chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 30-year-old patient with recurrent respiratory papillomatosis (RRP) treated with Gardasil; Literature Report:   This literature marketed information has been received from the authors of a published article, title as above, regarding to a 30-year-old healthy female non-smoker with known recurrent respiratory papillomatosis (RRP)experienced rapid recurrence three months after initial surgical intervention, and repeated recurrence two months after additional surgical intervention. She declined further surgery and opted for quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination(strength, dose, route of administration, lot# and expiration date were not provided)( Off label use), which led to spontaneous regression of most visible disease after a single injection. The remaining disease resolved completely after her second dose of the three-injection series.  At the initial presentation (October 2017) Videolaryngostroboscopic Exam Findings (Vocal fold mobility intact bilaterally during all exams): Papilloma presence was medial edges including superior surface of true vocal folds covered with sessile papilloma bilaterally, the medial edge appearance was irregular bilaterally, the glottic closure incomplete, and the mucosal wave and amplitude was absent on right, moderately decreased on left. The Derkay score was 10, 1 surgery was required, and the voice handicap index at the time was 29.  On an unspecified date in August 2018, (2 Months postop, prevaccination) the papilloma was present at left posterior and anterior commissure with a medial edge appearance of irregular bilaterally, the glottic closure was complete and the mucosal wave and amplitude was mild to moderately decreased bilaterally. The derkay score was 6, no surgery was required, and the voice handicap index at the time was 2.  On an unspecified date in October 2018, the patient received the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and two months post first vaccination dose, it was clear for papilloma, except one small site at right zones 8-9. The medial edge appearance was Straight, fullness on right posterior fold, the Glottic Closure was complete, the Mucosal Wave and Amplitude was Normal bilaterally. The Derkay score was 2, no surgery was required, and the voice handicap index at the time was 0.  On an unknown date in December 2018, the patient received the second dose of quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), and six months post second vaccination dose (June 2019), no papilloma was visualized, the medial edge appearance was straight, the glottic closure was complete and regular and the mucosal wave and amplitude was normal bilaterally. The Derkay score was 0, no surgery was required, and the voice handicap index at the time was 0.  A copy of the published article is attached as further documentation of the patient's experience.
DIZZINESS (+) SYNCOPAL EPISODE x1 w/FACIAL LACERATIONS
Patient started having chest pain and feeling weak 15 minutes after the dose was administered. 911 was called and she was transported to the ER for evaluation.
I got the shot at 1PM by the time was 6:00 PM I was so dizzy and nauseas I could not stand up, and I stayed like that till the next day, I couldn't walk, and I didn't eat, I was also vomiting. I had body aches and my weight started dropping. I was with these symptoms for 2 weeks. 2 weeks for me to eat anything.
The injection was given by vaccine clinic .  The next morning, my arm hurt pretty badly, but the lymph nodes in my right armpit were particularly sore. The area swelled up to the size of a softball, and I went to the  Urgent Care today for follow-up as not only do I have a large lump in my armpit, my entire arm is swollen.
covid vaccine breakthrough case   dose 1 Moderna 4/28/21  005C21A dose 2 Moderna 5/26/21 041C21A
1st dose in 2020, has not received the 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's Comments:  The reporter was the patient. The patient stated she received her first dose of Shingrix in September 2020 and had not yet received her second dose. The reporter consented to follow up with HCP (pharmacy). Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023012632:SAME REPORTER
About 23 minutes after the vaccination I started feeling tightness in my throat, began coughing and wheezing and had SOB, was taken to a secure area and given 25mg benedryl and they waited a few minutes and gave another 25mg of benedry.  I was given an EPI pen injection in the left thigh and was given an albuterol enhaler to help with the breating.  The symptoms resolved after the EPI and the albuterol and I was released from their care
Presented to ER with tachycardia, chest pain. Evaluation most c/w a myocarditis.
