chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the authors in a published literature article. Aim of this retrospective study was to determine sufficient clinical response to measles vaccine in at-risk population (e.g. healthcare workers). Measles vaccine is given as part of MMR vaccine series in 2 separate doses, achieving approximately 95-99% seroconversion rate. Methods: retrospective chart review was performed on authors hospital center employees identified as having negative measles titers, despite repeated vaccination with MMR. Results: three healthcare workers were identified with negative titers to measles during pre-employment laboratory analysis. All three cases had normal white blood cell counts differential (mean WBC counts 6.1 K/uL), negative hepatitis panel and positive Hepatitis B antibody (HepBs Ab) titers. Two cases were female employees who each received a total of 4 MMR doses, with the last doses given on December 2012 and February 2014, respectively. Their MMR titers were respectively measured on April 2015 and August 2014, showing positive mumps and rubella IgG titers yet negative measles IgG. The third case involved a male employee who received a total of 6 doses of MMR, with the last dose given on December 2013. His MMR titers were measured on May 2014, similarly showing positive mumps and rubella IgG titers; however, measles IgG titer was equivocal-with negative repeat measles IgG on June 2014. His serum CD3/CD4/CD8/B & T cell counts were normal. There was no history of immunodeficiency or recurrent infections in all three cases. This case refers to a female patient of unknown age. The patient had no history of immunodeficiency or recurrent infections. The patient had normal white blood cell counts differential, negative hepatitis panel and positive hepatitis B antibody (HepBs Ab) titers (unspecified tests performed on unspecified dates). On an unspecified date in December 2012, the patient was vaccinated with fourth dose of MMR (manufacturer unknown) (strength, lot#, dosage and route unspecified). On an unspecified date in April 2015, measles, mumps, and rubella (MMR) titers were measured with the results showed positive mumps and rubella IgG titers yet negative measles IgG. Vaccination failure was reported. The outcome of the events were unknown. The authors considered the events to be related to the suspect therapy MMR (manufacturer unknown). This report is linked to MARRS #1603USA004010 and #1603USA004011 (same literature link). Additional information has been requested.
Vaccine placement too high, near shoulder joint. Patient experiencing "zing" of pain with certain ROM movements.
On 5/31/00, the infant developed twitching of one leg. She was seen in the ER on 6/5/00 for a full-blown seizure. While in the ER, she experienced 2 additional seizures which lasted 15 minutes. The infant was admitted to the hospital. The neurologist indicated that the pt experienced focal seizures. The infant was discharged after 2 to 3 days.  Follow-up dated 7/10/00 stated that a second EEG in June 2000 revealed hypsarrythmias. A dx of infantile spasm was identified. The pt remains on phenobarbital and was recently started on ACTH. Follow-up info was received from the reporter on 04/02/2002, stating that the initial infantile spasms seemed to have resolved with ACTH treatment; however, the child continues to have simple seizures and significant motor developmental and speech delay. She remains on chronic seiaure medication. The reporter indicated tha tthe pt partially recovered. This event is considered medicaly important.
SEVERE STOMACH CRAMPS/SHARP PAIN; SEVERE FLUSHING ON EAR, FACE AND CHEST; HIVES; SCRATCHY THROAT; SWELLING ON GROIN AREA; NODULES ON INJECTION SITE; NUMB TONGUE; BUMPS AND RASH ALL OVER HER BODY; DIARRHEA; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mast-cell activation syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 10-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAR-2021 30 min after vaccination the patient experienced severe stomach cramps/sharp pain. On 10-MAR-2021, 4 hours after vaccination the subject experienced multiple symptoms like severe flushing on ear, face, and chest. hives, bumps, and rash all over her body, scratchy throat, diarrhea, swelling on groin area, nodules on injection site and numb tongue. The patient was expecting to have these side effects since she has mast-cell activation syndrome an took Benadryl which seemed to help, and she did not go to emergency room (ER). The patient would follow up with her PCP.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramps/sharp pain, severe flushing on ear, face and chest, hives, scratchy throat, swelling on groin area, nodules on injection site, bumps and rash all over her body, and diarrhea on 10-MAR-2021, and the outcome of numb tongue was not reported. This report was non-serious.; Sender's Comments: MAC- MAC not required per standard procedure as the case assessed as non-serious.
I had a chest flutter and chest tightness four hours after the vaccine. This lasted for about 5 seconds. Two days later I had extreme fatigue and low body temperature. The chest flutter came back for short durations multiple times. I went to urgent care and my EKG was normal. That evening 12/8/2021 I went to the emergency room. Through blood work they found that my creatinine level was 1.8 and I had acute kidney injury. They did more imaging and gave me three bags of IV. I stayed in the hospital over night for the kidney issue. I also had a urinalysis, COVID test, and additional creatinine test at the hospital. My creatinine had lowered at the hospital. I did not receive any medications, just the saline solution from the IV bags. Since leaving the hospital I have had continued chest tightness although it is better than it was. The doctors believe this was an immune response to the vaccine.
