chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/23/2021 - woke up with full body itch sensation (like dry skin). By 8/9am covered in hives head to toe. Started Benadryl every 4 hours (Woudl give some relief for 2 hours). 4/26 visited primary care, put on Claritin 2x/day, pepsid 2x/day, given steroids to start close to day 14 from Moderna. I started steroids on 4/29 as I couldn't tolerate rash.  So a little relief going into May. By May 10th full body intense rash was back. Saw PCP again 4/16, more Steroid's (Started May 16), hives were less intense.  Believe I was on Steriods close to 60 days May-June.  Then May 17-19 highly intense rash, waking up covered trunk of body and scalp.  5/20 saw Dermatologist and Allergist. 5/20 Allergist took over care. Continued Steroids. Trial and Error, on antihistamines. Minimum 10 antihistamines a day plus 4 Hydroxyzine's as needed just to keep rash tolerable. Allergist recommended I carry Epi Pen all times, which is new. Some Rashes were so bad they would fade and leave bruises. Also saw Rheumatologist to rule out Autoimmune (see bloodwork). Does 1 of Xolair on  June 17th. Does 2 of Xolair on July 15th. Little to no hives starting July 17th. Still taking 10-11 antihistamines a day. Sometimes I have joint swelling or discomfort - was hard to tell if that was rash/immune reaction or steroid side effect.  I had to spend 10 days at beach in shade, out of water or in AC, couldn't swim or play with my kids.  I've missed HOURS of work, going to Dr appointments, getting blood work. Now sitting for 2 hours to get Xolair.  I would estimate I've spent more than $500 in out of pocket copays, OTC medicines.  I have not been able to walk outdoors, workout, enjoy most summer activities outdoors. Some days I cannot even go to store as rash looks horrific.  Due to inactivity and steroids, gained 15#. I've had to modify diet to avoid high histamine foods. I've  NOTE: as a child (preschool & early elementary) I would get a cold, as I recovered break out in very similar rash. The rash would last 2-3 days max. I would need 75mg of benadryl. Last Bad rash was in High School after a bad flu. As an adult, random cold or flu might trigger a very mild rash.
Burning throughout left side of body after second shot; 4 weeks later, consistent burning and squeezing in chest region; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration on 12Mar2021 (at the age of 29-year-old) in right arm as dose 2, single for covid-19 immunization. The patient's medical history was reported as none. No other vaccine in four weeks, no covid prior vaccination and no known allergies. Concomitant medications included spironolactone (SPIRONOLACTONE); cyamopsis tetragonoloba gum (BENEFIBER FIBER SUPPLEMENT) and ethinylestradiol, norgestimate (ESTARYLLA) all taken for an unspecified indication, start and stop date were not reported. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW6198) via an unspecified route of administration in left arm on 19Feb2021 at 12:45 (at the age of 29-year-old) as dose 1, single for covid-19 immunization and experienced burning in back region after first shot that never went away. On an unspecified date in 2021, the patient experienced burning throughout left side of body after second shot and 4 weeks later, consistent burning and squeezing in chest region. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 19Mar2021, the patient underwent lab tests and procedures which included covid test post vaccination (nasal swab): negative. Therapeutic measures were taken, and the patient was treated with Gabapentin prescription and testing. The outcome of both the events was not resolved.   No follow-up attempts are possible. No further information is expected.
About 8 hrs. after vaccination, patient became stiff, slight shaking, looked "frozen", made gurgling sounds while riding in car. Lasted just few seconds by the time car was pulled over to check, patient became alert.
He received the vaccine around noon on 7 Sep 2021. The following morning on 8 Sep 2021, he noted a bumpy, itching rash on his forearm and R thigh. The rash persisted and remained in the same areas but worsened and spread on 24 September 2021. The rash spread to involve both arms and both legs. He also had some rash on his abdomen. He went to the ER on 24 September 2021 and was treated with Prednisone 50mg daily for 5 days and oral diphenhydramine, 50mg every 6 hours. He repots the rash being painful with some but little improvement with the oral steroid and H1 blocker. He went to on 28 September 2021 and was started on an oral prednisone taper starting at 60mg daily and tapering off over 10 days. He was also prescribed triamcinolone 0.1% cream. He stopped the oral steroids on 4 October 2021 due to GI side effects. He noted gradual improvement but still persistence of lesions. He reports some small residual lesions on his R arm and leg.
marked swelling of thigh one day after administration, mild reddness, no pain, no heat, some itching, some fussiness.
