chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's assistant concerning a 34 year old female who on 19-SEP-2006 was vaccinated SC with a dose mumps virus live (Jeryl Lynn) (lot # 650394/1113R). There was no concomitant medication. On 26-SEP-2006 the patient developed numbness of her tongue and eye twitching. Unspecified medical attention was sought, there were no lab diagnostics. At the time of the report, the patient had not recovered. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Tinnitus within 90 minutes of receiving vaccine. Lasted 3 days. Soreness at injection site. Lasted 4 days. Pain and decreased range of motion in left shoulder joint. Ongoing.
unsure if shingles rash; Rash along their torso; Rash along their torso; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received Shingrix (intramuscular). In September 2019, less than a week after receiving Shingrix, the patient experienced shingles, rash and injection site rash. On an unknown date, the outcome of the shingles, rash and injection site rash were unknown.   It was unknown if the reporter considered the shingles, rash and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient received Shingrix and developed a rash at the injection site and along their torso (unsure if shingles rash). No details were regarding lot or expiration date, onset and duration of rash, administrator of vaccine, location of administration available at this time. The reporter consented to follow up.
10MAR98 pt aunt states pt recv vax 27FEB98 & c/o sore throat, enlarged glands neck, dizzy & nausea;advised to have pt eval by MD;dx strep throat;
no additional adverse events; A patient in their clinic was inadvertently administered an expired dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 10-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 2 milliliter, oral, lot number 1660994, expiration date 01-MAY-2021 for prophylaxis. The vaccine had not undergone any temperature excursion. No adverse event was reported.
100 deg F fever; Joints aching severely; Headache; Slight loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and acid reflux. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC) and ethinylestradio/norgestimate (TRI-CYCLEN LO) and bupropion hydrochloride(WELLBUTRIN); all taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously 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 04Apr2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 03:00, the patient experienced 100 degrees Fahrenheit fever, joints aching severely, headache and slight loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 26Apr2021, the patient underwent body temperature and the result was 100 degrees Fahrenheit. The clinical outcome of the events 100 degrees Fahrenheit fever, joints aching severely, headache and slight loss of appetite was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started with vomiting and abdomen pain. Taken to hospital and admitted on 12/11/09 with diagnosis of pancreatitis of unknown etiology and dischaged 12/15/09 without problems.
chills; fatigue; The injection was also red; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced chills, fatigue and injection site erythema. On an unknown date, the outcome of the chills, fatigue and injection site erythema were recovering/resolving.   It was unknown if the reporter considered the chills, fatigue and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient had the 1st dose on either 15th October 2019 or 16th October 2019. The patient experienced chills and fatigue for a few days and the injection site was also red for a few days. The reporter did not consent to follow up.
MUSCLE PAIN, FEVER, JOINT PAIN, BONE PAIN, MORNING RIGIDITY, INVOLUNTARY MOVEMENTS IN THE FINGERS, UNBALANCE, PAIN IN THE RIGHT EYE. THREE MONTHS AFTER POSITIVE LABORATORY RESULTS; ANA TEST POSITIVE.. ANTI RNP POSITIVE. SMOOTH MUSCLE AP POSITIVE. SED RATE POSITIVE.
Information has been received from a 61 year old female with no medical history and no drug reaction or allergies who on 22-JUL-2010 was vaccinated injection with ZOSTAVAX (Merck). Concomitant therapy included LIPITOR. The patient was experiencing pain, warmth and headaches after receiving the ZOSTAVAX (Merck) and had persisted for 10 to 20 weeks. At the time of reporting, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Redness in the stomach,red spot in left abdominal zone,redness growing; pain in the red spots; the red spots are itching and expanding; flu like symptoms; A spontaneous report was received from a consumer concerning a female patient of 86 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced event(s) Redness in the stomach,pain,itchiness,redness is growing, Red spots in the left abdominal zone, Itching in the red spots, Pain in the red spots, Red spots expanding and Flu like symptoms.  The patients medical history ,as provided by the reporter included hypertension.Concomitant medications reported included METROPROLOL 50 mg two times a day for hypertension,SATUTEN and AMLODIPINE,used for unknown indication.  On 12 jan 2021,at 2 pm, prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 026L20A ) vaccine through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 12 jan 2021,patient experienced redness in her stomach, pain and itchiness. The redness was growing. Patient remained in the facility for 20 minutes to look after any allergic reaction. The patient left the facility ok. When arrived home,approximately 40 minutes after receiving the vaccine, patient noticed red spots in the left abdominal zone, starting under her breast and expanding to the ribs. This red spots are itching and expanding since then. The patient is also experienced pain in the spots and "flu-like"symptoms. Treatment for the event included Amphetamine C and an antihistaminic to treat the symptoms but on her own behalf.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  the outcome of the event(s) Redness in the stomach,pain,itchiness,redness is growing, Red spots in the left abdominal zone, Itching in the red spots, Pain in the red spots, Red spots expanding and Flu like symptoms was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2nd Gardasil dose given 1 year after first dose.  Dosing not according to schedule.  Consider 10/10/2011 dose as first dose as discussed with Merck representative and VFC program representative.