Shingles - left arm palm and fingers; pain in left shoulder and neck; pain in left shoulder and neck; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN5318, Expiration date: not reported), via an unspecified route of administration in arm left on 02Feb2021 at 15:00 (at the age of 74-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was reported as unknown. The patient had any known allergies were reported as unknown. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL1283, Expiration date: not reported), via an unspecified route of administration in arm right on 12Jan2021 (at the age of 74-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. Covid prior vaccination and Covid tested post vaccination was reported as unknown. On 06Feb2021, the patient experienced pain in left shoulder and neck, then went to emergency room on 13Feb2021 and diagnosed with Shingles - left arm palm and fingers. The AE resulted in emergency room/department or urgent care. Treatment was received for the events and treatment medications included valtrex, prednisone, gabapentin. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Symptoms begun at 7:00 pm: slight fever and queasy stomach. 8:00pm: felt inordinately cold, additional clothing was put on.  9:00 pm: chills and fever elevated more.  10:00 pm: shivering, soreness where shot was given, eyes were red and filmed over.  11:00 pm: took temperature, read 101, normal temp is 97.8, took two Tylenols and within five minutes heaved stomach contents, then retired to bed.  3:00 am: awoke to still high fever (101.3), again took two Tylenols and returned to bed.  8:30 am: awoke to reduced temp of 99.8, aching muscles in upper body, soreness where shot was given and red eyes. 10:00 am:  feeling better, expect all symptoms to pass okay.
Arm pain,soreness and tenderness still ongoing Extreme headache- lasted 3 days the first night the most severe Fever- lasted one day Chills- first evening lasted all thru the evening Hydrated and self medicated with Tylenol
short term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID:   An 82-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), at 11 mg daily. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMNESIA (non-serious) with onset Aug2022, outcome "unknown", described as "short term memory loss". The action taken for tofacitinib citrate was unknown.  Additional information: The patient wanted to know if Xeljanz and Pfizer Covid vaccine could potentially cause short term memory loss, whether individually or together. Patient has been suffering short term memory loss since Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a Nurse Practitioner concerning a 15 year old female with a recent upper respiratory tract infection and irritable bowel syndrome, a history of migraine, allergies to NIACIN and ZOMIG, who on 19-FEB-2008 was vaccinated intramuscularly with a dose of GARDASIL, (Lot # 659653/1448U). Concomitant therapy included TOPAMAX. A few minutes after the vaccination, the patient experienced nausea, general malaise and body aches. Laboratory diagnostic studies included creatine kinase and complete blood count, both within normal ranges. The symptoms have continued to the present. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
RASH ON BILATERAL LEGS,  FEET, ARMS, AND HANDS. ITCHING SYSTEMATICALLY. THE RASH SHOWED UP THE NEXT MORNING. WOKE UP WITH THE RASH.  I HAVE USED HYDROCORTISONE CREAM AND TAKING ANTIHISTAMIES
40 minutes after receiving the vaccine I experienced hives, tachycardia, facial and throat swelling. Treated onsite at the vaccination event with benedryl, taken to emergency room via ambulance and received an IV of Pepcid.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 06-JAN-2015, the patient was vaccinated with an improperly stored GARDASIL (lot # K004204, expiry date 12-JAN-2017) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
10/31/08 5pm c/o sore right armpit, took ibuprofen 800mg,11/1/08 3pm injection site size of a quarter, fever & chills, temp 101 degree: 11/2/08 injection site size of palm of hand taking ibuprofen q 4 hr; 11/3/08 injection site measured by PHN 18.5cm wide, 15 cm long, temp 98.7; resolved by 11/10/08
Not self; Warm to touch at the site of the injection; Mild swelling at the site of the injection; Fatigue; Tiredness; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self.  The patient's medical history was not provided. Concomitant medications reported were apixaban, metoprolol for drug use for unknown indication.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the events mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self.Consent granted for safety to follow up  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, mild swelling at the site of the injection, warm to touch at the site of the injection, fatigue, tiredness, not self was unknown.
patient was administered 1 ml of Moderna Covid Vaccine, dose is 0.5 ml, no known s/s
Shooting back pain; Chest pains; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 18:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 19:30, the patient experienced shooting back pain, chest pains and difficulty breathing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shooting back pain, chest pains and difficulty breathing was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in and requested to receive Pfizer bivalent booster. Upon order entry patient stated that when I get the vaccines I take my inhaler after but I forgot it today. Patient stated after receiving all three doses of the covid vaccine she felt a little short of breath but it went away after she used her inhaler. Allergist was notified of situation and suggested to watch her for 30 minutes after vaccination to observe for any reaction. 1703 patient was adminstered Pfizer Bivalent booster and at 1720 patient requested to use inhaler. Patient puffed 6 puffs and was monitored for 10 minutes without improvement. Upon visualization of the throat the throat was patent patient was AxOx4 speaking in full complete sentences. Patient skin was dry and warm to the touch. At 1745 patient was given IM Benadryl and Allergist was notified of situation. Patient stated she feels like she is getting better after IM Benadryl at 1755, Dr. requested ordered to monitor patient for another 30 minutes; if SOB worsens administer IM EPI and send to the ED, if patient states shes getting better she can be sent home. After 30 minutes of monitoring patient is AxOx4 speaking in full complete sentences with no SOB and in no acute distress. Patient was educated that if any S/S such as difficulty swallowing,  uncontrollable coughing, worsening SOB to immediately go to the ER. Patient stated "I feel better my tongue and tonsils feel way better after the Benadryl I feel like I am good to go home." Patient ambulated with strong and steady gait out of vaccine clinic accompanied with husband and 2 kids at 1828.