This spontaneous report is the second of two reports as received from a registered nurse concerning a 13 years old female patient with a history of previous vagal response to blood draw (date unspecified) who on 07-AUG-2012, was vaccinated with the first dose of GARDASIL (lot# 0459AE, exp 13-DEC-2014) (route not reported). Secondary suspect vaccine given on the same day included a dose of VAQTA (lot# 0535AE, ex 24-JAN-2015) (dose and route not reported). Concomitant medications included: ZOLOFT. The nurse reported that the patient had an episode of syncope following the first dose of GARDASIL. It was reported that the patient was sitting on the exam table following vaccination with GARDASIL and became lightheaded. The nurse had the patient lie down on the exam table. The patient lost consciousness for about 2 minutes with eye twitching and some mouth movements. The patient was reported to be pale and had low blood pressure during this time. The patient recovered quickly from all symptoms and was recovered with in a half hour and left the office. On 07-AUG-2012, the patient recovered. It was unknown if the patient sought medical attention. The relatedness for lost consciousness, low blood pressure, pale, some mouth movements, eye twitching, lightheaded and episode of syncope was unknown for VAQTA and GARDASIL. Upon internal review lost consciousness was considered to be medically significant. This is one of several report from the same source (report# 1208USA010653). Additional information is not expected.
HARD TIME BREATHING; SUSPECTED SINUS INFECTION; FELT BAD AND MISERABLE; LEFT ARM HURTS WHILE PRESSING INJECTION SITE; DIFFICULTY LIFTING LEFT ARM; MUSCLE ACHE; SEVERE INFLAMMATION ALL OVER THE BODY; PAIN EVERYWHERE; JOINT ACHE; TENDON ACHE; SLEPT FOR 6 HOURS THROUGHOUT THE DAY/SLEEPINESS; DRY COUGH; INJECTION SITE WAS RED; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and other pre-existing medical conditions included patient has type-a blood group.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced injection site was red. On 07-MAR-2021, the subject experienced severe inflammation all over the body. On 07-MAR-2021, the subject experienced pain everywhere. On 07-MAR-2021, the subject experienced tendon ache. On 07-MAR-2021, the subject experienced slept for 6 hours throughout the day/sleepiness. On 07-MAR-2021, the subject experienced dry cough. On 07-MAR-2021, the subject experienced joint ache. On 07-MAR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced difficulty lifting left arm. On 07-APR-2021, the subject experienced left arm hurts while pressing injection site. On an unspecified date, the subject experienced hard time breathing, suspected sinus infection, and felt bad and miserable. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Unknown, EKG (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) indicated inflammation, and Fibrin D dimer (NR: not provided) indicated inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept for 6 hours throughout the day/sleepiness on 07-MAR-2021, had not recovered from severe inflammation all over the body, pain everywhere, joint ache, left arm hurts while pressing injection site, hard time breathing, dry cough, muscle ache, and tendon ache, and the outcome of difficulty lifting left arm, injection site was red, suspected sinus infection and felt bad and miserable was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
SEVERE BREAST PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disorder. The patient experienced joint pain when treated with influenza vaccine for prophylactic vaccination. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced severe breast pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe breast pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20221257637.
December 3, 2021, I noticed that I beginning to be out of breathe and I started having a burning feeling in my chest and I had a lot of pressure in my chest and a fast heart rate. I called the HCF nurse line around 2 to 3pm and they instructed me to come in because my symptoms could be serious. I went to urgent care around 4pm, they did an ECG on me and noticed that the rhythm of my heart was off so they sent me to the ER, at a local HCF. They ran a bunch a labs on me, blood work, x-ray of my heart, and consulted with an cardiology and found that it was pericarditis.
No adverse effects reported.; the 53 year old patient, was inadvertently administered PROQUAD.; This spontaneous report was received from a nurse referring to a 53 years old patient of unknown gender. Information about pertinent medical history, concurrent conditions and drug reaction/allergy was not provided. The patient's concomitant therapy included sterile diluent.  On 14-JUN-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (therapy type rHA (recombinant Human albumin); lot # S003171 with expiration date 30-JUL-2020; strength, dose and route were not reported) for prophylaxis (inappropriate age at vaccine administration). No adverse effects was reported. The outcome of the event was unknown. The causality of the event was not provided.
administration error - pt. was given extra doses of IPV, MMR, and VZV. No immediate complications or adverse side effects.
