chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning a 53 year old female on chemotherapy who on 05-JUN-2009 was vaccinated with PNEUMOVAX 23 (lot# 662745/1576X, route and site of administration not reported). On 06-JUN-2009 the patient developed rash on his chest and face, hypotension and local reaction at the injection site. The patient went to the emergency room for treatment, and he was given I.V. BENADRYL and sent home. The patient recovered on unknown date. She received chemotherapy on 18-JUN-2009. Upon internal review, rash, hypotension and local reaction at the injection site treated with I.V. BENADRYL was determined to be an other important medical event. This is a consolidation of two reports concerning the same patient. Additional information has been requested. It has been determined that WAES#0906USA03647 is a duplicate of WAES#0906USA02593. Therefore, WAES#0906USA03647 is being deleted from our files and consolidated into WAES#0906USA02593. WAES#0906USA03647 was previously submitted to the FDA on 22-JUN-2009.
Sore arm started abt 3 hours after injection- fever chills body aches fatigue  10 hours after shot lasting day and a half.  Red warm itchy pain at injection site worse 2nd day.
I?ma breastfeeding Mom. On Friday, my supply dropped and was barely enough to feed my baby. It took almost 4 weeks for it to come back.
Half dose administered (0.25 ML); This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 13-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 5277A, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUARIX TETRA).   On 20th October 2021, the patient received the 2nd dose of Fluarix Quadrivalent 2021-2022 season .25 ml and Fluarix Tetra Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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 details were provided as follows: The reporter was a clinical supervisor. On 16th September 2021, the patient received 1st dose of Fluarix tetra. The reporter stated that, half dose (0.25 ml) was administered to infant patient, which led to underdose. The reporter consented to follow up. This case is linked to the case US2021222733 and US2021222782, reported by the same reporter. Note: Event outcome date was reported as 26th October 2021 however was not captured considering the nature of event (medication error).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021222733:same reporter US-GLAXOSMITHKLINE-US2021222782:same reporter
Dizziness, pale, weakness, pain muscles in arms hurt, front of legs standing from sitting.
Injection site erythema, swelling, and pain radiating from site across chest.  Fevers to 102 F, myalgias, malaise, dizziness.  Presented to ED with febrile with tachycardia, was admitted overnight due to concern for cellulitis with 2/4 SIRS criteria.  Treated with Tylenol, toradol, and discharged home with supportive measures.
Information has been received from a pharmacist referring to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. Approximately in December 2015 (reported as "about 5 months ago"), the patient was vaccinated with his first dose of unidentified Merck human papillomavirus (HPV) vaccine (dose, route, lot# and expiration were unknown). On 18-MAY-2016, the patient was in the office to receive his "second" dose with GARDASIL 9 (dose, route, lot# and expiration date were unknown). The pharmacist reported that neither he nor the patient know if the first dose of vaccine the patient received was GARDASIL or GARDASIL 9. No adverse events were reported. Additional information has been requested.
This spontaneous report has been received from a nurse, refers to 3 unspecified patients. Concomitant therapies included sterile diluent(manufacturer unknown).  On 05-SEP-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N014949 (rHA albumin status) for prophylaxis. No adverse event were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA002084:
I experienced a bad rash on my shoulder blade which was determined as shingles, headaches and body aches.
This case was reported by a pharmacist and described the occurrence of a 51-year-old female subject not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medications included Ziac and Premarin.  On 18 July 2005 at 11:19 the subject received 4th dose of Engerix B in the right arm.  A negative titer was discovered in March 2007.  The subject had not responded to therapy.  At the time of reporting the outcome of the event was unspecified.  Follow-up information received on 22 May 2007 indicated that the subject had completed the three dose series of Engerix B with three vaccinations given on 10 August 2004, 08 February 2005 and the 3rd on 20 April 2005.  A 4th dose of Engerix B was given on 18 July 2005.  No additional information was provided.