five minutes after vaccine was received patient lost consciousness and fell out of his chair.   It is unclear if the patient hit his head or shoulder against the wall, but patient was talkative and responsive and did not want to call an emt.  The patient did call his mom to have her drive him home as a precation. The patient was given water, asked to lie down.   After about 10 minutes the patient stated he felt normal.
I felt sudden pain and said to my family ?I feel like a vein is going to pop in my foot.?  Then within seconds a blood vessel burst in my foot.  It swelled up, and I couldn?t walk on it and bruised.  I have inconsistent feeling in the tips of three of my toes.
Day 1, 09/17/01, at approximately 11:40 spiked fever of 102 - 103 at 1 pm a little fussy, decreased appetite; sites fine. Day 2, 09/18/01 - Still temp 102 - 103 for 24 hours fussy, decreased appetite. Day 3, 09/19/01, temp 102 - 103, crying non-stop, Not eating, not sleeping. Admitted to the hospital for a septic work-up. Labs normal. Crying ceased 09/20/01. Fever ceased 09/19/01 in the AM. Appetite returned 09/21/01. Discharged on 09/21/01 at 8 am. Discharge Summary Diagnosis is Fever resolved, irritability resolved, above most likely due to immunization reaction.
Experienced swelling in my throat and hives all over my body.  Body aches and fever up to 103 degrees.  I took 2 benadryl tabs at the time of my vaccine.  After the hives started, I took more benadryl, tylenol and albuterol inhaler.
adult patient was accidentally given a pediatric dose of Engerix-b; adult patient was accidentally given a pediatric dose of Engerix-b; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 16-MAY-2023, the patient received Engerix B pediatric. On 16-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-b) and adult use of a child product (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-b). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter wished to know how to proceed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt exhibited rash on both arms, that  he noticed after 15 min wait, observed pt, rash itch worsened, 50 mg benadryl chewed, within minutes pt complained of facial and mouth numbness/tingling, then a couple minutes later difficulty swallowing. 911 called, 1 dose epipen administered in right thigh. mother did not wait on 911, took son to ER. mother Chambree called to say pt was fine.
extreme shortness of breath; chest pressure; fatigue; sensation of heaviness in my legs; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 71-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration in Arm Left on 27Feb2021 10:00 (age at the time of vaccination 71-years-old), as a single dose for COVID-19 immunization. The patient's medical history included allergy with narcotics. The patient's concomitant medications included Ropinerole 1mg, and Olmesartin 10mg. The patient previously took first dose of BNT162B2 vaccine, on 06Feb2021 11:30 (age at the time of vaccination 71-years-old), as a single dose for COVID-19 immunization and experienced shortness of breath. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 08Mar2021 11:30, the patient experienced extreme shortness of breath, chest pressure, fatigue, and sensation of heaviness in my legs. The adverse event result in emergency room/department or urgent care. No treatment was received for the adverse event. The outcome for all the events was recovering.  No follow-up attempts are needed. No further information is expected.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) :  Same reporter, patient/ similar events/ different dose;US-PFIZER INC-2021304348 Same reporter, patient/ similar events/ different dose
tested positive for COVID; fever; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional. An 81-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 20Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced fever, and was taken to hospital for a different issue and subsequently tested positive for COVID. The adverse event resulted in emergency room/department or urgent care and hospitalization. It was unknown if other vaccines received in four weeks. It was unknown that patient received treatment for adverse event. No covid prior vaccination. Covid was tested post vaccination in Feb2021. The outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Moderna vaccine was administered outside of office- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/19/2022 ADJUSTMENT DISORDER W ANXIETY
4 year old otherwise healthy girl, who was in her usual state of health until 5 days following MMR vaccine, developped acute hemolysis with autoimmune findings of direct coombs test, positive C3, negative IgG.
Low-grade fever, feeling of being flushed, dizziness, headache, general malaise - came on the morning after the vaccine. Symptoms lasted approximately 4 hours although the malaise/fatigue lasted the rest of the day
A rash started yesterday evening with redness and itching on the left shoulder blade. Resolved later in the evening. This evening my left deltoid became itchy, swollen with a red rash.  So far I have not taken any medication for the rash. I did have diarrhea and nausea yesterday morning and again this morning with continued lower abdomen pain. I have not taken any medicine for diarrhea or nausea.