Red rash, swelling and mild pain at point of SC shingles vaccination injection. 3 inches by 1.5 inches wide.
Patient received a dose of Pfizer vaccine where the dose exceeded beyond use dating (BUD) as determined by manufacturer by 5 days.  As advised by Pfizer, they recommended that he receive an additional dose of vaccine as soon as possible to ensure appropriate protection.  Patient was given this information and scheduled an additional dose.
devel significant stiffness in neck & hips; particularly noted upon awakening &  moving about in the morning;
Initially, I had no symptoms, but on 4/29/21, just over two weeks after my second vaccine dose, I had blood drawn for my routine diabetic health check-up and my live function test results (ALT and AST) were alarmingly high. For several years, these numbers have been right in the normal range (13/16, 22/18, etc.) but at this post-vaccine blood test, my ALT was 386 and AST was 108. My diabetic specialist was horrified and immediately thought I had liver damage or disease. But with such good liver function numbers as recently as February 2021, I was doubtful. I have experienced no other symptoms of liver damage or disease, and have not changed any medications, foods, or habits. I can only conclude the elevated numbers were the result of the vaccine. Furthermore, a week after the 4/29/21 blood test, on 5/6/21, I had those blood tests repeated, and my liver function numbers decreased: ALT was 211 and AST was 85.
Some Chest pain in the middle @ 2:30 AM while sleeping .  06/25/2021
12/28/2021, my arm was red hot and swollen that night, became more painful and spread between shoulder and elbow. It was achy and I had chills. I couldn't get off the couch. By 12/31/2021, I had my husband drive me to the emergency room. They prescribed KEFLEX. I had three doses and developed a rash. My husband drove me back to the emergency room and they did an IV with fluids. I felt better.
Booster dose: Has pretty severe pain in right shoulder and clavicle; Booster dose: Has pretty severe pain in right shoulder and clavicle; The whelp is red around it and is worsening; Booster dose: has a very large whelp around injection site; Booster dose: has a very large whelp around injection site/The whelp is red around it and is worsening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 (Lot number: FJ1614) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Anxiety", start date: Dec2020 (ongoing), notes: Verbatim: Anxiety; "Panic attack", start date: Dec2020 (ongoing), notes: Verbatim: panic attacks. Concomitant medication(s) included: CITALOPRAM taken for anxiety, panic attack (ongoing). Vaccination history included: Bnt162b2 (Pfizer Covid 19 Vaccine: , First dose: 24Mar2021 , lot: ER8730, NDC: Unknown , Expiration: Unknown , Route of administration: right arm), administration date: 24Mar2021, when the patient was 34 years old, for Covid-19 immunization, reaction(s): "First dose: after first dose, both thumbs went numb"; Bnt162b2 (second dose: 15Apr2021 , lot: ER8729, NDC: Unknown , expiration: unknown, Route of administration: right arm), administration date: 15Apr2021, when the patient was 35 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 15Jan2022, outcome "not recovered", described as "Booster dose: has a very large whelp around injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 15Jan2022, outcome "not recovered", described as "Booster dose: has a very large whelp around injection site/The whelp is red around it and is worsening"; ARTHRALGIA (non-serious), BONE PAIN (non-serious) all with onset 16Jan2022, outcome "not recovered" and all described as "Booster dose: Has pretty severe pain in right shoulder and clavicle"; CONDITION AGGRAVATED (non-serious) with onset 15Jan2022, outcome "not recovered", described as "The whelp is red around it and is worsening".  No follow-up attempts are possible. No further information is expected.
Immediate raised wheals with erythema around injection sites. Diphenhydramine HCl 12.5mg/5ml given orally.
05/08/2022 Vaccination; 05/17/2022-05/30/2022 Traveled; 06/02/2022 Woke up extremely ill. COVID+ (@home test) *still testing COVID+ but very Asymptomatic.