Since vaccination pt. reports left arm pain travelling to her fingertips. Patient states area of injection is swollen, tender, not red but a little hot to touch.
No signs/symptoms at this time. We mistakenly administered the bivalent vaccine when they were actually in for their very first dose of COVID vaccine and should have received the original.
on the next day after the vaccine, he began to have a fever up to.  102 Fahrenheit rash spreads to this day throughout the body with itching, the child also has strange behavior, fatigue.  the attending physician denies us an appointment and tells us to call 911.
body aches; full body chills; temp of 100.1; moderate headache; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (lot number unknown), via an unspecified route of administration in right arm, on 09Jan2021 08:00 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19.  No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient experienced body aches, full body chills, temp of 100.1 and moderate headache on 09Jan2021 10:00 PM. Treatment was received for the events included Tylenol, ibuprofen. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
102F fever, body aches, fussiness, rash, and excessive crying for 4 days. Also, gave a friend the chicken pox 6 days after vaccination.
COVID-19; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19, and suspected clinical vaccination failure. On an unspecified date, the patient died from covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210950686, 20210950658 and 20210950539.; Sender's Comments: V0: 20210950479- COVID-19 VACCINE AD26.COV2.S-  covid-19 - This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210950479-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID-19
pt recv vax & exp fevers & arthralgias which lasted through the third day post vax & were untreated;sx then resolved;
Child received vaccines on 10/25/04. On 10/27 she noticed that he was scratching his left arm. On exam left outer upper arm (deltoid area) was warm and indurated surrounding a pinpoint puncture (from vaccine) approximately 2.5x1.5 inches.
I?m due in July 2021 and also breastfeeding. One week after the shot which is today my arm has broken out in hive like bumps all around the injection site with a larger bump directly where the shot went. My skin is raised with a large lump underneath. It?s very itchy, but not painful at this time.
2 hours after the injection I began to feel "off" a weird feeling ,went home and had a lay down. I felt drunk, that lasted abut 4 hrs then woke up Saturday and felt ok until 5:00 pm then I had to lay down and slept 2 hrs just felt tired at 10:00 pm my legs started hurting really bad, bad enough that I started crying because of the pain . have been taking Ibuprofen every 6 hrs woke up on Sunday still with leg pains and lower back slept off and on all day Sunday. Around 7:00 pm on Sunday the pain shifted to my left leg, lt arm and lt side of back. Today is Monday 11-15-2021 and I am at work it's 9:15 AM still with lt arm,back and lt leg pain discomfort, weakness feeling. Took last dose of ibuprofen at 8:15 Am today.
Headache; fever; shaking; dizziness; body ache; stomach cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 12:45 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADDERALL. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "fever"; TREMOR (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "shaking"; DIZZINESS (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "dizziness"; PAIN (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "body ache"; ABDOMINAL PAIN UPPER (non-serious) with onset 28Nov2021 08:15, outcome "not recovered", described as "stomach cramps". Therapeutic measures were not taken as a result of headache, pyrexia, tremor, dizziness, pain, abdominal pain upper.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Positive covid test. Nasal congestion and loss of smell and taste. 4 weeks postpartum.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 24-month-old male. Neither the patient's medical history nor the concomitant medications were reported. The reporter indicated that she was not sure whether the patient received FLUMIST IV or not. The product expired on 18-Dec-2011. On 19-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of two years to 59 months of age. Additional information was obtained on 30-Jan-2012: the reporter stated that the patient did not experience any late occurring adverse events.
Covid monitoring documentation. PT admitted 12/16/21 documented to have positive covid. PT received 1st dose Janssen 3/15/21 Lot 1805018.
Varicella-like rash from varicella vaccine. Vesicles (fluid-filled) which crust over in a few days.
Patient reports injection site reaction of the left arm, below the site of injection. symptoms included: redness, swelling, warm to the touch and a hardness in the area of discomfort. the pain subsided over the next few days, but the redness remained when she came to the pharmacy to discuss the reaction.