HZ after vaccination/  Suspected vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: HZ after vaccination/  Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 2 weeks).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he/she had the shot and still got shingles and lighter case though lasting about 2 weeks. This case was considered as suspected vaccination failure, since the details regarding vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available
onset with headache which resolved, then weakness, muscle pain/aches, tingling sensations, fatigue, loss of strength (feels like acute onset of arthritic like pains
The day after my first Moderna COVID-19 shot, I began having diarrhea multiple times. It was pretty bad that first week after shot #1--to the point that I was afraid to leave the house for fear that I might have to urgently use the bathroom. After that, the diarrhea gradually improved over the course of that month. Then, a couple days before shot #2, I relapsed and had loose stools 4 times. The day right before shot #2 and almost for two weeks after shot #2, my stools were normal.  Then, almost two weeks after shot #2, I relapsed again having loose stools three times in a row. Since then, I occasionally have loose stools or "shaggy looking" stools. When the diarrhea was at its worst, I also had painful burning gas pain before going #2. Even now, I sometimes have gas pain that is mildly burning.
severe chills and body aches, arm soreness, inability to sleep, sweating and fatique
pt received booster dose of pfizer one month after 2nd dose.  pt has no side effects
HEADACHE, DIZZINESS, PROBLEMS WITH SPEECH, NAUSEA, STOMACH ACHE, SLEEPINESS, NO APPETITE.  6/12/09 Medical records received DOS 9/14/2006 to 6/4/09. Medical progress notes are illegible.
After the second vaccine, it felt like she had bee stings all through her legs for 3 hours.; Her legs were stinging and burning and, it was just like when she got her second vaccination; Her legs were stinging and burning and, it was just like when she got her second vaccination; Her legs started to have twitching, like muscle twitching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose 1, Lot Number / Expiry Date: Unknown, Route of administration and Anatomical Location: not provided), administration date: 24Jun2021, when the patient was 46-year-old, for COVID-19 immunization; Tetanus shot (Her tetanus shot, like 5 or 6 years ago), for immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "After the second vaccine, it felt like she had bee stings all through her legs for 3 hours."; BURNING SENSATION (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "Her legs were stinging and burning and, it was just like when she got her second vaccination"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "Her legs started to have twitching, like muscle twitching". Therapeutic measures were taken as a result of limb discomfort, burning sensation, pain, muscle twitching.  Additional information: Reporter stated that, patient did not receive any prior vaccinations (within 4 weeks). Patient has not had any vaccinations since her tetanus shot, like 5 or 6 years ago. No family medical history reported relevant to ae(s). After the second vaccine, it felt like she had bee stings all through her legs for 3 hours, patient felt this the other day when she put her feet up. Patient legs started to have twitching, like muscle twitching. Her legs were stinging and burning and, it was just like when she got her second vaccination. It was clarified that patient experienced events the other day after the vaccination. Reporter stated that, patient was still experiencing events but, it was not as much of the deep throbbing and aching. It was her whole entire limbs of her legs. Patient tried Aleve and stated that it doesn't help.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
01/31/2022 Noticed hard red knot and soreness around 7-8 pm.  On evening of 02/01/2022 soreness worsened and had a nerve type pain that shot down from neck to foot.  No improvement noted in knot.  On am of 02/02/2022 noted swelling of hand/fingers of left extremity and numbness also noted.   Patient reports taking ibuprofen, Tylenol and using warm compresses without relief.  Made an appointment with PCP today @ 1030am
I almost died here, when I took the booster shot; I almost have a heart attack in my heart; my arms still swelled up; Booster; Off label use; This is a spontaneous case received from a non- contactable consumer (patient). A patient of unspecified age and gender received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number not reported), via an unspecified route of administration on an unknown date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that his arms still swelled up, he almost died here, when he took the booster shot and he almost had a heart attack in his heart on an unspecified date. The outcome of the event arms still swelled up was not resolved and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
dizziness shortness of breath tachycardia  hypertension forceful heart contractions
My face went numb for about 30 minutes with slight dyspnea; My face went numb for about 30 minutes with slight dyspnea; difficulty focusing and remembering stuff; Been having headaches daily ever since booster; difficulty focusing; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 (Lot number: FK9729) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "s/p lap cholecystectomy more than 5 years ago" (unspecified if ongoing), notes: s/p lap cholecystectomy more than 5 years ago; "Spinach" (unspecified if ongoing), notes: known allergies: Spinach; "some type of alcoholic beverages" (unspecified if ongoing), notes: known allergies: Some type of alcoholic beverages. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6201, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 32 years old, for Covid-19 Immunization, reaction(s): "My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses", "slight dyspnea"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 32 years old, for Covid-19 Immunization, reaction(s): "My face went numb for about 30 minutes with slight dyspnea. Got this reaction for all 3 doses", "slight dyspnea". The following information was reported: HYPOAESTHESIA (non-serious), DYSPNOEA (non-serious), outcome "recovered with sequelae" and all described as "My face went numb for about 30 minutes with slight dyspnea"; MEMORY IMPAIRMENT (non-serious) with onset 2022, outcome "recovered with sequelae", described as "difficulty focusing and remembering stuff"; HEADACHE (non-serious) with onset 2022, outcome "recovered with sequelae", described as "Been having headaches daily ever since booster"; VISION BLURRED (non-serious) with onset 2022, outcome "recovered with sequelae", described as "difficulty focusing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, memory impairment, headache, vision blurred, dyspnoea.  Additional Information: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
lip swelling without respiratory problem, open air, vital signs normal, given loratadine 10 mg Stat, then daily PRN
This spontaneous report was received from a healthcare professional referring to an approximately 8 months old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with a third dose of hepatitis b vaccine, (dose, route of administration, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, in 2015, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. This is one of several reports from the same source. Additional information has been requested.
