inside of arms and front of legs).  Took a Benadryl on the advice of a nurse at about 10:00 AM and another Benadryl again at about 10:00 PM.  The rash was gone on Sunday, March 14.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 65-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and eye swelling. The patient was treated with ophthalmologicals (Eye Drops). On an unknown date, the outcome of the rash and eye swelling were recovered/resolved. It was unknown if the reporter considered the rash and eye swelling to be related to SHINGRIX. Additional information was received as follows: The patient was basically healthy. The case was reported by the patient's friend. The age at vaccination was not reported. The patient experienced the rash on her face, eyes, chest, back and hands. The patient's physician got the condition under control, but it flared up again. She took eye drops to treat her eyes.
Vitals of patient were taken in mornings after initial dose of vaccine.  On the 12th day after said inoculation patient blood pressure dropped from normal 140/72 to 100/58 for period of 2 - 3 days.  Patient demonstrated no additional adverse symptoms, i.e., fever, joint pains, respirator distress, headaches, etc.
Approximately 5-10 minutes after pt received vaccines, noted blank stare and when asked if she feels fine, pt states, "I do not feel well." Lowered head to her knees, applied ice compress on nape, provided with ammonia inhalant,  offered food and water, and monitored vitals signs.
Onset of rash, nasal drainage, congestion on 2-22. Parents brought child to an urgent care on 2-24-15. He was diagnosed with otitis media and pharygitis. The physician also ordered IgG and IgM for measles and a viral swab was sent for viral culture.
I received my first Shingrix shot on 9/3/19, on 9/5/19 I felt like I was going to be sick and went to the bathroom and blacked out. I was unconscious for 5 minutes. My husband called 911, My breathing was labored and I was pale in color. and was extreemly weak. with my neck and right arm in so much pain. I went to the emergency room and was given IV therapy, labs and a CT scan. was told that this was a reaction of the Shingrix vaccine. Today my right arm and shoulder and neck are still achy. I still have a faint headache and arm still fatigued.
This spontaneous report as received from a registered nurse refers to a 13 year old patient (unspecified gender). On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 26 year old female with pain in shoulder and reflux and a history of abnormal PAP in June 2008 who was vaccinated with the first and second dose of GARDASIL on 29-JAN-2009 and 26-MAR-2009 respectively. Concomitant therapy included NAPROXEN and ranitidine. The patient was pregnant after the second dose of GARDASIL. After the patient was given the dose, the patient was given a pregnancy test because she was reporting symptoms of "being tired and missed her monthly cycle". The patient sought medical attention- spoke to her physician. Additional information has been requested.
High fever of 102.8 (degree) - fever reducers weren't helping; Cough; Congestion; Achy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 5-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2022 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years, in right leg for covid-19 immunisation. The patient's relevant medical history included: "Extensive medical history due to unbalanced translocation of chromosomes 2 and 10" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: CLONIDINE; PRILOSEC [OMEPRAZOLE]; ERYTHROMYCIN; SINGULAIR; ZYPREXA. The following information was reported: PAIN (non-serious) with onset 18May2022 at 01:00, outcome "recovering", described as "Achy"; NASAL CONGESTION (non-serious) with onset 18May2022 at 01:00, outcome "recovering", described as "Congestion"; COUGH (non-serious) with onset 18May2022 at 01:00, outcome "recovering"; PYREXIA (non-serious) with onset 18May2022 at 01:00, outcome "recovering", described as "High fever of 102.8 (degree) - fever reducers weren't helping". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, cough, nasal congestion, pain.  Additional information: The Reporter was reported about covid vaccine and Events .The Reporter was Patient. The patient Age group: Child (2-11 Years) Current age: 5 and Gender was Female at no pregnant. The Patient occupation was None of the above .The patient Dose received: 1 was received. The Most recent dose details product COVID 19. The brand was Pfizer-BioNTech COVID-19 Vaccine. The Lot unknown reason Not available/provided to reporter at the time of report completion .The Administration date 16May2022 time03:45 PM and Dose number 1 at Vaccine location Right leg. The Facility type vaccine: Doctor's office/urgent care in Facility country. The patient no other vaccine in four weeks and Other medications in two weeks: Clonidine, Prilosec, erythromycin, singulair, zypr .The Adverse event at High fever of 102.8 (degree) - fever reducers weren't helping Cough Congestion Achy .The Adverse event start date: 18May2022 time: 01:00 AM. The patient recovered Recovering and no treatment received. The COVID prior vaccination and no covid tested post vaccination. The Known allergies was Unknown and Other medical history was Extensive medical history due to unbalanced translocation of chromosomes 2 and 10.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Hives, myalgias, headache, joint pain, pain to walk, severe pruritus, Sx started day after vaccine.