erythematous rash over entire body; face swollen, feet swollen & other patches of angioedema; given all other vaxs prev 4DTP & 4OPV & MMR w/o any problems;
I had a headache that lasted a few hours; slight arm soreness in my left arm which is the arm I got the vaccine administered in; I had very slight arm soreness in my left arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021374888 (Pfizer).  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EP6955) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin for Allergy to Augmentin, notes: Augmentin. Vaccination history included: Bnt162b2 (Dose No.1, vaccine location= Left arm, lot number= EL3247), administration date: 11Mar2021, when the patient was 28 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "I had a headache that lasted a few hours"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "slight arm soreness in my left arm which is the arm I got the vaccine administered in"; PAIN IN EXTREMITY (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "I had very slight arm soreness in my left arm". Therapeutic measures were taken as a result of headache.  Additional information: The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. A few hours after my second COVID vaccine dose the patient had a headache that lasted a few hours and took tylenol to relieve. The headache did go away less than 12hrs after the vaccine was administered. Also the patient had very slight arm soreness in my left arm which was the arm where got the vaccine administered in. The arm soreness was much less than the arm soreness the patient experienced after the first dose of the vaccine and has already resolved.   No follow-up attempts were needed. No further information was expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous potential legal report received from a patient concerned a patient of unspecified age and sex. Initial information was processed along with the additional information received from a regulatory authority on 30-DEC-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported, administered 1 in total for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that on an unspecified dates, the patient caught covid twice(coded as suspected covid-19 infection and suspected clinical vaccination failure) and reporter also stated that "If anyone is doing a class action lawsuit against these clowns, hit me up. I want in". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000209391. The suspected product quality complaint has been confirmed to be voided(did not meet RA criteria) (as reported complaint was covid with no symptoms and test performed therefore did not meet RA criteria, hence was confirmed as voided) based on the RA evaluation/investigation performed.; Sender's Comments: V0: 20211263430 -Covid-19 vaccine ad26.cov2.s-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
SHIVERING/TEETH CHATTERING; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced shivering/teeth chattering, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shivering/teeth chattering, nausea, and fever. This report was non-serious.
Patient reported itching, hive on back at approximately 30 minutes post vaccination. Also throat felt funny. She could speak and breath but swallowing was uncomfortable. EpiPen 0.3MG was given IM, and 911 was called. According to EMT, symptoms appeared to begin to resolve, but patient was taken to a hospital for follow up care.
Immediately following the injection soreness and muscle pain in arm. Headache began to worsen overnight. 2pm throbbing headache, muscle pain throughout body, tightness in chest, coughing. Very lathargic and severe headache. Unable to talk due to fatigue(Asthenia). 6pm severe symptoms including, headache, body ache, fatigue, tight chest, muscle pain, nausea, chills, sweats, unable to call for help. Unable to control bowels...soiled self. Attempted to get to bathroom fell against walls and furniture. Feces everywhere in home, dehydration has been a big problem. Low blood pressure 107/40. Disoriented, lathargic and pale. Trouble keeping fluid down or in..forgetful and unable to keep a thought. Blacked out .etc.
General feeling of aching all over, tiredness, trouble sleeping and problem with bursitis in left foot (hardly ever stops hurting). Hands aching and an all over feeling of lousiness. Treated with cortisone shots and is seeing doctor for further testing.
dry cough; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry cough in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced dry cough (Verbatim: dry cough).  The outcome of the dry cough was unknown.   It was unknown if the reporter considered the dry cough to be related to Shingrix.     It was unknown if the company considered the dry cough to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient reported that she had the first shingrix vaccination over 24 hours ago and had experienced almost every common side effect. Additionally she had developed a dry cough. The reporter enquired can that be associated with the vaccine. The reporter did not consent to follow up.
The patient seems to have a long term adverse reaction to the Moderna Covid vaccine.  He has been experiencing generalized muscle soreness and fatigue for weeks since the immunization was administered.  The only change was that he has received Pfizer in the past and received Moderna for this vaccination.  He says it is slowly getting better.
Rash: her cheek is completely red.; Mass on left arm; Fingers losing sensation; mass is inflamed, raised, and warm to the touch.; she couldn't lift her arm.; Body itching; Became a little dehydrated; Arm sore; rash is very itchy; This is a spontaneous report from a Pfizer sponsored program support. A contactable 28-year-old female consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Unknown) via an unspecified route of administration on 12Apr2021 (age at vaccination: 28 years-old) as dose 1,single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient became a little dehydrated and arm sore, that she spoke with her grandmother who is a nurse, and grandmother informed her to rub her arm to make sure that the vaccine dispersed. She rubbed her arm some more to make sure that the Covid-19 vaccine was spread out. On 13Apr2021, her body became very itchy. She reported that the itching started in her arm and then went into her legs, but was nothing major and on the same day it was reported that she couldn't lift her arm. Patient reported that on 16Apr2021, from her right cheek all the way down to her left arm on a diagonal, she is covered in a rash, that her cheek is completely red. She reported that the rash is very itchy. The patient reported that at time of call on 16Apr2021, she was still experiencing body itching. she took a shower and put cortisone cream on the rash, but the rash is still very red and inflamed. She reported that she has a hard mass on her lower left arm between the wrist and elbow, that the mass is inflamed, raised, and warm to the touch, the mass is about the size of her fist and it feels like there is a hard piece of tissue in there. The fingers in her left arm are losing sensation, she reported that it felt a little like arthritis, but she doesn't have a history of arthritis. She reported that she was healthy and does not have a primary care physician, so she contacted her gynecologist and her gynecologist informed her that they weren't able to assist her. Afraid to get second dose of Covid-19 vaccine. The reporter reported that she could deal with the itching, but the rash and mass developing 5 days later is concerning to her. The outcome of the events mobility decreased ,rash pruritic and hypoaesthesia was unknown and all other events were not recovered.  No follow-up attempts are needed. No further information is expected.~
redness, swelling and warmth at injection site; treated with cool compress and OTC analgesics
No additional adverse events; Expired dose of PNEUMOV AX-23 was inadvertently administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age. and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 16-FEB-2021, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 ml, injected once, lot # S012246 with expiration date 10-FEB-2021, for prophylaxis (strength was not reported). No additional adverse events were reported. The product had never had a temperature excursion.