The healthcare worker is reporting that a patient received improperly stored vaccine.; No adverse event; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown day, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #X0006983 (lot number X0006983 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX)), expiration date 07-MAR-2025 or lot #x000999, expiration date 09-JAN-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error). It was unknown which of the two lots was given to the patient.   On unknown dates, the vaccines experienced temperature excursion of 6 degrees Fahrenheit (F) up to 14 F for 10 hours and 14 F up to 46 F for 3 hours 30 minutes. No additional adverse events (AEs) were reported (No adverse event). No further information was provided. No previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA005860:linked case
Joint pain, all joints but mostly hips, knees, elbows; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 12:30 (Lot number: EP7533) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 12:30), administration date: 09Mar2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 14Apr2021, outcome "not recovered", described as "Joint pain, all joints but mostly hips, knees, elbows". The event "joint pain, all joints but mostly hips, knees, elbows" was evaluated at the physician office visit. Therapeutic measures were taken as a result of arthralgia.  Additional information: The patient didn't receive any other vaccines within 4 weeks. Prior to the COVID vaccine other medications in two weeks included Thyroid. The patient didn't have known allergies. The treatment received for the adverse event included Anti-inflammatory meds. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 07-JUL-2018, the patient was inoculated with ZOSTAVAX at a community health center for recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles.  On or about 28-MAY-2016, he was treated by a Family Nurse Practitioner (FNP) at the same community health center for symptoms of a blistering vesicular outbreak, which was diagnosed as severe shingles with ophthalmic complication (shingles that had spread into the eye). On or about 11-OCT-2016, the patient sought subsequent treatment from the FNP for continued and worsening symptoms of zoster pain, which was diagnosed as post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. The patient was prescribed acyclovir and gabapentin for management of his painful symptoms. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Myocarditis after COVID-19 vaccination;   A 31 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of vaccination). The following information was reported: MYOCARDITIS (medically significant), outcome "not recovered", described as "Myocarditis after COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: blood test: elevated troponin of 1.7; c-reactive protein: negative; echocardiogram: revealed an ejection fraction of 55% with no wall, notes: motion abnormalities; ejection fraction: 55 %, notes: with no wall motion abnormalities; electrocardiogram: no acute ischemic changes; magnetic resonance imaging: showed an area of myocardial hyper-enhancement in, notes: the apical anterior segment suggesting the diagnosis of myocarditis; red blood cell sedimentation rate: negative; troponin: 1.7. Therapeutic measures were taken as a result of myocarditis.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the event Myocarditis with the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This spontaneous report was received from a 64 year old male patient and refers to himself. The patient's medical history included herpes zoster in approximately 2010 (reported as "5 or 6 years ago"). The patient had no drug reactions and no allergies. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration and lot# were not reported). Concomitant therapies included other unspecified medications. On 02-NOV-2015, the patient experienced rash on both ankles and the rash looked and felt similar to the previous experience (when he suffered from shingles). Patient described the rash as "like poison ivy" and stated that when he itched the rash "blisters formed and broke and the scabs formed". No lab diagnostic studies were performed. The patient did not receive any treatment for the adverse event. The outcome of the event was reported as not recovered. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information is not expected as the patient declined to provide his primary care physician demographics and wished for him not to be contacted.
could not get out of bed  for months  or focus on anything, my kidneys were shutting down and P.E. up grade as   serious exacerbation of  2018  P.E.  I got the vaccination  for transition from a medical LOA  I was just starting to get better - when that vaccine nearly killed me.  I ended up losing  both my jobs as was returning from  2018  P.E.  personal medical  LOA  - I could not remember anything as it is one big blur.  I  could not fill out this form  before last month
Modera 2/23/21, 3/23/21. Pfizer 11/19/21. Positive on 11/23/22
On 2/23/00, the pt developed a red macular papular rash most confluent on abdomen. It was noted that a few were located on the pt's arm and legs. Subsequently, the pt recovered.