No additional AE reported.; VARIVAX had a temperature excursion on 10 OCT; This spontaneous report was received from the office manager and refers to a patient of unknown age. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 19-OCT-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) that had a temperature excursion on 10-OCT-2020, for prophylaxis, reported lo# T012548 with expiration date of 09-APR-2022.    It was stated that the vaccine underwent a temperature excursion of -14 degrees Celsius (°C) to -10 °C (max -14.3°C) for 1 hour and 15 minutes; -9 degrees Celsius (°C) to 8 °C (max -9.3°C) for 32 minutes; total time 1 hour and 47 minutes. No previous temperature excursion occurred. The call was because of a "data logger."; Sender's Comments:  US-009507513-2010USA007244:
This spontaneous report has been received from a Bachelor of Science in Nursing refers to a patient who was vaccinated with the third dose of VAQTA on 08-AUG-2012 in the morning. The patient received the first dose of VAQTA in 2003 and the second in 2006. No symptoms were reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
This literature marketed report was received from the authors in a published literature article title as stated below, concerning 6 child of unknown age and gender. On an unknown dates, 4 of 6 patients were fully vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally (dose, frequency, lot# and the expiration date were not reported) for prophylaxis. 2 of 6 patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown)orally (dose, frequency, lot# and the expiration date were not reported) for prophylaxis. On an unknown date, the patients experienced an outbreak of acute gastroenteritis (AGE) at a child care center (Vaccination failure). On an unknown date, stool specimens tested positive by reverse-transcription polymerase chain reaction (RT-PCR) for Gastroenteritis rotavirus. At the time of reporting, the outcome of vaccination failure and Gastroenteritis rotavirus was unknown. Current rotavirus vaccines were highly effective against severe diarrheal illness, but they did not necessarily prevent infection or milder disease. Thus, rotavirus disease and outbreaks could occur even in populations where vaccination coverage was high. Upon internal review the Gastroenteritis rotavirus was considered as medically significant.
Phlegm, lots of spit, bubbles, sneezing, coughing, wheezing.
Pt recv vax on 10/20/98; on 2/18/99 pt exp flu-like illness
One week after 1st shot I got Covid arm. A large red rash in arm (size of baseball) that lasted 5 days and was very itchy.
This spontaneous report was received from a pharmacist via company representative and refers to a male patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, dose number, vaccination site, route, # lot, expiry date unspecified). A few months later, the patient experienced shingles (date unspecified). The patient sought the medical attention (unspecified). Product quality complaint was not reported. The outcome of shingles was unknown. Causality assessment was not provided. No additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Hot, red circular rash around injection site, not sensitive to the touch, roughly 3cm in diameter, appeared 7 days after injection (no reaction was present prior).  Doctor  said maybe it was an infection at the injection site and quickly prescribed an antibiotic. No antibiotic was given at parent's discretion.  Redness began to fade 2 days later, not longer warm to touch 2 days later.  Faded circle still visible 15 days post-injection, but does not seem to be affecting patient's health.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, (lot # M029233, expiration date 09-AUG-2018) (lot # M018625, expiration date 11-AUG-2018), (dose number, route and anatomical location of administration were unknown). The temperature excursions reported was 10.7 C for 1.5 hours. There was no previous temperature excursion. The temperature excursion was detected by a digital data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
diaherra muscle spasms tinnitus Old illnesses and injuries activated randomly, sudden onset.
10 min after vaccine & well child exam, she was standing at our check out area & she fell straight back hitting her head on wall & falling to the floor w/ seizure activity. Rescue squad called & she was transported to hosp.
Died from the Moderna vaccine; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and died from the Moderna vaccine/death.   The patient's medical history was not provided. No concomitant product use was reported.  On unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient died after receiving the Moderna vaccine (Seriousness criteria: death, medically significant).   The date of death was unknown. Autopsy results not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.    The outcome of the event, died from the Moderna vaccine/death, was considered fatal. .; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. No further information has been requested.; Reported Cause(s) of Death: Died from the Moderna vaccine