Postnasal drip; Reflux; Glands on the left side are swollen; Ear hurts a little bit; uncomfortable; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced postnasal drip, reflux, glands on the left side are swollen, ear hurts a little bit, uncomfortable. Patient has to receive her second vaccine tomorrow and had a lot of post-nasal drip and also had reflux. And occasionally, at times in the past, she got swollen glands. So right now, her glands on the left side were swollen, her ear hurts a little bit. Certainly, they don't want you to have the COVID if you get the vaccine. But what about, she doesn't think it was a viral or bacterial infection, but she doesn't know if it was a danger for her to get the Pfizer vaccine tomorrow, her second one. Clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My injection site was sore. I had chills the night after I received the vaccine and bodyaches the next day.
Initial and follow up information has been received from a physician and nurse for the Pregnancy Registry for GARDASIL regarding a 19 year old female who on 12-APR-2007 was vaccinated intramuscularly with her first dose of GARDASIL (lot #655165/1425F). On 12-JUN-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (lot #655165/1425F). There was no concomitant medication. On an unspecified date, the patient took an over-the-counter pregnancy test and the results were positive (date unspecified). The patient sought medical attention via telephone. As of 04-JUN-2008, the patient is 38 weeks + 1 day pregnant, her estimated due date is reported as 17-JUN-2008 (LMP estimated as 09-SEP-2007). Follow-up information was received on 05-NOV-2008 via phone call from a nurse indicating that the patient had an estimated delivery date of 16-JUN-2008 and went into spontaneous labor on 22-JUN-2008. She progressed well through the first stage and reached full dilatation, pushed for one and a half hours and had a cesarean section for a diagnosis of failure to descend. The patient delivered a healthy and normal baby girl, weighing 8.2 pounds, at 40 and 5/7 weeks RGA. The patient had a normal post-operation recovery and was doing well. Upon internal review, "failure to descend" was determined to be an other important medical event. Additional information is not expected.
A spike in her BP; This is a spontaneous report from a contactable pharmacist. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) intramuscularly in the left arm on 11Mar2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date and unspecified if ongoing (not taking meds for this prior to this event) and strawberries - anaphylaxis from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient was pregnant. Concomitant medications ("other medications in two weeks") included acetaminophen taken for an unspecified indication from an unspecified date and unspecified if ongoing, as needed. It was unknown whether the patient received any other vaccine within four weeks of the COVID-19 vaccine. The patient experienced a spike in her BP (blood pressure) on an unspecified date ("with her first dose"). The clinical outcome of the event a spike in her BP was unknown. Since the vaccine, it was unknown whether the patient was tested for COVID-19.   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 information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of "a spike in her BP" cannot be excluded. The event was confounded by underlying hypertension. 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.
Felt bad; flu-like symptoms; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included unspecified disorder of knee joint. Previously administered products included Shingles vaccine (Recived 10 years ago prior to reporting).   On 12th August 2019, the patient received the 1st dose of Shingrix (intramuscular). In August 2019, 16 hrs after receiving Shingrix, the patient experienced influenza-like symptoms and feeling bad. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient herself. On 12th November 2019, patient had knee replacement and wondered whether it would be okay for her to get the 2nd dose of Shingrix vaccine. It was reported that the knee problem was pre-existing and she did not feel that the knee surgery was related to having received the first Shingrix shot. On 12th August 2019, around 6pm , the patient received her 1st dose of Shingrix. The next day, around 10 am, she felt bad with flu like symptoms that lasted about 24 hours. The reporter asked if the injection was given intramuscularly and she said she assumes so because her left arm where she received the injection was sore. The soreness resolved within 24 hours. She did not see the lot and the expiration date on the paperwork that her pharmacy gave her. The patient had pre-existing knee problems. The reporter consented to follow up. This case has been linked with case US2019232371 and US2019232378, reported by the same reporter.
pt received 3 vaccinations MMR DTAP and IPV and as she was with her father and grandmother at our check out counter she passed out and fell to the floor
pt recvd vax; swelling, redness & knot at inject site; onset unk; to clinic w/ rpt of rxn;