pt recv vax NOV95&21FEB96 pt devel painful,blistering lesions on rt shoulder,arm,& hand;also had a patch of blisters on the rt-center of back;seen by MD&dx w/shingles;tx included acyclovir;
drug allergy: Pneumovax; This spontaneous report was received from a nurse via Pfizer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis. (strength, formulation, dose number, anatomical location vaccination, lot number and expiration date were not provided).       On an unspecified date, the patient experienced a drug allergy to vaccine, polyvalent (23-valent) (PNEUMOVAX23) (drug hypersensitivity). At the time of this report, the outcome of event drug hypersensitivity was unknown.  The causality assessment of the reported event drug hypersensitivity was considered to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).; Sender's Comments:  US-PFIZERINC-2019343499 :
No symptoms reported.; Improper storage of product in use (as per label); This spontaneous report was received from pharmacist and refers to a 17-year-old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, drug reactions, or allergies, and concomitant medications was not provided.  On 13-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter (mL) /once, lot number W0252273 with (expiration date of 02-JUN-2023), but upon internal validation established as W025273 with an (expiry date of 10-AUG-2024) (conflicting information as it was reported that the product was expired)) administered for prophylaxis (route of administration and anatomical location were not provided)( product storage error). The administered dose of the vaccine had experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023. It was not reported if the information was obtained from the data logger or not. There was no adverse effect reported. On 29-JUN-2023, it was confirmed from a nurse that the lot number for varicella virus vaccine live (oka/merck) (VARIVAX) was as W025273, upon internal validation, expiration date was established as 10-AUG-2024.  This is one of several reports received from the same reporter.
cannot afford second dose; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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 details were provided as follows: The patient's relative reported the case. The age at vaccination was not applicable for this report. The reporter stated that, the patient got the 1st dose of Shingrix without any charge.  When the patient went to get her second shot, she could not afford the vaccine charge as she had no script coverage. Till the time of reporting, the patient might have not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAREs details pertains to 1st dose of Shingrix. GSK note- From the reported information, it is not clear if patient had exceeded time interval to receive the 2nd dose of Shingrix or not and also contact to reporter was also not possible. Therefore, by considering worst case approach, the case is considered for incomplete course of vaccination.
This child had swelling below injection site to the knee. Tender to touch, slightly red, warm to touch. Patient walking and playing with out complaints.
Patients arm was very tender around site of injection, injection area was bright red and hot, about an inch diameter. Sore/tender for about 4 days after she noticed it.
Patient received COVID dose for age 6m-4 year, rather than the correct dose for 5-11y. No adverse side effects noted.
After 2nd shot, got sick for a day; felt crummy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 2, single (Lot number: ER8731) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 2000 (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Tendon on right wrist", start date: 2020 (unspecified if ongoing); "Fall", start date: 2020 (unspecified if ongoing), notes: Two falls in 2020; "Tore knee", start date: 2020 (unspecified if ongoing); "Tore muscles on upper right side", start date: 2020 (unspecified if ongoing). The patient's family history included: "Pre-diabetic", start date: 2019 (unspecified if ongoing), notes: Mother's family has sugar diabetes and she was 91 and did not have it. Concomitant medication(s) included: IRON taken for anaemia. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8735; Expiration date: Unknown; Vaccination time:13:45; Anatomical location: left upper arm near shoulder), administration date: 03Apr2021, when the patient was 60-year-old, for Covid-19 immunization; Shingrex shot, for immunisation; Flu shots, for immunisation, reaction(s): "Soreness in arm". The following information was reported: ILLNESS (non-serious) with onset 24Apr2021, outcome "recovered" (25Apr2021), described as "After 2nd shot, got sick for a day"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt crummy". Therapeutic measures were not taken as a result of illness, malaise.  Additional information: The patient was also taking vitamins for anaemia. The patient had confirmed that she had anemia and was overweight, prior to getting Pfizer COVID vaccines. The patient received Shingrix shot and could not remember if it was before or after the first between the first and 2nd. Her mother got Shingles, so reporter got a Shingrix shot. There was no any other vaccine was administered on same date of Pfizer Suspect vaccine. The events did not result in emergency room or physician office visit. The patient might have received Shingrex within four weeks prior to the first administration date of the suspect vaccine. The patient had two falls and fell about 10 months ago on the same side. She was not hospitalized. She went to various doctors, but did not have to go to the hospital to stay. The patient did not have any relevant tests. The patient family history included: the patients dad died at 65 of heart attack. Mom had a rare lung disease, that she won't get because it was for skinny weight women and she won't be in that category.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201094682 same reporter/patient/product, different dose/AEs;US-PFIZER INC-202201094977 same reporter/patient/product, different dose/AEs;
Intussusception, Ileocolic: Dx 7/1/19 -vomiting and lethargy 7/1/19 @ PMD, sent to ER.
Left Deltoid is red, swollen, and warm to touch. Under the left arm it is red, swollen, and warm to touch.