After leaving vaccination clinic, pt return to report neck stiffness, lightheadedness, generalized weakness. Pt went to ED, denied any shortness of breath, chest pain, back pain, difficulty swallowing, voice changes,  nausea, vomiting, abdominal pain.  No  previous history of reactions to vaccines. Pt observed, symptoms resolved. Believe vasovagal response to getting vaccine and discharged to home. Pt did receive 2nd dose of vaccine on 06/17/2021 without incident
Large area of arm Swelling, redness, discomfort, liquid filled blisters with clear fluids, then irritation reduced and then skin started to flake. Patient came to see me on 09/11/2017 and skin was flaking around injection site.
On 5/5/08 fever to 105 with ? seizure, shaking of arms and legs as well as blue around the mouth.  He did have a post ictal state for 30 minutes post episode.
Patient received a Pfizer Monovalent booster instead of a bivalent booster. Patient has been notified of the vaccine administration error.
Within 10 minutes of vax, the pt experienced a 2" red area and hives.
did get Omicron after being vaccinated; did get Omicron after being vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (173415; 176414). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "did get Omicron after being vaccinated".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200458084 same patient/drug, different dose/event
Itchy, erythematous nausea/vomiting/wheezing.  Temperature 100 ER.  Epi loaded.  Patient refused the injection (got better) 1/12/10 follow up ; itchy eyes, throat irritaion,
This 10 year old male received the first dose of the oral typhoid vaccine on 06/05/2004 before noon, after 10:00 pm he experienced fever and nausea/ vomiting for one day. He completely recovered.
Evening of first dose I had a 102.5 fever,  chills,  body aches and headache. The next day still ran a fever,  body acts, chills and fatigue.  The second evening fever of 103.5 same other symptoms.  Woke up in the middle of the night drenched in sweat,  fever spiked. The next morning (3rd day) fever was low grade and I felt better but tired.
Severe abdominal cramping lasting for approximately 1 hour with 3 event occurrences. Still getting cramping events. Both hands and forearms have a constant tingling and burning sensations.
contracting pneumonia/the causative agent was the "Achromobacter xylosidans"; contracting pneumonia/the causative agent was the "Achromobacter xylosidans"; can't hardly breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization), ACHROMOBACTER INFECTION (hospitalization), outcome "unknown" and all described as "contracting pneumonia/the causative agent was the "Achromobacter xylosidans""; DYSPNOEA (non-serious), outcome "unknown", described as "can't hardly breathe". Events details: Caller is a patient. Caller said that she got Prevnar 13 and Prevnar 20 but still end up contracting pneumonia twice and they found a rare bacterium. Caller said that the bacteria they found was the "Achromobacter xylosidans sub specie" which was a blood resistant, and usually caused cystic fibrosis. Caller stated that she got pneumonia 1 year and 4 months ago, and was hospitalized for 9 and a half days, year later she contracted pneumonia again, they found that on her both Pneumonia the causative agent was the "Achromobacter xylosidans". Caller said that she is now considered as "colonizer", no cystic fibrosis, can't hardly breathe. Caller asked the reason why she got contracted pneumonia even though she got the Prevnar 13 and Prevnar 20.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300160117 same patient/AE, different drug;
Patient had already had Covid-19 and had been recovered for 12+ months.  Regular screening showed that patient was still positive for Covid-19 antibodies.  About 2 weeks after vaccination patient did notice some abnormal fatigue and head aches, blood pressure became high and uncontrolled with normal medication for several weeks.  at this time patient had Semiquantitative Covid Antibody test and found to have High antibody level  >2500.  Patient consulted with Primary care Physician, and was told to closely monitor  BP for next several weeks and return for follow-up.  Over this time BP was monitored and has been been inconsistent even with medication.  Also over this time patient has still had abnormal fatigue and continuing onsets of random joint and muscle pain  despite no significant change in activity or any injury or trauma.  During follow-up with  PA , BP medication Dosage was increased, Steroid pack prescribed to address the joint and muscle pain and patient has been referred to a Cardiologist for Echo and further evaluation.
Developed Poly Myalgae Rheumatica muscles got so weak unable to get out of bed, walk, pick up anything heavy.   Was on Prednisone starting in May of 2022 20mg.  Had to decrease dosage until one mg.  That lasted until 1/31/2023.  Been off for 2 days and body not doing well.  Been healthy all of my life.  Still bowl twice a week.  Was unable to throw horseshoe 30 feet in Spring of 2022 and barely able to walk when I finished games
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. On 03-OCT-2014, the patient was vaccinated with PNEUMOVAX 23 (vial, lot #: J004332, intramuscular, dose, anatomical location not reported) that had expired on 26-SEP-2014. Concomitant medications were not reported. No known adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
PT. was vaccinated on 3/08/2021, tested + 08/24/2021.
Case number PHEH2016US023357, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 45 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.